Sterilization for biotechnology

Treatment with radiation: Sterilization of biotechnological working materials and input materials

The importance of biotechnological research, development and production has increased significantly in the public consciousness since the pandemic years: Biotechnology played a central role in the development of testing options and vaccines against SARS CoV-2. Biotechnology is also used in drug production, cell cultivation and fermentation, purification of proteins and other biological substances, as well as various laboratory and diagnostic procedures.

Compliance with the highest quality standards is mandatory to all industrial biotechnological processes:

• Sterile working materials and consumables are a basic requirement for valid results.
• Controlled conditions for sampling, testing or research must be ensured and contamination of the products with microorganisms must be prevented.

Radiation sterilization guarantees the sterility of working materials and input materials and thus makes an important contribution to the quality assurance of biotechnological products.

Normative requirements: Validation Process for biotechnology products

If biotechnological products or laboratory materials are labeled as sterile, they must be validated before being placed on the market or used. The validation of radiation sterilization is regulated by the standard DIN EN ISO 11137.
The validation process consists of three parts:

• Microbiological validation
• Dosimetric validation
• Application validation

This required for the market launch of a product, the qualification of a second system or a second supplier while retaining the selected sterilization process. A new validation process is also necessary when changing from an established sterilization method to another, for example from gamma to E-Beam.