Critical Environments Featured Articles
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New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters
9/11/2023
The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.
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Replacing Bleach In Removal Of DNA
8/8/2023
Learn about an effective cleaning solution that removes DNA from laboratory equipment and materials without the need for bleach.
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Cleaning Proteins, RNA, And DNA From Laboratory Equipment
8/8/2023
Learn about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.
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Navigating The Pros And Cons In Annex 1’s PUPSIT Requirements
7/12/2023
Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.
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Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters
6/28/2023
ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).
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All You Need To Know About Contamination Control Strategies, Part 2
5/22/2023
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.
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Let’s Explore Packaging For Aseptic Manufacturing
5/19/2023
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
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All You Need To Know About Contamination Control Strategies, Part 1
5/12/2023
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
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5 Characteristics Of The Automated Microbiology Lab Of The Future
4/24/2023
The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.