NHS QA Symposium, September 2013

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1 1 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain NHS QA Symposium, September 2013 John Cobb Microbiology Support Manager

2 2 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain Contents of Presentation 1. TSI s BioTrak Real Time Microbiology Monitoring System for Air, based on Laser Induced Fluorescence (LIF)

3 3 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain Contents of Presentation 2. Emtek s P100 New Portable Active Air Sampler

4 Environmental Monitoring in Real-Time Respond in realtime Segregate Product Root Cause Investigations Real-time viable particle data Information Knowledge QRM ICH Q9 CAPA PAT QbD ICH Q8 FMS Training Qualification BioTrak

5 BioTrak-Three Instruments in One Particle Counter ISO compliant particle counter 28.3 lpm HEPA filter Particle Concentrator Viability detector-laser Induced Fluorescence (LIF) Viability Detector Collection filter 37mm Collection filter for speciation of analyzed particles

6 BioTrak Same as an Airborne Particle Counter (APC) Particle Counter ISO compliant particle counter 28.3 lpm Particle Concentrator HEPA filter Collection filter Viability Detector Easy to use GUI

7 BioTrak Benefits High Flow Rate 28.3 lpm 4 lpm Takes over 4hrs to sample 1m³ 28.3 lpm means you can certify and monitor exactly as with a standard particle counter Seven times faster to take a 1m³sample than a 4 lpm instrument

8 BioTrak High Flow Rate 28.3 lpm flow is too fast for any viability detector.. Clean air and small particles The flow is slowed down for the viability detector using a concentrator Most particles of interest What impact does the concentrator have on the particle collection efficiency? BioTrak uses a patented high efficiency concentrator, we communicate the BioTrak particle collection efficiency performance

9 TSI Concentrator Design + Utilizes circumferential slit instead of discrete nozzles + Minimize edge effects and losses + Well characterized performance + Licensed Patented* design with TSI development collaboration *US Patent Number 7,261,007

10 BioTrak- Viability Detector Particle Counter Particle Concentrator HEPA filter Collection filter Viability Detector Patented* Laser Induced Fluorescence (LIF) Viability Detection TSI collaborative technology development over the past 20 years *Patents 5,701,012; 5,895,922 and 6,831,279

11 BioTrak - Real-time Aerosol Optical Spectroscopy Laser Induced Fluorescence (LIF) Viable cell metabolites tryptophan, NADH, and flavin s (riboflavin) fluoresce when excited by ultra-violet light Excitation Wavelength Emission Wavelength Advanced Trigger Development Jeyes et al, Lincoln Laboratory Journal Volume 17, Number 1, 2007

12 BioTrak - Real-Time Aerosol Optical Spectroscopy Viable Cell Metabolites Microorganisms and simulants Nonviable particles with fluorescent properties Advanced Trigger Development Jeyes et al, Lincoln Laboratory Journal Volume 17, Number 1, 2007

13 BioTrak - Real-time Aerosol Optical Spectroscopy Particle Counter 1 Particle Concentrator HEPA filter Viability Detector 2 Collection filter 3 BioTrak uses 3optical parameters to determine viability in real-time

14 BioTrak - Real-time Aerosol Optical Spectroscopy What happens when you try to determine viability using just 2 parameters? Scattered Light Fluorescence B Fluorescence A 2 Parameters: Cannot discriminate interferents!

15 BioTrak - Delivering Performance Real-time aerosol optical spectroscopy Scattered Light Fluorescence B Fluorescence A 3 Parameters: Can discriminate! What happens when you try to determine viability using 3 parameters?

16 LIF-BioTrak Discrimination Discrimination Parameter Perfect instrument does not have viable-nonviable ambiguity Viable and nonviable particles are clearly separated Due to the complex nature of LIF signatures and limited number of analysis parameters, this instrument response is not achievable

17 Discrimination Better Discrimination + Number of analysis parameters + Algorithms + Orthogonal measurements Discrimination Parameter TSI Incorporated 10/10/

18 LIF-BioTrak Sensitivity High Sensitivity Large viable particle area in 3-D data space Identify a high percentage of viable particles (low # false negatives) Identify a number of nonviable particles as viable (higher false positives) Performance is a tradeoff between Sensitivity and False Positives

19 LIF-BioTrak Sensitivity Low Sensitivity Small viable particle area in 3-d data space Identify a lower percentage of viable particles (higher # false negatives) Identify a smaller number of non-viable particles as viable (lower false positives) Performance is a tradeoff between Sensitivity and False Positives

20 LIF-BioTrak Dual Sensitivity +BioTrak will incorporate the ability to select a high or low sensitivity setting + Adjust instrument response to application space Clean Environments Low number of viable particles Low number of total particles Lower number of particles with fluorescent characteristics Unacceptable to miss viables HIGH SENSITIVITY Dirty Environments Higher number of viable particles Higher number of total particles Don t want excessive false positives Higher limit of viable particulates acceptable to miss some LOW SENSITIVITY

21 BioTrak Particle Analysis and Speciation BioTrak Integrated Collection Filter Load Collection Filter Insert Filter Holder Lock Filter Holder Up to 9 Hrs continuous air flow Load Agar Plate Incubate and identify

22 Validation

23 Real-Time Viable Particle Counting - Important Considerations + Need to understand the product s capabilities and limitations Effectiveness of LIF Measurement - Discrimination capability - False Positives versus False Negatives Functionality - Ease of use - Total particulate sizing capability - Viable particle detection capability - Data availability Particle capture capability Regulatory Challenges

24 Characterisation of Real-Time Viable Particle Counter + Needs to be characterised with existing methods + Comparability studies: efficiency of the instrument under test as compared to the reference sampler must be considered + Correlate to existing methods

25 Instrument Validation Rapid Method Active Air Sampling ISO Compendial Method Comparison: Equivalent or Better USP 1223, EP 5.1.6, PDA TR33 Real -Time Aerosol Viable Detection

26 Instrument Validation BioTrak Test Panel Bacteria Fungi Yeast Interferents Drug Master File FDA

27 Applicability +LIF results will be different than current active sampler based results!! We are not counting cfu s +What is the value? Real time data Continuous data Understanding processes Training feedback + Evolution to real-time release

28 Instrument Field Validation IQ OQ PQ

29 New Information: Grade C Example Grade C Monitoring Location In Operation

30 Root Cause Investigations Particle Counts compliant to ISO Particle Counter Particle Concentrator HEPA filter Collection filter Viability Detector 0.5 µm Counts 5 µm Counts 11 AM

31 Root Cause investigations 2 different conclusions.. #/M^3 #/M^3 11 AM OR 12:30 PM

32 Root Cause Investigations Root cause Investigations #/M^3

33 Root Cause Investigations Collection Filter Particle Counter Particle Concentrator HEPA filter Collection filter Viability Detector

34 ICH Q8(R2) Improved Process Knowledge Root Cause Investigations Leads to Improved root cause investigations The BioTrak detector high temporal resolution means you know when a microbial excursion occurred

35 ICH Q8(R2) Improved Process Knowledge Identifying Microbiological Contamination Sources Investigation Tool Quicklydetermine the source of airborne microbiological contamination Geiger Counter mode User configurable Beep for Viable counts

36 ICH Q8(R2) Improved Process Knowledge Root Cause Investigations Leads to Improved root cause investigations More effective CAPA

37 ICH Q9 Quality Risk Management Qualification Tool: Early risk based release of (manufacturing) areas -Supported by existing methods: results days later OPC Monitoring location Loc 1 Loc 2 Environmental Monitoring location 6m Loc 3 Loc 4 Loc 5 Loc 6 Grade B BioTrak Real-time OPC and Airborne Viables 6m

38 ICH Q9 Quality Risk Management Risk Analysis: Data to support monitoring position rationale for Settle Plates, Active Air Sampling and Particle Monitoring : Monitoring location fine tuning OPC Monitoring location Loc 1? Loc 1 Environmental Monitoring location Grade B BioTrak Real-time OPC and Airborne Viables

39 ICH Q9: Quality Risk Management Training- Immediate notification of poor practice Gowning

40 ICH Q9: Quality Risk Management Training- Immediate notification of poor practice Aseptic technique

41 ICH Q9: Quality Risk Management Training- Immediate notification of poor practice Poor cleanroom practice

42 Application Road Map The Innovation Highway Confidence in the measurement Vendor Validation Operator Training Comparability Studies Monitoring Locations + Zone Qualification Root cause Investigations Realtime release Validated in Process Measurement Immediate benefit Long term benefit

43 BioTrak Summary

44 BioTrak real-time viable particle counter Three portable instruments in one Low False Positives ISO compliant particle counter 28.3 lpm Particle fluorescence -viability detector 37mm Collection filter for speciation of analyzed particles

45 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain 45 New Emtek P100 Portable Active Air Sampler

46 46 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

47 47 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

48 48 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

49 49 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

50 50 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

51 51 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

52 52 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

53 53 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain

54 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain Please come and visit us at our stand. As well as the BioTrak, PMT has a Facility Management System and Emtek P100 Portable Air Sampler on display. 54

55 55 Germany - Benelux T o g e t h e r W e c r e a t e S o l u t i o n s France - Great Britain Thanks for Listening Any Questions?