Kaye Validator ITMS
Kaye Validator ITMS
Kaye Validator ITMS
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The <strong>Kaye</strong> <strong>Validator</strong><br />
<strong>ITMS</strong><br />
GE Sensing<br />
Pharmaceutical<br />
Group<br />
GE Sensing<br />
ralf.wottrich@ge.com<br />
++49-7231-14335-30
Innovation Award at the Powtech /<br />
Technopharm 2007<br />
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August, 2005
Summary<br />
- Challenges in Cleaning Validation<br />
- <strong>ITMS</strong> Technology Background<br />
- Use in Pharmaceutical Environment<br />
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Cleaning Validation<br />
Validation<br />
Verification<br />
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Current Regulations<br />
Process Validation<br />
All drug product manufacturing processes must be<br />
validated. This includes but is not limited to:<br />
Measuring<br />
Weighing<br />
Mixing<br />
Blending<br />
Cleaning<br />
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Cleaning Validation<br />
FDA Warning letters Top 10<br />
- 2004<br />
Place 2: Cleaning Validation!<br />
- 2005<br />
Place 4: Cleaning Validation!<br />
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<strong>ITMS</strong> technology<br />
Ion Trap Mobility Spectrometry<br />
- a gas phase separation and detection method<br />
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GE Implementation of IMS <strong>ITMS</strong><br />
- GE’s implementation of IMS is<br />
called Ion Trap Mobility<br />
Spectrometry (<strong>ITMS</strong>)<br />
- Technology acquired as part of<br />
Ion Track acquisition in 2002<br />
- Used widely in Security<br />
applications: Airports, Border<br />
Crossings, prisons, customs<br />
- New EntryScan Portal being<br />
rolled our at airports in US<br />
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<strong>ITMS</strong> Instrument<br />
• Portable (~25 lbs)<br />
• Battery life of > 1hr<br />
• Embedded Software is<br />
Part 11 compliant<br />
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<strong>ITMS</strong> Technology<br />
Measurement Procedure<br />
- Sample Introduction<br />
- Desorption Vapor Phase<br />
- Ionization<br />
- Separation of Ions based on Time of Flight (TOF)<br />
- Detection and Data processing<br />
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<strong>Kaye</strong> <strong>Validator</strong> <strong>ITMS</strong> – Specific trace detection<br />
within seconds …<br />
1. Direct swabbing of a surface<br />
4. Immediate “Go or No<br />
Go” feedback to the<br />
operator<br />
2. Direct sample introduction 3. Just 30 to 90 sec. analysis time<br />
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Advantages of <strong>ITMS</strong> Technology<br />
- Very sensitive detection of trace amounts of active compounds<br />
- Narcotics, Explosives<br />
- Pharmaceutical API’s<br />
- Established in security sector for over 12 years<br />
- Very Fast Sampling.<br />
- No more consumables than sample traps and membranes<br />
- Portable instrument<br />
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Use in Pharmaceutical Environment<br />
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Use in Pharmaceutical Environment<br />
Applications:<br />
- Cleaning<br />
- Monitoring<br />
- Verification<br />
- Validation<br />
- Substance identification (Counterfeit<br />
identification!)<br />
- Environmental monitoring<br />
- Cross contamination control (Penicillin!)<br />
- Production method Development<br />
- in process controls<br />
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Regulatory Requirements on a scale<br />
…<br />
Environmental monitoring Cleaning verification<br />
Cleaning monitoring Cleaning validation<br />
Fine chemicals<br />
API production<br />
Finished products<br />
solids<br />
liquids<br />
…less<br />
Regulatory requirements<br />
…more<br />
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Potential Utility<br />
Replacing Analytical Method<br />
At Line Direct Swabbing<br />
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At-Line Use<br />
- API residue limits based on allowable<br />
dose in next batch of product<br />
- Method Dev./Quantification “Alarm”<br />
- Alarm “Go/No-go” on clean state<br />
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Adaption to the analytical method<br />
Swabbing<br />
or rinse<br />
Sample<br />
preparation:<br />
Extraction<br />
Delution<br />
Confinemen<br />
t<br />
Analytical<br />
method<br />
Direct swabbing possible?<br />
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<strong>ITMS</strong> Advantages<br />
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CV Cycle Time<br />
Cleaning<br />
Swab/Rinse Sampling<br />
Production<br />
Equipment Release<br />
Residue<br />
Analysis<br />
HPLC<br />
• Time consuming, costly<br />
TOC<br />
• Fast . . .<br />
• Non-specific<br />
• Water is the only solvent<br />
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CV Cycle Time<br />
Cleaning<br />
2 Hours<br />
6 Hours<br />
Production<br />
Cleaning<br />
Production<br />
Equipment Release<br />
Residue<br />
Analysis<br />
The dominant component of CV<br />
cycle Cycle time time: is residue 1 – 4 analysis days and<br />
waiting for equipment release<br />
1 – 3<br />
Days<br />
Residue<br />
Analysis<br />
And<br />
Equipment<br />
Release<br />
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CV Cycle Time<br />
Cleaning<br />
2 Hours<br />
6 Hours<br />
Production<br />
Cleaning<br />
Production<br />
Equipment Release<br />
Residue<br />
Analysis<br />
Hours<br />
Analysis &<br />
Release<br />
Residue<br />
Analysis<br />
1 – 3<br />
Taking CV testing Daysfrom And the<br />
lab to the process floor has<br />
the potential to Equipment<br />
dramatically cut the largest Release<br />
contributor to equipment<br />
downtime.<br />
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<strong>ITMS</strong>: Value Proposition<br />
Speed &<br />
Specificity<br />
Faster turnaround<br />
PAT – more effective<br />
monitoring<br />
Portable<br />
Technology<br />
Simple<br />
Operation<br />
Takes measurements<br />
from the lab to the<br />
process floor<br />
Shifts user-base from<br />
strictly analytical chemists<br />
to at-line operators<br />
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Customer Screening Service<br />
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Compound Screening Service<br />
• Free of charge<br />
• Testing your samples for detectability using the <strong>Kaye</strong><br />
<strong>Validator</strong>® <strong>ITMS</strong><br />
• Check for the possibility of quantification.<br />
• Prerequisite for any further on-site demonstrations.<br />
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Key takeaways<br />
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Key Takeaways<br />
- Fast, specific and extremely sensitive<br />
method for residue identification and<br />
quantification<br />
- Well established in security<br />
applications over past 12 years<br />
- Goal of at-line validation/verification<br />
has potential to dramatically reduce<br />
downtime<br />
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