Chematic_Analytical_Tech_Transfer_package

analytical
Technical Transfer
package
A complete analytical package to validate Chematic Formulated
Detergents as part of your high performance equipment cleaning.
D
BER

DELIVERING & SUPPORTING
ANALYTICAL CLEANING
VALIDATION RESULTS
WITH THE TECH DATA PACKAGE
Thank you for selecting Dober’s Chematic Formulated Detergent as your go-to
choice for high performance equipment cleaning. We understand that getting
to a validated state is critical. We also understand the time and added expense
associated with the analytical work, which must happen to validate that your
cleaning detergent is entirely removed from your processing equipment before
production, is of the utmost importance in achieving operational efficiency.
Rather than be burdened with contracting out this analytical work, we provide
our customers with everything (yes, everything) you need to achieve validation
for our formulated detergents.
We provide an entire analytical technical transfer package with all
documentation including:
• Toxicology Data (ADE Values)
• Chemical & Physical Data
• Validated HPLC & TOC Test Methods
• Transfer of Analytical Procedures
We also provide Technical & Validation Support with
approved NDA/CDA.
2 • Analytical Technical Transfer Package

Table of contents
1
Toxicology Data
• ADE Values
• LD50 & Composition
2
Chemical & Physical Data
• Product Technical Data Sheet
• Conductivity
• pH
• TOC Curve
• Material Compatibility
• Cloud Point
3
Validated Test Methods
• HPLC
- Detection by ELSD or UV/VIS
• Last to Leave Component
• Analytical Standard
• TOC
4
Transfer of Analytical Procedure (TAP)
• Comparative Testing
• Pre-approved Transfer Protocol
Analytical Technical Transfer Package • 3

1 Toxicology Data
ADE MONOGRAPH
C1chematic·)
formulated detergents
CONFIDENTIAL & PROPRIETARY
ADE Classification Report
Chematic ® Cleaner
Acceptable Daily Exposure (ADE}
xxx mg/day Chematic Cleaner
Generic Name: Chematic ® Cleaner
Acceptable Daily Exposure (ADE): xxx mg/day
Component C.A.S. #:
12345-12-1 • 12345-12-1 • 12345-12-1 • 12345-12-1 • 12345-12-1 •
12345-12-1 • 12345-12-1 • 12345-12-1 • 12345-12-1 • 12345-12-1 •
Potential Routes of Exposure
• Ingestion
• Inhalation
• Skin
Indication and Uses
Structure of major constituent (x)
Chematic Cleaner is indicated as cleaning material or detergent (1).
Efficacy and Dose
SAMPLE
Efficacy of the cleaning solution is measured by lack of residual product detected on objects
that have been subjected to a cleaning protocol utilizing Chematic Cleaner (1).
The ADE for the mixture is based upon the application of the mixture formula, which is a
percent-weighted additivity formula of the individual ADEs of each of the components.
Confidential
DUBER
4 • Analytical Technical Transfer Package

1 Toxicology Data
FORMULA COMPOSITION AND LD50 VALUES
Ingredient
(common name)
CONFIDENTIAL & PROPRIETARY
Chematic ® X Cleaner
Confidential Chemical Formula
Accepted Daily Exposure (ADE): xxx mg/Day *
Weight
Percentage
LD50, oral,
rats, mg/kg
CAS registry
Nos.
Water 83.00 GRAS xxxx-xx-x
Chematic Ingredient 2 0.50 >xxxx xxxxx-xx-x
Chematic Ingredient 3 1.00 xxxx xxxxxx-xx-x
Chematic Ingredient 4 2.00 >xxx
Chematic Ingredient 5 3.00 xxx xxxx-xx-x
Chematic Ingredient 6 4.00 >xxxx xxxxx-xx-x
Chematic Ingredient 7 0.50 xxxx xxxxxx-xx-x
Chematic Ingredient 8 1.00 >xxx
Chematic Ingredient 9 2.00 xxx xxxx-xx-x
Chematic Ingredient 10 3.00 xxx xxxxx-xx-x
*Affygility Solutions, LLC (Toxicology Group)
xxxxx-x
xxxxx-x
SAMPLE
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 5

1 Toxicology Data
THEORETICAL TOC
CONFIDENTIAL & PROPRIETARY
Chematic ® X Cleaner
Confidential Chemical Formula
Ingredient
(common name)
Weight
Percentage
Percent
Theoretical
TOC
CAS registry
Nos.
Water 63.0 0.00 xxxx-xx-x
Ingredient 2 10.0 3.45 xxxx-xx-x
Ingredient 3 7.0 1.24 xxxx-xx-x
Ingredient 4 6.0 1.67 xxxx-xx-x
Ingredient 5 5.0 0.59 xxxx-xx-x
Ingredient 6 3.0 0.00 xxxx-xx-x
Ingredient 7 2.0 0.37 xxxx-xx-x
Ingredient 8 1.5 1.05 xxxx-xx-x
Ingredient 9 1.5 0.75 xxxx-xx-x
SAMPLE
Ingredient 10 1.00 0.63 xxxx-xx-x
Total Theoretical TOC 9.73%
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
6 • Analytical Technical Transfer Package
www.dober.com

2 Chemical & Physical Data
TECH DATA SHEET
DESCRIPTION
Chematic ® X is a highly concentrated liquid cleaner ideally suited for CIP, COP,
spray, and high pressure cleaning of processing equipment found in pharmaceutical,
biopharmaceutical, cosmetics, and food facilities. A proprietary combination
of chelating agents and surfactants enables Chematic ® X to remove a wide
variety of soils while remaining effective in hard water. Chematic ® X is free rinsing
and phosphate-free.
PHYSICAL PROPERTIES
Physical Form
Appearance
pH Use Solution
Liquid
>11.0
SUBSTRATE COMPATIBILITY
Product is safe on stainless steel, glass and
most plastics and polymers.
Product should be thoroughly rinsed off surfaces.
Not recommended for soft metals.
Precautionary Statement: Please refer to the current
Material Safety Data Sheet.
AVAILABLE IN
20 L /
209 L /
5 gal 55 gal
FOR ADDITIONAL INFORMATION,
CONTACT CHEMATIC AT:
630.410.7300
chematic@dober.com
www.dober.com
Chematic
®
X
Colorless to Light Straw
1020 L /
270 gal
Specific Gravity at 68˚F
Foaming
Typical Storage Temperature
Low Foaming @ Use Temperature
CLEANING VALIDATION SUPPORT
HPLC, TOC and other methods are provided by Dober.
Validation consulting support ranging from complete project
management to sampling and swabbing methodologies and
assistance is available from our validation consulting group.
APPLICATIONS & USAGE
CIP COP Spray
Concentrations from 1%-10% v/v
Temperatures of 70˚C–80˚C
Manual
1.09-1.13
40 ˚F - 100 ˚F
Concentrations from 0.5%-2% v/v
Temperatures of 25˚C–50˚C
ALKALINE
SAMPLE
Analytical Technical Transfer Package • 7

2 Chemical & Physical Data
HIGH LEVEL CONDUCTANCE
Conductivity (mS/cm)
3500.00
3000.00
2500.00
2000.00
1500.00
1000.00
500.00
0.00
CONFIDENTIAL & PROPRIETARY
Product: Chematic® X Cleaner
Data Set: High Level Conductivity
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used.
The range of conductivity measurements taken covers typical use dilutions.
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.
High High Level Conductivity
Concentration
Conductivity
Conductivity
(v/v)
(µS/cm)
0.5% 0.5 % 224.40 224.40 µS / cm
1% 1 % 415.00 415.00 µS / cm
2% 2 % 776.00 776.00 µS / cm
5% 5 % 1729.00 1729.00 µS / cm
7% 7 % 2302.00 2302.00 µS / cm
10% 10 % 3160.00 3160.00 µS / cm
High Level Conductivity
SAMPLE
Concentration (percent v/v)
y = 308.44x + 123.51
R² = 0.9984
0.0 2.0 4.0 6.0 8.0 10.0 12.0
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
8 • Analytical Technical Transfer Package

2 Chemical & Physical Data
LOW LEVEL CONDUCTANCE
Conductivity (µS / cm)
2.50
2.00
1.50
1.00
0.50
0.00
CONFIDENTIAL & PROPRIETARY
Product: Chematic® X Cleaner
Data Set: Low Level Conductivity
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used. The
range of conductivity measurements taken covers low level concentrations as might be found in
rinsate samples.
Note: The water used for rinsing will affect the conductivity values and should be taken into
consideration when analyzing rinse water samples for detergent content. The data presented
below is not blank corrected.
The data in this table were generated using a ThermoElectron Orion 3Star Conductivity meter.
Low Low Level Conductivity
Concentration Conductivity
Concentration (v/v) Conductivity
(v/v)
(µS/cm)
DI DI Water Water Blank Blank 0.39 0.39µS / cm
1 ppm1 ppm 0.54 0.54µS / cm
2 ppm2 ppm 0.58 0.58µS / cm
5 ppm5 ppm 0.62 0.62µS / cm
7 ppm7 ppm 0.63 0.63µS / cm
10 ppm10 ppm 0.83 0.83µS / cm
20 ppm20 ppm 0.97 0.97µS / cm
25 ppm25 ppm 1.07 1.07µS / cm
50 ppm50 ppm 2.33 2.33µS / cm
Low Level Conductivity
SAMPLE
y = 0.035x + 0.4215
R² = 0.9512
0 10 20 30 40 50 60
Concentration (ppm)
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 9

2 Chemical & Physical Data
pH DATA
CONFIDENTIAL
Product: Chematic® X Cleaner
Data Set: pH Data
Dilutions were prepared in deionized water. Temperature compensation to 25°C was used. The range of
pH measurements taken covers typical detergent use concentrations down to very low levels, as might be
found in rinsate water.
Note: The water used for rinsing will affect the pH values and should be taken into consideration when
analyzing rinse water samples for detergent content.
The data in these tables were generated using a ThermoElectron Orion 3Star pH meter.
pH pH –– Low Levels
Concentration
pH
DI Water Blank
DI Water Blank
5.53
5.53
1 ppm 5.53
1 ppm 5.53
2 ppm 5.60
2 ppm 5.60
5 ppm 5.91
5 ppm
7 ppm
5.91
5.96
7 ppm10 ppm 6.02 5.96
10 ppm20 ppm 6.40 6.02
25 ppm
20 ppm
6.63
6.40
50 ppm 7.93
25 ppm 6.63
50 ppm 7.93
pH pH – Use Dilutions
Concentration
Concentration (v/v)
pH
pH
0.5 % (v/v)
0.5%
10.59
10.59
1 % (v/v)
1%
10.73
10.73
2% 2 % (v/v) 10.88 10.88
5% 5 % (v/v) 11.02 11.02
7% 7 % (v/v) 11.05 11.05
10% % (v/v) 11.07 11.07
SAMPLE
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
10 • Analytical Technical Transfer Package
www.dober.com

2 Chemical & Physical Data
MATERIAL COMPATIBILITY REPORT 1 (NEAT SOLUTION)
CONFIDENTIAL & PROPRIETARY
Product: Chematic® X Cleaner
Data Set: Material Compatibility
The following table provides the material compatibility testing results for various elastomeric
and non-elastomeric materials including stainless steel. A water bath was used to maintain a
constant temperature when materials were exposed to detergents at elevated temperatures
for the length of exposure listed below. Results are based on material weight data collected
from three coupons and any observable changes to the material during the study are noted in
the observations column
Chematic® X Cleaner Dilution in DI Water (v/v): None, neat
Water Bath Temperature: Ambient
Total Duration of Test: 3 days
Materials
Materials
of
Average Weight Change (%)/Day
of Average Weight Change (%)/Day
Observations
Construction
Observations
Construction Day 1 Day 2 Day 3
Day 1 Day 2 Day 3
316 Stainless Steel NT NT 0.00 No changes in solution, No changes to surface
No changes in solution., No changes to surface
316 Stainless Steel NT NT 0.00
304 Stainless Steel NT NT 0.00 No changes No in solution., in solution, No changes No to surface changes to surface
304 Stainless Steel NT NT 0.00
Hypalon
Hypalon
0.13
0.13
0.23
0.23
0.40
0.40
No changes No in solution., in solution, No changes No to surface changes to surface
EPDM
EPDM
0.14
0.14
0.19
0.19
0.34
0.34
No changes No in solution., in solution, No changes No to surface changes to surface
Silicone Silicone 0.50 0.50 0.47 0.47 0.54 0.54 No changes No in solution., in solution, No changes No to surface changes to surface
Neoprene Neoprene -0.34 -0.34 -0.68 -0.68 -0.80 No changes
No in solution.,
in solution,
No changes
No
to surface
changes to surface
Viton A Viton A 0.02 0.02 0.03 0.03 0.01
No in solution., No changes to surface
No changes in solution, No changes to surface
Buna N Buna N 0.46 0.46 0.80 0.80 1.41
No in solution., No changes to surface
No changes in solution, No changes to surface
Viton Extreme Viton Extreme 0.03 0.03 0.03 0.03 0.03
No changes in solution., No changes to surface
No changes in solution, No changes to surface
HDPE
No changes in solution., No changes to surface
HDPE NT NT NT NT 0.02 0.02 No changes in solution, No changes to surface
No changes in solution., No changes to surface
Acetal (Derlin)
Acetal (Derlin) NT
NT
NT
NT 0.12
0.12 No changes in solution, No changes to surface
No changes in solution., No changes to surface
PVDF (Kynar) NT NT 0.00
PVDF (Kynar) NT NT 0.00 No changes in solution, No changes to surface
No changes in solution., No changes to surface
PTFE (Teflon) NT NT 0.00
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface
No changes in solution., No changes to surface
Plexiglass (Acrylic) NT NT 0.19
Plexiglass (Acrylic) NT NT 0.19 No changes
No changes in solution.,
in solution,
No changes
No
to surface
changes to surface
Borosilicate Glass NT NT -0.01
Borosilicate Glass
Aluminum 319
NT
NT
NT
NT
-0.01
-0.20
No changes No in solution., in solution, No changes No to surface changes to surface
Aluminum 319 NT NT -0.20 No changes in solution, No changes to surface
NT = Not Tested.
SAMPLE
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material compatibility in
your application. This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction.
For a complete guide of Chemical Compatibility Ratings please consult the maerial manufacturer. Remember to use suitable safe guards
and/or personnel protective equipment when handling chemicals.
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 11

2 Chemical & Physical Data
MATERIAL COMPATIBILITY REPORT 2 (10% SOLUTION)
CONFIDENTIAL & PROPRIETARY
Product: Chematic® X Cleaner
Data Set: Material Compatibility
The following table provides the material compatibility testing results for various elastomeric
and non-elastomeric materials including stainless steel. A water bath was used to maintain a
constant temperature when materials were exposed to detergents at elevated temperatures
for the length of exposure listed below. Results are based on material weight data collected
from three coupons and any observable changes to the material during the study are noted in
the observations column.
Chematic® X Cleaner Dilution in DI Water (v/v): 10%
Water Bath Temperature: 60˚C
Total Duration of Test: 3 days
Materials of
Average Weight Change (%)/Day
Materials of Average Weight Change (%)/Day
Observations
Construction
Observations
Construction
Day 1 Day 2 Day 3
316 Stainless Steel NT
Day 1
NT
Day 2 Day
0.00
3
No changes in solution, No changes to surface
316 Stainless Steel NT NT 0.00 No changes in solution., No changes to surface
304 Stainless Steel NT NT 0.00 No changes in solution, No changes to surface
304 Stainless Steel NT NT 0.00 No changes in solution., No changes to surface
Hypalon 2.98 6.68 9.46 No changes in solution, No changes to surface
Hypalon 2.98 6.68 9.46 No changes in solution., No changes to surface
EPDM
EPDM
0.83
0.83
1.60
1.60
2.20
2.20
No changes in solution, No changes to surface
No changes in solution., No changes to surface
Silicone
Silicone
0.36
0.36
0.43
0.43
0.60
0.60
No changes in solution, No changes to surface
No changes in solution., No changes to surface
Neoprene Neoprene 0.54 0.54 0.92 0.92 1.23 1.23 No changes No in in solution., solution, No changes No to changes surface to surface
Viton A Viton A 0.22 0.22 0.41 0.41 0.44 No changes No in in solution., solution, No changes No to changes surface to surface
Buna N Buna N 2.92 2.92 4.40 4.40 4.01 No changes No in in solution., solution, No changes No to changes surface to surface
Viton Extreme Viton Extreme 0.36 0.36 0.66 0.66 0.82 No changes No in in solution., solution, No changes No to changes surface to surface
HDPE HDPE NT NT NT NT 0.10 No changes
No in
in
solution.,
solution,
No changes
No
to
changes
surface
to surface
Acetal (Derlin) Acetal (Derlin) NT NT NT NT 0.67 No in solution., No changes to surface
No changes in solution, No changes to surface
PVDF (Kynar)
PVDF (Kynar)
NT NT NT NT 0.06 0.06 No in solution., No changes to surface
No changes in solution, No changes to surface
PTFE (Teflon) NT NT 0.00 No changes in solution., No changes to surface
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface
Plexiglass (Acrylic) NT NT 0.76 No changes in solution., No changes to surface
Plexiglass (Acrylic) NT NT 0.76 No changes in solution, No changes to surface
Borosilicate Glass NT NT -0.03 No changes in solution., No changes to surface
Borosilicate Glass NT NT -0.03 No changes in solution, No changes to surface
Aluminum 319 NT NT -0.05 No changes in solution., No changes to surface
Aluminum 319 NT NT -0.05 No changes in solution, No changes to surface
NT = Not Tested.
SAMPLE
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material
compatibility in your application. This information, collected by Dober should be used only as a guide in selecting the
appropriate materials of construction. For a complete guide of Chemical Compatibility Ratings please consult the
material manufacturer. Remember to use suitable safe guards and/or personnel protective equipment when handling
chemicals.
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
12 • Analytical Technical Transfer Package
www.dober.com

2 Chemical & Physical Data
MATERIAL COMPATIBILITY REPORT 3 (H 2
O)
CONFIDENTIAL & PROPRIETARY
Product: DI Water
Data Set: Material Compatibility
The following table provides the material compatibility testing results for various elastomeric and non-elastomeric materials
including stainless steel. A water bath was used to maintain a constant temperature when materials were exposed to
detergents at elevated temperatures for the length of exposure listed below. Results are based on material weight data
collected from three coupons and any observable changes to the material during the study are noted in the observations
column.
DI Water Only
Water Bath Temperature: 60˚C
Total Duration of Test: 3 days
Materials of
Average Weight Change (%)/Day
Materials of
Average Weight Change (%)/Day
Construction
Construction Day 1 Day 2 Day 3
Day 1 Day 2 Day 3
Observations
Observations
316 Stainless 316 Stainless Steel Steel NT NT NT NT 0.00 0.00 No changes in solution, in solution, No No changes changes to surface to surface
304 Stainless 304 Stainless Steel Steel NT NT NT NT 0.00 0.00 No No changes changes in solution, in solution, No No changes changes to surface to surface
Hypalon NT NT 2.09 No changes in solution, No changes to surface
HypalonEPDM NT NT NT NT 0.26 2.09 No changes in solution, in solution, No No changes changes to surface to surface
EPDM
Silicone
NT
NT
NT
NT -0.12
0.26
No
No
changes
changes
in solution,
in solution,
No
No
changes
changes
to surface
to surface
Neoprene NT NT 0.08 No changes in solution, No changes to surface
Silicone Viton A NT NT NT NT 0.00 -0.12 No changes in solution, in solution, No No changes changes to surface to surface
Neoprene Buna N NT NT NT NT 0.29 0.08 No No changes in solution, in solution, No No changes changes to surface to surface
Viton Extreme NT NT 0.16 No changes in solution, No changes to surface
Viton A NT NT 0.00 No changes in solution, No changes to surface
HDPE NT NT 0.01 No changes in solution, No changes to surface
Buna N Acetal (Derlin) NT NT NT NT 0.64 0.29 No changes in in solution, No No changes changes to surface to surface
PVDF (Kynar) NT NT 0.06 No changes in solution, No changes to surface
Viton Extreme NT NT 0.16 No changes in solution, No changes to surface
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface
HDPE Plexiglass (Acrylic) NT NT NT NT 0.78 0.01 No changes in in solution, No No changes changes to surface to surface
Borosilicate Glass NT NT -0.01 No changes in solution, No changes to surface
Acetal (Derlin) NT NT 0.64 No changes in solution, No changes to surface
Aluminum 319 NT NT 0.21 No changes in solution, No changes to surface
PVDF (Kynar) NT NT 0.06 No changes in solution, No changes to surface
PTFE (Teflon) NT NT 0.00 No changes in solution, No changes to surface
Plexiglass (Acrylic) NT NT 0.78 No changes in solution, No changes to surface
SAMPLE
Borosilicate Glass NT NT -0.01 No changes in solution, No changes to surface
Aluminum 319 NT NT 0.21 No changes in solution, No changes to surface
NT = Not Tested.
*Use-concentrations, temperatures, pressures and duration of exposure vary by application and may affect the material compatibility in your
application.
This information, collected by Dober should be used only as a guide in selecting the appropriate materials of construction. For a complete guide
of Chemical Compatibility Ratings please consult the material manufacturer. Remember to use suitable safe guards and/or personnel protective
equipment when handling chemicals.
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 13

2 Chemical & Physical Data
ACCELERATED STABILITY STUDY
Real Time in
Oven 1 (Days)
Accelerated
Age
(Days)
CONFIDENTIAL & PROPRIETARY
Chematic ® X Cleaner
Accelerated Stability Study Report
pH 2
Specific
Gravity 3
Appearance
0 0 11.51 1.021 Liquid, Amber, Clear
4 32 11.47 1.023
12 96 11.51 1.020
25 200 11.48 1.022
34 272 11.50 1.020
46 368 11.53 1.020
68 544 11.48 1.021
90 720 11.46 1.021
113 904 11.39 1.022
137 1096 11.43 1.023
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and solution is clear.
Liquid, Amber, separated but combines when
mixed and becomes clear.
Liquid, Dark Yellow to Light Amber, separated but
combines when mixed and solution is clear.
SAMPLE
1. Oven Temperature is 50°C and Room Temperature is 20°C.
2. Specification Range for pH: 11.00 – 11.80
3. Specification Range for Specific Gravity: 1.005 – 1.035
Liquid, Dark Yellow to Light Amber, separated
but combines when mixed and solution is clear.
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
14 • Analytical Technical Transfer Package
www.dober.com

2 Chemical & Physical Data
BSE-TSE STATEMENT
CONFIDENTIAL & PROPRIETARY
Product: Chematic® X Cleaner
Subject: BSE/TSE Statement
Bovine Spongiform Encephalopathy (BSE)/
Transmissible Spongiform Encephalopathy (TSE)
The raw materials used in the production of Dober’s Chematic detergents are not of animal
origin. Rather, Chematic detergents are manufactured from chemicals that are produced
following organic and inorganic synthetic production routes. All products in the Chematic
product line are manufactured from similarly produced chemical constituents, and no products
of animal origin have been knowingly introduced to our cGMP production facility. We maintain
controls over our production and raw material supplies to ensure that no new materials are
introduced without prior review. A BSE/TSE statement from each of the raw material suppliers
is kept on file.
Based on the raw materials in use, their sources and our production processes, there are no
known or expected Bovine Spongiform Encephalopathy (BSE) / Transmissible Spongiform
Encephalopathy (TSE) risks in our production facility or in its equipment or utilities.
SAMPLE
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 15

By selecting Dober
as your partner . . .
We’ll give you everything you need to
confidently transfer information to your lab and
get you a step closer to achieving a validated
state in your pharmaceutical, personal care or
biopharmaceutical processing.
Adhere to regulatory guidelines
• Detergent components that are “last-to-leave” during
cleaning have been identified
• Achieve successful results
Chematic detergents have validated analytical test
methods including ADE/PDE values
Train customer on how to execute transfer of analytical
procedure, if needed
Test method transfer protocol performed simultaneously at
Dober’s lab and at customer’s lab
Post test methods transfer, the customer will receive the test
method, transfer data and results package as part of the
Technical Data Package
Achieve validation
16 • Analytical Technical Transfer Package

test method
validation
Analytical method validation is the process used to prove that the analytical procedure
established for a specific test is suitable for its intended use. Our test method validation process
is comprehensive, consistent with current pharmaceutical regulatory guidelines and cGMP, fully
documented, and ensures that the test results will be reliable and fit for its purpose.
Method
Development
Request
Develop
Test Method
Evaluate
Method for
Validation
Acceptable
Create Method
Validation
Protocol
Not
Acceptable
Not
Approved
Evaluate Data
from Both
Analysts
Validate Test
Method
2nd
Analyst
Validate Test
Method
1st
Analyst
Approved
Evaluate
Protocol
& Sign
Data & Results
Acceptable
Data & Results Not Acceptable
Investigate
Write Project
Report
Send Report
for Approvals
Approved
Establish Test
Method in Quality
System
Not
Approved
Investigate
Analytical Technical Transfer Package • 17

3 Validated Test Methods
ANALYSIS BY HPLC WITH ELSD
Confidential
Chematic ® X Cleaner Analysis by HPLC with ELSD
Document No: HPLC-xxx
Revision No: X
I. Principle
This HPLC method is used for the determination of ingredient compound that is a component of Chematic® Cleaner. The
ingredient compound is used as a marker for the Chematic® Cleaner. Samples are extracted with water and may be from
rinse sampling, swab sampling, or process rinse water. The water sample is then injected into the HPLC by the
autosampler, separated by reversed-phase gradient HPLC program, and detection is by ELSD (evaporative light scattering
detector). Quantification is calculated using Dober’s ingredient compound analytical standard and the results are
reported as concentration (ppm) of the Cleaner.
II. Scope
The scope of this SOP is limited to the Quality Control and Chematic Pharma Applications Laboratory functions at Dober.
The scope of this method may be extended to customer laboratories using a test method transfer protocol. This method
is applicable to the detection and measurement of residual detergents from water samples which include rinse and swab
samples for analytical cleaning validation.
III. Responsibilities
All laboratory personnel who have completed the established training protocols for this method and who have been
deemed qualified to perform the duties within the method in a safe and reliable manner.
IV. Structures/Abbreviations
Abbreviation
Description
HPLC
ELS
ELSD
L
mg
ppm
RSD
SD
μg
μL
High Performance Liquid Chromatography
Evaporative Light Scattering
Evaporative Light Scattering Detector
Liter
Milligram
Parts per million (μg/mL or mg/L)
Relative Standard Deviation
SAMPLE
μm
Standard Deviation
Microgram
Microliter
Micrometer
V. Apparatus
A. High performance liquid chromatograph (HPLC) system equipped with a gradient pump, autosampler, column
heater, ELS detector (ELSD), and an electronic data system.
B. HPLC Guard Column: ThermoScientific, Acclaim Surfactant Plus, 3.0 x 10mm x 5μm particle, P/N 078951.
C. HPLC Analytical Column: ThermoScientific, Acclaim Surfactant Plus, 3.0 x 150mm x 3μm particle, P/N 078959.
D. Autosampler vials (2 mL), Waters, Screw top vial with PTFE/Silicon septa cap, P/N 186000272C or equivalent.
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
18 • Analytical www.dober.com Technical Transfer Package

3 Validated Test Methods
1.1 DOCUMENT ANALYTE FOR TEST
METHOD DEVELOPMENT
1. What is analyte/material that requires
test method validation?
2. What are the physical and chemical
characteristics of the analyte/material?
3. Do we have a sample of the analyte/
material?
4. Is a reference standard available?
1.2 DETERMINE WHAT ANALYTICAL
METHODOLOGY TO BE USED
1. HPLC w/RI
2. HPLC w/ELSD
3. HPLC w/UV/Vis
4. TOC (Total Organic Carbon)
1.3 DEVELOP TEST METHOD
1. Test method parameters using ICH Q2, USP
Pharmacopeia, and/or EudraLux.
2. Generate data for the validation elements to
be used for developing acceptance criteria
for the test method validation.
3. Create analytical test method SOP.
Analytical Technical Transfer Package • 19

3 Validated Test Methods
2.1 CREATE TEST METHOD VALIDATION
PROTOCOL
1. Validation elements follow ICH Guidelines
Q2, USP formats, and EudraLex.
2. Two analysts, on two different days for each
analyst, and one instrument (two
instruments if available).
3. Use data and results generated in the test
method development to develop acceptance
criteria for each of the validation elements.
4. Review and signature approval to start
validation protocol prior to execution.
2.2 EXECUTE TEST METHOD VALIDATION
PROTOCOL
1. Linearity
a. Using authentic, reference, or analytical
standard or material.
b. Minimum of 5 standards prepared by
serial dilutions.
c. Repeatability injection of one concentration
9 times.
2. Range
a. Upper and lower concentration of the linear
range as determined by the linearity study.
3. Accuracy
a. Will be determined using the data from the
linearity study and assessed using the
intermediate precision study data.
20 • Analytical Technical Transfer Package

3 Validated Test Methods
2.2 EXECUTE TEST METHOD VALIDATION
PROTOCOL CONTINUED
4. Intermediate Precision
a. Three concentrations (50%, 100%, & 150% of
the target concentration) will each be prepared
in triplicate.
b. One preparation of the 100% concentration
will be injected 9 times for repeatability.
c. Tested by two analysts on different days.
5. Spike/Recovery Study
a. The 50% concentration used in the
Intermediate precision will be spiked so that
the final concentration will be 100% when
diluted to volume.
b. The 100% concentration used in the
Intermediate precision will be spiked so that
the final concentration will be 150% when
diluted to volume.
6. Limit of Detection (LOD)
a. Determine by actual analysis.
7. Limit of Quantitation (LOQ)
a. The LOQ is the lowest concentration of the
linear range from the linearity study.
8. Robustness
a. Parameters are determined from method
development studies and demonstrated in the
validation.
Analytical Technical Transfer Package • 21

3 Validated Test Methods
2.2 EXECUTE TEST METHOD VALIDATION
PROTOCOL CONTINUED
9. System Suitability Testing
a. Incorporated into the test method where the
criteria is derived from the data generated in
the validation study and is used each time an
analysis is performed using the test method.
10. Rinse Sampling Spike and Recovery
a. Stainless steel surface
b. One or more different concentrations in
triplicate
c. Appropriate concentrations to be determined
11. Swab Sampling Spike and Recovery
a. Stainless steel surface
b. Determine appropriate swab
c. Determine appropriate swab solvent
d. One or more different concentrations in
triplicate
e. Appropriate concentrations to be determined
22 • Analytical Technical Transfer Package

3 Validated Test Methods
2.3 TEST METHOD POST VALIDATION
PROTOCOL APPROVAL
1. Review data and results for entry and
transcription errors.
2. Verify calculation and results.
3. Verify results against acceptance criteria.
4. Review any validation errors or failures to meet
acceptance criteria.
5. Adjust test method acceptance criteria as
needed based on validation data.
6. Review and approve to accept and close
validation protocol and establish the test
method as a validated test method.
Analytical Technical Transfer Package • 23

3 Validated Test Methods
ATTACHMENT 1: ANALYTICAL METHOD
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 1
ANALYTICAL METHOD
Printed copies of the analytical method from the Waters software, including the instrument and
processing methods, are attached. The table below lists all reagents used in the execution of
this protocol.
Chemical Manufacturer Lot #
Ultra-Pure
Water
Methanol
HPLC grade
Surfactant
Millipore
Fisher
Thomah
REAGENTS USED IN PERFORMANCE OF ASSAY
Expiration
Date
Storage
Conditions
N/A
Flammable. Store
in area segregated
for flammable
reagents.
Store in tightly
closed container in
dry, wellventilated
area.
Verified By
(Initials)
SAMPLE
Acceptance Criteria: The analytical method used in the execution of this protocol must be
attached. A list of all reagents and their lot numbers used in the execution of this protocol
must be documented along with the appropriate storage conditions for samples.
Date
Reviewed By: _______________________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
24 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
ATTACHMENT 2: EQUIPMENT CALIBRATION
Validation of the Detection of
Surfactant in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 2
EQUIPMENT CALIBRATION
The table below identifies all equipment used in the validation of this method.
EQUIPMENT USED IN THIS PROTOCOL
Component Make Model Serial # Due Date for Annual
PM and Calibration
Quaternary Pump Agilent Infinity 1260
Autosampler Agilent Infinity 1260
Column Heater Agilent Infinity 1260
DAD (Detector) Agilent Infinity 1260
ELSD (Detector) Agilent Infinity II 1290
Acceptance Criteria: All instruments used in the execution of this protocol must be fully
identified and within their calibration interval at the time of use. Calibration data sheets or
reports must be attached.
SAMPLE
Compiled By: _______________________________
Date: _______________________
Reviewed By: _______________________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 25

3 Validated Test Methods
ATTACHMENT 3: DATES OF TESTING
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 3
DATES OF TESTING & OPERATOR ASSIGNMENTS
Operator 1 __________________ _______________________ ____________
Printed name Signature Initials
Operator 2 __________________ _______________________ ____________
Printed name Signature Initials
Operator 1 Sample Activity
Sample Concentration Preparation date Initials
SAMPLE
Reviewed By: _______________________________
Date: __________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
26 • Analytical www.dober.com Technical Transfer Package

3 Validated Test Methods
ATTACHMENT 4: RESULTS FROM ANALYSES
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 4
RESULTS FROM ANALYSES
All results generated during the method validation are attached here in
the form of chromatograms printed from the Waters software.
Acceptance Criteria: All analytical results must be attached and signed
and dated by the operator performing the assay.
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 27

3 Validated Test Methods
ATTACHMENT 5: LINEARITY
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 5
LINEARITY
The linearity of this method shall be determined using a least squares regression plot of the
results of the 2ppm, 5ppm, 10ppm, 15ppm, 20ppm and 25ppm concentrations from Day 1. The
calibration curve generated in the Waters software is attached and shows the equation and r 2
value for the line.
Acceptance Criteria: Linearity (r 2 ) must be at ≥ 0.98 for the designated range of the assay.
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
28 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
ATTACHMENT 6: PRECISION
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 6
PRECISION
The precision of the method will be demonstrated with the results of the ten replicate
injections of the 10ppm concentration sample from Day 1. The relative standard deviation is
calculated from this data and presented in the table below.
Ten Replicate Injections of 10 ppm Analyte
Injection #
1
2
3
4
5
6
7
8
9
10
Average
Standard Deviation
Relative standard
deviation
Concentration (ppm)
SAMPLE
Acceptance Criteria: Relative standard deviation of the ten injections must be £ X%.
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 29

3 Validated Test Methods
ATTACHMENT 7: INTERMEDIATE PRECISION
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 7
INTERMEDIATE PRECISION
Results from Day 1 and Day 2 samples and between two operators were compared to
demonstrate the ruggedness of the method.
Basis of Comparison: 5 replicate injections at each of the concentrations prepared and analyzed on
Day 1
Conc.
Conc.
Conc.
Sample
Sample
Sample
(ppm)
(ppm)
(ppm)
2ppmOP1D1-1 5ppmOP1D1-1 10ppmOP1D1-1
2ppmOP1D1-2 5ppmOP1D1-2 10ppmOP1D1-1
2ppmOP1D1-3 5ppmOP1D1-3 10ppmOP1D1-1
2ppmOP1D1-4 5ppmOP1D1-4 10ppmOP1D1-1
2ppmOP1D1-5 5ppmOP1D1-5 10ppmOP1D1-1
Average Average Average
Standard
Standard
Standard Deviation
Deviation
Deviation
Relative Standard
Deviation
Relative Standard
Deviation
Relative Standard
Deviation
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
30 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
ATTACHMENT 8: ACCURACY & SPECIFICITY
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 8
ACCURACY & SPECIFICITY
5 ppm Spike 10 ppm Spike
Actual Concentration-Inj 1 Actual Concentration-Inj 1
Actual Concentration-Inj 2 Actual Concentration-Inj 2
Actual Concentration-Inj 3 Actual Concentration-Inj 3
Actual Concentration-Inj 4 Actual Concentration-Inj 4
Actual Concentration-Inj 5 Actual Concentration-Inj 5
Actual Concentration-Avg
Actual Concentration-Avg
Theoretical Concentration
Theoretical Concentration
% Recovery % Recovery
Acceptance Criteria: The method must demonstrate that it is accurate to within ± 20% of the
theoretical concentration of the surfactant (i.e., 80%-120% recovery). No interference from the
cleaning agent constituents in the determination of the surfactant concentration will have been
demonstrated.
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 31

3 Validated Test Methods
ATTACHMENT 9: LOD & LOQ
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 9
LIMIT OF DETECTION & LIMIT OF QUANTITATION
For this method, the limit of detection will be determined as the concentration of the analyte that is three
times the baseline noise. The LOD is the lowest concentration of the analyte in the linear curve from the
linearity study. The limit of quantitation will be calculated as a ratio of 10:1, signal to noise.
Acceptance Criteria:
LOD
LOQ
X.XX ppm
X.XX ppm
The limit of detection and the limit of quantitation
must be reported.
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
32 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
ATTACHMENT 10: RANGE
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 10
RANGE
From the analysis of linearity, accuracy, precision, and intermediate precision, this method
has demonstrated linearity with an r 2 value of _________ over the range _________PPM
to ________ PPM.
SAMPLE
Acceptance Criteria: The range of the assay demonstrated is recorded in ppm.
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 33

3 Validated Test Methods
ATTACHMENT 11: DISCREPANCY SUMMARY
Discrepancy
Number
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 11
METHOD VALIDATION DISCREPANCY SUMMARY
Protocol
Section
Brief Description of Discrepancy
Approved
(Yes / No)
Issue Closed
(Yes / No)
SAMPLE
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
34 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
ATTACHMENT 12: REVISION RECORD
Validation of the Detection of Surfactant
in Chematic ® Cleaner by HPLC
Document No: VAL HPLC-1
Revision No: 0
ATTACHMENT 12
HISTORICAL RECORD FOR METHOD REVISIONS
Date Description of Change Initiator
SAMPLE
Disclaimer:
Attachments 1-12 are examples and not intended to
represent a complete set.
Compiled By: _______________________________
Reviewed By: _______________________________
Date: _______________________
Date: _______________________
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 35

3 Validated Test Methods
METHOD VALIDATION PROTOCOL
CONFIDENTIAL & PROPRIETARY
Analytical Laboratory Method Validation Protocol
Title:
Protocol Number:
Revision Number: 0
Validation of the Detection of Surfactant
in Chematic® Cleaner by HPLC
VAL HPLC-1
_____________________________________________________________________________________
Title Name Signature Date
Originator
QC Manager
Approvals
Laboratory Manager
Application Laboratory
Manager
Alex Schaller
Amy Bulger
Adam Kowalewicz
_____________________________________________________________________________________
SAMPLE
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
36 • Analytical Technical Transfer Package
www.dober.com

3 Validated Test Methods
METHOD VALIDATION REPORT
Title:
Summary Report Number:
Revision Number: 0
CONFIDENTIAL & PROPRIETARY
Analytical Laboratory Method
Validation Summary Report
Summary Report for the Validation of the Detection of Surfactant
in Chematic® Cleaner by HPLC
MVR HPLC-1
_____________________________________________________________________________________
Originator
Title Name Signature Date
Analytical Laboratory
Approvals
Laboratory Manager
Application Laboratory
Manager
Alex Schaller
Amy Bulger
Adam Kowalewicz
_____________________________________________________________________________________
SAMPLE
Confidential
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
Analytical Technical Transfer Package • 37

3 Validated Test Methods
TOC METHOD
Chematic ® X Cleaner Analysis by HPLC with Refractive Index Detector
Document No: HPLC-xxx
Revision No: X
I. Principle
This HPLC method is used for the determination of analyte that is a component of Chematic® X Cleaner. The analyte is
used as a marker for the Chematic® X Cleaner. Samples are extracted with water and may be from rinse sampling, swab
sampling, or process rinse water. The water sample is separated by isocratic reverersed-phase HPLC and detection is by
RI (refractive index) detector. Quantification is calculated using Dober’s analyte analytical standard and the results are
reported as concentration (ppm) of the Cleaner.
II.
III.
IV.
Scope
The scope of this SOP is limited to the Quality Control and Chematic Applications Laboratory functions at Dober. The
scope of this method may be extended to customer laboratories using a test method transfer protocol. This method is
applicable to the detection and measurement of residual detergents from water samples which include rinse and swab
samples for analytical cleaning validation.
Responsibilities
All laboratory personnel who have completed the established training protocols for this method and who have been
deemed qualified to perform the duties within the method in a safe and reliable manner.
Confidential
Structures/Abbreviations
Abbreviation
HPLC
L
mg
ppm
RSD
SD
μg
Description
High Performance Liquid Chromatography
Liter
Milligram
Parts per million (μg/mL or mg/L)
Relative Standard Deviation
Standard Deviation
Microgram
SAMPLE
μL
μm
USP
Microliter
Micrometer
United States Pharmacopeia
V. Apparatus
A. High performance liquid chromatograph (HPLC) system equipped with a gradient pump, autosampler, column
heater, RI detector, and electronic data system.
B. HPLC Guard Column: Waters NovaPak C 18 , 3.9 x 20mm x 4μm particle.
C. HPLC Column: Waters NovaPak C 18 , 3.9 x 150mm x 4μm particle.
D. Autosampler vials (2 mL), Waters, Screw top vial with PTFE/Silicon septa cap, P/N 186000272C or equivalent.
E. Analytical Balance, Ohaus, Explorer, minimally capable of weighing to 0.0001 g or equivalent.
F. Volumetric equipment, Class A (graduated cylinders, volumetric flasks, and glass pipets).
D
BER
11230 Katherine’s Crossing | Woodridge, IL 60517-5075
Phone 630 410-7300 | Toll 800 323-4983 | Fax 630 410-7444
www.dober.com
38 • Analytical Technical Transfer Package

transfer of analytical
procedure protocol
Create
Transfer of
Analytical
Procedure
Protocol (TAP)
Yes
Approval by
Initiating Lab
(Dober)
Yes
Approval by
Receiving Lab
(Customer)
Yes
Initiating & Receiving
Lab Execute TAP
Protocol
No
Initiating Lab
Compiles and
Evaluates Data
& Results from
Both Labs
Yes
Receiving Lab
sends TAP
Protocol Data
& Results to
Initiating Lab
No
Yes
No
Initiating Lab
meets TAP
Protocol
Acceptance
Criteria
Investigate
Yes
No
Investigate
Receiving
Lab meets
TAP Protocol
Acceptance
Criteria
No
Investigate
TAP Protocol
Data &
Results Meet
Acceptance
Criteria
Yes
Initiating Lab
Writes TAP
Protocol
Summary
Report
Yes
Copies of TAP
Summary Report,
Data, & Results
from Both Labs to
Receiving Lab
Yes
Initiating Lab
Archives
TAP Protocol
Summary, Report,
Data, & Results
from Both Labs
Analytical
Method
Transferred
Analytical Technical Transfer Package • 39

4 Transfer of Analytical Procedure (TAP)
3.1 DRAFT TEST METHOD TRANSFER
(TMT) PROTOCOL
1. Consists of initiating Lab and Receiving Lab.
2. The acceptance criteria is from the test
method validation.
3. The validated test method will be included in
the test method transfer protocol package.
4. It will be determined if training will be
needed for the test method or rinse & swab
sampling/preparation at the receiving
lab through collaboration of the two labs.
3.2 APPROVAL OF THE TEST METHOD
TRANSFER PROTOCOL (PRIOR TO
EXECUTION)
1. The TMT will be reviewed and approved by
the initiating lab.
2. All appropriate documentation will be sent to
the receiving lab.
3. The receiving lab will review the TMT
package and either:
a. Discuss issues with the initiating lab
until resolved.
b. If all is acceptable the TMT protocol is
approved by the receiving lab.
40 • Analytical Technical Transfer Package

4 Transfer of Analytical Procedure (TAP)
3.3 EXECUTION OF THE TEST METHOD
TRANSFER PROTOCOL
1. Signature approvals by both the initiating and
receiving labs are in place.
2. One analyst from each Lab will execute the TMT.
3. The protocol will be executed by both the
initiating and receiving Labs.
3.4 POST EXECUTION OF THE TEST
METHOD TRANSFER PROTOCOL
1. After all testing is complete, data and TMT
elements are reviewed and approved by
each Lab.
2. The receiving Lab will send copies of the raw
data and results to the initiating Lab for review.
3. The initiating lab will send copies of the raw
data and results to the receiving Lab for their
review and records retention.
4. The initiating Lab will review all data, draft a
report that includes data from both Labs,
statistical analysis with comparison to the
acceptance criteria, and conclusion which also
states whether or not the TMT was successful
and transferred.
3.5 APPROVAL OF THE TEST METHOD
TRANSFER PROTOCOL
1. Both Labs sign/date the approval section in the
TMT indicating that the TMT was successful and
the test method is transferred to the receiving Lab
from the initiating Lab.
2. The receiving Lab can now perform analyses
using the transferred test method and incorporate
into their documentation.
Analytical Technical Transfer Package • 41

SCIENCE
CLEANING
Every industry has its challenging residues.
We are experts at tackling every one of them.
We offer science with cleaning - unparalleled cleaning solutions, which match the right detergent to the right
cleaning process. Our scientific approach includes understanding every aspect of your cleaning parameters
and goals, so we can increase your production capacity, while reducing labor costs and cleaning time with
cleaning recommendations that are optimized for your residue, your equipment, your safety, and your
operational goals.
We use our decades of application research and development to produce value-adding solutions for our
customers. We don’t just make cleaning products. We develop comprehensive cleaning solutions to ensure
that our customers achieve cleaning success. Our formulated detergents are part of an Application Cleaning
Methodology (ACM) study, which provides customized cleaning recommendations. These recommendations
ensure that our clients are able to meet market demands by maximizing the use of their assets with an
efficient cleaning process that is tailored to their products and equipment.
OPTIMAL CLEANING:
EFFICIENCY IS EVERYTHING
A ROBUST CLEANING PROCESS CAN:
1
Minimize
Equipment
Down Time
2
Maximize
Use of
Assets
3
Ensure
Safety
4
Achieve
Validated
State
42 • Analytical Technical Transfer Package

APPLICATION CLEANING
METHODOLOGY
We are experts in building business efficiencies through the research, testing, application and training of a proper
cleaning process. As a result of our Application Cleaning Methodology (ACM) process we are able to deliver not only
cleaning benefits, but bottom line improvements. With every ACM study we perform, we look to achieve a validated state
and cost savings through maximized use of assets, increased production capacity, improved operator safety, reduced
cleaning time and eliminated need for re-cleaning.
Client Provides
Data to Chematic
Lab
Application
Chemists Analyze
Data
Chematic Lab
Hypothesizes a
Cleaning Plan
$
Chematic Lab
Performs Cleaning
Study
Chematic Lab
Optimizes
Cleaning Study
Chematic Lab
Delivers Cleaning
Recommendations
=
WE ASSIST
YOU IN
ACHIEVING
YOUR
TARGETED
GOAL:
Our cleaning
process
recommendations
and formulated
detergents are
proven to reduce
operating costs.
SCALING UP: WORKING TOWARD A VALIDATED STATE
ACM Lab Study
Recommendations
Analytical Tech
Transfer Package
Lab Study
On-Site Trials
Analytical Technical Transfer Package • 43

OUR COMMITMENT TO OUR
CUSTOMERS
RIGOROUS STANDARDS
Chematic production meets cGMP standards
Complete lot traceability
All inbound raw materials are QC tested
Every lot meets rigorous QC
Product C of A’s provided
Change control policy
ADDITIONAL SERVICES & SUPPORT
A cleaning process optimized for your equipment
Complete Analytical Technical Transfer Package
Controlled formulation for all formulated Chematic detergents
Detection method for all formulated Chematic detergents
Committed to continuity of supply for the life of your product
LET’S GET STARTED!
CONTACT US TODAY.
11230 Katherine’s Crossing | Woodridge, IL 60517
Phone: 630.410.7300 | Toll Free: 800.323.4983
chematic@dober.com
www.dober.com
D BER
© 2017 | All rights reserved | CHEM_01990_16