What is Pharmaceutical Sterilization?

Pharmaceutical sterilization is the process of eliminating microbial life from human and veterinary pharmaceutical products to ensure they are safe for use. STERIS Applied Sterilization Technologies (AST) offers a comprehensive array of contract sterilization services to the pharmaceutical industry.

How are Pharmaceuticals Sterilized?

At STERIS AST, human and veterinary pharmaceutical products are processed using gamma irradiation, electron beam irradiation, X-ray irradiation, and ethylene oxide sterilization technologies.

What Types of Pharmaceutical Products are Sterilized?

At STERIS AST, we process a broad range of pharmaceutical products using radiation and gas sterilization technologies. The sterilization technology used is dependent on the unique properties of the pharmaceutical product and its packaging.

The following lists outline the pharmaceutical product ranges we process for each of the modalities:

Which Pharmaceutical Products are Processed Using Irradiation?

  • 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

Learn more about gamma irradiation, electron beam irradiation, and X-ray irradiation.

Which Pharmaceutical Products are Processed Using Ethylene Oxide Sterilization?

  • 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

To learn more about ethylene oxide sterilization: click here

Pharmaceutical Packaging

Our radiation and gas sterilization technologies are used to process a range of pharmaceutical and medical device packaging, including pouches, bags, vials, lids, and blister packs.

To learn more about our packaging solutions: click here

STERIS Pharmaceutical Processing Services Advantages

  • Global network of processing facilities
  • Multi-disciplinary technical staff and on-site quality assurance personnel
  • Detailed certification of the irradiation or ethylene oxide process
  • Dedicated radiation and ethylene oxide technology centers

At STERIS, we take our responsibility for public health and the safety of patients and providers very seriously. We strive for excellence in everything that we do – and we are committed to compliance with established legal requirements and ethical standards. Go here to learn about our commitment to regulatory, quality, and safety compliance.

Why STERIS AST?

STERIS AST has over 50 years’ experience in providing sterilization and decontamination services to the pharmaceutical industry.
For more information on “Why STERIS?”: click here

Contact us to find out more about our global contract sterilization, testing, and validation services.