In all areas of modern life, people rely on products that are free from pathogenic germs. For medical devices and in medical diagnostics, sterility is essential.
But also in many production processes of modern industry, the sterility of raw materials as well as of working and packaging materials are indispensable in order to ensure reproducible results, consistent quality and the safety of final products. For example:
Due to globalised trading flows new challenges have emerged: Consumers expect hygienically flawless products. The sterilization with beta or gamma rays significantly contributes to consumer protection, if consumer goods are brought on to the market in countries with high hygienic standards, or if they are to be exported to countries with strict quarantine requirements.
Even under the best ambient hygiene conditions, the production of medical devices including their packaging cannot result in a sterile state. Therefore, a separate sterilization step is always necessary. For decades now, BGS has taken on the responsibility for this sensitive process – from industry packaging materials and consumables to highly sensitive medical devices such as endoprostheses and implants.
Sterility means that a product is free from microorganisms capable of reproduction. This is only possible to a limited extent in technical manufacturing processes. Therefore, the standard EN 556 defines a medical product as “sterile”, if the theoretical probability of finding a replicable microorganism on a product is less than one to 1,000,000 (Sterility assurance level: SAL 10-6).
In the microbiological validation the radiation dose is determined which will convert a non-sterile product into a sterile one. Therefore, the initial microbiological state – number and nature of microorganisms – is specified. For such validation, we work in close cooperation with accredited microbiological laboratories that identify the bioburden on the products. Based on these results and our consulting, we specify the parameters for the ionizing radiation together with you in order to achieve the desired sterility result. We also take on the revalidation (dose audits) of your products in cooperation with these laboratories and guarantee that your process meets the current requirements and standards.
Dosimetric validation ensures that the determined dose with the specified packaging and stipulated packing scheme is adhered to in all areas. In this regard, intensive tests are conducted and documented to ensure that your product fulfils the requirements for a sterile product after the radiation. We will accompany and advise you in the development and definition of your products and packing schemes, prepare reports and dossiers for the radiation in accordance with the current regulatory requirements and standards.
The manufacturer verifies whether the sterilised product fulfils the required properties profile beyond the best before date, whereas the packaging material is to be included. Since the construction materials are decisive for the applicability of radiation sterilization, our experts will be happy to advise you already in the product development stage.
Materials have different resistances to radiation due to their chemical properties. Radiation may cause chemical reactions in the treated materials. Accordingly, it is highly relevant to determine any possible changes in the product or in its packaging. The changes range from slight colour changes to changes in the internal structure which may have negative effects on the function of the materials. Our experts will be happy to advise you already in the development stage in order to make allowance for optimal materials.