Featured Articles

31. Steps To Ensuring A Successful Audit: Effective Risk Assessment Design 4/29/2021

    When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination. The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented. There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.

32. Microbial Control And Monitoring In Aseptic Processing Cleanrooms 4/27/2021

    Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.

33. Considerations And Steps For Building A Contamination Control Strategy 4/22/2021

    Contamination control strategies (CCS) are designed to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources all the more important. Learn how to create an effective CCS.

34. Techniques To Understand And Mitigate Variability In Aerosol Particle Measurement Applications 4/22/2021

    Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively.

35. Viable And Non-Viable Environmental Monitoring To Meet USP 797 1/15/2021

    The USP 797 requires sterility of all Compounded Sterile Products (CSP). Environmental Monitoring is an essential component to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. Learn more about what viable and nonviable monitoring involves.

36. A Guide to Annex 1 Requirements For Particle Monitoring 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.

37. 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.

38. A Practical Guide To Aerosol Particle Counter Matching 1/15/2021

    This short application note provides a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.

39. Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations 1/14/2021

    Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.

40. Contamination Control Strategies For Pharmaceutical Manufacturing Environments 1/14/2021

    Many GMP standards recommend sampling process gases for contamination before use in critical manufacturing areas. Read on to learn about relevant regulatory requirements, microbial survival, and more.