Hawotest Seal Check

Another invaluable tool for seal integrity monitoring

Van der Stähl Scientific and HAWO are excited to bring you this powerful sterile packaging validation tool. In accordance with ISO 11607, Part 2, the sealing seams must show the following quality characteristics within the Operational Qualification (OQ). 1. intact seal for a specified seal width 2. no channels or open seals 3. no punctures or tears 4. no material delamination or separation. With the hawotest Seal Check, an indicator strip shows whether these quality features are fulfilled. A subjective interpretation of the seal seam is excluded, regardless of the type of sealing device.

With the Hawotest Seal Check, an indicator strip shows whether these quality features are fulfilled. A subjective interpretation of the seal seam is excluded, regardless of the type of sealing device. An optimum seal seam can only be guaranteed if such critical parameters as sealing temperature and sealing pressure are correctly set and adjusted to the material to be sealed. If one of these parameters shows a deviation, this is visible on the indicator strip. When used daily, the Hawotest Seal Check can ensure that the sealing device is working at optimum efficiency and is performing correctly.

It seems one of the biggest issues facing medical device packagers, it is of the creeping of the process. Despite all of the thorough IQ OQ PQ work that is performed during the early days of validation, many packagers seem to have far too many failures at the point of use. With even the most quality, accurate packaging equipment, a process can creep out of its expected parameters, oftentimes without device packaging companies being aware of the failure. Now under the new sterile barrier system, there is increasing demand on medical device packagers to check their process often.

With units like our model PTT-100V and our Viu Visual Inspection Unit, medical device packagers can pull pouches out of production and inspect and test often with a great deal of ease. There is now another tool that medical device quality teams can use in order to better keep their sterile device quality plan on track, the Hawotest Seal Check.

This system is effectively a colormetric test film that allows medical device packagers to look closer at the sealed area by using a sensitive contrasting background. This film can show pleats, fissures, channels, holes, etc. that may warrant secondary testing of the pouch in order to understand the seal’s total quality.

The Hawotest Seal Check assures by means of a daily test, whether your sealing device works in a correct way. This depends on the composition of the material, the temperature, the pressure and the time. Sterilization foils consist of paper and laminated foil. During the sealing process, the laminated foil must connect the whole surface of the paper to guarantee a safe seal seam. If the temperature is incorrect during a test or the pressure is not calibrated optimally, then you can see that on the Hawotest Seal Check test sheet. Hawotest Seal Check ensures you always have a perfect sealing seam.

After the sealed specimen is performed, quality can make notes on the film and archive for later evaluation. It is a great record path to demonstrate the state of machine functions throughout the course of the year. Although this system is not intended to be the last word on seal strength or integrity, it can certainly be an important tool when using visual, unaided eye inspection of a sterile seal. Call customer service today. We would be happy to send you a free sample of this film for you to try out on your own packaging line 800-550-3854.