ETO Sterilisation of Single Use Part supplied in Non-Sterile State

[priya]

At my current organisation, we supply a non sterile single use accessory with our medical device. We have provided adequate labeling and information in IFU that the accesory is to be ETO sterilised before its single use. The MSDS of the material that the accessory is made of confirms that the product is ETO sterilisable.

My questions are:

Given the above scenario

1. Does it make any sense for us to run a Bioburden test on this accessory at all? One opinion in the organisation is that by running a bio burden test, we can identify the type and population of micro organisms on the accessory and based on this information we can decisively announce that the ETO sterilisation is good for making the part sterile.

However, the manufacture of the accessory is not in a controlled environment, so I assume that if we test parts from 2 different batches the bio burden may vary very largely and we can come to no conclusion with this information.

2. Does it make any sense to run a sterility test? Again, the opinion is that suppose we take a few numbers of accessory parts, sterilised by one of our customers in their ETO plant, and run a sterility test and if the test confirms the sterility, then it means that the part can be rendered sterile through ETO sterilisation. We have no information on whether the ETO sterilisation process of this customer has been validated at all..

But whichever test, we need to demonstrate the suitability and effectiveness of ETO sterilisation on the accessory part

i do know that ISO 11135 and ISO 11737 relate to ETO sterilisation, but in the given scenario, can someone give me direction on what test to perform if at all we need to.

 

[somashekar]

At my current organisation, we supply a non sterile single use accessory with our medical device. We have provided adequate labeling and information in IFU that the accesory is to be ETO sterilised before its single use. The MSDS of the material that the accessory is made of confirms that the product is ETO sterilisable.

My questions are:

Given the above scenario

1. Does it make any sense for us to run a Bioburden test on this accessory at all? One opinion in the organisation is that by running a bio burden test, we can identify the type and population of micro organisms on the accessory and based on this information we can decisively announce that the ETO sterilisation is good for making the part sterile.

However, the manufacture of the accessory is not in a controlled environment, so I assume that if we test parts from 2 different batches the bio burden may vary very largely and we can come to no conclusion with this information.

2. Does it make any sense to run a sterility test? Again, the opinion is that suppose we take a few numbers of accessory parts, sterilised by one of our customers in their ETO plant, and run a sterility test and if the test confirms the sterility, then it means that the part can be rendered sterile through ETO sterilisation. We have no information on whether the ETO sterilisation process of this customer has been validated at all..

But whichever test, we need to demonstrate the suitability and effectiveness of ETO sterilisation on the accessory part

i do know that ISO 11135 and ISO 11737 relate to ETO sterilisation, but in the given scenario, can someone give me direction on what test to perform if at all we need to.

First part is that you are running into a big risk with your single use accessory as you state that this is not manufactured under controlled environment, and it is a terminally sterilized device. Your device which is a carrier of the challenge to the sterilization is not in control.
A good practice is to determine the controlled conditions necessary, provide the same and based on the continued validation of the sterilization process, you maintain the controlled conditions.
If you are faced with a customer complaint on sterilization, you will stand exposed to some weak areas during your root cause analysis.
It is always a good and sound practice to know the challenge you are feeding the sterilization process, so that you are assured of the final results.

 

[bio_subbu]

At my current organisation, we supply a non sterile single use accessory with our medical device. We have provided adequate labeling and information in IFU that the accesory is to be ETO sterilised before its single use. The MSDS of the material that the accessory is made of confirms that the product is ETO sterilisable.

Priya

I understand that you are supplying non sterile single use accessory along with your device, also you are clearly stating in your IFU that the end user should use the accessory after ETO sterilization only. Am I correct?

Please confirm that who has the control on the sterilization activities whether the manufacturer or end user?

 

[priya]

subbu

User has to sterilise- it is VERY clearly stated in the user manual.

priya

 

[priya]

Mr.somasekar-by controlled conditions- i am only referring to the bio burden levels- we co not have clean room levels of control, but manufacturing is controlled enough to provideparts that do not vary batch to batch in terms of product specifications. Does this change the scanario in any way?

 

[somashekar]

Mr.somasekar-by controlled conditions- i am only referring to the bio burden levels- we co not have clean room levels of control, but manufacturing is controlled enough to provideparts that do not vary batch to batch in terms of product specifications. Does this change the scanario in any way?

OK. With some more clarity now, can you tell how you have addressed the 7.5.1.2.1 a) and 6.4 a) in your ISO 13485:2003 QMS ?
If this is established well and good, then you have controlled conditions. Bio burden levels can be one of the measure of cleanliness. Clean room provision is an other aspect which can contribute to the continued GMP requirement.

 

[bio_subbu]

subbu

User has to sterilise- it is VERY clearly stated in the user manual.

priya

Hi Priya

As you are a manufacturer, the sterilization activities are not fall under your control, and also the sterilization standards ISO 11135 & ISO 11137 are not applicable to you, It applicable to your end users/contract sterilizers. Please check below scope of the standards.

ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process.

However, you are insisting your end users that the accessory should sterilize prior to use. In this case, you have you have a minimum control to avoid microbial contamination during manufacturing and packing. The high load of bio-burden may lead your accessory fail from sterility.

Regards
S. Subramaniam

 

[priya]

OK. With some more clarity now, can you tell how you have addressed the 7.5.1.2.1 a) and 6.4 a) in your ISO 13485:2003 QMS ?
If this is established well and good, then you have controlled conditions. Bio burden levels can be one of the measure of cleanliness. Clean room provision is an other aspect which can contribute to the continued GMP requirement.

Sir

We have claimed that 7.5.1.2.1 is not applicable
a) product is NOT cleaned by the organization prior to sterilization and/or its use

However

b) product is supplied non-sterile but we do not prescribe that it be subjected to a cleaning process prior to sterilization and/or its use,


Now: as far as 6.4 a goes, we do have a documented procedure, but as for the monitoring of the work and environment conditions, I have very less to say...

(Looks like I have a weak case on my side)

Priya

 

[somashekar]

Sir

We have claimed that 7.5.1.2.1 is not applicable
a) product is NOT cleaned by the organization prior to sterilization and/or its use

However

b) product is supplied non-sterile but we do not prescribe that it be subjected to a cleaning process prior to sterilization and/or its use,


Now: as far as 6.4 a goes, we do have a documented procedure, but as for the monitoring of the work and environment conditions, I have very less to say...

(Looks like I have a weak case on my side)

Priya

Not knowing much about your product, can you not put in a final cleaning cycle and pre-sterilization packaging under a laminar flow bench, with the operator performing under good hygiene condition and following proper handwashing procedures, clothing procedures and use of nose and mouth masks etc etc as deemed necessary ?
This way you include the 7.5.1.2.1. and provide the documented requirements and the 6.4 a) and b) do not apply to your other processes prior to the cleaning ....
Think about it .... I would rather say you have a good case for Improvement Priya >>>

 

[priya]

Sir

After writing to you, and speaking to Subbu, I have proposed that we introduce a pre-cleaning step to be implemented at the supplier's end. Very MANY thanks to you and Subbu, finally i am seeing light at the end of the tunnel- esp. with the audit a week away!!!!!

Priya