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Packaging plays a vital role in assuring the sterility of medical devices and instruments from manufacture to point of use. Applying effective heat seals to the package of terminally sterilized medical devices is arguably the most critical step to ensure the aseptic presentation of a product when it comes into contact with an end user or patient. No matter how robust the sterilization and disinfection process, if the packaging and seal closures of a medical pouch are compromised, there is significant risk of product contamination during shipping and storage that could pose serious danger to the end user.
Validating the heat sealing process is thus critical both to comply with regulatory oversight and to be confident in the overall quality of the final product. Bosch’s white paper “Validating Medical Heat Sealers” reviews the relevant regulatory standard for medical heat sealing (ISO 11607-2) and discusses some of the important considerations that should go into implementing an effective validation process.
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