Aseptic/Sterile Processing

Apr 02, 2005
Pharmaceutical Technology
A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and assess the precision of each device.
Apr 02, 2005
Pharmaceutical Technology
An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.
Apr 02, 2005
Pharmaceutical Technology
The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.
Apr 02, 2005
Pharmaceutical Technology
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.
Apr 01, 2005
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.
Apr 01, 2005
A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and to assess the precision of each device.
Mar 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.
Nov 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.
Oct 02, 2004
Pharmaceutical Technology
Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.
Oct 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.
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