The initial validation (IQ, OQ, PQ) is carried out on site according to the requirements of ISO 11607-2. Finally, the customer receives complete validation documentation – also according to ISO 11607-2. If the packing process has already been validated, only an annual revalidation is needed. This usually only involves Performance Qualification (PQ) which is documented in the validation documentation.
The validation of the sealing process is needed to evaluate and establish the optimum sealing temperature of the sealing material used. At this temperature, the process then has to deliver optimum seal seams that are strong enough and peelable. For validation, sealing devices that fulfil the ISO 11607-2 standard. At hawo, all sealing devices with a ‘V’ (e.g. hm 950 DC-V) fulfil these requirements. These sealing devices are supplied with a declaration of conformity to ISO 11607-2.
Raditec Medical AG is the official service partner of hawo GmbH in Switzerland.