hm 4000 DC-VI
Rotary sealing machine for the sealing of sealable packaging.

AppCtrl – TOUCHSCREEN.

A 7” TFT touch screen and an intelligent controller in connection with the AppCtrl applications allowing to call up device and programming functions make operation and validation child’s play. The main screen can be adapted individually by the user according to his needs. The hm 4000 DC-VI is equipped with an HDMI port and can be  connected to any commercially available monitor or TV.

intuitive user guidance via
hawo’s own apps

DocLink – COMMUNICATION.

Due to the innovative DocLink communication unit the hm 4000 DC-VI can easily be linked to batch documentation and tracking systems. DocLink has four USB A and one RS 232 interfaces. An additional Ethernet interface makes the hm 4000 DC-VI network-compatible.

TraceLog – DIGITAL LOGBOOK.

The hm 4000 DC-VI is equipped with the new hawo TraceLog technology. All actions are recorded and can be viewed if required. If the DataMatic function is activated via a connected USB stick, each action is automatically copied and can then be viewed in a spreadsheet program (e.g. Excel).

ValiUp – VALIDATION.

The hm 4000 DC-VI has been fitted with the new system-integrated function to determine the optimum sealing temperature during process validation (ValiUp). This innovative tool complies exactly with the pre-set process of the international Guidance on the application of ISO 11607-1 and ISO 11607-2 (CEN ISO/TS 16775).

IntelligentScan – PROGRAMMING.

The hm 4000 DC-VI can be operated as usual with a scanner. Entering data is now even more convenient and more secure. With hawo IntelligentScan technology you can enter all the relevant device configurations, such as packaging materials, print and personnel data, as well as the print sequences beforehand, via the PC software.

hawo IntelligentScan

FontMatic – PRINTER.

The printer of the hm 4000 DC-VI is capable of not only printing the required text information, but it can also print barcodes. Make your selection via the print application. The FontMatic technology automatically adjusts the font size to match the width of the packaging. The printer is able to print international languages characters (e.g. Chinese).

SealPeak – SEAL STRENGTH.

For the sealing seam, the proven SealPeak technology is used.  hawo SealPeak sealing seams are 12 mm (0,5 inch) wide flat seams with a so called barrier of extremely high solidity at their centre, the SealPeak. The seal strength increases steadily from the edges towards the SealPeak. The advantage of these soft edges is that the product cannot break through the edges, but gently pierces them and is then caught by the SealPeak at the centre. SealPeak sealing seams also have excellent peeling properties without paper shredding, even if the user peels the pack open in the wrong direction. Thanks to the tried-and-tested hawoflex sealing technology, SealPeak sealing seams are also ideal for uncoated Tyvek^® and polyolefin packagings.

ProTrack – PROCESS TRACKING.

ProTrack is an optional technology for the holistic monitoring of the sealing process over the entire sealing seam length – a technology for highest demands. For each sealing seam the temperature, contact pressure and speed (dwell time) are monitored and recorded on a USB stick. The innovative technology can record up to 1,000 measured values within one seam (additional USB dongle required). 

GreenTek – SUSTAINABILITY.

Environmental protection and sustainability are not ends in themselves. The hm 4000 DC-VI is consistently focusing on resource-efficent design with a completely new type of sealing technology, which only needs a fraction of the energy required by similar devices. The heating works with the highly efficient 24 Volt system which reduces the power consumption to a mininum. The stand-by function and automatic shut-down, when not in use, complete the hawo‘s GreenTek concept. All this is achieved without compromising the quality of the sealing seam.

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)