Critical Environments Columns

  1. Designing Facility Monitoring Systems For Cleanrooms 12/4/2023

    Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.

  2. A Brief Introduction To Environmental Monitoring For Startups 11/17/2023

    Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

  3. Macro Trends In Bio/Pharma Manufacturing We'll See More Of In 2024 10/16/2023

    As we get closer to the end of the calendar year, pharma/biotech manufacturers should keep an eye on the trends that will impact the industry as we head into 2024. We caught up with Laks Pernenkil, principal and life sciences product, supply, and manufacturing operations practice leader at Deloitte Consulting LLP, to discuss.

  4. Is 'Human Error' The Cause Or The Outcome Of GMP Deviations? 10/6/2023

    Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.