Integrated packaging, documentation and labelling system
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The hawo ValiDoc is the new documentation, labelling and packaging system 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 system helps medical professionals meet the packaging inspection and labelling requirements. It includes sterilization control using a process indicator along with a formal approval as well as documentation for the patient’s file.
ValiPak sealing device
At The centre piece of the ValiDoc system is the validatable ValiPak sealing device (hd 380 WSI-V, Version 2.0 and higher), which is 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.
Integrating all packaging systems
If wrappable sterilization sheets or reusable containers are used, the system can be notified after the required visual inspection whether or not it has passed. 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 is detected. All required information such as batch number, name of the packer and product information is simply transferred to the ValiPak sealing device via the easy-to-use ValiScan barcode scanner and an individualized barcode list. This information is printed on the packaging label after a successful sealing or a passed visual inspection (wrapped sets or containers). After the instrument has been used, the label can be removed from the packaging and placed in the patient’s file. Other barcodes with batch numbers or batch numbers generated by external systems (e.g. washer-disinfector or sterilizer) can be converted to a barcode readable by the ValiScan barcode scanner via the supplied software or using a smartphone app. This information is then automatically assigned to the batch symbol on the label and printed.
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.
- No additional computer peripheral equipment required to record important packaging information
- Integrated packaging, documentation and labelling system
- Validatable hd 380 WSI-V ValiPak heat sealer
- hawo IntelligentScan Technology
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.
- 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)