Validation of Stability Testing for Sutures

R

raghuramas

#1
Dear Friends,

Last week, One of my customer asked me to submit the report " validation of stability". From my view, I hope, it is related with accuracy, precision, specificity, linearity, robustness, range, quantification limit. I doubt whether I am right or wrong.

Can anyone help me in this regard. (The medical device manufactured is Surgical sutures).

Regards,
Raghu :bonk:
 
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Jim Wynne

Staff member
Admin
#2
Re: Validation of stability

Dear Friends,

Last week, One of my customer asked me to submit the report " validation of stability". From my view, I hope, it is related with accuracy, precision, specificity, linearity, robustness, range, quantification limit. I doubt whether I am right or wrong.

Can anyone help me in this regard. (The medical device manufactured is Surgical sutures).

Regards,
Raghu :bonk:
I assume you're referring to stability of the production process? If that's the case, "stability" refers to a state of statistical control, whereby it's been confirmed that the process is subject only to random ("common cause") variation. Note that the concept of stability is independent from conformance to specifications; a process may be stable but uncapable of meeting the specifications.

Note that there might be medical-device terminology here that I'm not familiar with.
 
C

curryassassin

#3
Re: Validation of stability

Your question could also be related to the stability of the sutures themeselves. Therefore, the stability report should detail the tests performed to show that the sutures meet all quality requirements (sterility included) over an extended or accelerated time period and under normal or maybe also abnormal usage conditions.
 

Ajit Basrur

Staff member
Admin
#4
Re: Validation of stability

I agree with curryassassin but to be on a safer side, I suggest you to get clarification from customer. :)

Just for additional info - FDA recommends the following -

Expiration dating should be supported by stability study results demonstrating that the critical parameters of a device (e.g., sterility, package integrity, coating integrity, delivery system tensile strength tests, deployment, and fatigue) will perform consistently during its entire shelf life.
The appropriateness of accelerated stability data is determined by device composition. The value of accelerated stability test data depends on identical decomposition mechanisms at both standard and elevated temperatures. When device failure or decomposition occurs by different mechanisms at the standard and elevated temperatures of accelerated stability testing (e.g., loss of sterility at 25ºC versus protein denaturation at 50ºC), we believe accelerated stability test data is not appropriate. Generally, accelerated stability data may be appropriate if you have validated it by real time aging studies or there is peer-review literature showing your material decomposes by similar mechanisms at standard and elevated temperatures.

In addition, we recommend you describe the packaging that is used to maintain sterility.
 
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