Critical Environments Featured Articles
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A Practical Guide To Navigate The EU's Revised GMP Annex 1
9/9/2022
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
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Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
8/31/2022
Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.
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The Environmental Impact Of Biopharma Continuous Manufacturing
8/8/2022
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
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Mold Investigations Using Biofluorescent Particle Counting Systems
6/27/2022
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.
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AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs
5/31/2022
Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.
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Calculating Process Capability Of Cleaning Processes With Partially Censored Data
5/19/2022
When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or "left-censored" data. There are basically two broad classes of methods that are applied to left-censored data: Substitution and Estimation. This article explores these methods for use with cleaning sample data when some of the points are below the DL.
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How To Evaluate & Manage Safety Risks In Biopharma
5/2/2022
Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).
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Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions
4/14/2022
Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.
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Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility
4/8/2022
As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.
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Key Considerations For cGMP Building Conversions
3/16/2022
As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.