BLOG: The Data Quality Concept for Pharmaceutical
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…
BLOG: USP 788 vs 1788: How do They Compare?
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…
BLOG: Chemical Batch Sampling to 20 nm with the SLS-20
Chemical Batch Sampling to 20 nm with the SLS-20 Sulfuric acid particle counters have special obstacles to overcome including background scatter, laser safety, bubbles, leaks, etc. All those topics are covered in detail in the paper, 20 nm Chemical Batch Sampling Solution. The SLS-20 and Chem 20 sampling system is…
Cleanroom Cleaning & Disinfection Per Annex 1, rev 12
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…
