Why Sterility?
Many medical devices must be Steril. Class I or IIa products, such as wound dressings, disposable gloves or surgical accessories, must be sterilised in accordance with standards EN ISO 11135 (ethylene oxide), EN ISO 11137 (irradiation) or EN ISO 17665 (moist heat) to kill microorganisms – until the end of the process . .
And as always, the MDR accurate documentation of standardised Sterilisation – validation.
Steril, but not Validated?
It happens time and again: a product is found to be perfectly Steril in individual tests. However, the product is Notified Body not approved or recalled. The reason? Faulty validation!
After all, it’s not just the result that matters, but above all the documentation of the process!
As is so often the case, the journey is the destination. We’ll now explain how to carry out an audit-proof validation and which common mistakes can easily be avoided.
Mistake 1: Documentation does not Match the Process Status
The validation protocol originates from the regulatory approval project – and has not been updated since then. The sterilisation equipment has since been replaced, the contract sterilisation provider has moved premises, and the production batch size has increased. The document makes no mention of any of this.
ISO 13485 and the MDR require that sterilisation procedures be fully documented and kept up to date. Notified bodies check precisely this: does the documentation match the actual process? Discrepancies – even seemingly minor ones – can quickly turn an audit into a nightmare.
Practical tip: Link sterilisation validation directly to the change management process within your QMS. Any change to a process, equipment or supplier must automatically trigger a review of the validation documentation.
Mistake 2: Neglecting Revalidation and Routine Monitoring
Much like the first mistake: once the initial validation is complete, the sterilisation process and its documentation are not finished for good! ISO 11135 and ISO 17665 require regular routine monitoring – at least once a year.
However, depending on the context, it is advisable to repeat this monitoring and revalidation more frequently, particularly following initial validation. ISO 13485 places the emphasis on justified adequacy, particularly in order to account for seasonal fluctuations in microbial load (bioburden).
Practical tip: Make sure to include bioburden monitoring and revalidation cycles as fixed items in your QMS annual plan – with clear responsibilities and automated reminders. This is particularly important in the first year following validation: four measurements are mandatory.
Mistake 3: Changes to Packaging are not Recognised as Relevant to Sterilisation
A new supplier of film material, a change in the width of the seal, a change in the sterilisation indicator on the packaging – at first glance, these may seem like minor details. On closer inspection, however, they are changes that may require validation.
Practical tip: In your change management SOP, explicitly define which packaging parameters are considered relevant to sterilisation. A short assessment form with a few targeted questions is sufficient – it encourages careful consideration before the change is implemented.
Mistake 4: The Selection of Worst-Case Scenarios and the Formation of Product Families are not Justified in aCclear and Comprehensible Manner
Sterilisation validation procedures are often established not for individual products, but for product families. This makes sense – however, it means that a worst-case scenario must be selected, against which the validity of the sterilisation process is assessed for the entire product family. If validity can be demonstrated for this ‘worst-case scenario’, it can also be assumed for the other cases.
But beware: choosing this scenario is by no means trivial, and the Notified Bodies scrutinise the justification for the ‘worst-case scenario’ very closely.
Practical tip: Document the worst-case justification in a risk-based, empirically verifiable manner and link it to the product’s technical documentation. A brief, clear section in the validation plan is sufficient – but it must be included.
Mistake 5: The External Sterilisation Service Provider is not Adequately Qualified and Monitored
Many small and medium-sized manufacturers do not carry out sterilisation themselves. They contract out the work to service providers – and thus regard the matter as outsourced. The MDR does not see it that way. The manufacturer remains responsible, even if a third party carries out the process.
What is regularly missing from audits: a comprehensive supplier qualification process with documented audits, clear contractual provisions regarding revalidation deadlines and reporting obligations in the event of process changes, as well as a defined escalation procedure in the event of a non-conformity at the service provider.
Practical tip: Treat your sterilisation service provider like any other critical supplier: with qualification, a contract, regular audits and a clear communication procedure. Ensure that your contract stipulates that the service provider must notify you of any process changes – before they are implemented.
Conclusion: Validation is not a One-Off Project – it is an Ongoing Task
The good news is that the five errors described are well-known, well-documented and avoidable. They almost never arise from negligence, but rather from a misunderstanding of what validation entails. Anyone who embeds sterilisation validation as an ongoing component of their QMS – linked to change management, supplier management and a realistic audit plan – is on the safe side.
If you’d like to take a look at the relevant standards:
- EN ISO 11135 – Sterilisation using ethylene oxide (EO)
- EN ISO 17665 – Sterilisation using moist heat (steam)
- EN ISO 11137 – Sterilisation by irradiation
- EN ISO 11607 – Packaging for medical devices intended for terminal sterilisation
- MDR (EU) 2017/745, Annex I – Essential safety and performance requirements
- ISO 13485:2016 – Quality Management System for Medical Devices
If you would like assistance in setting up and organising a robust quality management system that easily meets the requirements of sterilisation validation, please contact the experts at BEO BERLIN!
We look forward to see you!
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