As part of the Aseptic process simulation, after completion of media fill in the primary components to the time of the incubation, what is the allowed time period. What will be the risk if we keep the media filled vials in the atmospheric temperature for more than 5 days prior to incubation? If we performing the GPT by using the incubated vials after 14 days incubation period, will there be any risk to the Media?
After 14 days incubated media. they will degrade the protein and risk to the contamination in media.
Thank you for the response. we are doing the GPT after 14days and that showing the growth promotion. If the protein is degrading how does the contamination occur. contamination means of appearance or the microbial growth. if it is an integral unit how does the organisms grow. if the contamination is only appearance then how can we differentiate between growth and contamination?
- Ideal practice is to keep as soon as session filling is complete, let say half hr. time taken to carry it to incubation chambers.
- As atmospheric temperature may not be properly controlled temperature and excursion can happen any time, which is not good for media fill study…
- You can perform GPT…Also it’s required to know it’s potential…
Thank you Asif.
I understand the good practice. But i would like to know the potential risks in the case of the long delay between the filling and incubation time period
As media fill simulation study is to perform injectable product. As simply as soon as possible after completion of Media fill simulation study , include inspection time. This validate your entire intervention & manual settings. So as per regulatory requirements we have to incubation period
first 7 days @ 25°c for fungal growth
Remaining 07 [email protected]°c for bacterial growth
As per USP requirements.
While there is question about media you have to perform after 14 days to check fertility of Media .
This depends upon you are using fresh medium or near about expiry medium.
14 days study shows that your facility for aseptic technique behaviour complies and GPT shows rate of fertility which is necessary to provide growth of bacteria,B.O.D .
thank you Rakesh for the detailed reply. I understand the good practice. my question mainly the risk factors if i keep the media filled product in room temperature / controlled temperature for longer time prior to incubation.
is there any guide clearly defining it need to be incubated immediately or as soon as possible.
Sir this is as soon as possible… like wise your production time. Bz immediately it’s impossible.
You have to cover all the intervention manual .
You are performing 24 hrs study or 48 hrs study. Time will extend.
Media fill vials/ containers should be incubated as soon as possible. But if there is any problem to incubate later for 24-48 days, I think it shouldn’t be high quality issue. Because you could be kept in controlled area. In pharmaceutical plant most of the controlled area is 20-25 degree Celsius. But kept in outside for longtime is a deviation issue also.