hawo

hv 460 AP2-V / hv 660 AP2-V

Validatable vacuum welding machines (Impulse)

hv 460 AP2-V / hv 660 AP2-V

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hv 460 AP2-V / hv 660 AP2-V

Vacuum impulse welding machines for professional use in industry and medical industry.

The hv 460 AP2-2 / hv 660 AP2-V hawo vacuum impulse welding devices possess many features, which make the vacuum sealing, aeration and welding of thermoplastic pouches user friendly, safe and simple. The packaging process is validatable in accordance with ISO 11607-2.

Functionality
Various packaging materials can be used (see technical data for detailed information). By default, all vacuum impulse welding machines are equipped with two nozzles for even and rapid suction and gassing.

The casing is made of stainless steel and is suitable for use in a clean room. Especially the impulse vacuum welding machine hv 460 AP2-V is accredited with Fraunhofer IPA Qualification Seal and therefore suitable for use in cleanrooms fulfilling the specifications of air cleanliness class 6 according to ISO14644-1.

The vacuum impulse welding machines possess a RS 232 interface for bi-directional communication and thus to integrate into the existing infrastructure for process and batch documentation.

SealCom — optional communication module with touch screen
The intelligent SealCom communication module with 7” TFT color touch screen is optionally available for the hv 460 AP2-V and hv 660 AP2-V. In addition to the clear presentation of the monitored process parameters the SealCom automatically records and documents them. The recorded data can be further processed via USB, Ethernet or RS 485 interface. The SealCom features following functions:

  • Displays the process parameters temperature, contact pressure and sealing speed (dwell)
  • Records the process parameters in the memory and on USB stick for transfer to an external PC
  • Creation and storage of up to 50 function lists with process parameters and operating modes
  • User statistics
  • Service menu for adjustment and calibration of the machine with backup of the calibration data
  • Password-protected entries
  • Network-enabled (USB, Ethernet and RS 485)

Features

  • Validatable process in accordance with ISO 11607-2
  • Vacuuming, gas flushing and sealing of plastic bags
  • Stainless steel casing
  • Suitable for use in cleanrooms fulfilling the specifications of Air Cleanliness Class ISO Class 6 (Fraunhofer IPA)
  • Optionally available with SealCom communication module with 7” TFT color touch screen

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)
Download product brochure
hv 460 AP2-V / hv 660 AP2-V

Accessories

ht 180 PT-USB
ht 180 PT-USB
Keyfeatures
  • External process documentation
  • PC backup via USB stick
  • Compatible with all validatable hawo sealing devices ("V")
ht 780 SC SealCom
ht 780 SC SealCom
Keyfeatures
  • Displays the process parameters temperature, contact pressure and sealing speed (dwell) or sealing time
  • Plug and Understand: interactive operating guidance
  • Network-enabled (USB, Ethernet and RS 485)
  • Compatible with hawo IntelligentScan-technology