14/11/2007

Entrhal Medical GmbH

More and more authorities increase inspection of DIN EN ISO 11607 conformity.

Implementing of validation requirements acc. DIN EN ISO 11607 of heat sealing devices are controlled more and more by the local authorities.
Nevertheless there is still some confusion about what it means to validate the packaging process.

Since many decades there are a lot of measures to assure the quality of sterile goods. But until this standard was introduced a determination of documentation and check procedures for the chain link that should assure sterility of products until it is used at the patient – the packaging process - was missing.

Here the DIN EN ISO 11607 plays an important roll. Through definition of minimal standards the role of the whole packaging process is recognized in it’s importance for maintenance of sterility.

Important issues for validated sterile barrier systems (SBS) with heat sealers are:

1. A sealer must have a calibratable temperature and sealing force measurement and stop the sealing process if one of the parameters is out of the allowed range.

2. The critical process parameters must be defined and documented.

3. The seam must be tested frequently acc. EN 868-5. For daily test and documentation process data can be printed on the sealed pouch and after visual control archived.

Sealers that are not DIN EN ISO 11607 conform, mostly do not fulfill the requirements regarding monitoring the parameters. So will sealers that do not monitor temperature or sealing force seal, even if one of the parameters deviate too much. In this case the seam will not meet the requirements of the standard. The user is not able to recognize this. In the worst case insufficient packed products could come into circulation and endanger the patients health.

Modern sealers as the EM30KLC of Entrhal Medical GmbH fulfill all requirements of the DIN EN ISO 11607, are much more compact, uses less energy and have implemented a lot of functions that make it easier and more effective.

In the interest of the patients and also the responsible people in the CSSD, all sealers that do not fulfill the newest standards should be phased out as soon as possible and be replaced by norm compliant sealing devices.

So everybody can look forward to the next visit of the authorities.

Entrhal Medical GmbH www.entrhal.com