Low-Temperature Plasma Decontamination of Pharmaceutical Manufacturing Fill/Finish Operations

Physical Sciences Inc. (PSI) has been awarded a contract from the National Institutes of Health to develop a pharmaceutical manufacturing decontamination system using the innovative PSI atmospheric pressure microwave microplasma technology.

PSI’s technology is targeted to replace the use of vapor phase hydrogen peroxide (VPHP) in parenteral drug manufacturing facilities, including barrier isolator sterilization systems and lyophilizers. The replacement of VPHP in decontaminating aseptic pharmaceutical manufacturing facilities will eliminate the significant shortcomings associated with residual VPHP following sterilization, including its deleterious effects on biotechnology drug therapies and the challenge associated with reliably monitoring part per billion (ppb) levels of VPHP in manufacturing environments. This development targets the USFDA process analytical technology (PAT) initiative for building quality into pharmaceutical products, the industry Quality by Design (QbD) initiative, and the national goal to modernize pharmaceutical manufacturing.

This technology supports increasing the availability of critical drug products like vaccines and biotechnology drugs, the fastest growing segment of the industry. Improved manufacturing technologies will ultimately reduce the costs of prescription drug products.

For more information, contact:

Mr. William Kessler
Vice President, Applied Optics

kessler@psicorp.com
Physical Sciences Inc.
Telephone: (978) 689-0003