Shelf Life Determination - Sterility test (Stasis test)

S

sushil khatri

#1
Hello Everyone,
I need assistance regarding the determination of shelf life of a pack. Our company perform sterility test (Stasis test) on the outer cover of the expired pack. In that way we could justify that product is still sterile after the expiry and we can give expiry date . Now the problem is, we didn?t use sterility testing validation method for that particular product.
As per TGA requirement , Company need to perform validation of sterility testing of specific product and then perform the sterility testing on that product.

Is there any way, I can justify that the test is still valid even those the test method was not validated and regulator can consider that.



Thanks in advance
 
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v9991

Trusted Information Resource
#3
Re: Shelf life determination (Urgent Help Needed)

I think that this might depend upon the category of device you are handling...
however, as per quick review of respective requirements ...... .
....."justification"/"evidence" need to be in place for all the aspects highlighted below.

Medical devices to be supplied in a sterile state
(1) This clause applies in relation to a medical device that is intended by the manufacturer to be supplied in a sterile state.
(2) The device must be designed, produced and packed in a way that ensures that the device is sterile when it is supplied, and will remain sterile, if stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged.
(3) The device must be produced and sterilised using an appropriate validated method.
(4) The device must be produced in appropriately controlled conditions.


205. For terminally sterilised products the samples should be made up from units drawn from various sites throughout the steriliser load. Some of the units should be taken from that place in the load known to be least accessible to the sterilising agent. Samples may be taken representatively from across each load, if the conditions for filling the containers were such as to satisfy the conditions for aseptically filled containers or the design of the equipment, the specification of the sterilising cycles and the validation data for each class of product are acceptable to the competent authority

TABLE 2: SAMPLING SCHEDULE - MINIMUM NUMBER OF ITEMS TO BE TESTED FROM EACH BATCH
hope this helps....& experts join in to correct/add the points.
 
S

sushil khatri

#4
Re: Shelf life determination (Urgent Help Needed)

Thanks for replying, it is very helpful, i wanted to add up few points, as we did sterility testing without validated method. later we did validate the method for sterility but didn't repeat the sterility testing on outer wrap to demonstrate the shelf life
So can we justify on that basis of results of validation of sterility method that previous sterility test was valid?
 

v9991

Trusted Information Resource
#5
Re: Shelf life determination (Urgent Help Needed)

Thanks for replying, it is very helpful, i wanted to add up few points, as we did sterility testing without validated method. later we did validate the method for sterility but didn't repeat the sterility testing on outer wrap to demonstrate the shelf life
So can we justify on that basis of results of validation of sterility method that previous sterility test was valid?
I believe, yes;
However on compliance front, need to trigger a incident, that your "systems allowed/released a product using a method which is not validated";
the all round redressal of closing the incident will determine the confidence in release the batch or submitting same for review.
 

Ajit Basrur

Staff member
Admin
#6
<snip> assistance regarding the determination of shelf life of a pack. Our company perform sterility test (Stasis test) on the outer cover of the expired pack. In that way we could justify that product is still sterile after the expiry and we can give expiry date . Now the problem is, we didn’t use sterility testing validation method for that particular product. As per TGA requirement , Company need to perform validation of sterility testing of specific product and then perform the sterility testing on that product. Is there any way, I can justify that the test is still valid even those the test method was not validated and regulator can consider that. <snip>
Sushil, could you provide more info ?

To whom are you justifying this ?

The bottom line is that the product needs to be tested for Sterility and if that is not validated, my suggestion is not to go round the bush to prove the point.
 

v9991

Trusted Information Resource
#7
Sushil, could you provide more info ?

To whom are you justifying this ?

The bottom line is that the product needs to be tested for Sterility and if that is not validated, my suggestion is not to go round the bush to prove the point.
yes, i agree...there is no point go around..... at the same time,
considering that you have data in hand...what to do when we have a situation where product is released....sterility done...need to submit data to regulatory....
option (ideal) 1: is to always go through entire cycle...validate->batch->release etc., OR validate -> analysis
option (practical) 2 :- to deal with the instance through incident mechanism....see if the investigation brings out any valid-justification to rely on the analysis which is already performed.
(possibly provide a commitment to follow through in next batches!!!?)
of course all these are subject to extent/confidence of justification/investigation
 

Ajit Basrur

Staff member
Admin
#8
yes, i agree...there is no point go around..... at the same time,
considering that you have data in hand...what to do when we have a situation where product is released....sterility done...need to submit data to regulatory....
option (ideal) 1: is to always go through entire cycle...validate->batch->release etc., OR validate -> analysis
option (practical) 2 :- to deal with the instance through incident mechanism....see if the investigation brings out any valid-justification to rely on the analysis which is already performed.
(possibly provide a commitment to follow through in next batches!!!?)
of course all these are subject to extent/confidence of justification/investigation
Thats why I asked a question before - "To whom are you justifying this ?"
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Thats why I asked a question before - "To whom are you justifying this ?"
As far as I understand, to the TGA.

From my impression, no amount of regulatory stunts will help. The key (if there is one) is in the method validation details, and the aim should be to show that its scope / coverage / applicability is wide enough to include sterility testing of the subject product.

Sushil, Which lab did the sterility testing for you? according to what standards did they validate the method, and test? Is the lab and its work methods up to TGA expectations? Maybe have a sit down with their method expert and try to understand how the method validation was done and what exactly are its consequent coverage boundaries. Hopefully you'll be able to conclude that the subject product & testing fall within.

If you need more specific help and have confidentiality concerns, you can send me a private message. I'm nearby, only 4 hours flight away...:lol:

Cheers,
Ronen.
 
S

sushil khatri

#10
Thanks everyone for providing your guidance, my problem is that i don't have time to validate the sterility testing method and perform sterility test again.
I have received a non-conformance from TGA "Sterility testing method was used to determine the shelf life of pack but the method was not validated and no justification"
as i said previously we performed the sterility testing but the sterility testing method was not validated. testing was performed as per ISO 11737-2
i saw that on the report that after sterility testing, stasis test was perform.
is it possible to justify on the basis of stasis test?
 
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