Rapid Micro Biosystems, Inc. · NASDAQ:RPID
Rapid Micro Biosystems — Technical Presentation (November 2021)
20 slides from Rapid Micro Biosystems's technical presentation, Nov 29, 2021
Slide 1: Annex 1 update – Potential changes and impacts on microbial QC automation
Annex 1 update – Potential changes and impacts on microbial QC automation PREPARED FOR THE Growth Direct EU users group 1
Slide 2: Agenda
November 29, 2021 Agenda Attendees • Introductions • Annex 1 update EU Users Group Presenters • Significant Micro updates Valsource Marc Glogovsky Senior Microbiology Consultant Rapid Micro Biosystems David Jones • Compliance and Automation Director of Industry Affairs 2
Slide 3: Annex 1 "The Elephant in the room"
Annex 1 “The Elephant in the room”. First Issued in 1989. Public Review in 2017 Revision proposed in 2012 Re write selected sections Public Review in 2020 Started in 2014 with a goal to release in 2018 But….. SOON??? 3
Slide 4: Most Controversial Chapters by Comment Count
Most Controversial Chapters by Comment Count. Chapters Topics Ch 8 Production & specific Technologies • PUPSIT Ch 4 Premises Isolators & RABS • Definition “Open”, “Closed”. Ch 9 Viable & non-viable EM and process monitoring • Level vs limit, • Particle size 0.5 vs 5.0µ, • process simulations. 4 • CF
Slide 5: Annex 1 Microbial Updates
Annex 1 Microbial Updates® Marc Glogovsky 5 | SPEEDING QC RESULTS: The Growth Direct® System for ATMPs | Rapid Micro Biosystems
Slide 6: EM Site Selection & Frequency
EM Site Selection & Frequency • Risk assessments should be performed in order to establish a comprehensive environmental monitoring program, i.e., sampling locations, frequency of monitoring, monitoring method used and incubation conditions (e.g., time, temperature(s), aerobic and/or anaerobic condi
Slide 7: Classification vs. Monitoring
Classification vs. Monitoring • Potential loss for particle sizes > 1 µm withing sampling system • Statistical limitation of low particle counts • Corresponds to removal of 5.0 µm in ISO 14644-1:2015 • Current guideline is “Not Defined”, with no need to establish maximum limits. 2020 draft states th
Slide 8: Trends & Trend Analysis
Trends & Trend Analysis • Monitoring procedures should define the approach to trending. Trends can include, but are not limited to: i. Increasing numbers of action limit or alert level breaches. ii. Consecutive breaches of alert levels. iii. Regular but isolated breaches of action limits that may ha
Slide 9: Monitoring Equipment
Monitoring Equipment • The Grade A zone should be monitored continuously (for particulates ≥ 0.5 and ≥5 μm) and with a suitable sample flow rate (at least 28 liters (1 ft3) per minute) so that all interventions, transient events and any system deterioration is captured. • Sampling methods and equipm
Slide 10: Static, Dynamic & Continuous Monitoring
Static, Dynamic & Continuous Monitoring • Viable particle monitoring should also be performed within the cleanrooms when normal manufacturing operations are not occurring (e.g., post disinfection, prior to start of manufacturing, on completion of the batch and after a shutdown period), and in associ
Slide 11: Operator Monitoring
Operator Monitoring • (V13: A risk assessment should evaluate the locations, type and frequency of personnel monitoring based on the activities performed and the proximity to critical zones) Monitoring should include sampling of personnel at periodic intervals during the process. Sampling of personn
Slide 12: Operator Monitoring (continued)
Operator Monitoring (continued) • Personnel gloves (and any part of the gown that may potentially have direct impact on the product sterility (e.g., the sleeves if these enter a critical zone) should be monitored for viable contamination after critical operations and on exit from the cleanroom • Mic
Slide 13: Utilization of RMMs
Utilization of RMMs • Limits are applied using CFU throughout the document. If different or new technologies are used that present results in a manner different from CFU, the manufacturer should scientifically justify the limits applied and where possible correlate them to CFU. • The adoption of sui
Slide 14: Compliance and Automation
Compliance and Automation 14
Slide 15: Most Common EM Inspection Findings
Most Common EM Inspection Findings • Very important to understand the limitations of EM testing • Absence of recoveries from viable monitoring does not mean absence of contamination • Often see weak or deficient EM rationales • Locations not based on process understanding • Total particle monitoring
Slide 16: "Remove the Human" "Find organisms faster"
“Remove the Human” “Find organisms faster” 2.i Facility, equipment and process design should be optimized, qualified and validated according to the relevant sections of the Good Manufacturing Practices (GMP) guide. The use of appropriate technologies (e.g. Restricted Access Barriers Systems (RABS),
Slide 17: "Continuous" Active Air sampling
“Continuous” Active Air sampling Organism Recovery MAS and SAS Samplers Extended active air sample: Compares 10 min to take 1m3 vs 4 hr to take 1m3 collection time. Organisms spiked post sampling. Gelatin filters an option? 17
Slide 18: Continuous Real Time Microbial sampling
Continuous Real Time Microbial sampling Continuous viable air samplers: • Azbil, TSI, PMS and New- Plair Rapid-C Continuous Water testing • Azbil and Mettler Toledo AZBIL (previously known as BioVigilant), 10 years trying to get acceptance! Presentations at PDA, Pharmig, Pharmalab all in 2021 18 HAS
Slide 19: Automation effect on EM test volume
Automation effect on EM test volume 19 19 | Rapid Micro Biosystems Confidential
Slide 20: Questions & Answers
Questions & Answers 20
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