Vacuum Chamber Sealer

Brand: Hawo

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.

SKU: hv321K-V Category:

Benefits

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.

 

IntelligentScan

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).

 

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.

Specifications

TECHNICAL DATAhv 321 K-V MediVac
Mains connection400 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 H495 x 650 x 370 mm
HousingStainless steel AISI 304
Weight74 kg
Seal seam width8 mm ± 1 mm
Seal seam length400 mm
VACUUM AND GAS FLUSHING
Pump output21 m3/h
Vacuum50 – 99 %
Gas/residual vacuum50 – 99 %
Permissible inert gasesCO2, N2, CO2  + N2  + Ar
Soft ventilation10 – 99 %
PACKAGING MATERIALS
Maximum pouch size400 x 500 mm
Film made of polyethylene, polypropylenex
Film made of PVCx
Film made of peelable PA/PEx
All types of laminate, including aluminium laminatex
ELECTRONICS
Sealing systemImpulse
ControlMicroprocessor
OPERATION AND COMMUNICATION
OperationTouchscreen (optional IntelligentScan)
InterfaceUSB, RS 232, Ethernet
PROCESS VARIABLES AND PARAMETERS
Sealing temperaturemax. 210 °C
Sealing time0.5 – 10 s
Contact pressure< 200 N
Cooling temperature80 – 210 °C
Cooling time0.5 – 10 s
CONTROL FUNCTIONS AS PER EN ISO 11607-2
Process sequenceautomatic / reproducible
Process variablesmonitored
Automatic switch-off in the event of process variables deviationx
Warning function in the event of process variables deviationx

 

Note: Specifications subject to change without prior notice.

Accessories

hm 980 BR                  Barcode scanner 2D

hd ValiPrint                 Label printer

Seal Seam Test

Seal Check                       Seal check sheets for paper pouches (250 pcs per pack)

Seal Check HDPE            Seal check sheets for HDPE pouches (250 pcs per pack)

Ink Test PRO                    Dye penetration test sachet for paper pouches (30 packs per box)

Ink Test PRO HDPE         Dye penetration test sachet for HDPE pouches (30 packs per box)

Brochure

hv 321 K-V

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