hd 680 DEI-V
Validatable rotary sealer
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hd 680 DEI-V
The validatable hd 680 DEI-V hawo Generation Easy rotary sealer with interface connection is used in the automatic closing of sealable pouches and reels in clinics, doctors and dentists surgeries. With a sealing speed of 10 m/min, it is also suitable for use in handling high numbers of instruments in small and mid-sized medical institutions. The hd 680 DEI-V rotary sealer fulfils all necessary requirements for process validation in accordance to ISO 11607-2 as well as the therefrom resulting specifications of the World Forum for Hospital Sterile Supply (WFHSS) detailed in the ‘Guideline for the Validation of the Sealing Process’.
Quickly graspable functions and thought through solutions make perfect operation possible. Due to the patented hawoflex sealing
technology of the hd 680 DEI-V rotary sealer the device conforms to every sealing material, even HDPE (Tyvek®). The device can be fastened to the wall with a special mounting to save place. The hd 680 DEI-V provides an interface connection for external process documentation (e.g. ht 180 PT-USB, see figure) and for batch documentation systems.
NEW ValiDoc PRO labelling, documentation and packaging system
The centre piece of the ValiDoc PRO system is the validateable ValiPak PRO sealing device (hd 680 DEI-V, Version 3.0 and higher). Together with the ValiScan barcode scanner (hawo IntelligentScan technology), the sealing device is linked to the ValiPrint label printer via the PrintBox print server. No additional computer peripheral equipment is required to record important packaging information and print it onto a label. The sealing device monitors critical process parameters (sealing temperature, contact pressure and sealing speed) and alerts the user when any deviations occur. If sealing parameters are in order during the sealing process, then this is printed on the label (sealing parameters okay). If one of the parameters is not in order, then a label is printed with information corresponding to the error display. The packaging may not be used. more
Work processes in the preparation of instruments should be as simple and comfortable as possible. That's why the unit is aligned for the ideal utilization of the work area. The high quality material guarantees high durability and makes cleaning truly simple. Maintenance is reduced to a minimum; worn parts are easily replaceable.
- Validatable process in accordance with ISO 11607-2
- Sealing speed of 10 m/min
- Interface connections for external tracking systems (e.g. ht 180 PT-USB) and for the most batch documentation systems
- Sophisticated combination of the materials plastic and stainless steel
- Reproducible sealing results
- The sealing process satisfies the criteria of the EN 868-4/5.
- The device is CE certified.
- Ergonomical work processes
- Easy maintenance
- Energy-saving thanks to permanently heated sealing system and automatic stand-by function to shut off the motor when not in use
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.
- 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)
hd 680 DEI-V