hm 8000 AS/AS-V SealCut
FULLY AUTOMATIC.

hm 8000 AS/AS-V SealCut.

Regardless of whether flat or gusseted reels made from paper/plastic or uncoated Tyvek^®/plastic are used, the material consumption is kept to a minimum, since the pouch length can be determined on a customised basis. The small footprint of 74 cm / 29 in and the fact that no inlet or outlet area is required on either side means that the device can be used in even the smallest of spaces.

Sealing of pre-formed
sterile barrier systems

HIGH PRODUCTIVITY.

The high production rate, which results from up to 13 cycles per minute (over 780 cycles per hour), allows film pouches to be produced cost-effectively. The extremely wide reel holder can support up to six reels of film, all of which can be used simultaneously. The machine can therefore produce almost 4,700 pouches an hour*. In seal-only mode, the pre-made pouches are conveniently sealed after filling.

* 4,700 pouches per hour based on 6 reels (pouch length 100 mm (4 in.), temperature 200°C (392°F), sealing time 1 sec., in performance mode (PER)

hm 8000 SD – OPTIONAL SORTING MODULE.

Another of the device’s advantages is its ability to sort the pouches. The hm 8000 AS/AS-V SealCut can sort the finished pouches by size, conveniently remove them, finish them, bag them or shrink-wrap them. You also have the option of adding an hm 8000 SD sorting module to the device.

Optional sorting module
hm 8000 SD (flexible adjustable)

FUNCTIONALITY.

Operation and configuration are performed either via the integrated keypad or optionally using the innovative hawo IntelligentScan system. Different formulas can therefore be pre-programmed and changed with just a ‘scan’ (e.g. pouch length 30 cm / 12 in, sealing temperature 190 °C / 375 °F, sealing time 2 sec.). An optional label printer can be connected for labelling and documentation purposes. The devices can also be connected to existing batch documentation systems using standard RS 232, USB and Ethernet interfaces.

The following processing modes can be set:

• Production mode: Pouch sealed on 3 sides are produced completely automatically.
• Seal only mode: Pre-produced pouches can be sealed on the fourth side after filling.
• Cutting mode: Pouches are precut and not sealed.

Handling via IntelligentScan

SizeMatic SCALE.

Thanks to this innovative technology, sterilisation pouches that are too long or too short are a thing of the past, since the optional scanner and SizeMatic Scale allows the length of an instrument, followed by the required number of pouches, to be scanned in. The ideal pouch length is then calculated automati-cally. SizeMatic also takes into account all of the safety distances required by applicable standards. This function is only available in the automatic pouch production device hm 8000 AS/AS-V SealCut.

SizeMatic Scale

hm 8000 WST – WELL ORGANIZED.

The new mobile and modular hm 8000 WST workstation offers the perfect workstation for the fully automatic production of film pouches. 

• Desk with manual height adjustment from 700 to 950 mm
• Pillars on the side for hanging height-adjustable consoles 
• Four castors, two of which can be locked
• Chrome-plated steel
• Height-adjustable basket with flexible compartments for the flexible sorting of produced pouches in production mode
• Hanging attachment for scanners
• Resting area for scanners
• Attachment option for scanning lists and SizeMatic Scale

Perfect sorting with
flexible compartments

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)