hd 480 WSI-V ValiPak TOUCH
Validatable bar sealer (constant heated)
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hd 480 WSI-V ValiPak TOUCH
The validatable, constant heated hd 480 WSI-V ValiPak TOUCH bar sealer is used for heat sealing of sterile barrier systems (pouches and reels) and is the first device from hawo which guides the user easily step by step via 4.3“ touchscreen through the qualification processses according to the validation requirements. Thanks to the compact design, it is ideal for use in in clinics, as well as dentist’s surgeries and smaller healthcare facilities. As the first sealing system in its class the ValiPak TOUCH meets all the validation requirements according to ISO 11607-2.
The process is fully validatable. With its compact dimensions and its simple handling of AppCtrl via 4.3“ touchscreen ValiPak TOUCH becomes the perfect companion for everyday infection control – with patient safety included!
Quickly graspable functions and thought through solutions make perfect operation possible. Intuitive functions and carefully thought-out solutions ensure perfect handling. The large 4.3“ touchscreen is always in the user‘s field of vision and shows all status and warning messages. The Valipaks are heated up after around two minutes, the sealing time is only around three seconds and the films can be sealed sequentially without interruption. The devices feature an integrated piece and operating hours counter. The integrated cutting device means that the best pouch length can be cut for the size of the instrument.
Using hawo’s unique control apps, all device and programming functionscan be called up directly. Thanks to AppCtrl, operation and communication become child‘s play.
ValiUp is a new, device-integrated validation tool that guides the user step by step through the qualification processes according to the validation requirements. ValiUp is unique in this class of devices!
ValiPak Touch can be connected via the integrated interfaces to process or documentation systems (e.g. ValiDoc Touch). ValiPak Touch additionally features 4 USB ports and one Ethernet interface (WLAN and bluetooth on request).
With DataMatic, all process data can be recorded on a conventional USB stick or pen drive and transferred to any computers (PC or Mac) for further data processing. Seamless documentation is therefore possible even without connecting the device to external process or documentation system.
NEW ValiDoc TOUCH Labelling and documentation system
The heart of the ValiDoc / ValiDoc Touch systems are the validatable ValiPak / ValiPak Touch sealing devices (hd 480 WSI-V and hd 380 WSI-V), which are fitted with interfaces for the label printer and a barcode scanner (hawo intelligent-scan technology). In all systems, no additional computer peripheral equipment is required to scan important packaging information and print it onto a label. Both devices can be easily upgraded to ValiDoc / ValiDoc Touch systems.
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.
- AppCtrl: Operation and communication become child's play
- Easy and safe guiding through the qualification processes via 4.3“ touchscreen
- Meets all requirements according to ISO 11607-1 (validatable process)
- Automatic monitoring of process parameters sealing time, sealing temperature and contact pressure
- Allert-function in case the preset parameter deviate
- Display of incorrect parameters on the display
- Interface for ValiScan barcode scanner and ValiPrint label printer (version 2.0)
- DocLink: PC interface connection for automatic process and batch documentation
- Short heating-up time (< 2 min)
- Integrated piece and operating hours counter
- Less maintenance by sealing system without PTFE tape and strip heater, as well as energy efficient thanks to continuously heatedsealing system and stand-by function (GreenTek)
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 480 WSI-V ValiPak TOUCH