Vacuum Chamber Sealer hv 321 K-V
The hv 321 K-V MediVac vacuum chamber machine in stainless steel for the evacuation and / or gas flushing of flexible plastic packaging, has been developed to address the specialist needs of the medical and pharmaceutical supplies (life sciences) as well as industrial and consumer goods. It guarantees GMP-compliant packaging in relation to packaging quality and process reliability.
Flexibility and Performance
The hawo hv 321 K-V MediVac vacuum chamber machines feature a raft of properties that make evacuation, gas flushing and sealing user-friendly, safe and easy. The 8 mm (0.3 inch) wide sealing seam as well as the individual setting options for the process variables therefore offer maximum flexibility when it comes to choosing the packaging materials, such as:
- Polymer vacuum films
- Aluminium laminate vacuum films
The housing is made from stainless steel and is suitable for use in cleanroom environments. The device has a seal seam width of 400 mm (15.8 inch).
The vacuum and gas flushing time can be adjusted independently of each other. The sealing and cooling temperature can be set individually for the selected packaging material. Precise temperature control ensures consistent quality of the sealing seam. The machines are suitable for high volume use in multi-shift operation. The sealing process can be validated in accordance with the requirements set out in EN ISO 11607-2.
AppCtrl – Touch Screen
The communications module with a 4.3“ TFT colour touchscreen has input applications developed especially by hawo that make operating the machine simplicity itself (AppCtrl). The following functions are also intuitive and easily grasped:
- Display of process parameters
- Creation and backup of 50 function lists with process parameters and operating modes
- User statistics
- Password-protected inputs
DataMatic – USB
With DataMatic, all process data (CSV format) can be saved to a USB stick, and transferred to an independent computer for further data processing.
DocLink – Communication
The monitored process variables are clearly displayed on the touchscreen, recorded by the machine, documented and can be processed further via the supported interfaces.
Operation is made even easier thanks to the hawo IntelligentScan function: individual specifications for the sealing and vacuum parameters can be programmed quickly and easily via the barcode scanner and barcode lists for the various materials. The barcode lists themselves can be generated individually using the PC-software supplied (e.g. different temperatures).
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.
|TECHNICAL DATA||hv 321 K-V MediVac|
|Mains connection||400 V / 3-phase + N + PE / 50 Hz|
|Power consumption (during the vacuum and gas-flushing process)||1,078 W|
|Power consumption (only during the sealing process)||2,800 W|
|Dimensions W x D x H||495 x 650 x 370 mm|
|Housing||Stainless steel AISI 304|
|Seal seam width||8 mm ± 1 mm|
|Seal seam length||400 mm|
|VACUUM AND GAS FLUSHING|
|Pump output||21 m3/h|
|Vacuum||50 – 99 %|
|Gas/residual vacuum||50 – 99 %|
|Permissible inert gases||CO2, N2, CO2 + N2 + Ar|
|Soft ventilation||10 – 99 %|
|Maximum pouch size||400 x 500 mm|
|Film made of polyethylene, polypropylene||x|
|Film made of PVC||x|
|Film made of peelable PA/PE||x|
|All types of laminate, including aluminium laminate||x|
|OPERATION AND COMMUNICATION|
|Operation||Touchscreen (optional IntelligentScan)|
|Interface||USB, RS 232, Ethernet|
|PROCESS VARIABLES AND PARAMETERS|
|Sealing temperature||max. 210 °C|
|Sealing time||0.5 – 10 s|
|Contact pressure||< 200 N|
|Cooling temperature||80 – 210 °C|
|Cooling time||0.5 – 10 s|
|CONTROL FUNCTIONS AS PER EN ISO 11607-2|
|Process sequence||automatic / reproducible|
|Automatic switch-off in the event of process variables deviation||x|
|Warning function in the event of process variables deviation||x|
Note: Specifications subject to change without prior notice.
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