Featured Articles
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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.
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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.
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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.
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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.
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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.
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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.
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Contamination Control Strategies For Pharmaceutical Manufacturing Environments
1/14/2021
Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.
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An Introduction To Particle Technology In Pharmaceutical Manufacturing
1/14/2021
A basic understanding of particles and particle counting to help improve your cleanliness levels. In this beginner's guide to particle technology, you will learn about the physical nature, origins and behavior of particles.