Critical Environments Columns
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Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm
4/19/2021
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.
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Tools And Best Practices For Trending Environmental Monitoring Data
4/11/2021
Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.
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An Introduction To Trending In Environmental Monitoring Programs
4/5/2021
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
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Future Delivery Models For ATMPs: Practical Considerations
2/17/2021
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.
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9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants
2/12/2021
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
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Best Practices: Risk-Based Environmental Monitoring Of Biopharma Facilities
2/3/2021
While EM programs are one of the most effective tools in monitoring the state of control of classified manufacturing areas, designing an EM program is a relatively complex task. Facilities vary considerably and there is inadequate specific guidance on how to design EM programs and no single standard risk assessment methodology exists.
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Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues
1/8/2021
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
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Facility Design & Construction Tips For Up-Start Biotech Companies
1/4/2021
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.
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Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
12/4/2020
A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.
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Slow-Walking The Isolator: A Cautionary Tale
12/2/2020
Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.