Questions on Depyrogenation and Viable Environmental Monitoring

The Question posed on LinkedIn:

Hi all, I need your support to find the answers of the following questions:
1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents / studies/ gown).
2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?
Thanks in advance…

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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