Sterility
PET Power offers customers an irradiation process to assist in bringing a sterile product to the market. Manufacturers, particularly in the pharmaceutical sector, set extremely high standards of hygiene. At the end of the production process, PET Power, which has a Class 7 Cleanroom available, packs products in special hermetically sealed foil if required. It must certainly be made clear that PET Power assists in achieving sterility. Final responsibility lies at all times with the customer, who in the end fills the products, transports them, packages them, and places them on the market.
 What is irradiation?
Irradiation is exposing a hermetically sealed packaging to gamma radiation. This kind of radiation is not sufficient to make a product radioactive, just as the waves in a microwave oven do not do that to deepfrozen foods. However, gamma radiation does halt cell division processes caused by any residual bacteria. This treatment is fatal to these undesirable micro-organisms. The final result is regarded as 'sterile'.
 Irradiation process
The dose of radiation applied depends on the product and the contamination level at the beginning of the process. A dose of 25 kiloGray (kGy) is standard. PET Power provides the entire process from transport to and from the irradiation facility to the irradiation itself, and furnishes the relevant documentation. Products receive a Certificate of Irradiation, on which the data of those involved and the dose applied are indicated. A guided tour of the service provider is possible. PET Power also submits the relevant quality certification and schedules an audit if so required.
 Laboratory services (1)
As noted, the extent of the radiation depends on the product and the level of contamination. Those involved must first determine the appropriate method, as well as the required dose and the parameters of the process. PET Power will assist the customer in this process, beginning with determining the level of contamination. This takes place by means of microbial analyses, carried out by a certified lab. Then the dose. What is sufficient? Analysts determine this on the basis of an official method acknowledged by government bodies: ISO 11137. Several samples are treated and analysed in this process. Important: during the subsequent phases of the process, experts test the analysis constantly for validity. The treatment must remain effective, so the starting point for product and product configuration must be the same. The lead time of the complete process, supported by PET Power, can be up to 13 weeks. An independent laboratory sends the results of the tests directly to the customer.
Laboratory services (2)
In the case of foodstuffs in particular it is important that the packaging does not spread any substances into the contents of the bottle or jar. This process is called migration. A test of whether this does in fact not take place is a second laboratory service offered by PET Power. It tests this for the raw materials used by means of three reference materials and makes the results available if so required. PET Power also provides specific testing to screen customer's individual products. |
