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Pharmaceutical Industry Cleanroom Monitoring: Viable and Non-Viable Particle Detection

... both viable and non-viable. What is a Viable Particle? A viable particle is a particle that contains one or more livingmicroorganisms. These can affect the ...

Article - admin - 2010-04-23 20:07 - 0 attachments

Instantaneous Microbial Detection

... liquid or air, and simultaneously determine whether each particle is inert or biologic, all in real time. ... liquid or air, and simultaneously determine whether each particle is inert or biologic, all in real time. The technology, developed by ...

Article - admin - 2010-04-23 18:45 - 0 attachments

Airborne Particle Monitoring: Satisfying The Changing Demands in Regulations and Methods

... consistency of sampling across the inventory of various particle counters at a user’s site through enhanced on-site calibration ... aseptic processing effort, including specifying airborne particle counts in key areas of manufacture and support. The FDA guidance ties ...

Article - admin - 2010-04-21 20:07 - 0 attachments

Detection of Microorganisms and Particulates in Controlled Environments

... 9 (See Table 5) <!--pagebreak--> PARTICLE EMISSIONS FROM PERSONNEL Gowning materials in a cleanroom are ...

Article - admin - 2010-03-29 19:02 - 0 attachments

Changes Affecting EU GMP and The FDA's CGMP Non-Viable Particle Cleanliness in Cleanrooms

... standard for calibration and verification of air particle counters, ISO 21501-4. CLEANROOM CONTAMINATION For decades, ... quality and protect patients’ lives, the non-viable particle cleanliness levels in pharmaceutical cleanrooms has been closely ...

Article - Controlled Envi... - 2010-04-29 13:06 - 0 attachments

The Status of Particle Measurement

... Kochevar, an Aerosol/Vacuum/Gas Applications Specialist at Particle Measuring System, Inc. in an interview conducted by Bartlett Bay ... Kochevar, an Aerosol/Vacuum/Gas Applications Specialist at Particle Measuring System, Inc. in an interview conducted by Bartlett Bay ...

Article - admin - 2010-04-23 18:50 - 0 attachments

The Evolution of Airborne Particle Counters

... has advanced in leaps and bounds, so too has the airborne particle counter. The first particle counters manufactured in the late 1980s and early 1990s were large, ...

Article - admin - 2010-04-21 19:54 - 0 attachments

New Considerations in High Purity Chemical Distribution

... are producing on-line analytical tools for monitoring particle concentrations and ionic contamination. These functions will be ...

Article - admin - 2010-07-01 14:04 - 0 attachments

Water Under The Bridge -- In Process Monitoring Part 1

... for example, it may be desirous to quickly test the particle count or pH of incoming process chemicals or scan the surface of a ... of fluid monitoring techniques include: Liquid particle counting pH monitoring conductivity measurement ... Out of the Cleanroom, March 2010, Contamination Control, Particle & Microbial Testing) ...

Article - Controlled Envi... - 2010-04-26 13:50 - 0 attachments

Water Under The Bridge -- In Process Monitoring, Part 2

... In and Out of the Cleanroom, Contamination Control, Particle & Microbial Testing) ...

Article - Controlled Envi... - 2010-04-26 13:44 - 0 attachments