Aseptic/Sterile Processing

May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.
May 01, 2005
Pharmaceutical Technology
The complete elimination of human-derived contamination is possible only with the elimination of human intervention.
May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.
May 01, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
New technologies and improvements to existing ones can reduce contamination risk in aseptic processing.
Apr 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.
Apr 02, 2005
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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
By Pharmaceutical Technology Editors
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
By Pharmaceutical Technology Editors
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
By Pharmaceutical Technology Editors
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.
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