BIOPROCESSING

Reliable sterilization using electron beam irradiation. 

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RADIATION STERILIZATION

A BETTER WAY TO STERILIZE BIOPROCESSING WORK MATERIALS AND INPUT MATERIALS

The importance of biotechnological research, development, and production has increased significantly since the COVID-19 pandemic. Specially, biotechnology played a central role in the development of test options and vaccines against the SARS CoV-2 virus. Bioprocessing is also used in drug production, cell cultivation and fermentation, purification of proteins and other biological substances, and various laboratory and diagnostic procedures.

Compliance with the highest quality standards is mandatory in all industrial biotechnological processes because sterile work materials and input materials are a basic requirement for achieving valid results and controlled conditions in sampling, testing, and research. These conditions are necessary to prevent microorganisms from contaminating products and endangering human health.

Radiation sterilization achieves the sterility of work materials and input materials and makes an important contribution to the quality assurance of bioprocessing activities.

FOR SENSITIVE MATERIALS

ADVANTAGES OF RADIATION STERILIZATION

Why is radiation sterilization ideal for sensitive materials?
Because it is a cold sterilization process, radiation sterilization is ideal for materials that are heat sensitive and whose chemical structure could change due to high temperatures or humidity.
What are the benefits of radiation sterilization to biotechnological products and laboratory materials?

Radiation sterilization ensures the highest hygienic standards and offers a variety of advantages for the treatment of biotechnological products and laboratory materials. Through radiation sterilization, microorganisms, bacteria, viruses, fungi, and their spores lose their reproducibility.

Another advantage of radiation sterilization is penetration ability. Work materials or input materials can therefore be sterilized in their sealed packaging.

Does radiation sterilization ensure residue-free products?

Unlike chemical sterilization methods, radiation sterilization leaves no residue. This benefit is particularly important for products that are used directly on or in the human body. After the irradiation process has been completed, the applied radiation dose is checked using dosimeters attached to the product. If all specifications are met, our quality assurance team will immediately release the product. Products can be used directly without waiting. This benefit makes sterilization with radiation, particularly E-Beam, the optimal solution for time-critical supply chains.

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RADIATION STERILIZATION

Are you interested in the sterilization or bioburden reduction of biotechnology products? We would be happy to discuss how we can irradiate your products more effectively than the technology you are using.

 

VIDEO

WHAT RADIATION STERILIZATION IS & HOW IT CAN BENEFIT YOUR PRODUCTS

STANDARD REQUIREMENTS

VALIDATION OF RADIATION STERILIZATION

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

  • Microbiological validation
  • Dosimetric validation
  • Application validation

The validation is necessary before the initial market launch, but also when a product is already on the market and its sterilization method is switched, for example, from gamma to E-Beam.

STERILIZE WITH RADIATION

BIOTECHNOLOGY PRODUCTS & APPLICATIONS

With the help of radiation sterilization, many biotechnological materials and products can be reliably sterilized. As an external service provider, BGS can support you with the sterilization of:
 

  • Work materials for handling and sampling
  • Container and dosing systems
  • Packaging material
  • Planting substrates

STERILE DISPOSABLE PRODUCTS

SINGLE-USE LABORATORY SUPPLIES FOR INDUSTRY 
& RESEARCH

Whether in the production of medicines and vaccines, cell cultivation and fermentation, or the purification of proteins and other biological substances, single-use laboratory supplies play a vital role in the biotechnological and pharmaceutical industries as well as in research laboratories. Using radiation-treated, sterile disposables during the production process reduces contamination risks to a minimum.
Among the services we provide our customers is the sterilization of:
 

  • Pipettes and trays
  • Blood collection tubes
  • Petri dishes
  • Sample containers
  • Lancets and blood gas capillary tubes
  • Test kits

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