Manufacturing Process Control
Bio-Safety
Environmental
Validation
Equipment
Materials
Facilities
Biomass
Terminology
Biological Systems Characterization

Standards for Materials, Products, Systems and Services and the Promotion of Related Knowledge

Invitation from the Chairman
Manufacturing products using living organisms in the process makes ASTM Committee E48 on Biotechnology unique to all other ASTM committees. E48 is chartered to develop special test methods, practices, guides, and terminology standards for use in this emerging industry. The scope of activity extends from identification of biological materials to GMP process validation and includes issues of Biosafety, environmental and process equipment design.

Committee E48 has membership from industry, research institutions, government and academia. This balance of interests is important to the development of high quality voluntary consensus standards. About 40 standards have been published by E48 and many more are under study now. Cooperative effort is international with such countries as Japan, Netherlands, and Germany.
We have liaison members with other standards organizations such as DIN, ASME, ISPE, etc.

We invite you to bring your expertise and technical knowledge to the E48 Subcommittees where these standards are prepared with the goal of benefiting your industry. We invite you to attend our next meeting. Contact ASTM for dates and locations of future E48 meetings. There is no fee to attend and membership in ASTM is not required.

G. Larry Eitel
Chairman, ASTM Committee E48
303-966-4475

What is ASTM Committee E48E48 is a dynamic group of more than 100 scientists, engineers, manufacturers, researchers, government representatives and members of the private sector who apply their knowledge to develop standards in biotechnology. The topics represented in the seven technical subcommittees are:

Biosafety: includes new approaches for employee health and safety protection from materials used in biotechnology such as media, solvents and organisms. Subcommittee plans to develop a generic "Safety Action Plan" that can be customized for biotech operations. For additional information contact Subcommittee Chairman: Tom Vegella, FDA, 301-827-0346.Characterization and Identification of Biological Systems: test methods for plasmids, cell cultures, viruses, bacteria, fungi and tissues. Includes determination of purity and contamination in biological drug products. Also standardizes preservation methods for biological materials. PCR test methods and guides to meet FDA in-vitro diagnostics requirements. Contact Subcommittee Chairman: Larry Bockstahler, FDA, 301-443-7287.

Unit Processes and Their Control: test methods, guides, practices for aseptic sampling, fermentor/bioreactor design, membrane ultrafilter characterization, protein size determination, biosensors and bio-specific equipment. Contact Subcommittee Chairperson: c/o Larry Eitel, Jacobs Engineering, 303-966-4475

Environmental Issues: develop guides to decontaminate biological process fluids and equipment, containment, safety equipment to avoid bio-material losses, clean rooms, environmental monitoring inside and outside fermentation plants and bioremediation. Contact Subcommittee Chairman: Stephen Frost, Jacobs Engineering,

Biomass Conversion: test methods for characterizing wood, grasses and other cellulosics. Includes test methods and practices for converting cellulose feedstocks to fuels by enzymes, yeasts and pyrolysis. Contact Subcommittee Chairman: Foster Agblevor, Virginia Polytechnic Institute

Biotechnology Equipment Qualification and Process Validation: test methods, guides, protocols, practices for qualifying equipment and validating manufacturing processes to meet cGMP guidelines in biological processes. Contact Subcommittee Chairman: Mike Zdanowski, Valcor Associates, 913-268-2737

Terminology: established standard terminology for biotechnology. Contact Subcommittee Chairman: Larry Eitel, Jacobs Engineering, 303-966-4475