Meeting ISO 11137 for sterile products

Most commons mistake dealing with the sterilization supplier in the Med Tech industry

The ISO 11137 and the sterilization validation is getting more and more in focus during the last years. The notified bodies and the auditors a looking more deeply into this topic.

Therefore, auditors are trying to understand and apply specially the ISO 11137. They ask for the explanation of e.g. the dose mapping reports and the sterilization validation during a recertification audit.

The medical device business is structured the way that specially the gamma, e-beam and X-Ray sterilization is done by external service providers. The medical device manufacturer rely on the service providers and have little knowledge by themselfs.

Accountability for the ISO 11137 requirements

By saying that the expertise regarding the process is always with the supplier. In conclusion every simple question regarding this topic could lead to a critical deviation in the audit simply because the knowledge is not there, and wrong answers are given.

On the other hand, the lack of knowledge could lead to undetected failures and in the worst case to unsterile product on the market. This is what should be the main concern regarding this topic.

The general perspective that only the sterilization supplier is accountable for meeting the requirements for ISO 11137 has changed. The medical device manufacturer must meet the requirements and make sure that the supplier is meeting these requirements.

To be honest the perspective was always the same what has changed is that the accountability is now been checked by the notifying bodies.

Specially during the change from the MDV to the MDR.

Common question in audits

Some of the common questions during the audits which lead to deviations are:

  • Why are the dose mapping reports not meeting the basic requirements of the ISO 11137-3?
  • Lack of process knowledge at the sterilization provider site. How can you be sure that the product is sterile when you get it back from the provider?
  • Do you have the calculation of the dose range verified?
  • etc.

There are much more which is addressed in the audit but medical devices manufactures fail to answer them.

Avumed can help you prepare these answers for the audits. Check your sterilisation validation documentation. In addition to that we can prepare your Quality Management System to meet the requirements of the ISO 11137.

We perform supplier audits and mock audits with sterilization experts. We will train your staff in order to be ready for an audit and an inspection.

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