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ISO 11607-2 대응

IQ,OQ문서 포함

 

 

hm 780 DC-V

Microprocessor-controlled rotary sealer with printer and hawo IntelligentScan for the packaging of sealable pouches and reels (SBS) in hospitals as well as in doctors' and dentists'’ surgeries.

The hm 780 DC-V rotary sealer accomplish the sealing of sealable pouches and reels (Sterile Barrier Systems SBS) in healthcare facilities. 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. Due to a rotary speed of 10 m/min they are ideal for a high volume of instruments.

Functionality 
The hm 780 DC-V sealing device possess the newly developed hawo htr 780 Process Controller. All functions and settings are provided for the user in this central operating unit. Operation is even easier with the accompanying hs 780 PC software. It allows simple programming of the device via PC. The optional hs 780 PC-PT extension module additionally allows continuous documentation of the critical process parameters on the PC. The hm 780 DC-V can also be completely operated with a barcode scanner (hawo IntelligentScan).

Integrated Printer
Any normatively required information can be printed directly on the packaging during the sealing process (pictograms as per EN 980). Thanks to the built in FontMatic-technology the printer unit of the hm 780 DC-V automatically adjusts the printout to the film width. Thus, printing past the edge of the film is now history. A maximum of flexibility in the choice of films is guaranteed.

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.

Ecology  
During development, value was placed on a minimum use of material, reduced abrasion and low energy use. Due to the unique sealing system in the hm 780 DC-V, only 390 VA is needed, which is considerably less power than before. In addition, a stand-by function exists, which turns the motor off when not in use.

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)
  
  

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