Aseptic/Sterile Processing

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
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
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.
Jun 02, 2004
Pharmaceutical Technology
The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.
Jun 01, 2004
Pharmaceutical Technology Europe
The article describes the basic principles of blow-fill-seal (BFS) technology together with the advantages it offers. Although BFS technology is an ideal process for aseptic filling of liquid pharmaceutical products there is still a risk of contaminating the product inside the filling area. This, together with regulatory requirements for the microbiological control of critical areas in pharmaceutical production, makes microbiological monitoring a necessity.
May 01, 2004
Pharmaceutical Technology
Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
May 01, 2004
Pharmaceutical Technology
In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.
May 01, 2004
Pharmaceutical Technology
FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.
May 01, 2004
Pharmaceutical Technology
Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
Mar 01, 2004
Pharmaceutical Technology Europe
Hydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
native1_300x100
lorem ipsum