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analytical<br />
<strong>Tech</strong>nical <strong>Transfer</strong><br />
package<br />
A complete analytical package to validate Chematic Formulated<br />
Detergents as part of your high performance equipment cleaning.<br />
D<br />
BER
DELIVERING & SUPPORTING<br />
ANALYTICAL CLEANING VALIDATION RESULTS<br />
WITH THE TECH DATA PACKAGE<br />
Thank you for selecting Dober’s Chematic Formulated Detergent as your go-to<br />
choice for high performance equipment cleaning. We understand that getting<br />
to a validated state is critical. We also understand the time and added expense<br />
associated with the analytical work, which must happen to validate that your<br />
cleaning detergent is entirely removed from your processing equipment before<br />
production, is of the utmost importance in achieving operational efficiency.<br />
Rather than be burdened with contracting out this analytical work, we provide<br />
our customers with everything (yes, everything) you need to achieve validation<br />
for our formulated detergents.<br />
We provide an entire analytical technical transfer package with all<br />
documentation including:<br />
• Toxicology Data (ADE Values)<br />
• Chemical & Physical Data<br />
• Validated Test Methods<br />
• <strong>Transfer</strong> of Analytical Procedures<br />
• <strong>Tech</strong>nical & Validation Support<br />
with approved NDA/CDA<br />
1 2 3<br />
Test Method<br />
Development<br />
Test Method<br />
Validation<br />
<strong>Transfer</strong> of<br />
Analytical Procedures<br />
2 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
Table of contents<br />
1<br />
Toxicology Data<br />
• ADE<br />
• LD50 & Composition<br />
2<br />
Chemical & Physical Data<br />
• Product <strong>Tech</strong>nical Data Sheet<br />
• Conductivity<br />
• pH<br />
• TOC Curve<br />
• Material Compatibility<br />
• Cloud Point<br />
3<br />
Validated Test Methods<br />
• HPLC<br />
• Detection ELSD or UV/VIS<br />
- Last to Leave<br />
- Analytical Standard<br />
• TOC<br />
4<br />
<strong>Transfer</strong> of Analytical Procedure (TAP)<br />
• Comparative Testing<br />
• Pre-approved <strong>Transfer</strong> Protocol<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 3
1 Toxicology Data<br />
CHEMATIC CLEANER ADE MONOGRAPH<br />
SAMPLE<br />
4 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
1 Toxicology Data<br />
CHEMATIC CLEANER ADE AND LD50 VALUES<br />
Ingredient<br />
(common name)<br />
CONFIDENTIAL & PROPRIETARY<br />
Chematic ® Cleaner<br />
Confidential Chemical Formula<br />
Accepted Daily Exposure (ADE): xxx mg/Day *<br />
Weight<br />
Percentage<br />
LD50, oral,<br />
rats, mg/kg<br />
CAS registry<br />
Nos.<br />
DI Water 83.00 GRAS xxxx-xx-x<br />
Chematic Ingredient 2 0.50 >xxxx xxxxx-xx-x<br />
Chematic Ingredient 3 1.00 xxxx xxxxxx-xx-x<br />
Chematic Ingredient 4 2.00 >xxx Proprietary<br />
Chematic Ingredient 5 3.00 xxx xxxx-xx-x<br />
Chematic Ingredient 6 4.00 >xxxx xxxxx-xx-x<br />
Chematic Ingredient 7 0.50 xxxx xxxxxx-xx-x<br />
Chematic Ingredient 8 1.00 >xxx Proprietary<br />
SAMPLE<br />
Chematic Ingredient 9 2.00 xxx xxxx-xx-x<br />
Chematic Ingredient 10 3.00 xxx xxxxx-xx-x<br />
*Affygility Solutions, LLC (Toxicology Group)<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 5
1 Toxicology Data<br />
CHEMATIC CLEANER THEORETICAL TOC<br />
CONFIDENTIAL & PROPRIETARY<br />
Chematic ® Cleaner<br />
Confidential Chemical Formula<br />
Ingredient<br />
(common name)<br />
Weight<br />
Percentage<br />
Percent<br />
Theoretical<br />
TOC<br />
CAS registry<br />
Nos.<br />
Water 63.0 0.00 xxxx-xx-x<br />
Ingredient 2 10.0 3.45 xxxx-xx-x<br />
Ingredient 3 7.0 1.24 xxxx-xx-x<br />
Ingredient 4 6.0 1.67 xxxx-xx-x<br />
Ingredient 5 5.0 0.59 xxxx-xx-x<br />
Ingredient 6 3.0 0.00 xxxx-xx-x<br />
Ingredient 7 2.0 0.37 xxxx-xx-x<br />
Ingredient 8 1.5 1.05 xxxx-xx-x<br />
Ingredient 9 1.5 0.75 xxxx-xx-x<br />
SAMPLE<br />
Ingredient 10 1.00 0.63 xxxx-xx-x<br />
Total Theoretical TOC 9.73%<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
6 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
www.dober.com
2 Chemical & Physical Data<br />
CHEMATIC TECH DATA SHEET<br />
®<br />
DESCRIPTIONChematic 1<br />
Chematic® 1 is a highly concentrated liquid cleaner ideally suited for CIP, COP,<br />
spray, and high pressure cleaning of processing equipment found in pharmaceutical,<br />
biopharmaceutical, cosmetics, and food facilities. A proprietary combination of<br />
chelating agents and surfactants enables Chematic® 1 to remove a wide variety of<br />
soils while remaining effective in hard water. Chematic® 1 is free rinsing and<br />
phosphate-free.<br />
PHYSICAL PROPERTIES<br />
Physical Form<br />
Appearance<br />
pH Use Solution<br />
Liquid<br />
>11.0<br />
SUBSTRATE COMPATIBILITY<br />
Product is safe on stainless steel, glass and<br />
most plastics and polymers.<br />
Product should be thoroughly rinsed off surfaces.<br />
Not recommended for soft metals.<br />
Precautionary Statement: Please refer to the current<br />
Material Safety Data Sheet.<br />
AVAILABLE IN<br />
20 L /<br />
209 L /<br />
5 gal 55 gal<br />
FOR ADDITIONAL INFORMATION,<br />
CONTACT CHEMATIC AT:<br />
630.410.7300<br />
chematic@dober.com<br />
www.dober.com<br />
Colorless to Light Straw<br />
1020 L /<br />
270 gal<br />
Specific Gravity at 68˚F<br />
Foaming<br />
Typical Storage Temperature<br />
Low Foaming @ Use Temperature<br />
CLEANING VALIDATION SUPPORT<br />
HPLC, TOC and other methods are provided by Dober.<br />
Validation consulting support ranging from complete project<br />
management to sampling and swabbing methodologies and<br />
assistance is available from our validation consulting group.<br />
APPLICATIONS & USAGE<br />
CIP COP Spray<br />
Concentrations from 1%-10% v/v<br />
Temperatures of 70˚C–80˚C<br />
Manual<br />
1.09-1.13<br />
40 ˚F - 100 ˚F<br />
Concentrations from 0.5%-2% v/v<br />
Temperatures of 25˚C–50˚C<br />
ALKALINE<br />
SAMPLE<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 7
2 Chemical & Physical Data<br />
CHEMATIC CLEANER HIGH LEVEL CONDUCTANCE<br />
Conductivity (mS/cm)<br />
3500.00<br />
3000.00<br />
2500.00<br />
2000.00<br />
1500.00<br />
1000.00<br />
500.00<br />
0.00<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Data Set: High Level Conductivity<br />
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used.<br />
The range of conductivity measurements taken covers typical use dilutions.<br />
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.<br />
High Level Conductivity<br />
Concentration<br />
(v/v)<br />
Conductivity<br />
0.5 % 224.40 µS / cm<br />
1 % 415.00 µS / cm<br />
2 % 776.00 µS / cm<br />
5 % 1729.00 µS / cm<br />
7 % 2302.00 µS / cm<br />
10 % 3160.00 µS / cm<br />
High Level Conductivity<br />
SAMPLE<br />
0.0 2.0 4.0 6.0 8.0 10.0 12.0<br />
Concentration (percent v/v)<br />
y = 308.44x + 123.51<br />
R² = 0.9984<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
8 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
www.dober.com
2 Chemical & Physical Data<br />
CHEMATIC CLEANER LOW LEVEL CONDUCTANCE<br />
Conductivity (µS / cm)<br />
2.50<br />
2.00<br />
1.50<br />
1.00<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Data Set: Low Level Conductivity<br />
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used. The<br />
range of conductivity measurements taken covers low level concentrations as might be found in<br />
rinsate samples.<br />
Note: The water used for rinsing will affect the conductivity values and should be taken into<br />
consideration when analyzing rinse water samples for detergent content. The data presented<br />
below is not blank corrected.<br />
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.<br />
Low Level Conductivity<br />
Concentration (v/v) Conductivity<br />
DI Water Blank 0.39 µS / cm<br />
1 ppm 0.54 µS / cm<br />
2 ppm 0.58 µS / cm<br />
5 ppm 0.62 µS / cm<br />
7 ppm 0.63 µS / cm<br />
10 ppm 0.83 µS / cm<br />
20 ppm 0.97 µS / cm<br />
25 ppm 1.07 µS / cm<br />
50 ppm 2.33 µS / cm<br />
Low Level Conductivity<br />
SAMPLE<br />
0.50 y = 0.035x + 0.4215<br />
R² = 0.9512<br />
0.00<br />
0 10 20 30 40 50 60<br />
Concentration (ppm)<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 9
2 Chemical & Physical Data<br />
CHEMATIC CLEANER PH DATA<br />
CONFIDENTIAL<br />
Product: Chematic® Cleaner<br />
Data Set: pH Data<br />
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used. The range of<br />
pH measurements taken covers typical detergent use concentrations down to very low levels, as might be<br />
found in rinsate water.<br />
Note: The water used for rinsing will affect the pH values and should be taken into consideration when<br />
analyzing rinse water samples for detergent content.<br />
The data in this table were generated using a ThermoElectron Orion 3Star pH meter.<br />
pH – Low Levels<br />
Concentration<br />
pH<br />
DI Water Blank 5.53<br />
1 ppm 5.53<br />
2 ppm 5.60<br />
5 ppm 5.91<br />
7 ppm 5.96<br />
10 ppm 6.02<br />
20 ppm 6.40<br />
25 ppm 6.63<br />
50 ppm 7.93<br />
pH – Use Dilutions<br />
Concentration<br />
pH<br />
0.5 % (v/v) 10.59<br />
1 % (v/v) 10.73<br />
2 % (v/v) 10.88<br />
5 % (v/v) 11.02<br />
7 % (v/v) 11.05<br />
10 % (v/v) 11.07<br />
Rev. 11 Apr 2016<br />
SAMPLE<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
10 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
www.dober.com
2 Chemical & Physical Data<br />
CHEMATIC CLEANER MATERIAL COMPATIBILITY REPORT 1<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Data Set: Material Compatibility<br />
The following table provides the material compatibility testing results for various elastomeric<br />
and non-elastomeric materials including stainless steel. A water bath was used to maintain a<br />
constant temperature when materials were exposed to detergents at elevated temperatures<br />
for the length of exposure listed below. Results are based on material weight data collected<br />
from three coupons and any observable changes to the material during the study are noted in<br />
the observations column<br />
Chematic® Cleaner Dilution in DI Water (v/v): None, neat<br />
Water Bath Temperature: Ambient<br />
Total Duration of Test: 3 days<br />
Materials of Average Weight Change (%)/Day<br />
Construction<br />
Day 1 Day 2 Day 3<br />
316 Stainless Steel NT NT 0.00<br />
304 Stainless Steel NT NT 0.00<br />
Hypalon 0.13 0.23 0.40<br />
EPDM 0.14 0.19 0.34<br />
Silicone 0.50 0.47 0.54<br />
Neoprene -0.34 -0.68 -0.80<br />
Viton A 0.02 0.03 0.01<br />
Buna N 0.46 0.80 1.41<br />
Viton Extreme 0.03 0.03 0.03<br />
HDPE NT NT 0.02<br />
Acetal (Derlin) NT NT 0.12<br />
PVDF (Kynar) NT NT 0.00<br />
PTFE (Teflon) NT NT 0.00<br />
Plexiglass (Acrylic) NT NT 0.19<br />
Borosilicate Glass NT NT -0.01<br />
Aluminum 319 NT NT -0.20<br />
Observations<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
SAMPLE<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
NT = Not Tested.<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material compatibility in<br />
your application. This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction.<br />
For a complete guide of Chemical Compatibility Ratings please consult the maerial manufacturer. Remember to use suitable safe guards<br />
and/or personnel protective equipment when handling chemicals.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 11
2 Chemical & Physical Data<br />
CHEMATIC CLEANER MATERIAL COMPATIBILITY REPORT 2<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Data Set: Material Compatibility<br />
The following table provides the material compatibility testing results for various elastomeric<br />
and non-elastomeric materials including stainless steel. A water bath was used to maintain a<br />
constant temperature when materials were exposed to detergents at elevated temperatures<br />
for the length of exposure listed below. Results are based on material weight data collected<br />
from three coupons and any observable changes to the material during the study are noted in<br />
the observations column.<br />
Chematic® Cleaner Dilution in DI Water (v/v): 10%<br />
Water Bath Temperature: 60˚C<br />
Total Duration of Test: 3 days<br />
Materials of Average Weight Change (%)/Day<br />
Construction<br />
Day 1 Day 2 Day 3<br />
Observations<br />
316 Stainless Steel NT NT 0.00 No changes in solution., No changes to surface<br />
304 Stainless Steel NT NT 0.00 No changes in solution., No changes to surface<br />
Hypalon 2.98 6.68 9.46 No changes in solution., No changes to surface<br />
EPDM 0.83 1.60 2.20 No changes in solution., No changes to surface<br />
Silicone 0.36 0.43 0.60 No changes in solution., No changes to surface<br />
Neoprene 0.54 0.92 1.23 No changes in solution., No changes to surface<br />
Viton A 0.22 0.41 0.44 No changes in solution., No changes to surface<br />
Buna N 2.92 4.40 4.01 No changes in solution., No changes to surface<br />
Viton Extreme 0.36 0.66 0.82 No changes in solution., No changes to surface<br />
HDPE NT NT 0.10 No changes in solution., No changes to surface<br />
Acetal (Derlin) NT NT 0.67 No changes in solution., No changes to surface<br />
PVDF (Kynar) NT NT 0.06 No changes in solution., No changes to surface<br />
PTFE (Teflon) NT NT 0.00 No changes in solution., No changes to surface<br />
Plexiglass (Acrylic) NT NT 0.76 No changes in solution., No changes to surface<br />
Borosilicate Glass NT NT -0.03 No changes in solution., No changes to surface<br />
Aluminum 319 NT NT -0.05 No changes in solution., No changes to surface<br />
NT = Not Tested.<br />
SAMPLE<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material<br />
compatibility in your application. This information, collected by Dober should be used only as a guide in selecting the<br />
appropriate materials of construction. For a complete guide of Chemical Compatibility Ratings please consult the<br />
material manufacturer. Remember to use suitable safe guards and/or personnel protective equipment when handling<br />
chemicals.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
12 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
www.dober.com
2 Chemical & Physical Data<br />
CHEMATIC CLEANER MATERIAL COMPATIBILITY REPORT H2O<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic ® Cleaner<br />
Data Set: Material Compatibility<br />
The following table provides the material compatibility testing results for various elastomeric and non-elastomeric materials<br />
including stainless steel. A water bath was used to maintain a constant temperature when materials were exposed to<br />
detergents at elevated temperatures for the length of exposure listed below. Results are based on material weight data<br />
collected from three coupons and any observable changes to the material during the study are noted in the observations<br />
column.<br />
Materials of<br />
Construction<br />
DI Water Only<br />
Water Bath Temperature: 60˚C<br />
Total Duration of Test: 3 days<br />
Average Weight Change (%)/Day<br />
Day 1 Day 2 Day 3<br />
Observations<br />
316 Stainless Steel NT NT 0.00 No changes in solution, No changes to surface<br />
304 Stainless Steel NT NT 0.00 No changes in solution, No changes to surface<br />
Hypalon NT NT 2.09 No changes in solution, No changes to surface<br />
EPDM NT NT 0.26 No changes in solution, No changes to surface<br />
Silicone NT NT -0.12 No changes in solution, No changes to surface<br />
Neoprene NT NT 0.08 No changes in solution, No changes to surface<br />
Viton A NT NT 0.00 No changes in solution, No changes to surface<br />
Buna N NT NT 0.29 No changes in solution, No changes to surface<br />
Viton Extreme NT NT 0.16 No changes in solution, No changes to surface<br />
HDPE NT NT 0.01 No changes in solution, No changes to surface<br />
Acetal (Derlin) NT NT 0.64 No changes in solution, No changes to surface<br />
PVDF (Kynar) NT NT 0.06 No changes in solution, No changes to surface<br />
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface<br />
Plexiglass (Acrylic) NT NT 0.78 No changes in solution, No changes to surface<br />
Borosilicate Glass NT NT -0.01 No changes in solution, No changes to surface<br />
Aluminum 319 NT NT 0.21 No changes in solution, No changes to surface<br />
NT = Not Tested.<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material compatibility in your<br />
application.<br />
This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction. For a complete guide<br />
of Chemical Compatibility Ratings please consult the material manufacturer. Remember to use suitable safe guards and/or personnel protective<br />
equipment when handling chemicals.<br />
SAMPLE<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 13
2 Chemical & Physical Data<br />
CHEMATIC CLEANER ACCELERATED STABILITY STUDY<br />
Real Time in<br />
Oven 1 (Days)<br />
Accelerated<br />
Age<br />
(Days)<br />
CONFIDENTIAL & PROPRIETARY<br />
Chematic ® Cleaner<br />
Accelerated Stability Study Report<br />
pH 2<br />
Specific<br />
Gravity 3<br />
Appearance<br />
0 0 11.51 1.021 Liquid, Amber, Clear<br />
4 32 11.47 1.023<br />
12 96 11.51 1.020<br />
25 200 11.48 1.022<br />
34 272 11.50 1.020<br />
46 368 11.53 1.020<br />
68 544 11.48 1.021<br />
90 720 11.46 1.021<br />
113 904 11.39 1.022<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and solution is clear.<br />
Liquid, Amber, separated but combines when<br />
mixed and becomes clear.<br />
Liquid, Dark Yellow to Light Amber, separated but<br />
combines when mixed and solution is clear.<br />
SAMPLE<br />
137 1096 11.43 1.023<br />
1. Oven Temperature is 50°C and Room Temperature is 20°C.<br />
2. Specification Range for pH: 11.00 – 11.80<br />
3. Specification Range for Specific Gravity: 1.005 – 1.035<br />
Liquid, Dark Yellow to Light Amber, separated but<br />
combines when mixed and becomes clear.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
14 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
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2 Chemical & Physical Data<br />
BSE-TSE STATEMENT<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Subject: BSE/TSE Statement<br />
Bovine Spongiform Encephalopathy (BSE)/<br />
Transmissible Spongiform Encephalopathy (TSE)<br />
The raw materials used in the production of Dober’s Chematic detergents are not of animal<br />
origin. Rather, Chematic detergents are manufactured from chemicals that are produced<br />
following organic and inorganic synthetic production routes. All products in the Chematic<br />
product line are manufactured from similarly produced chemical constituents, and no products<br />
of animal origin have been knowingly introduced to our cGMP production facility. We maintain<br />
controls over our production and raw material supplies to ensure that no new materials are<br />
introduced without prior review.<br />
Based on the raw materials in use, their sources and our production processes, there are no<br />
known or expected Bovine Spongiform Encephalopathy (BSE) / Transmissible Spongiform<br />
Encephalopathy (TSE) risks in our production facility or in its equipment or utilities.<br />
SAMPLE<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 15
By selecting Dober<br />
as your partner . . .<br />
We’ll give you everything you need to<br />
confidently transfer information to your lab and<br />
get you a step closer to achieving a validated<br />
state in your pharmaceutical, personal care or<br />
biopharmaceutical processing.<br />
Adhere to regulatory guidelines<br />
Dober performs lab testing to isolate the detergent<br />
components that are “last-to-leave” during cleaning –<br />
Achieve successful results<br />
Chematic detergents have validated analytical test<br />
methods including ADE/PDE values<br />
Train customer on how to execute transfer of analytical<br />
procedure, if needed<br />
Test method transfer protocol performed simultaneously at<br />
Dober’s lab and at customer’s lab<br />
Post test methods transfer, the customer will receive the test<br />
method, transfer data and results package as part of the<br />
<strong>Tech</strong>nical Data <strong>Package</strong><br />
Achieve validation<br />
16 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
test method<br />
validation<br />
Our testing methodology is comprehensive, proven and reliable. We achieve<br />
successful results by following a protocol with steps to ensure that you are provided<br />
with a formulated detergent that targets your specific residue and a customized<br />
cleaning process that is within your cleaning parameters. Our results are reproducible<br />
and aim to achieve industry validation.<br />
Method<br />
Development<br />
Request<br />
Develop<br />
Test Method<br />
Evaluate<br />
Method for<br />
Validation<br />
Acceptable<br />
Create Method<br />
Validation<br />
Protocol<br />
Not<br />
Acceptable<br />
Not<br />
Approved<br />
Evaluate Data<br />
from Both<br />
Analysts<br />
Validate Test<br />
Method<br />
2nd<br />
Analyst<br />
Validate Test<br />
Method<br />
1st<br />
Analyst<br />
Approved<br />
Evaluate<br />
Protocol<br />
& Sign<br />
Data & Results<br />
Acceptable<br />
Data & Results Not Acceptable<br />
Write Project<br />
Report<br />
Send Report<br />
for Approvals<br />
Approved<br />
Establish Test<br />
Method in Quality<br />
System<br />
Not<br />
Approved<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 17
3 Validated Test Methods<br />
CHEMATIC CLEANER ANALYSIS BY HPLC WITH ELSD<br />
Chematic ® Cleaner Analysis by HPLC with ELSD<br />
Document No: HPLC-xxx<br />
Revision No: X<br />
I. Principle<br />
This HPLC method is used for the determination of ingredient compound that is a component of Chematic® Cleaner. The<br />
ingredient compound is used as a marker for the Chematic® Cleaner. Samples are extracted with water and may be from<br />
rinse sampling, swab sampling, or process rinse water. The water sample is then injected into the HPLC by the<br />
autosampler, separated by reversed-phase gradient HPLC program, and detection is by ELSD (evaporative light scattering<br />
detector). Quantification is calculated using Dober’s ingredient compound analytical standard and the results are<br />
reported as concentration (ppm) of the Cleaner.<br />
II. Scope<br />
The scope of this SOP is limited to the Quality Control and Chematic Pharma Applications Laboratory functions at Dober.<br />
The scope of this method may be extended to customer laboratories using a test method transfer protocol. This method<br />
is applicable to the detection and measurement of residual detergents from water samples which include rinse and swab<br />
samples for analytical cleaning validation.<br />
III. Responsibilities<br />
All laboratory personnel who have completed the established training protocols for this method and who have been<br />
deemed qualified to perform the duties within the method in a safe and reliable manner.<br />
IV. Structures/Abbreviations<br />
Abbreviation<br />
Description<br />
HPLC<br />
ELS<br />
ELSD<br />
L<br />
mg<br />
ppm<br />
RSD<br />
SD<br />
μg<br />
μL<br />
High Performance Liquid Chromatography<br />
Evaporative Light Scattering<br />
Evaporative Light Scattering Detector<br />
Liter<br />
Milligram<br />
Parts per million (μg/mL or mg/L)<br />
Relative Standard Deviation<br />
SAMPLE<br />
μm<br />
Standard Deviation<br />
Microgram<br />
Microliter<br />
Micrometer<br />
V. Apparatus<br />
A. High performance liquid chromatograph (HPLC) system equipped with a gradient pump, autosampler, column<br />
heater, ELS detector (ELSD), and an electronic data system.<br />
B. HPLC Guard Column: ThermoScientific, Acclaim Surfactant Plus, 3.0 x 10mm x 5μm particle, P/N 078951.<br />
C. HPLC Analytical Column: ThermoScientific, Acclaim Surfactant Plus, 3.0 x 150mm x 3μm particle, P/N 078959.<br />
D. Autosampler vials (2 mL), Waters, Screw top vial with PTFE/Silicon septa cap, P/N 186000272C or equivalent.<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
18 • Analytical www.dober.com <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
3 Validated Test Methods<br />
1.1 DOCUMENT REQUEST FOR TEST<br />
METHOD DEVELOPMENT<br />
Product: Chematic® Cleaner<br />
CONFIDENTIAL & PROPRIETARY<br />
Data Set: High Level Conductivity<br />
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used.<br />
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.<br />
The range of conductivity measurements taken covers typical use dilutions.<br />
1. What is analyte/material that requires<br />
test method validation?<br />
High Level Conductivity<br />
Concentration<br />
Conductivity<br />
(v/v)<br />
0.5 % 224.40 µS / cm<br />
1 415.00 µS cm<br />
2 % 776.00 µS / cm<br />
2. What are the physical and chemical<br />
characteristics of the analyte/material?<br />
www.dober.com<br />
3500.00<br />
3000.00<br />
2500.00<br />
2000.00<br />
1500.00<br />
1000.00<br />
500.00<br />
Conductivity (mS/cm)<br />
0.00<br />
5 1729.00 µS cm<br />
7 % 2302.00 µS / cm<br />
10 % 3160.00 µS / cm<br />
High Level Conductivity<br />
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3. Do we have a sample of the analyte/<br />
material?<br />
4. Is a reference standard available?<br />
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1<br />
0.0 2.0 4.0 6.0 8.0 10.0 12.0<br />
Concentration (percent v/v)<br />
y = 308.44x + 123.51<br />
R² = 0.9984<br />
1.2 DETERMINE WHAT ANALYTICAL<br />
METHODOLOGY TO BE USED<br />
1. HPLC w/RI<br />
2. HPLC w/ELSD<br />
3. HPLC w/CAD<br />
4. HPLC w/UV/Vis<br />
5. Ion Chromatography<br />
6. TOC (Total Organic Carbon)<br />
7. Wet Chemistry<br />
1.3 DEVELOP TEST METHOD<br />
1. Develop test method to meet business<br />
needs.<br />
Product: Chematic® Cleaner<br />
Subject: BSE/TSE Statement<br />
CONFIDENTIAL & PROPRIETARY<br />
2. Test method parameters using ICH Q2, USP<br />
Pharmacopeia, and/or EudraLux.<br />
introduced without prio review.<br />
Bovine Spongiform Encephalopathy (BSE)/<br />
Transmissible Spongiform Encephalopathy (TSE)<br />
The raw materials used in the production of Dober’s Chematic detergents are not of animal<br />
origin. Rather, Chematic detergents are manufactured from chemicals that are produced<br />
fo lowing organic and inorganic synthetic production routes. A l products in the Chematic<br />
product line are manufactured from similarly produced chemical constituents, and no products<br />
of animal origin have been knowingly introduced to our cGMP production facility. We maintain<br />
controls over our production and raw material supplies to ensure that no new materials are<br />
Based on the raw materials in use, their sources and our production processes, there are no<br />
known or expected Bovine Spongiform Encephalopathy (BSE) / Transmissible Spongiform<br />
Encephalopathy (TSE) risks in our production facility or in its equipment or utilities.<br />
3. Generate linearity, repeatability, intermediate<br />
precision, spike/recovery, ruggedness data,<br />
LOQ, and LOD to be used for developing<br />
acceptance criteria for the test method<br />
validation.<br />
4. Create analytical test method SOP.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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www.dober.com<br />
1<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 19
1<br />
3 Validated Test Methods<br />
2.1 CREATE TEST METHOD VALIDATION<br />
PROTOCOL<br />
1. Validation elements follow ICH Guidelines<br />
Q2, USP formats, and EudraLex.<br />
2. Two analysts, on two different days for each<br />
analyst, and one instrument (two<br />
instruments if available).<br />
3. Use data and results generated in the test<br />
method development to develop acceptance<br />
criteria for each of the validation elements.<br />
4. Review and signature approval to start<br />
validation protocol prior to execution.<br />
2.2 EXECUTE TEST METHOD VALIDATION<br />
PROTOCOL<br />
1. Linearity<br />
a. Using authentic, reference, or analytical<br />
standard or material.<br />
b. Minimum of 5 standards prepared by<br />
serial dilutions.<br />
c. Repeatability injection of one concentration<br />
9 times.<br />
2. Range<br />
a. Upper and lower concentration of the linear<br />
range as determined by the linearity study.<br />
3. Accuracy<br />
a. Will be determined using the data from the<br />
linearity study and assessed using the<br />
intermediate precision study data.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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www.dober.com<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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1<br />
Product: Chematic® Cleaner<br />
Data Set: Material Compatibility<br />
CONFIDENTIAL & PROPRIETARY<br />
The fo lowing table provides the material compatibility testing results for various elastomeric<br />
and non-elastomeric materials including stainless steel. A water bath was used to maintain a<br />
constan temperature when materials were exposed to detergents at elevated temperatures<br />
for the length of exposure listed below. Results are based on material weight data co lected<br />
from three coupons and any observable changes to the material during the study are noted in<br />
the observations column<br />
Materials of<br />
Construction<br />
Chematic® Cleaner Dilution in DI Water (v/v): None, neat<br />
Water Bath Temperature: Ambient<br />
Total Duration of Test: 3 days<br />
316 Stainless Steel NT NT 0.00<br />
304 Stainless Steel NT NT 0.00<br />
Average Weight Change (%)/Day<br />
Hypalon 0.13 0.23 0.40<br />
EPDM 0.14 0.19 0.34<br />
Day 1 Day 2 Day 3<br />
Silicone 0.50 0.47 0.54<br />
Neoprene -0.34 -0.68 -0.80<br />
Viton A 0.02 0.03 0.01<br />
Buna N 0.46 0.80 1.41<br />
Viton Extreme 0.03 0.03 0.03<br />
HDPE NT NT 0.02<br />
Acetal (Derlin) NT NT 0.12<br />
PVDF (Kynar) NT NT 0.00<br />
PTFE (Teflon) NT NT 0.00<br />
Plexiglass (Acrylic) NT NT 0.19<br />
Borosilicate Glass NT NT -0.01<br />
Aluminum 319 NT NT -0.20<br />
NT = Not Tested.<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may a fec the material compatibility in<br />
your application. This information, co lected by Dober should be used only as a guide in selecting the appropriate materials of construction.<br />
For a complete guide of Chemical Compatibility Ratings please consul the maerial manufacturer. Remember to use suitable safe guards<br />
and/or personnel protective equipment when handling chemicals.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
1<br />
Observations<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
Product: Chematic ® Cleaner<br />
Data Set: Material Compatibility<br />
CONFIDENTIAL & PROPRIETARY<br />
The following table provides the material compatibility testing results for various elastomeric and non-elastomeric materials<br />
including stainless steel. A water bath was used to maintain a constan temperature when materials were exposed to<br />
detergents at elevated temperatures for the length of exposure listed below. Results are based on material weight data<br />
co lected from three coupons and any observable changes to the material during the study are noted in the observations<br />
column.<br />
Materials of<br />
Average Weight Change (%)/Day<br />
Construction<br />
Day 1 Day 2 316 Stainless Steel NT NT 304 Stainless Steel NT Hypalon NT EPDM Silicone Neoprene Viton A Observations<br />
0.00 No changes in solution, No changes to surface<br />
0.00 No changes in solution, No changes to surface<br />
2.09 No changes in solution, No changes to surface<br />
NT 0.26 No changes in solution, No changes to surface<br />
NT -0.12 No changes in solution, No changes to surface<br />
NT NT 0.08 No changes in solution, No changes to surface<br />
NT NT 0.00 No changes in solution, No changes to surface<br />
NT NT 0.29 No changes in solution, No changes to surface<br />
NT NT 0.16 No changes in solution, No changes to surface<br />
NT NT 0.01 No changes in solution, No changes to surface<br />
(Derlin) NT NT 0.64 No changes in solution, No changes to surface<br />
NT NT 0.06 No changes in solution, No changes to surface<br />
NT NT 0.00 No changes in solution, No changes to surface<br />
(Acrylic) NT NT 0.78 No changes in solution, No changes to surface<br />
NT NT -0.01 No changes in solution, No changes to surface<br />
NT NT 0.21 No changes in solution, No changes to surface<br />
(Teflon) Buna N (Kynar) Viton Extreme HDPE Acetal NT NT NT NT Day 3<br />
Plexiglass PTFE Borosilicate 319 PVDF Glass Aluminum Water Bath Temperature: 60˚C<br />
Total Duration of Test: 3 days<br />
DI Water Only<br />
NT = Not Tested.<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may a fect the material compatibility in your<br />
application.<br />
This information, co lected by Dober should be used only as a guide in selecting the appropriate materials of construction. For a complete guide<br />
of Chemical Compatibility Ratings please consul the material manufacturer. Remember to use suitable safe guards and/or personnel protective<br />
equipment when handling chemicals.<br />
Product: Chematic ® Cleaner<br />
Data Set: Material Compatibility<br />
CONFIDENTIAL & PROPRIETARY<br />
The fo lowing table provides the material compatibility testing results for various elastomeric and non-elastomeric materials<br />
including stainless steel. A water bath was used to maintain a constan temperature when materials were exposed to<br />
detergents at elevated temperatures for the length of exposure listed below. Results are based on material weight data<br />
collected from three coupons and any observable changes to the material during the study are noted in the observations<br />
column.<br />
Materials of<br />
Average Weight Change (%)/Day<br />
Construction<br />
Day 1 Day 2 316 Stainless Steel NT NT 304 Stainless Steel NT Hypalon NT EPDM Silicone Neoprene Viton A Observations<br />
0.00 No changes in solution, No changes to surface<br />
0.00 No changes in solution, No changes to surface<br />
2.09 No changes in solution, No changes to surface<br />
NT 0.26 No changes in solution, No changes to surface<br />
NT -0.12 No changes in solution, No changes to surface<br />
NT NT 0.08 No changes in solution, No changes to surface<br />
NT NT 0.00 No changes in solution, No changes to surface<br />
NT NT 0.29 No changes in solution, No changes to surface<br />
NT NT 0.16 No changes in solution, No changes to surface<br />
NT NT 0.01 No changes in solution, No changes to surface<br />
(Derlin) NT NT 0.64 No changes in solution, No changes to surface<br />
NT NT 0.06 No changes in solution, No changes to surface<br />
NT NT 0.00 No changes in solution, No changes to surface<br />
(Acrylic) NT NT 0.78 No changes in solution, No changes to surface<br />
NT NT -0.01 No changes in solution, No changes to surface<br />
(Teflon) Buna N (Kynar) Viton Extreme HDPE Acetal NT NT NT NT Day 3<br />
Plexiglass PTFE Borosilicate PVDF Glass NT = Not Tested.<br />
equipment when handling chemicals.<br />
Water Bath Temperature: 60˚C<br />
Total Duration of Test: 3 days<br />
DI Water Only<br />
Aluminum 319 NT NT 0.21 No changes in solution, No changes to surface<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affec the material compatibility in your<br />
application.<br />
This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction. For a complete guide<br />
of Chemical Compatibility Ratings please consult the material manufacturer. Remember to use suitable safe guards and/or personnel protective<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
20 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
D BER<br />
3 Validated Test Methods<br />
2.2 EXECUTE TEST METHOD VALIDATION<br />
PROTOCOL CONTINUED<br />
4. Intermediate Precision<br />
a. Three concentrations (50%, 100%, & 150% of<br />
the target concentration) will each be prepared<br />
in triplicate.<br />
b. One preparation of the 100% concentration<br />
will be injected 9 times for repeatability.<br />
5. Spike/Recovery Study<br />
a. The 50% concentration used in the<br />
Intermediate precision will be spiked so that<br />
the final concentration will be 100% when<br />
diluted to volume.<br />
b. The 100% concentration used in the<br />
Intermediate precision will be spiked so that<br />
the final concentration will be 150% when<br />
diluted to volume.<br />
6. Limit of Detection (LOD)<br />
a. Determine by actual analysis.<br />
7. Limit of Quantitation (LOQ)<br />
a. The LOQ is the lowest concentration of the<br />
linear range from the linearity study.<br />
8. Robustness<br />
a. Parameters are determined from method<br />
development studies and demonstrated in the<br />
validation.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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Confidential 1<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
D BER<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
The linearity of this method sha l be determined using a least squares regression plot of the<br />
results of the 2ppm, 5ppm, 10ppm, 15ppm, 20ppm and 25ppm concentrations from Day 1. The<br />
calibration curve generated in the Waters software is attached and shows the equation and r 2<br />
value for the line.<br />
ATTACHMENT 5<br />
LINEARITY<br />
Acceptance Criteria: Linearity (r 2 ) must be at ≥ 0.98 for the designated range of the assay.<br />
Compiled By: _______________________________ Date: _______________________<br />
Reviewed By: _______________________________ Date: _______________________<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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Confidential 1<br />
Analytical Laboratory Method Validation Protocol<br />
D BER<br />
CONFIDENTIAL & PROPRIETARY<br />
Title: Validation of the Detection of Surfactant in Chematic® Cleaner<br />
by HPLC<br />
Protocol Number: VAL HPLC-1<br />
Revision Number: 0<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Originator<br />
QC Manager Alex Scha ler<br />
Approvals<br />
Laboratory Manager Amy Bulger<br />
Application Laboratory<br />
Manager Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
Originator<br />
Summary Report Number: MVR HPLC-1<br />
Revision Number: 0<br />
Analytical Laboratory Alex Scha ler<br />
Approvals<br />
CONFIDENTIAL & PROPRIETARY<br />
Analytical Laboratory Method<br />
Validation Summary Report<br />
Title: Summary Report for the Validation of the Detection Surfactant in<br />
Chematic® Cleaner by HPLC<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Laboratory Manager Amy Bulger<br />
Application Laboratory<br />
Manager Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
Confidential 1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 21
Originator<br />
Approvals<br />
D BER<br />
3 Validated Test Methods<br />
2.2 EXECUTE TEST METHOD VALIDATION<br />
PROTOCOL CONTINUED<br />
9. System Suitability Testing<br />
a. Incorporated into the test method where the<br />
criteria is derived from the data generated in<br />
the validation study and is used each time an<br />
analysis is performed using the test method.<br />
10. Rinse Sampling Spike and Recovery<br />
a. Stainless steel surface<br />
b. Customer Request<br />
c. At least two different concentrations in<br />
triplicate<br />
d. Appropriate concentrations to be determined<br />
e. Rinse volume to be determined<br />
11. Swab Sampling Spike and Recovery<br />
a. Stainless steel surface<br />
b. Customer Request<br />
c. Determine appropriate swab<br />
d. Determine appropriate swab solvent<br />
e. At least two different concentrations in<br />
triplicate<br />
f. Appropriate concentrations to be determined<br />
Confidential 1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
D BER<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
The linearity of this method sha l be determined using a least squares regression plot of the<br />
results of the 2ppm, 5ppm, 10ppm, 15ppm, 20ppm and 25ppm concentrations from Day 1. The<br />
calibration curve generated in the Waters software is attached and shows the equation and r 2<br />
value for the line.<br />
Acceptance Criteria: Linearity (r 2 ) must be at ≥ 0.98 for the designated range of the assay.<br />
Compiled By: _______________________________ Date: _______________________<br />
Reviewed By: _______________________________ Date: _______________________<br />
Confidential 1<br />
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ATTACHMENT 5<br />
D BER<br />
LINEARITY<br />
Analytical Laboratory Method Validation Protocol<br />
CONFIDENTIAL & PROPRIETARY<br />
Title: Validation of the Detection of Surfactant in Chematic® Cleaner<br />
by HPLC<br />
Protocol Number: VAL HPLC-1<br />
Revision Number: 0<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Originator<br />
QC Manager Alex Schaller<br />
Approvals<br />
Laboratory Manager Amy Bulger<br />
Application Laboratory<br />
Manager Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
CONFIDENTIAL & PROPRIETARY<br />
Analytical Laboratory Method<br />
Summary Report Number: MVR HPLC-1<br />
Revision Number: 0<br />
Validation Summary Report<br />
Title: Summary Report for the Validation of the Detection Surfactant in<br />
Chematic® Cleaner by HPLC<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Analytical Laboratory Alex Scha ler<br />
Laboratory Manager Amy Bulger<br />
Application Laboratory<br />
Manager Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
Confidential 1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
2.3 TEST METHOD VALIDATION PROTOCOL<br />
APPROVAL<br />
1. Review data and results for entry and<br />
transcription errors.<br />
2. Verify calculation and results.<br />
3. Verify acceptance criteria.<br />
4. Review any validation errors or failures to meet<br />
acceptance criteria.<br />
5. Adjust test method acceptance criteria as<br />
needed based on validation data.<br />
6. Review and signature approval to accept and<br />
close validation protocol and establish the test<br />
method as a validated test method.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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3500.00<br />
3000.00<br />
2500.00<br />
2000.00<br />
1500.00<br />
1000.00<br />
500.00<br />
0.00<br />
Conductivity (mS/cm)<br />
1<br />
Product: Chematic® Cleaner<br />
Data Set: High Level Conductivity<br />
High Level Conductivity<br />
0.0 2.0 4.0 6.0 8.0 10.0 12.0<br />
Concentration (percent v/v)<br />
y = 308.44x + 123.51<br />
R² = 0.9984<br />
CONFIDENTIAL & PROPRIETARY<br />
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used.<br />
The range of conductivity measurements taken covers typical use dilutions.<br />
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.<br />
High Level Conductivity<br />
Concentration<br />
Conductivity<br />
(v/v)<br />
0.5 % 224.40 µS / cm<br />
1 415.00 µS cm<br />
2 % 776.00 µS / cm<br />
5 1729.00 µS cm<br />
7 % 2302.00 µS / cm<br />
10 % 3160.00 µS / cm<br />
Product: Chematic® Cleaner<br />
Subject: BSE/TSE Statement<br />
CONFIDENTIAL & PROPRIETARY<br />
Bovine Spongiform Encephalopathy (BSE)/<br />
Transmissible Spongiform Encephalopathy (TSE)<br />
The raw materials used in the production of Dober’s Chematic detergents are not of animal<br />
origin. Rather, Chematic detergents are manufactured from chemicals that are produced<br />
following organic and inorganic synthetic production routes. A l products in the Chematic<br />
product line are manufactured from similarly produced chemical constituents, and no products<br />
of animal origin have been knowingly introduced to our cGMP production facility. We maintain<br />
controls over our production and raw material supplies to ensure that no new materials are<br />
introduced without prio review.<br />
Based on the raw materials in use, their sources and our production processes, there are no<br />
known or expected Bovine Spongiform Encephalopathy (BSE) / Transmissible Spongiform<br />
Encephalopathy (TSE) risks in our production facility or in its equipment or utilities.<br />
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3 Validated Test Methods<br />
ATTACHMENT 1 - PROTOCOL: ANALYTICAL METHOD<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 1<br />
ANALYTICAL METHOD PROTOCOL<br />
Printed copies of the analytical method from the Waters software, including the instrument and<br />
processing methods, are attached. The table below lists all reagents used in the execution of<br />
this protocol.<br />
REAGENTS USED IN PERFORMANCE OF ASSAY<br />
Chemical Manufacturer Lot # Expiration<br />
Date<br />
Ultra-Pure Millipore<br />
Water<br />
Methanol<br />
HPLC grade<br />
LAE<br />
Surfactant<br />
(C 11 - 7 EO)<br />
Fisher<br />
Thomah<br />
Storage<br />
Conditions<br />
Lab Unit<br />
Flammable. Store<br />
in area segregated<br />
for flammable<br />
reagents.<br />
Store in tightly<br />
closed container in<br />
dry, wellventilated<br />
area.<br />
Verified By<br />
(Initials)<br />
SAMPLE<br />
Acceptance Criteria: The analytical method used in the execution of this protocol must be<br />
attached. A list of all reagents and their lot numbers used in the execution of this protocol<br />
must be documented along with the appropriate storage conditions for samples.<br />
Date<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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ATTACHMENT 2 - PROTOCOL: EQUIPMENT CALIBRATION<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 2<br />
EQUIPMENT CALIBRATION<br />
The table below identifies all equipment used in the validation of this method. Calibration data<br />
sheets are attached.<br />
EQUIPMENT USED IN PERFORMANCE OF ASSAY<br />
Make Model Serial # Due Date for Annual<br />
PM and Calibration<br />
Separations Module Waters Alliance<br />
2695<br />
Waters Detector 2410<br />
Waters Software Empower 2<br />
Acceptance Criteria: All instruments used in the execution of this protocol must be fully<br />
identified and within their calibration interval at the time of use. Calibration data sheets must<br />
be attached.<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
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3 Validated Test Methods<br />
ATTACHMENT 3 - PROTOCOL: DATES OF TESTING<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 3<br />
DATES OF TESTING & OPERATOR ASSIGNMENTS<br />
Operator 1 __________________ _______________________ ____________<br />
Printed name Signature Initials<br />
Operator 2 __________________ _______________________ ____________<br />
Printed name Signature Initials<br />
Operator 1 Sample Activity<br />
Sample Concentration Preparation date Initials<br />
SAMPLE<br />
Reviewed By: _______________________________<br />
Date: __________________<br />
Confidential 1<br />
D<br />
BER<br />
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ATTACHMENT 4 - PROTOCOL: RESULTS FROM ANALYSES<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 4<br />
RESULTS FROM ANALYSES<br />
All results generated during the method validation are attached here in<br />
the form of chromatograms printed from the Waters software.<br />
Acceptance Criteria: All analytical results must be attached and signed<br />
and dated by the operator performing the assay.<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
ATTACHMENT 5 - PROTOCOL: LINEARITY<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 5<br />
LINEARITY<br />
The linearity of this method shall be determined using a least squares regression plot of the<br />
results of the 2ppm, 5ppm, 10ppm, 15ppm, 20ppm and 25ppm concentrations from Day 1. The<br />
calibration curve generated in the Waters software is attached and shows the equation and r 2<br />
value for the line.<br />
Acceptance Criteria: Linearity (r 2 ) must be at ≥ 0.98 for the designated range of the assay.<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
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ATTACHMENT 6 - PROTOCOL: PRECISION<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 6<br />
PRECISION<br />
The precision of the method will be demonstrated with the results of the ten replicate<br />
injections of the 10ppm concentration sample from Day 1. The relative standard deviation is<br />
calculated from this data and presented in the table below.<br />
Ten Replicate Injections of 10ppm Linear Alcohol<br />
Ethoxylate C11-7EO Surfactant<br />
Injection #<br />
Concentration (ppm)<br />
1<br />
2<br />
3<br />
4<br />
5<br />
6<br />
7<br />
8<br />
9<br />
10<br />
Average<br />
Standard Deviation<br />
Relative standard<br />
deviation<br />
SAMPLE<br />
Acceptance Criteria: Relative standard deviation of the ten injections must be £ 15%.<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
ATTACHMENT 7 - PROTOCOL: RUGGEDNESS<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 7<br />
RUGGEDNESS<br />
Results from Day 1 and Day 2 samples and between two operators were compared to<br />
demonstrate the ruggedness of the method.<br />
Basis of Comparison: 5 replicate injections at each of the concentrations made and run on<br />
Day 1<br />
Conc.<br />
Conc.<br />
Conc.<br />
Sample<br />
Sample<br />
Sample<br />
(ppm)<br />
(ppm)<br />
(ppm)<br />
2ppmOP1D1-1 5ppmOP1D1-1 10ppmOP1D1-1<br />
2ppmOP1D1-2 5ppmOP1D1-2 10ppmOP1D1-1<br />
2ppmOP1D1-3 5ppmOP1D1-3 10ppmOP1D1-1<br />
2ppmOP1D1-4 5ppmOP1D1-4 10ppmOP1D1-1<br />
2ppmOP1D1-5 5ppmOP1D1-5 10ppmOP1D1-1<br />
Average Average Average<br />
Standard<br />
Standard<br />
Standard Deviation<br />
Deviation<br />
Deviation<br />
Relative Standard<br />
Deviation<br />
Relative Standard<br />
Deviation<br />
Relative Standard<br />
Deviation<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
ATTACHMENT 8 - PROTOCOL: ACCURACY & SPECIFICITY<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 8<br />
ACCURACY & SPECIFICITY<br />
5 ppm Spike 10 ppm Spike<br />
Actual Concentration-Inj 1 Actual Concentration-Inj 1<br />
Actual Concentration-Inj 2 Actual Concentration-Inj 2<br />
Actual Concentration-Inj 3 Actual Concentration-Inj 3<br />
Actual Concentration-Inj 4 Actual Concentration-Inj 4<br />
Actual Concentration-Inj 5 Actual Concentration-Inj 5<br />
Actual Concentration-Avg<br />
Actual Concentration-Avg<br />
Theoretical Concentration<br />
Theoretical Concentration<br />
% Recovery % Recovery<br />
Acceptance Criteria: The method must demonstrate that it is accurate to within ± 20% of the<br />
theoretical concentration of the surfactant (i.e., 80%-120% recovery). No interference from the<br />
cleaning agent constituents in the determination of the surfactant concentration will have been<br />
demonstrated.<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
ATTACHMENT 9 - PROTOCOL: LOD & LOQ<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 9<br />
LIMIT OF DETECTION & LIMIT OF QUANTITATION<br />
For this method, the limit of detection will be calculated as a ratio of 3:1, signal to noise. The<br />
limit of quantitation will be calculated as a ratio of 10:1, signal to noise.<br />
Baseline Noise<br />
LOD 3:1<br />
LOQ 10:1<br />
LOD = RSD*3.3 = 64.33*3.3 = 0.259<br />
Slope 820<br />
0.259 ppm<br />
0.785 ppm<br />
LOD = RSD*10 = 64.33*10 = 0.785<br />
Slope 820<br />
RSD = Residual Standard Deviation of the calibration line<br />
Slope = Slope of calibration<br />
Acceptance Criteria: The limit of detection and the limit of quantitation must<br />
be calculated and reported.<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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ATTACHMENT 10 - PROTOCOL: RANGE<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 10<br />
RANGE<br />
From the analysis of linearity, accuracy, precision, and ruggedness, this method has<br />
demonstrated linearity with an r 2 value of _________ over the range _________PPM<br />
to ________ PPM.<br />
SAMPLE<br />
Acceptance Criteria: The range of the assay demonstrated is recorded in ppm.<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
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3 Validated Test Methods<br />
ATTACHMENT 11 - PROTOCOL: DISCREPANCY SUMMARY<br />
Discrepancy<br />
Number<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 11<br />
METHOD VALIDATION DISCREPANCY SUMMARY<br />
Protocol<br />
Section<br />
Brief Description of Discrepancy<br />
Form Approved<br />
(Yes / No)<br />
Issue Closed<br />
(Yes / No)<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
ATTACHMENT 12 - PROTOCOL: REVISION RECORD<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 12<br />
HISTORICAL RECORD FOR METHOD REVISIONS<br />
Date Description of Change Initiator<br />
SAMPLE<br />
Compiled By: _______________________________<br />
Reviewed By: _______________________________<br />
Date: _______________________<br />
Date: _______________________<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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3 Validated Test Methods<br />
CHEMATIC CLEANER METHOD VALIDATION PROTOCOL<br />
CONFIDENTIAL & PROPRIETARY<br />
Analytical Laboratory Method Validation Protocol<br />
Title:<br />
Protocol Number:<br />
Revision Number: 0<br />
Validation of the Detection of Surfactant in Chematic® Cleaner<br />
by HPLC<br />
VAL HPLC-1<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Originator<br />
QC Manager<br />
Approvals<br />
Laboratory Manager<br />
Application Laboratory<br />
Manager<br />
Alex Schaller<br />
Amy Bulger<br />
Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
SAMPLE<br />
Confidential 1<br />
D<br />
BER<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444<br />
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CHEMATIC CLEANER METHOD VALIDATION REPORT<br />
Title:<br />
Summary Report Number:<br />
Revision Number: 0<br />
CONFIDENTIAL & PROPRIETARY<br />
Analytical Laboratory Method<br />
Validation Summary Report<br />
Summary Report for the Validation of the Detection Surfactant in<br />
Chematic® Cleaner by HPLC<br />
MVR HPLC-1<br />
_____________________________________________________________________________________<br />
Originator<br />
Title Name Signature Date<br />
Analytical Laboratory<br />
Approvals<br />
Laboratory Manager<br />
Application Laboratory<br />
Manager<br />
Alex Schaller<br />
Amy Bulger<br />
Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
SAMPLE<br />
Confidential 1<br />
D<br />
BER<br />
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3 Validated Test Methods<br />
TOC METHOD CHEMATIC CLEANER<br />
CONFIDENTIAL & PROPRIETARY<br />
TOC Analysis of Chematic Cleaner<br />
Scope of Assay Method<br />
The procedure documented herein is an assay method for the determination of TOC using a<br />
persulfate-UV instrument (Sievers 800 – GE Analytical Instruments). This analyzer converts<br />
organic carbon to carbon dioxide and detects the amount of carbon by measuring the<br />
conductivity of the resultant sample. The analyzer has an operating range of 0.0005 to 50 ppm<br />
(mg/L) carbon. Other TOC analysis methods such as catalytic conversion or IR may be used in<br />
the analysis of Chematic® Cleaner, however it is important to ensure that all controls associated<br />
with the analysis are appropriate to ensure an accurate measurement of the residual detergent,<br />
especially such elements as the oxidizer setting, flow rate, and the like.<br />
This procedure is intended to provide a beginning assay method for a complete Cleaning<br />
Validation program. Due to the fact that TOC analysis is a non-specific technique, for each<br />
unique application, appropriate checks for interfering substances should be run. In the case of<br />
TOC it is especially important to ensure that the water used for cleaning and rinsing the<br />
equipment is of an appropriate quality (low TOC background). It is also necessary to ensure<br />
that sampling personnel have been qualified in the sampling techniques and to ensure that<br />
sampling and extraction techniques have been included in the methods validation and to<br />
demonstrate that they do not contribute to the carbon residuals.<br />
Background of Assay Development<br />
A standard curve of dilute Chematic® Cleaner was plotted by linear regression of standards<br />
covering a range of 2 to 50 mg/L or ppm of Chematic® Cleaner (see Figure 1). Standard curves<br />
should be run in accordance with GLP.<br />
SAMPLE<br />
Note: To reduce interference, all glassware used for pipetting, creating of stock solutions, or<br />
containing samples must be TOC grade or acid washed prior to use. Consult the current USP or<br />
your instrument vendor for glass pre-treatment procedures.<br />
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transfer of analytical<br />
procedure protocol<br />
Create<br />
<strong>Transfer</strong> of<br />
Analytical<br />
Procedure<br />
Protocol (TAP)<br />
Yes<br />
Approval by<br />
Initiating Lab<br />
(Dober)<br />
Yes<br />
Approval by<br />
Receiving Lab<br />
(Customer)<br />
Yes<br />
Initiating & Receiving<br />
Lab Execute TAP<br />
Protocol<br />
No<br />
No<br />
No<br />
No<br />
Initiating Lab<br />
Compiles and<br />
Evaluates Data<br />
& Results from<br />
Both Labs<br />
Yes<br />
Receiving Lab<br />
sends TAP<br />
Protocol Data<br />
& Results to<br />
Initiating Lab<br />
Yes<br />
Initiating Lab<br />
meets TAP<br />
Protocol<br />
Acceptance<br />
Criteria<br />
Yes<br />
Receiving<br />
Lab meets<br />
TAP Protocol<br />
Acceptance<br />
Criteria<br />
No<br />
TAP Protocol<br />
Data &<br />
Results Meet<br />
Acceptance<br />
Criteria<br />
Yes<br />
Initiating Lab<br />
Writes TAP<br />
Protocol<br />
Summary<br />
Report<br />
Yes<br />
Copies of TAP<br />
Summary Report,<br />
Data, & Results<br />
from Both Labs to<br />
Receiving Lab<br />
Yes<br />
Initiating Lab<br />
Archives<br />
TAP Protocol<br />
Summary, Report,<br />
Data, & Results<br />
from Both Labs<br />
Analytical<br />
Method<br />
<strong>Transfer</strong>red<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 39
2. Range<br />
study.<br />
1<br />
4 <strong>Transfer</strong> of Analytical Procedure (TAP)<br />
3.1 DRAFT TEST METHOD TRANSFER<br />
(TMT) PROTOCOL<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic® Cleaner<br />
Data Set: Material Compatibility<br />
The fo lowing table provides the material compatibility testing results for various elastomeric<br />
and non-elastomeric materials including stainless steel. A water bath was used to maintain a<br />
1. Consists of initiating Lab and Receiving Lab.<br />
2. The acceptance criteria is derived from the<br />
test method validation and not from industry<br />
standard literature which then leads to the<br />
question of, where is the supporting data.<br />
constan temperature when materials were exposed to detergents at elevated temperatures<br />
for the length of exposure listed below. Results are based on material weight data co lected<br />
from three coupons and any observable changes to the material during the study are noted in<br />
the observations column<br />
Materials of<br />
Construction<br />
Chematic® Cleaner Dilution in DI Water (v/v): None, neat<br />
Water Bath Temperature: Ambient<br />
Total Duration of Test: 3 days<br />
316 Stainless Steel NT NT 0.00<br />
304 Stainless Steel NT NT 0.00<br />
Average Weight Change (%)/Day<br />
Hypalon 0.13 0.23 0.40<br />
EPDM 0.14 0.19 0.34<br />
Day 1 Day 2 Day 3<br />
Silicone 0.50 0.47 0.54<br />
Neoprene -0.34 -0.68 -0.80<br />
Viton A 0.02 0.03 0.01<br />
Buna N 0.46 0.80 1.41<br />
Viton Extreme 0.03 0.03 0.03<br />
HDPE NT NT 0.02<br />
Acetal (Derlin) NT NT 0.12<br />
PVDF (Kynar) NT NT 0.00<br />
PTFE (Teflon) NT NT 0.00<br />
Plexiglass (Acrylic) NT NT 0.19<br />
Borosilicate Glass NT NT -0.01<br />
Aluminum 319 NT NT -0.20<br />
NT = Not Tested.<br />
Observations<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may a fec the material compatibility in<br />
your application. This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction.<br />
For a complete guide of Chemical Compatibility Ratings please consul the maerial manufacturer. Remember to use suitable safe guards<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
and/or personnel protective equipment when handling chemicals.<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
No changes in solution., No changes to surface<br />
www.dober.com<br />
3. The validated test method will be included in<br />
the test method transfer protocol package.<br />
1<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
No changes in solution., No changes to surface<br />
4. It will be determined if training will be<br />
needed for the test method or rinse & swab<br />
sampling/preparation at the receiving<br />
lab through collaboration of the two labs.<br />
CONFIDENTIAL & PROPRIETARY<br />
Product: Chematic ® Cleaner<br />
Data Set: Material Compatibility<br />
The fo lowing table provides the material compatibility testing results for various elastomeric and non-elastomeric materials<br />
including stainless steel. A water bath was used to maintain a constan temperature when materials were exposed to<br />
3.2 APPROVAL OF THE TEST METHOD<br />
TRANSFER PROTOCOL (PRIOR TO<br />
EXECUTION)<br />
1. The TMT will be reviewed and signature<br />
approved by the initiating lab.<br />
www.dober.com<br />
detergents at elevated temperatures for the length of exposure listed below. Results are based on material weight data<br />
co lected from three coupons and any observable changes to the material during the study are noted in the observations<br />
column.<br />
Materials of<br />
Average Weight Change (%)/Day<br />
Construction<br />
Day 1 Day 2 316 Stainless Steel NT NT 304 Stainless Steel NT Hypalon NT EPDM Silicone Neoprene Viton A Observations<br />
No changes in solution, No changes to surface<br />
No changes in solution, No changes to surface<br />
2.09 No changes in solution, No changes to surface<br />
0.26 No changes in solution, No changes to surface<br />
-0.12 No changes in solution, No changes to surface<br />
NT 0.08 No changes in solution, No changes to surface<br />
NT 0.00 No changes in solution, No changes to surface<br />
NT NT 0.29 No changes in solution, No changes to surface<br />
NT NT 0.16 No changes in solution, No changes to surface<br />
NT NT 0.01 No changes in solution, No changes to surface<br />
NT NT 0.64 No changes in solution, No changes to surface<br />
Buna N Acetal (Derlin) NT NT NT NT 0.00 0.00 Viton Extreme HDPE NT NT NT NT Day 3<br />
Water Bath Temperature: 60˚C<br />
Total Duration of Test: 3 days<br />
DI Water Only<br />
PVDF (Kynar) NT NT 0.06 No changes in solution, No changes to surface<br />
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface<br />
0.21 No changes in solution, No changes to surface<br />
No changes in solution, No changes to surface<br />
No changes in solution, No changes to surface<br />
NT NT -0.01 NT NT NT NT 0.78 NT = Not Tested.<br />
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may a fect the material compatibility in your<br />
application.<br />
This information, co lected by Dober should be used only as a guide in selecting the appropriate materials of construction. For a complete guide<br />
of Chemical Compatibility Ratings please consul the material manufacturer. Remember to use suitable safe guards and/or personnel protective<br />
equipment when handling chemicals.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
2. All appropriate documentation will be sent to<br />
the receiving lab.<br />
www.dober.com<br />
1<br />
3. The receiving lab will review the TMT<br />
package and either:<br />
a. Discuss issues with the initiating lab<br />
until resolved.<br />
Analytical Test Method Development, Validation,<br />
I. Test Method Development<br />
CONFIDENTIAL<br />
b. If all is acceptable the TMT protocol is<br />
signature approved by the receiving lab.<br />
and Test Method <strong>Transfer</strong> Workflow<br />
A. Document request for test method development<br />
1. What is analyte/material that requires test method validation?<br />
2. What are the physical and chemical characteristicsof the analyte/material?<br />
3. Do we have a sample of the analyte/material?<br />
4. Is a reference standard available?<br />
B. Determine what analytical methodology to be used.<br />
1. HPLC w/RI<br />
2. HPLC w/ELSD<br />
3. HPLC w/CAD<br />
4. HPLC w/UV/Vis<br />
5. Ion Chromatography<br />
6. TOC (Total Organic Carbon)<br />
7. Wet Chemistry<br />
C. Develop Test Method<br />
1. Develop test method to meet business needs.<br />
2. Test method parameters using ICH Q2, USP Pharmcopea, and/or EudraLux.<br />
3. Generate linearity, repeatability, intermediate precision, spike/recovery, ruggedness data,<br />
LOQ, and LOD to be used for developing acceptance criteria for the test method<br />
validation.<br />
II. Test method Validation<br />
4. Create analytical test method SOP.<br />
A. Create test method validation protocol.<br />
1. Validation elements fo low ICH Guidelines Q2, USP formats, and EudraLex .<br />
2. Two analysts, on two different days for each analyst, and one instrument (two<br />
3. Use data and results generated in the test method development to develop acceptance<br />
criteria for each of the validation elements.<br />
4. Review and signature approval to start validation protocol prior to execution.<br />
instruments if available).<br />
B. Execute Test Method Validation Protocol<br />
1. Linearity<br />
a. Using authentic, reference, or analytical standard or material.<br />
b. Minimum of 5 standards prepared by serial dilutions.<br />
c. Repeatability injection of one concentration 9 times.<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
a. Upper and lower concentration of the linea range as determined by the linearity<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
40 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
4 <strong>Transfer</strong> of Analytical Procedure (TAP)<br />
3.3 EXECUTION OF THE TEST METHOD<br />
TRANSFER PROTOCOL<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Validation of the Detection of<br />
1. Signature approvals by both the initiating and<br />
receiving labs are in place.<br />
DATES OF TESTING & OPERATOR ASSIGNMENTS<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 3<br />
Operator 1 __________________ _______________________ ____________<br />
Printed name Signature Initials<br />
Printed name Signature Initials<br />
Operator 2 __________________ _______________________ ____________<br />
Operator 1 Sample Activity<br />
Sample Concentration Preparation date Initials<br />
2. One analyst from each Lab will execute the TMT.<br />
3. The protocol will be executed by both the<br />
initiating and receiving Labs.<br />
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Reviewed By: _______________________________ Date: __________________<br />
Confidential 1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
3.4 POST EXECUTION OF THE TEST<br />
METHOD TRANSFER PROTOCOL<br />
D BER<br />
1. After all testing is complete, data and TMT<br />
elements are reviewed and approved by<br />
each Lab.<br />
2. The receiving Lab will send copies of the raw<br />
data and results to the initiating Lab for review.<br />
Validation of the Detection of<br />
Surfactant in Chematic ® Cleaner by HPLC<br />
Document No: VAL HPLC-1<br />
Revision No: 0<br />
ATTACHMENT 5<br />
LINEARITY<br />
The linearity of this method sha l be determined using a least squares regression plot of the<br />
results of the 2ppm, 5ppm, 10ppm, 15ppm, 20ppm and 25ppm concentrations from Day 1. The<br />
calibration curve generated in the Waters software is attached and shows the equation and r 2<br />
Acceptance Criteria: Linearity (r 2 ) must be at ≥ 0.98 for the designated range of the assay.<br />
3. The initiating lab will send copies of the raw<br />
data and results to the receiving Lab for their<br />
review and records retention.<br />
value for the line.<br />
4. The initiating Lab will review all data, generate<br />
appropriate statistics, overall results, draft a<br />
report that includes data from both Labs,<br />
statistical analysis with comparison to the<br />
acceptance criteria, final results, and conclusion<br />
which also states whether or not the TMT was<br />
successful and transferred.<br />
Confidential 1<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
www.dober.com<br />
Compiled By: _______________________________ Date: _______________________<br />
Reviewed By: _______________________________ Date: _______________________<br />
D BER<br />
3.5 APPROVAL OF THE TEST METHOD<br />
TRANSFER PROTOCOL<br />
1. Both Labs sign/date the approval section in the<br />
TMT indicating that the TMT was successful and<br />
the test method is transferred to the receiving Lab<br />
from the initiating Lab.<br />
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Confidential 1<br />
Analytical Laboratory Method Validation Protocol<br />
CONFIDENTIAL & PROPRIETARY<br />
Title: Validation of the Detection of Surfactant in Chematic® Cleaner<br />
by HPLC<br />
Protocol Number: VAL HPLC-1<br />
Revision Number: 0<br />
_____________________________________________________________________________________<br />
Title Name Signature Date<br />
Originator<br />
QC Manager Alex Scha ler<br />
Approvals<br />
Laboratory Manager Amy Bulger<br />
Application Laboratory<br />
Manager Adam Kowalewicz<br />
_____________________________________________________________________________________<br />
11230 Katherine’s Crossing | Woodridge, IL 60517-5075<br />
Phone 630 410-7300 | To l 800 323-4983 | Fax 630 410-7444<br />
2. The receiving Lab can now perform analyses<br />
using the transferred test method and incorporate<br />
into their documentation.<br />
D BER<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 41
EXPERTS IN CLEANING<br />
CHALLENGING RESIDUES<br />
PHARMA<br />
We specialize in cleaning pharmaceutical and nutraceutical manufacturing equipment. In addition to providing superior formulated<br />
detergents, we provide an optimized cleaning process customized for each client’s products and equipment, which<br />
meets cGMP standards, and offers a thorough and repeatable cleaning process to achieve a validated state.<br />
SOLID<br />
DOSAGE<br />
LIQUID/ORAL<br />
SUSPENSIONS<br />
OTIS &<br />
OPHTHALMIC<br />
TOPICAL<br />
INHALATION<br />
PARENTERAL<br />
SUPPOSITORIES<br />
PERSONAL CARE<br />
The Personal Care industry includes a wide array of beauty care and over-the-counter products often times regulated by the<br />
Food & Drug Administration. These products include sunscreens, lotions, hair care and cosmetics. Residues and hazes left on<br />
the equipment are the result of using the wrong detergent, or perhaps the wrong detergent and the wrong cleaning process.<br />
SUNSCREENS LOTIONS OINTMENTS CREAMS PASTES MAKE-UP<br />
BIOPHARMA<br />
Our detergents and cleaning recommendations tackle difficult proteinaceous residues with our industry leading<br />
non-chlorinated alkaline cleaners.<br />
CELL CULTURE<br />
& FERMENTATION<br />
MEDIA & BUFFER<br />
SOLUTION<br />
ALBUMIN<br />
INJECTABLES/<br />
VACCINES<br />
BLOOD<br />
PRODUCTS<br />
42 • Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong>
FORMULATED DETERGENTS<br />
Metal Oxides<br />
(Fe, Zn, Ti)<br />
Eudragit Coating<br />
Creams, Gels<br />
& Lotions<br />
Cosmetics<br />
CHEMATIC 630<br />
Sunscreen (SPF)<br />
Ethyl Cellulose<br />
Silicone<br />
Oral Suspension<br />
CHEMATIC 25<br />
Metal Oxides (Fe, Zn, Ti)<br />
Creams, Gels, & Lotions<br />
Sunscreen SPF<br />
PERSONAL CARE<br />
Metal Oxides<br />
(Fe, Zn, Ti)<br />
Eudragit Coating<br />
Creams, Gels<br />
& Lotions<br />
Acryl EZE<br />
CHEMATIC 1<br />
Sunscreen (SPF)<br />
Cosmetics<br />
Ethyl Cellulose<br />
Silicone<br />
Oral Suspension<br />
CHEMATIC 640<br />
Metal Oxides (Fe, Zn, Ti)<br />
Creams, Gels, & Lotions<br />
Sunscreen SPF<br />
Cosmetics<br />
Silicone<br />
CHEMATIC 670<br />
Metal Oxides (Fe, Zn, Ti)<br />
Creams, Gels, & Lotions<br />
Sunscreen SPF<br />
Cosmetics<br />
Silicone<br />
CHEMATIC 8700<br />
Creams, Gels, & Lotions<br />
Cosmetics<br />
CHEMATIC 8711 CHEMATIC 610<br />
CHEMATIC 82<br />
CHEMATIC 82EU<br />
Creams, Gels,<br />
& Lotions<br />
Metal Oxides (Fe, Zn, Ti)<br />
Creams, Gels, & Lotions<br />
Sunscreen SPF<br />
Cosmetics<br />
Silicone<br />
Veterinary Products<br />
Steroids<br />
Creams, Gels<br />
& Lotions<br />
Cosmetics<br />
Cell Culture &<br />
Fermentation<br />
Silicone<br />
Media & Buffer<br />
Solutions<br />
BIOPHARMA<br />
Albumin<br />
Cell Culture &<br />
Fermentation<br />
Media & Buffer<br />
Solutions<br />
CHEMATIC 570<br />
Metal Oxides<br />
(Fe, Zn, Ti)<br />
Ethyl Cellulose<br />
Media & Buffer<br />
Solutions<br />
CHEMATIC 573<br />
Veterinary Products<br />
Hardness/Scale<br />
Passivation<br />
Cell Culture &<br />
Fermentation<br />
CHEMATIC 7 CHEMATIC 300<br />
Veterinary Products<br />
Hardness/Scale<br />
Passivation<br />
Cell Culture &<br />
Fermentation<br />
PHARMA<br />
CHEMATIC 82<br />
CHEMATIC 82EU<br />
Veterinary<br />
Products<br />
Steroids<br />
Creams, Gels<br />
& Lotions<br />
Cosmetics<br />
Cell Culture &<br />
Fermentation<br />
Silicone<br />
Media & Buffer<br />
Solutions<br />
CHEMATIC 99 CHEMATIC 501<br />
CHEMATIC 99EU<br />
Metal Oxides (Fe, Zn, Ti)<br />
Opadry Coatings &<br />
Acryl EZE<br />
Aluminum Lake Dyes<br />
Media & Buffer Solutions<br />
Metal Oxides<br />
(Fe, Zn, Ti)<br />
CHEMATIC 422<br />
Opadry Coatings & Acryl EZE<br />
Metal Oxides (Fe, Zn, Ti)<br />
Aluminum Lake Dyes<br />
CHEMATIC L/S<br />
Eudragit L<br />
Metal Oxides (Fe, Zn, Ti)<br />
CHEMATIC NE/NM<br />
CHEMATIC RL/RS CHEMATIC 300<br />
CHEMATIC 9301<br />
CHEMATIC 91<br />
Eudragit Coating<br />
Eudragit Coating<br />
Veterinary Products<br />
Hardness/Scale<br />
Passivation<br />
Cell Culture &<br />
Fermentation<br />
Eudragit Coating<br />
Ethyl Cellulose<br />
CHEMATIC 91EU<br />
Steroids<br />
Creams, Gels, & Lotions<br />
Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong> • 43
OUR COMMITMENT TO OUR<br />
CUSTOMERS<br />
RIGOROUS STANDARDS<br />
Chematic production meets cGMP standards<br />
Complete lot traceability<br />
All inbound raw materials are QC tested<br />
Every lot meets rigorous QC<br />
Product C of A’s provided<br />
Change control policy<br />
ADDITIONAL SERVICES & SUPPORT<br />
A cleaning process optimized for your equipment<br />
Complete Analytical <strong>Tech</strong>nical <strong>Transfer</strong> <strong>Package</strong><br />
Controlled formulation and detection method for all formulated Chematic detergents<br />
Cycle development assistance<br />
Committed to continuity of supply for the life of your product<br />
11230 Katherine’s Crossing | Woodridge, IL 60517<br />
Phone: 630.410.7300 | Toll Free: 800.323.4983<br />
chematic@dober.com<br />
www.dober.com<br />
LET’S GET STARTED!<br />
CONTACT US TODAY.<br />
D BER<br />
© 2017 | All rights reserved | CHEM_01990_8
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