hd 380 WSI-V ValiPak
Validatable bar sealer (constant heated)
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hd 380 WSI-V ValiPak
The validatable, constant heated ValiPak bar sealer is used in the automatic sealing of pouches and reels (SBS) in clinics, doctors and dentists surgeries. Thanks to the compact design, they are ideal for use in small institutions. As the first sealing system in its class the ValiPak meets the validation requirements.
The sealing device hd 380 WSI-V ValiPak is the most compact device of hawo fulfilling the requirements of the process validation according to ISO 11607-2. It does not only meet the high standards of professionalism, aesthetics and reliability in medical and dental practices, but also connects as the first device in this class, the best properties of two worlds: the compact dimensions and simple handling of a bar sealer with the high packaging safety of our rotary sealers. The ValiPak is the perfect companion for the daily practice hygiene. test report
Safety guaranteed: Validation of heat sealing processes.
The safety of doctor and patient is at the forefront of all considerations. Primary objective of packing critical medical devices (instruments which penetrate the skin or mucous membrane and thus come into contact with blood, internal tissues or organs, including wounds) in medical and dental practices and clinics is the maintenance of sterility until the point of use. The international standards ISO 11607-2 and ANSI/AAMI/ ISO 11607-2 therefore explicitly call for validated processes for packing medical devices.
Sealing devices must meet the following validation requirements:
- monitoring of critical process parameters and
- warn the user in case of deviation from preset values
As the first heat sealer in its class the hd 380 WSI-V ValiPak meets these requirements. Three high-tech sensors monitor the critical process parameters (temperature, sealing time and sealing pressure) during the sealing process. If one of the parameters deviates, the user is notified acoustically and visibly via the display. Furthermore, the device has a PC interface (for process and batch documentation systems). Another safety feature is the extra wide seal seam width.
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
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.
NEW ValiDoc documentation and packaging system
At the heart of the ValiDoc system is the ValiPak heat sealer (hd 380 WSI-V) which comes with an interface for the ValiPrint label printer and intelligent ValiScan barcode scanner (hawo IntelligentScan technology). The sealing device monitors the critical process parameters of temperature, contact pressure and sealing time and alerts the user if any deviations occur. The error is indicated in the display and a label is output specifying the error. more
- Validatable process according to ISO 11607-2
- Compact design: roll conveyor and cutting device
- 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)
- Seal Check function for routine testing of the sealing seam
- PC interface connection for automatic process and batch documentation
- Short heating-up time (< 2 min)
- Less maintenance by sealing system without PTFE tape and strip heater, as well as energy efficient thanks to continuously heated
sealing 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 380 WSI-V ValiPak