Gamma radiation - We guarantee workflows that are gentle on the product
In our modern society, people rely on products being free of pathogenic microorganisms. Sterility is especially essential for medical devices and diagnostics.
Gamma sterilisation is the method of choice for a wide range of products. In addition to medical devices, gamma sterilisation is also used for medicine, pharmaceutical packaging, packaging materials and laboratory items.
Even when taking the greatest care and under the best hygienic conditions, it is impossible to achieve completely sterile products in the manufacture and packaging of medical devices. Therefore, a terminal sterilisation step in the final packaging is essential.
- Your advantages as a BBF steriXpert customer
- Plant description
- Validation of gamma sterilisation
- Notes and orders
- Contact persons for irradiation service
Your advantages as a BBF steriXpert customer
At BBF Sterilisationsservice GmbH, we have been responsible for the sensitive process of gamma sterilisation for our customers for 50 years. Our sterilisation system is the first plant in Germany that has been used for commercial purposes. Our customers enjoy a number of advantages, such as:
- Sterilisation through gamma rays allows processes that are gentle on the product: Product sterilisation in the final packaging (no contamination through subsequent packaging steps)
- Cost efficiency by means of flexible supplier forms (single boxes or pallets)
- Temperature-sensitive or frozen products can be sterilized on dry ice
- Standard lead times of approx. three days from delivery to shipment.
- Overnight express service for especially urgent products
- Parametric release of the product possible by means of our dose certificate
- Immediate availability after sterilisation, no quarantine time, no capital lockups
- Shipment of your products to the desired address
- Irradiation of pharmaceuticals according to AmRadV with a maximum dose of 32 kGy (on request)
- Tote box system enables exact irradiation dose (narrow dose range defined by minimum and maximum dose)
- Custom determination of the maximum dose possible
- Determination of dose distribution (dose mapping) for validation of irradiation process can be done at any time
- Residue-free sterilisation
Our plant is a carton system or tote box system in contrast to the widely available pallet systems.
This allows us to offer our customers maximum flexibility and cost efficiency as both individual cartons and pallets can be delivered to BBF and irradiated by us.
Our plant is perpetually inspected by the FDA and monitored by the responsible regional council. We have a GMP certificate and a GMP production permit. All product relevant processes of the plant have been validated according to the ISO 11137 standard.
It is possible to have your goods irradiated in aluminium boxes with internal dimensions of 530 x 435 x 850 mm (LxWxH) or in standard sterilisation boxes with internal dimensions of 548 x 448 x 438 mm (LxWxH). The standard sterilisation boxes can be ordered from us. Our radiation source is a Cobalt 60. The system’s setup allows exact radiation doses with low scattering to be achieved.
We offer irradiation at > 25 kGy as a standard cycle.
Regular special cycles running in our plant are: > 22 kGy, > 16 kGy, as well as other special cycles on request.
Validation of gamma sterilisation
The validation of the gamma sterilisation is subdivided into:
In addition to the application-technical validation and dose distribution measurement, gamma sterilisation also requires the validation of microbiological sterilisation.
This is the minimum irradiation dose required to bring the product into the sterile state. The initial microbiological state - number and type of microorganisms - is determined for this purpose. On the basis of the initial state, a certain dose, the verification dose, is determined. The products are irradiated with this verification dose and then tested for sterility. If the verification dose has been successfully verified by the sterility test, the sterilisation dose shall be confirmed. In doing so, it can be guaranteed that the validated sterilisation dose reaches a Sterility Assurance Level (SAL) of 10-6.
The sterilisation validations in our company are based on the following standards: ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2 and EN 556.
As far as possible, we recommend the so-called VDmax25 method and method I. The VDmax25 method is suitable for the validation of sterilisation with a minimum dose of 25 kGy (the usual method) and a bioburden of not more than 1000 CFU/product unit.
Method I, which is also widely used, is suitable for determining a minimum irradiation dose necessary for successful sterilisation. With this method, lower sterilisation doses can be achieved with demonstrably low microbial count, which are gentle on the product.
Revalidation / dose of gamma sterilisation audits
In addition, we offer our customers sterilisation dose testing to prove consistent efficacy by means of a typically quarterly revalidation (dose audit). Compared to microbiological validation, we only need a fraction of the test sample here. The dose audit consists of a microbial count determination (bioburden determination) and a check of the verification dose determined in the validation.
Special requests regarding gamma sterilisation
At the customer's request, individual batch validations and VDmaxSD methods in accordance with ISO 13004 can be carried out in our company.
Building on our numerous years of expertise, we can advise you comprehensively on the selection of the most suitable validation method for your product at any time.
The determination of the dose distribution ensures that the determined dose is adhered to in all areas with specified packaging and packing arrangement. For this dose distribution measurement / dose mapping, a large number of dosimeters are attached to the sterilisation unit as shown in the figure. These dosimeters can be used to determine the product-specific minimum and maximum doses as well as the permissible dose range at the routine measuring point.
The manufacturer must check whether the sterilised product fulfils its property profile beyond the expiry date. The packaging material must be included in this. The materials selected for the product are considered to be decisive for the application of radiation sterilisation. We will be happy to advise you on this during product and packaging development. An initial overview in the form of publications about the procedure can be found on the homepage of the Gamma Irradiation Panel. If you have any questions regarding the compatibility of your material with gamma radiation, please contact our contact persons. We generally recommend our customers to conduct a trial sterilization to determine the maximum tolerated radiation dose.
Notes and orders
In order to guarantee a smooth process and the safety of your products during irradiation, we provide you with packaging material specially adapted to our system.
We use standard sterilisation boxes for the irradiation, which you can purchase from us. To spread and secure your products within the standard sterilization box, you can use two A-boxes or four B-boxes.
If you already have your own packaging material and it is not possible to switch to our packaging material, we recommend an irradiation in our aluminium boxes with internal dimensions of 530 x 435 x 850 mm (LxWxH).
Packaging information for standard sterilisation boxes
Click on the image or the following link to download the packaging information as a pdf.
Your contact persons
Should you have any questions about our services, please do not hesitate to contact us.