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
- Bulk raw materials such as talcum powder, kaolin, vegetable fiber and coloring agents
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.
Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.