Manufacturing

Articles

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.

Design of an Aseptic Process Simulation

Robert R. Reich is the president of PSI, 909 Orchard Street, Mundelein, IL 60060, tel. 847.566.9229, fax 847.566.4960, rreich@pharmsystems.com

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.

Vapor-Phase Hydrogen Peroxide Resistance of Environmental Isolates

Berit Reinmuller is a senior researcher in building services engineering at Kungl Tekniska Hogskolan, SE 10044 Stockholm, Sweden, tel. +46 8 790 7537, fax +46 8 411 8432, berit.reinmuller@byv.kth.se. She is also a consultant for the cleanroom industry.

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.

The LR Method in Critical Areas: Airflow Patterns and the Design of Aseptic Interventions

Anthony M. Cundell is the director of microbiological development and statistics, Global Quality Technology, at Wyeth Pharmaceuticals, 401 N. Middletown Road, Pearl River, NY 10965-1299, tel. 845.602.2497, cundela@wyeth.com

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.

Microbial Testing in Support of Aseptic Processing

Elmar Herbig is a product manager at Sartorius AG, Weender Landstrasse 94â108, Dâ37075 Goettingen, Germany. Tel. +49 5513 083 629 elmar.herbig@sartorius.com www.sartorius.com

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.

Monitoring Airborne Micro-organisms in Blow-Fill-Seal Technology

Brian Wallace is a senior applications chemist at Teledyne Instruments, 4736 Socialville Foster Rd., Mason, OH 45040, tel. 513.229.7068, fax 513.229.7050, brian_wallace@teledyne.com.

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.

Implementing Total Organic Carbon Analysis for Cleaning Validation

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

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.

Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.

The Future of Aseptic Processing?An Update

David Hussong, PhD, is a microbiologist at FDA's Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 5600 Fishers Lane, Rockville, MD, 20857, tel. 301.827.7490, fax 301.827.3084, hussong@cder.fda.gov.

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.

Analysis of Environmental Microbiology Data from Cleanroom Samples

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.

Aseptic/Sterile Processing