Heat Sealer Validation

Your heat sealer must be operating as it should be. A poor seal compromises the sterility of the contents inside the heat-sealed pouch. Devices that are not adequately sterilized lead to Surgical Site Infections (SSIs), harming the patient.

There are preventative steps to avoid SSIs. In addition to providing to our customers Hawo high-quality heat sealers, the company has different ways of monitoring the integrity of your heat sealed pouch. The Ink Test PRO, Ink Test, Seal Check are ways of checking the quality of a seal. Moreover, organizations can combine one or more of the Test Systems carried out by one of our in-house, Hawo trained engineers.

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Heat Sealer Validation

As part of our Heat Sealer Validation (ValiSeal), the initial validation (IQ, OQ, PQ) is conducted locally (e.g., in the CSSD3) according to the requirements of ISO 11607-2. The customer obtains complete validation documentation. Only an annual revalidation is required if the packing process has been validated before.

The heat sealer validation is required to assess and confirm the optimum sealing temperature of the sealing material used. The process determines the delivery of optimum seal seams strong enough and peelable at this temperature.
For validation, heat sealing devices must fulfill the ISO 11607-2 standard. All Hawo heat sealing devices with a ‘V’ (e.g., hm 950 DC-V NanoPak) meet these requirements. A declaration of conformity can be provided on request for older heating sealing systems (e.g., hm 850 DC-V).