Sterilization of packaging materials
Ensuring the quality and shelf life of end products through radiation sterilization
Irradiation of packaging materials: Sterile and bioburden-reduced packaging
Sterile primary packaging for the pharmaceutical industry, medical technology and biotechnology or bioburden-reduced packaging for products in the food industry: radiation treatment of packaging before filling prevents products from
- suffering damage,
- contamination,
- losing quality or
- endangering the health of users.
The bioburden reduction or sterilization of packaging materials is indispensable in many manufacturing processes in order to ensure reproducible results as well as the quality and safety of the final products. The trend towards avoiding preservatives in the manufacture of cosmetic products or food stuffs also makes effective sterilization necessary and is an active contribution to consumer protection. Various processes can be used to sterilize packaging materials. At BGS, we rely on radiation sterilization and can advise you on the most suitable technology.
Typical applications radiation sterilization: pharmaceutical primary packaging
Adherence to and compliance with standards for the sterilization of medical devices (DIN EN ISO 13485 and DIN EN ISO 11137) are also common practice for the sterilization of pharmaceutical primary packaging. One reason for this is that their task is not just limited to enclosing a product and facilitating transportation. Pharmaceutical primary packaging always comes into direct contact with the medicinal product (e.g. injectable solutions or syrups). It therefore plays an important role in how the product is stored and used. Sterilized packaging is required by law and essential for the protection of patients. Among other things, we regularly sterilize for our customers:
- Ampoules
- Pouches
- Bottles
- Cans
- Tubes
Typical applications bioburden reduction: food packaging
The irradiation of packaging for the food industry is regulated by the Food Irradiation Ordinance (LMBestrV ). Among other things, it specifies the permitted types of irradiation, cans, packaging materials and labeling requirements.
Irradiation of packaging before filling, such as bag-in-box systems for milk or wine, extends the shelf life of the contents and ensures that consumers are protected from harmful germs and fungi. In addition, sterilizing the packaging in advance prevents the introduction of germs into the bottler’s production process and prevents undesirable changes to the product. Among other things, we regularly sterilize for our customers:
- Bag-in-box systems (bibs), inliners, flexitanks
- Outlet valves made of plastic, aluminum
- Plastic capsules
- Closures (inserts, caps, plugs, rings, etc.)
We are happy to advise you
Are you interested in sterilization or bioburden reduction of packaging material? We would be happy to check your request for the irradiation of your products.
Sterility or bioburden reduction: Normative specifications are decisive
Sterility
Sterility is defined in accordance with DIN EN 556: In one million products whose sterilization has been validated using a suitable method, no more than one viable microorganism may thus be detectable. Packaging is therefore only sterile if the theoretical probability of finding one living microorganism per object is no more than 1:1,000,000.
Sterility is a legal requirement for pharmaceutical primary packaging materials that are in direct contact with the pharmaceutical form or may be exposed to it. For example, packaging materials for liquid or moist pharmaceutical forms must be sterile, as they offer ideal growth conditions for microorganisms due to the moisture they contain in a closed system. It is necessary for these packaging materials to undergo a validation process.
Bioburden reduction
If packaging is only bioburden-reduced, however, the quantity of microorganisms is below a limit that is considered safe for a particular application. With these products, the theoretical probability of finding one surviving microorganism per article after the treatment process is less than 1:1,000 (SAL 10-3).
This is particularly relevant for packaging in the food industry. Sterilized packaging reduces the likelihood of contamination with pathogenic bioburden and contributes to a longer shelf life for food. Radiation sterilization quickly and efficiently sterilizes packaging such as bag-in-box systems (bibs), inliners, flexitanks and closures, thereby complying with regulatory standards. Pathogens such as salmonella, for example, are efficiently eliminated at sterilizing doses as low as 15 kGy.
Validation process : The way to a sterile product
The validation of radiation sterilization is regulated by the standard DIN EN ISO 11137, among others. In principle, a product may only be labelled “sterile” if the sterilization process has undergone a microbiological, dosimetric and application-related validation process.
Radiation sterilization: Bioburden-reduced and sterile products – fast, safe and reliable
Various processes and technologies can be used to convert packaging into a bioburden-reduced state or to sterilize it. Treatment with gamma rays and E-Beam is one of the most common methods. Gamma rays are used particularly frequently for bioburden reduction and sterilization, and increasingly, E-Beam. Microorganisms reliably lose their ability to reproduce and die through irradiation with gamma rays and E-Beam.
The radiation technology offers several advantages: The process is free of chemicals and does not cause any significant increase in temperature during the process. As the radiation dose can be precisely controlled, radiation sterilization also offers a high level of reliability and reproducibility.
With E-Beam, individual packages can be irradiated within a few seconds. Irradiation in gamma systems takes several hours, but is often the preferred choice: this is because gamma rays are able to penetrate entire pallets or packs due to their high penetration depth. Therefore high packing densities can also be penetrated.
We treat the products in their transport packaging without contact. This ensures bioburden reduction and sterility during shelf life. After irradiation, the products are immediately checked by our quality assurance team and released. Radiation sterilization is therefore very well suited for time-sensitive supply chains.
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