The Integritest 4 Was Assessed Using Oversize Volumes to Determine Accuracy of Results Sterilizing-grade filters are designed to reproducibly remove microorganisms from the process stream producing a ...
Three key options are available for carrying out filter integrity testing and the chosen option is dependant on the filter membrane material. Test procedures for filters with hydrophilic membranes ...
PORT WASHINGTON, N.Y., April 20, 2010 - The sensitive and accurate testing of process membrane filter integrity is critical to ensuring efficient, safe pharmaceutical production and regulatory ...
The new filter tester greatly improves the detectability of operator errors, improper test set-ups and out-of-tolerance environmental conditions. It is also more reliable and easier to use than ever ...
It is a complicated and lengthy process to bring a product to market, even more so when producing a sterile product, for example, ophthalmic preparations, injections, dialysis solutions, irrigation ...
A straightforward path toward regulatory compliance, data integrity, and computer systems validation
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
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