Aseptic/Sterile Processing

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.
Apr 01, 2005
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 to assess the precision of each device.
Mar 02, 2005
Pharmaceutical Technology
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
By Pharmaceutical Technology Editors
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.
Oct 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
This article discusses the basics of sterile filter qualification and validation, with emphasis on bacterial challenge protocol development and testing. Reference is made to Technical Report no. 26 of the Parenteral Drug Association.
Sep 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
Aug 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors examine the VHP resistance of microbial isolates recovered from controlled environments and compared them with commercially available biological indicators under various test conditions.
Jul 02, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.
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