Clinical Trials Feature Articles
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White Paper: Improving Water System Performance: A Continuous TOC Measurement Technology To Enhance Real-Time Process Control
2/20/2008
White Paper: Improving Water System Performance: A Continuous TOC Measurement Technology To Enhance Real-Time Process Control
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Building Safety Into Isolator Controls Systems
As isolators become more customized to meet the requirements of specific Pharmaceutical processes, the controls systems have been challenged to provide more safety and flexibility.
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ISO 21501 — An Optical Particle Counter Calibration Standard And What It Means To Cleanroom Owners
ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the life science industry with the increasing trend for real-time air particle monitoring in cleanrooms using light scattering air particle counters.
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Cleaning Validation References For Pharmaceutical Manufacturing And Medical Device
A cleaning validation involves testing for acceptable residues on pharmaceutical manufacturing or medical device surfaces. This procedure is used to document acceptable residues three or more times and then a rational monitoring program to maintain a validated state is put in place.