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The role of data quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other…
Why the USP 1788 update? New flow imaging technologies and therapeutic protein solutions widened the scope of USP 1788. Three primary technologies are discussed in each of the sub-parts of the guidance document: Light Obscuration (LO) is still the preferred first-pass method for the USP Normative chapters. If a solution is…
Chemical Batch Sampling Use Case Studies #1 The SLS-20 and Chem 20 system has been tested to sample contamination down to 20 nm in chemicals ranging from sulfuric acid to organic solvents. In this blog, we will be taking a look at the following process chemicals: Sulfuric acid PGME, PGMEA…
PMS outlines the basic methods of reporting data from aerosol particle counters and understanding how to appropriately apply data conversions.
The latest Annex 1 draft offers several updated expectations on cleanroom cleaning, decontamination and disinfection. Learn about these expectations and addressing them with a contamination control strategy (CCS) Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues from a cleanroom. Decontamination The overall process of removal…
In this blog series, we take a look at common terms and initial considerations for selecting an aerosol particle monitor for various applications.
In this blog series, we take a look at common terms and initial considerations for selecting an aerosol particle monitor for various applications.