New Challenges to the Cleanroom Paradigm for Multi-Product Facilities - Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a cont

ADVERTISEMENT

New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.


BioPharm International
pp. 38-47

CONCLUSIONS

As the industry challenges past assumptions and approaches, evolving technologies and operational practices are enabling lower cost and more flexible facilities while the highest standards of product quality and patient safety are maintained. The understanding of what it takes to achieve and demonstrate closed- and functionally closed systems is allowing ballroom or open-production halls to be employed so that build costs and ongoing operating expenses are lower. Risk-management strategies are being rigorously used to eliminate and mitigate potential product contamination from planned and unplanned breaches in multi-product concurrent production scenarios.

The reliance on clear and well thought out design and operating principles has been described. These key design and operating requirements include procedural controls, spatial and temporal segregation controls, and increased use of automation. The additional complexity and reliance on human factors from logistical segregation as opposed to physical segregation has been discussed. The added importance of contamination detection and control has been set out.

Not all considerations suggested are applicable in all situations, and many options exist within current and new facility designs to adopt these concepts. However, opportunities do exist to reduce area classification for specific operations or the consolidation of manufacturing processing areas to gain the benefits of flexible, low-cost biomanufacturing.

ACKNOWLEDGEMENTS

The authors would like to thank Marc Pelletier (CRB Engineers) who is leading initiatives via the ASME BPE and ISPE for helping us with the definitions section and for providing valuable comments generally. They would also like to thank Steve Buchholz (Gallus Biopharmaceuticals), Martyn Becker, Joe Rogalewicz (GSK), Beth Junker (Merck) and Teresa Feeser (BMS) for providing feedback on the draft.

Simon Chalk is director, BioPhorum Operations Group,
; Scott Probst is group head, healthCare and biotechnology, technology development, process design and optimization, Bayer Technology Services; Ken Green is director, global manufacturing services, Pfizer, Inc.; Russell Moser is validation manager, Janssen Biopharmaceuticals; Frank Urbanski is director, global engineering, Pfizer Inc.; Matthew Zicaro is an HVAC engineer; Paul Smock is senior director, technical quality, MedImmune; Larry Pranzo is associate director architect/engineer, global engineering, Merck; Liz Dooley is engineering director, Janssen Supply Chain, Ireland; Phil McDuff is senior director, Engineering, Biogen Idec.

REFERENCES

1. Chalk, S., et.al., BioPharm. Intl. 24(8) (August 2011).

2. ICH, Q9 Quality Risk Management (ICH, November 9, 2005).

3. ISPE, GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (ISPE 2007).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here