hd 380 WSI-V ValiPak
THE PRO-LINE.

ERGONOMICS.

Work processes in the preparation of instruments should be as simple and comfortable as possible. The hd 380 WSI-V is therefore sloped towards the user. The work process is in this way eased and a tray is not necessary. The generous handle is ergonomically angled and guarantees an even contact pressure and thereby the maximum sealing safety as well as reproducible and constant sealing results.

FUNCTIONALITY.

Quickly graspable functions and thought through solutions make perfect operation possible. There is room for up to three roll formats side by side. At insertion, the film roll is automatically and exactly positioned. The cutting blade runs in a guiding profile and is securely parked away from the cutting area. In addition, the device can be fastened to the wall with a special mounting.

ECOLOGY.

Environmental protection and cost-effectiveness is a matter of course for ValiPak Touch. As a result, the device uses very little energy during operation and has an automatic stand-by function when not in use. ValiPak TOUCH does not use any environmentally harmful wearing parts (e.g. Teflon^® or heating belts). This reduces material consumption to a minimum.

Safe packaging.

The correct reprocessing process of medical devices consists of the steps of washing & disinfection, packaging and sterilisation. The instruments can only be called sterilised when they are packaged before the sterilisation. The single-use (!) packaging, made from laminated poly film and a porous material (Tyvek^® or medical grade paper) is permeable for the sterilisation medium (e.g. steam, plasma, Formaldehyde FO or Ethylenoxide ETO), but not for bacteria or microorganisms. Only by following this reprocessing sequence and by using professional heat sealers to seal the instruments as well as professional packaging material can the sterility up to the point of use as well as the aseptic presentation of the instrument be guaranteed.

Medical devices delivered in a sterile state should be packed to ensure that they remain sterile until the point of use. The validation of packaging processes is crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users.

The international packaging standard ISO 11607-2 as well as the Technical Specification draft ISO/DTS 16775 explain how packaging processes should be validated. The international packaging validation guideline gives guidance how to validate packaging processes. During the validation of the heat sealing process the optimum sealing temperature of the packaging materials used has to be evaluated and established. At this temperature, the process then has to deliver optimum seal seams that are strong enough and peelable.

Professional heat sealing equipment for closing sealable pouches and reels (preformed sterile barrier systems) are essential for this. hawo therefore offers sealing devices whose processes can be validated according to ISO 11607-2, the Technical Specification draft ISO/DTS 167751 and in harmony with the international packaging validation guideline. The models marked with ‘V’ feature an integrated function for regulating and monitoring process parameters – the ‘V’ is the key! Sealing devices from hawo therefore guarantee efficient and reproducible packing, even for large volumes of instruments.

Definition:

• IQ Installation Qualification:essential information is checked according to a checklist (e.g. the sealing device is compliant to ISO 11607-2)
• OQ Operational Qualification: the optimal sealing temperature has to be established
• PQ Performance Qualification: determination of the seal strength at the optimal sealing temperature determined in the OQ (after sterilisation)