Clean Room Grade for change room in Sterile Area

The Question posed on LinkedIn.

“Please let me guide or give recommendations, what will be grade of change room just opening in Aseptic filling area. Please mention reference also.”

My advice:

PE 009-12 (Annexes) 2015.

Annex 1 states:
“Changing rooms should be designed as airlocks and used to provide physical separation of the different stages of changing and so minimise microbial and particulate contamination of protective clothing. They should be flushed effectively with filtered air. The final stage of the changing room should, in the at-rest state, be the same grade as the area into which it leads.”

So, what Grade is the filling facility? That is the grade you should validate your changing room/airlock to be.

A google search will find you the relevant PIC/S PDF.

Followup comment

You can download all the PIC/S documentation here:

Disinfection of active air-samplers

The Question posed on LinkedIn.

Avoiding cross-contamination when using microbiological air-samplers is a key activity. But how effective is the procedure? To evaluate this, Tim Sandle and Ravikrishna Satyada have written a paper based on test data…link to Disinfection of active-air samplers.

My comment:

For filling rooms, I’d always use a double wrapped autoclaved sampling head. For ancillary rooms where the risk to the product was lower, IPA was used rather than a new head.

With internal sanitation of air samplers, when I’ve validated units like the Merck MAS100 and Biomeriux RSC+, spraying with IPA was shown to be sufficient.

With regards of HEPA filtering the output airflow, smoke pencil studies showed laminar flow would take the air to the floor. Correct placement of the air samplers within the filling space and ensuring only samplers assigned to critical filling areas were used in critical filling areas would reduce the risk of cross contamination.

Good that you data showed effective sanitation and a lack (or low) cross contamination risk.