hm 3010 DC-V / hm 3020 DC-V / hm 3010 DC-VI
The validatable hm 3010 DC-V / hm 3020 DC-V / hm 3010 DC-VI rotary sealers with printer and hawo IntelligentScan are used for the automatic closing of sealable pouches and reels (Sterile Barrier Systems SBS) in hospitals (CSSD) and the medical industry. The sealing process is validatable in accordance with ISO 11607-2 as well as the requirements of the therefrom resulting specifications of the Guideline for the Validation of the Sealing Process.
These rotary sealers are distinguished by the ease with which you can navigate your way around the menu and enter data via the colour touchscreen or hs 3000 PC-PT software. Alternatively the systems can be programmed and operated easily via barcode scanner (hawo IntelligentScan).
During the sealing process, the critical parameters sealing temperature, contact pressure and sealing speed (dwell) are automatically monitored. If one of the parameters deviates from preset values, the devices warn the user acoustically and stop the sealing process. The hm 3010 DC-V / hm 3020 DC-V / hm 3010 DC-VI rotary sealers possess various PC interfaces (RS232, USB and Ethernet) for process and batch documentation. The hawo rotary sealing devices guarantee efficient and reproducible packing, especially for large volumes of instruments.
The hm 3010 DC-V, hm 3020 DC-V and hm 3010 DC-VI have an integrated printer. They can print all normatively requested information directly onto the packaging during the sealing process (symbols according to EN 980). Thanks to the patented FontMatic technology the rotary sealers automatically recognise the width of the sealing material and adjusts the font size to the available space. Printing over the edges is a thing of the past.
The hawoflex sealing system accommodates every material – even gusseted pouches and reels. Therefore a flawless, full-area sealing seam can also be achieved with materials of varying thickness. The unique design of the hawoflex-sealing seam guarantees an optimal sealing safety and seal seam strength.
Ergonomics and maintenance
Work processes in the preparation of instruments should be as simple and comfortable as possible. That is why the unit is designed for the ideal utilization of the work area. Maintenance is reduced to a minimum; worn parts are easily replaceable. The ink ribbon change is simply carried out from the front of the device.
- Integrated transport system for heavier packaging goods
- Validatable process in accordance with EN ISO 11607-2
- hawo IntelligentScan for safe and easy device operation via barcode scanner
- Interface connections for the documentation software hs 3000 PC/PC-PT and the process documentation system ht 180 PT-USB
- Connection to the most instrument management systems
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)