Memory Stick Simplifies Sealing Process Validation

EN ISO 11607-2 specifies the requirements for developing and validating processes for packaging medical devices that are terminally sterilised. Critical process parameters such as the minimum sealing temperature and contact pressure must be regulated, monitored and documented to ensure that the process delivers reproducible results at all times. Hawo GmbH (Obrigheim, Germany) has introduced a memory stick that provides a simple and flexible way to comply with process documentation requirements.

The 180 PT-USB storage unit is inserted into the serial interface of the sealing machine. Critical process parameter data and protocol data are stored on the USB stick and automatically transferred to a PC (the software is included), where it can be displayed graphically or in a text format. The sealing protocol is then approved, digitally signed and archived in a PDF format.

The German Society for Sterile Supply DGSV has published a validation guideline that is available for download at Hawo’s website.