Pharmaceutical Technology-05-01-2012

Pharmaceutical Technology

Pharmaceutical Technology, Bioprocessing Supplement 2012 (PDF)

May 01, 2012

Issue PDF

2012 Supplement

3

Bioprocessing and Sterile Manufacturing

Parametric Release and Real-Time Release Testing

May 01, 2012

Articles

2012 Supplement

3

Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.

A More Rational Approach for Sterile Product Manufacturing

May 01, 2012

Articles

2012 Supplement

3

The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.

Using Closed-Vial Technology in Aseptic Filling

May 01, 2012

Articles

2012 Supplement

3

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

Biological Indicator Growout Times: The Impact on Establishing a Reduced Incubation Time Protocol

May 01, 2012

Articles

2012 Supplement

3

The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.