hv 300 K-V MediVac
Vacuum chamber machine with touch screen
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hv 300 K-V MediVac
Vacuum chamber machines in stainless steel for the evacuation and / or gas flushing of flexible plastic packaging. The hv 300 K-V MediVac vacuum chamber machine 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. 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.
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. Functions like Display of process parameters, recording on USB stick, creation and backup of 50 function lists, user statistics and password-protection are also intuitive and easily grasped.
IntelligentScan – Programming
Operation is made even easier thanks to the hawo Intelligent-Scan 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 software supplied (e.g. different temperatures). hawo IntelligentScan
DataMatic – USB Data Transfer
With DataMatic, all process data can be saved to a USB stick, and transferred to an independent computer for further data processing.
DocLink – Communikation
The monitored critical process parameters are clearly displayed on the touchscreen, recorded by the machine, documented and can be processed further via the supported interfaces.
Flexibility and Strength
The hawo hv 300 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 critical process parameters therefore offer maximum flexibility when it comes to choosing the packaging materials, such as Polymer vacuum films and 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).
VALIDATION ACCORDING TO EN ISO 11607-2
The EN ISO 11607-2 (ANSI/AAMI ISO 11607-2) standard requires packaging processes of medical devices to be validated. When it comes to sealing, the critical process parameters must be monitored routinely. The new CEN ISO/TS 16775 provides guidelines for how to carry out process validation. During the validation of the sealing process, the parameters are determined for the packaging material being used. The process must then deliver the perfect sealing seam with these parameter settings. Professional sealing devices are therefore essential for the proper closure of medicinal device packaging. The hv 300 K-V MediVac vacuum chamber machine has an integrated function for monitoring critical sealing process parameters and therefore meets the standard requirements.
- Suitable for use in clean room
- Validatable sealing process according to EN ISO 11607-2 and the international guidance ISO/TS 16775
- Data transfering on USB-Stick
- Touch screen
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)
hv 300 K-V MediVac