ValiDoc
ValiDoc TOUCH

SAFETY AND PERFORMANCE.

hawo ValiDoc

The hawo ValiDoc and ValiDoc TOUCH are documentation, labelling and packaging systems for safe and professional reprocessing of medical devices in hospitals as well as doctors’ and dentists’ surgeries.

Regardless of whether it’s sealable pouches or reels, wrappable sterilization sheets or reusable containers, this systems help medical professionals meet the packaging inspection and labelling requirements. They include sterilization control using a process indicator along with a formal approval as well as documentation for the patient’s file.

hawo ValiDoc TOUCH

hawo ValiDoc TOUCH

 

 
  • No additional computer peripheral equipment required to record important packaging information
  • Integrated packaging, documentation and labelling system
  • Validatable hd 380 WSI-V ValiPak or hd 480 WSI-V ValiPak TOUCH heat sealer
  • hawo IntelligentScan Technology

 

ValiDoc
ValiDoc TOUCH

Features

  • HEAT SEALRES ValiPak AND ValiPak TOUCH.

    At The centre piece of the ValiDoc system is the validatable hd 380 WSI-V ValiPak (Version 2.0 and higher) or the hd 480 WSI-V ValiPak TOUCH device, which are equipped with interfaces for the ValiPrint label printer and the ValiScan barcode scanner (hawo IntelligentScan technology).

    No additional computer peripheral equipment is required to record important packaging information and print it onto a label. The sealing device monitors critical process parameters (sealing temperature, contact pressure and sealing time) and alerts the user when any deviations occur. If sealing parameters are in order during the sealing process, then this is printed on the label (sealing parameters okay). If one of the parameters is not in order, then an error code is printed on the label (F1, F2 or F3). The packaging may not be used.

    Both units can be easily upgraded to ValiDoc and ValiDoc TOUCH systems.

     
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    ValiPrint – LABEL PRINTER.

    Together with the practical indicator labels, it also provides helpful instrument labelling that complies with legal requirements. This is because all information previously input and processed is printed on the label and can be attached to the packaging.

    An HIBC (Health International Bar Code) is printed with all label information as well as process parameters. The integrated process indicator (ISO 11140-1, Class 1) shows whether or not the packaged instrument has already been sterilized. After instruments are used for treatment or operation, all labels can be placed in the patient’s file. This enables you to immediately determine that each instrument, set or container being used has been properly packaged and sterilized. The printer housing has an antibacterial coating and the control panel contains an antibacterial substance tested according to JIS Z 2801.

    The following labels are available:

    • Steam (STEAM)
    • Steam / Ethylene oxid (STEAM/ETO) combination label
    • Steam / Formaldehyde (STEAM/FORM) combination label
    • Plasma (VH2O2)
     
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    INTEGRATION.

    Regardless of whether it’s sealable pouches and reels, wrapped sets or trays or reusable containers, VeriDoc 2C assists medical professionals to meet packaging labelling requirements. It also includes sterilization inspection using a process indicator along with formal storage approval after a visual inspection, as well as documentation in the patient’s file.

    After the required visual inspection of the packaging, the system is informed whether or not it has passed by scanning the corresponding Data Matrix code (‘sterile barrier system approved’ or ‘sterile barrier system not approved’). Depending on the result of the visual inspection, a label is printed with the corresponding note. The packaging may not be used if an error (e.g. open or broken seal or closure system) is detected.

    All required information such as batch number, name of the packer, product information or the expiry date is simply transferred to the labels via the easy-to-use ValiScan 2D barcode scanner and an individualized Data Matrix code list. After the sterilization, the integrated process indicator (ISO 11140-1, Class 1) shows whether or not the packaged instrument has been sterilized. After sterilization, personalized approval can be given for storage using the field provided. After the instrument has been stored and used, the so- called duplex-label can be removed from the sterile barrier system and placed in an appendix to the patient’s file. This enables the user to immediately determine that each instrument, set or container being used has been properly packaged, sterilized and approved for storage. Instead of the approval field, all data can also be displayed as QR code. The data on the label can be easily transferred to electronic documentation systems or patient‘s file in this way

Validation

  • 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)