Are Your Smoke Studies Sufficient?

Smoke studies or air flow visualization studies are used in aseptic processing facilities to confirm airflow patterns.  While there are no specific GMP regulations that refer to smoke or visualization studies, the FDA has cited companies for lack of smoke testing or inadequate smoke testing citing the following CFR sections, 21 CFR 211.113(b) and 21 CFR 211.63.

A company recently received the following observation:

….. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Specifically, our review of your smoke study videos identified the following deficiencies:

a.         There were no smoke studies performed of the aseptic filling lines under dynamic and static conditions after constructing the … and pass through right outside of the Class 100 filling rooms: … and …  However, we observed the production of … in Cleanroom … being manufactured in filling room … after the construction of the … area.

b.         Smoke studies conducted for the newly constructed … and pass through do not simulate filling operations under dynamic conditions with the opening and closing of the pass-through door. For example, the use of the equipment in the Class 100 filling room and the movement of materials and personnel in and out of the … and pass-through was not conducted during the smoke study.

c.         During the review of your smoke study video for the pass through on the … side, turbulent air was observed coming into the … while the door was opened and closing. According to “Summary of Ad Hoc Committee’s Preliminary Review of Smoke Study Pursuant to …”, a curtain of air must be observed between the … and … when the door is open on the … side. Your firm evaluated this as meeting the requirement marking this as “Yes”.                

d.         There are no smoke study videos to show the air movement cascading down from the Class 100 … and pass-through vent openings placed along the bottom of the walls, under static conditions.

For more information regarding aseptic processing refer to FDA Guidance Document: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice.  To view more observations pertaining to smoke studies, refer to the following GMP Trends® Issues: 1115, 1101, 1096, and 1054

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