hm 950 DC-V NanoPak
VALIDATABLE ROTARY SEALER WITH TOUCH SCREEN.

AppCtrl – TOUCH SCREEN.

NanoPak is hawo’s most powerful heat sealer. Below the lid is a high-end processor to ensure that NanoPak can deliver top results over a long time period. A 4,3 inch touch screen and the Linux operating system together with the AppCtrl user applications, which allow you to call up instrument and programming functions, make operation and validation child’s play. Saving function lists makes it possible to store various sealing parameters, print settings and print orders. All settings are changed at the touch of a button by selecting the desired list.

Intuitive user guidance via
hawo’s own apps

DocLink – COMMUNICATION.

Due to the innovative DocLink communication module NanoPak can easily be linked to batch documentation systems. DocLink has USB A/B and RS 232 interfaces. An additional Ethernet interface makes NanoPak network-compatible.

DataMatic – USB DATA TRANSFER.

Thanks to DataMatic technology all data can be continuously recorded on a standard USB stick. 

FontMatic – PRINTER.

NanoPak‘s new printer is capable of not only printing the required text information, but it can also print bar codes. Make your selection via the print application. The FontMatic technology automatically adjusts the font size to match the width of the packaging. hm 950 DC-VI Version comes with an additional new printig unit, which is able to print international language characters (e.g. Chinese) and logos.

SealPeak – SEAL STRENGTH.

hawo SealPeak sealing seams are 12 mm wide flat seams that have a barrier with excellent stability in their centre - known as the SealPeak. The seal stability increases constantly from the outsides towards the SealPeak. These soft edges have the advantage that instruments do not break out at the edges, but instead press gently into the seam and are caught by the SealPeak in 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. 

TraceLog – DIGITAL LOGBOOK.

The NanoPak is equipped with the new hawo TraceLog technology. Actions of the switched-on device are recorded and can be viewed if required. If the DataMatic function is activated by a connected USB stick, on every date change or device switch-off the data of the logbook (tests carried out, operator logon and logoff, selected packing lists, device configurations carried out, maintenance dates carried out and much more) are automatically copied and can then be viewed in a spreadsheet program. 

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)