In an effort to prevent harm through contamination, the U.S. Pharmacopeial Convention has been working on a series of proposed changes to USP Chapter 797, Pharmaceutical Compounding– Sterile Preparations.
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Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
The Lasair III Particle Counter sets the standard for portable aerosol particle counters, and fully meets the requirements of ISO 14644-1 (including the new 2015 revision) and ISO 21501-4.
Application note: FacilityPro® Environmental Monitoring Systems – Data Processing and System Control
The FacilityPro® processor provides the central hub for an environmental monitoring system.
The MiniCapt Portable Microbial Sampler enables collection of biocontamination samples throughout cleanrooms and clean air facilities.
Keynote speakers announced for Lab Innovations 2019.
Video: The swab with its own culture broth reservoir, minimizing the risk of secondary contamination due to handling
The ICR Swab is a unique system for environmental monitoring of dry surfaces, such as filling needles, equipment recesses, uneven surfaces and tubing in clean rooms and isolators.
Particle Measuring Systems releases the new Pharmaceutical Net® Pro Environmental Monitoring Software for FacilityPro® Environmental Monitoring Systems.
Connect 2 Cleanrooms (C2C) and Elis Cleanroom have signed a partnership agreement on 18 May to further strengthen the contamination control solution packages offered to their customers.
Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…