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Sterilisation and microbiology –pitfalls to avoid

Johnathon Bis– VP Medical Devices Solutions Sales

Copyright © 2017 BSI. All rights reserved.

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Some discussion based on audit and design reviews.

From a microbiologists perspective.

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Manufacturer is Responsible

If it says sterile and you are legal manufacturer YOU ARE

RESPONSIBLE

It doesn’t say sterile but it needs to be sterile

for use

YOU ARE RESPONSIBLE

If it doesn’t say sterile and you provide a method

for cleaning and sterilisation

YOU ARE RESPONSIBLE

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“We’re going to…”

• BSI won’t certify what you are maybe going to do

• Sterilisation processes must be validated

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“It’s essentially the same as…”

“The product is equivalent based on this study and no further validation is required. Just as a precaution we plan to perform bioburden analysis on the first 3 batches.”

OK – we will wait until you have those bioburden results.

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Equivalence to an Equivalent to an Equivalent

• Families – defined characteristics

• Representative Product(s)/Master Products

• Validation of the Master Product Qualifies the Family

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Equivalence to an Equivalent to an Equivalent

Validation was completed years ago,

Validation references old standards,

Validation wasn’t ever finished

There are some sterility test results somewhere.

We tested the Prototype…I think

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We all have Standards

• Standards have stood the test of time

• Globally accepted

• QUIZ QUIZ QUIZ

• Do you know them all

• ISO 11135?

• ISO 14937?

• ISO 17665?

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“More Worst Case”

The standard specifies a method

• If It can be applied, why not apply it as written?

Example

• Selection of higher or lower doses for dose audit (“more worst case”)

• Selecting a new dose each dose audit

• Extreme Challenges that Fail

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Annex E of ISO 11135:2014

The method is not a process validation

• Single batch release method • Load is processed once to demonstrate lethality in a half cycle• The same products and indicators are processed in a full cycle.• Process must be validated (Clause 7.5.7)

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“It was a one off”

Failure Investigations

• Where is the risk assessment and risk control measures determined by it?

• It should be there?

• If it isn’t, what is wrong with your risk management process?

• With all of the overkill, what might cause a BI growth?

• Was it operator error/not following procedures?text

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A Few New Pitfalls

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Is it SAL 10-6

STERILE

• EN 556-1 – if labelled sterile

• ISO 19930 – approaches to select SAL

• Why don’t you apply 10-6

• Is cost a justification?

• Difficult to justify >1x10-6

• “our product won’t withstand the full dose”

text

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New Sterilisation Technologies

ISO 10993-7

Note that ISO 11135 does not apply to flexible chamber EO sterilisers.

Does apply to flexible chamber EO processes

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

ISO 11135ISO 14937

Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices

General requirementsfor characterizationof a sterilizing agentand the development,validation androutine control of asterilization processfor medical devices(ISO 14937:2009)

Gas Plasma, H2O2, ClO2

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How Clean is Clean?

• No standard for cleaning validation

• Is it OK to approve based on test 3 batches?

• French Standard NF S94-091 • Specs for maximum permitted particles and

contaminants

• What is safe?• Depends what might be there

• Does the validation demonstrate removal?

• What about a test soil? ISO 15883

• RISK RISK RISK

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Summary

• Take Responsibility• Use the Standards• Apply the Standards• Consider the risks• Apply appropriate controls• Lions and Cows