Pharmaceutical (Human & Veterinary) Microbiological Control
STERIS Applied Sterilization Technologies (AST) offers the pharmaceutical industry’s most comprehensive array of contract sterilization services.
Gamma Irradiation of Pharmaceutical Products
- Pharmaceutical manufacturing disposables
- Prescription pharmaceuticals, ointments, and solutions
- Containers and drug delivery systems
- Active substances
- Cleanroom garments and supplies
- Labware
- Excipients
- Bulk raw materials such as talcum powder, kaolin, vegetable fiber and coloring agents
- Desiccants
Ethylene Oxide Sterilization of Pharmaceuticals
- Custom procedure trays containing pharmaceuticals
- Cellulose and plastic products that may exhibit discoloration with irradiation
- Pharmaceutical products manufactured from materials whose physical properties degrade with irradiation or heat
- Pharmaceutical products containing components that must be reclassified as drugs when processed with irradiation
STERIS Pharmaceutical Sterilization Services Advantages
- High quality, cost-effective processing
- Widespread network of sterilization facilities
- Multi-disciplinary technical staff and on-site quality assurance personnel
- Detailed certification of your pharmaceutical sterilization process
- Dedicated radiation and ethylene oxide technology centers
A wide range of applications are derived from the unique benefits that the STERIS AST processes offer. With approval by the U.K. Department of Health for sub-contract sterilization of medicinal products, and U.S. FDA regulation, STERIS AST provides international regulatory compliance with the following licences:
- U.K. MIA – Human Manufacturers & Importers License
- U.K. IMP – Investigational Medicinal Products
- U.K. ManA – Veterinary Manufacturers & Importers License
- Japanese PAL – Japanese Pharmaceutical Affairs Law
- U.S. FDA – Food and Drug Administration 21 CFR §314.420 – Drug Master Files
Why STERIS AST?
As a global leading sterilization and decontamination specialist, STERIS AST has over 40 years experience in providing safe and effective pharmaceutical microbiological control.