Manufacturing

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

Articles

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FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative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.

The Relationship between Saturated Hydrogen Peroxide, Water Vapour and Temperature

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.

Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

Organic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.

Aqueous Cleaning and Solvent Substitution in Chemical Synthesis API Manufacturing

Jeff L. Folks is director of business development at Quintiles (Kansas City, MO).

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Aseptic Formulation and Filling Using Isolator Technology

When planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.

Aseptic/Sterile Processing