Tag Archives: validation
Question regarding sterile filter hold time validation
The Question posed on LinkedIn:
“How to validate maximum hold time for product sterile filter after autoclave sterilization? Any link to regulatory guidelines is much appreciated.“
Autoclave Validation
Updated June 2020:
With the age of my presentation and the recent PE009-14 update it was high time to review and update my Autoclave Validation training/presentation.
The linked to pdf contains Autoclave Validation training I have presented in person and via teleconference. Continue reading
Air Shower Qualification
The Question posed on LinkedIn.
“Can any body guide me how to perform the air shower qualification in potent drugs manufacturing? Is there any guidance for the same? Which test needs to be covered during qualification? ”
My advice:
Having worked in sterile production facilities, I’d consider an air shower a bad idea (increased particulates, impact on pressure differentials, ineffective removal of static particles (even creation of static particles) etc risk of forcing particles through PPE onto operator, cross contamination of surrounding de-gowning area/airlock).
I’ve found an old (2002) article that might help you with any URS and subsequent validation activities you develop:
https://www.alnmag.com/article/2002/12/how-do-air-showers-fit-contamination-reduction-plan
There are also two old (1999 and 2002) references at the end of the (linked) article.
The Validation Master Plan
I was recently asked where I would start if I was tasked with developing the Validation Master Plan or VMP for a microbiology laboratory.
That got me thinking. I’ve done my share of validations over the years, encompassing such things as viable particle air samplers, large format incubators, temperature mapping, autoclave validation, sterile media trials, computer system validation and various microbiological test methods. I’ve also written validation documentation in the form of user requirement specifications (URS), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ) as well as the validation protocols and reports. To take on the task of developing the master plan would be challenging and to my mind, an exciting and fun/rewarding project. I love documentation! Continue reading
Method Validation
Updated 18 June 2020
Introduction
This article is intended to give you an understanding of the following:
- What is validation.
- Why we need validation.
- What the impact of not having validated processes is.
- The stages of Validation.
- The type of validation.
- How will knowing about validation can assist you.