Insights On Critical Environments

  1. Virus Safety For Continuous Processing 9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

  2. Advanced Cleaning Mechanisms: Cold Or Warm For Proteins? 8/28/2020

    Warm temperatures can denature some hormones and proteins thus causing cleaning problems. A critical cleaning company gives insight on how temperature can effect enzymatic and emulsifying activity in cleaning mechanisms.

  3. EU GMP Annex 1 Insights 1/15/2021

    The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

  4. Superior Biopharmaceutical Manufacturing Facilities Prioritize Cleaning & Disinfection During Design 11/20/2020

    Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

  5. Modular Bioprocessing Alleviates Drug Manufacturing Woes 4/4/2019

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

  6. How To Implement Cleanroom Upgrades While Operating Your Facility 8/9/2019

    It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are a steps to help maintain control of production and changes—and demonstrate proof of control—while keeping the involved workers and the products safe.

  7. Best Practices For Cleanroom Project Delivery And Construction 10/24/2019

    Cleanroom Design, Manufacturing and Construction. AES provides complete cleanroom project delivery with guaranteed performance. Our integrated products + solutions offering provides risk mitigation with single source responsibility.

  8. Managing Risks With Potent Pharmaceutical Products 7/2/2019

    Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

  9. Guidelines To Bring Your Biologic To Market: Are You Prepared? 4/16/2019

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.

  10. Classification, Qualification And Monitoring According To EU GMP Annex 1 Rev 12 1/15/2021

    The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The latest Annex 1 draft has some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.