483 #2 – Facilities & Equipment

Learning Objectives

1. Explain the conditions USP Chapter <797> states for surfaces in classified areas
2. Discuss what USP Chapter <797> says about gaps in ceiling tiles and how they should be remediated
3. Explain the importance of not having cracks and crevices in your primary or secondary engineering controls

In this weeks 483 we’re going to highlight what some of the FDA may find in your facilities and engineering controls. USP Chapter <797> addresses the design and conditions for your engineering controls fairly clearly and the expectations for them. As always, I’ve de-identified this 483 because the purpose here is not to call out specific facilities. Rather, it’s to make note of what the FDA is finding in some facilities and if these same things are happening in your own facility this opens a discussion on how to remediate the issue(s).

Observation 1

Findings in your ISO 7 area(s) (your cleanroom; anteroom, buffer room) is one thing but in your ISO 5 primary engineering control is another. The FDA will definitely call out and focus on issues with your primary engineering controls. Here it’s noted that there’s visible discoloration, what appears to be rust, paint covering up the rust and cracks.

USP <797> talks specifically about the cleanroom suite and the conditions and expectations:

The surfaces of ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, and cabinets in the classified area must be smooth, impervious, free from cracks and crevices, and non-shedding so they can be cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.

USP Chapter <797> Cleanroom Suite

It goes on to say…

Surfaces should be resistant to damage by cleaning agents, disinfectants, sporicidal agents, and tools used to clean.

USP Chapter <797> Cleanroom Suite

Of course I’m reading this just as you are so I’m going on the assumption that this is in fact rust; possibly due to damage from cleaning agents. Covering up rust with paint is certainly not the way to properly deal with remediating this issue. Assuming this is stainless steel, the PEC could be either shut down for a period to properly remove the rust or if the condition warrants, decommission the equipment altogether.

Observation 2

The FDA inspectors use a specific word when talking about all of these issues with the PEC and buffer room: “visible”. Performing regular visual inspections of equipment and even materials is mentioned quite a bit in USP Chapter <797>. It’s very important to do a visible inspection of your materials prior to putting them into your controlled areas and this also goes for equipment prior to use.

Some improper materials were also used on this firm’s ceiling to correct issues with light fixtures. The inspector also notes something very important about the caulking of the ceiling, which is specifically mentioned in USP Chapter <797>:

Junctures between the ceiling and the walls and between the walls and the floor must be sealed to eliminate cracks and crevices where dirt can accumulate. If ceilings consist of inlaid panels, the panels must be caulked around each panel to seal them to the support frame…The exterior lens surface of ceiling light fixtures must be smooth, mounted flush, and sealed. Any other penetrations through the ceiling or walls must be sealed.

USP Chapter <797> Cleanroom Suite

Of surfaces in general for the compounding suite, USP <797> says:

Surfaces in the SCA should be smooth, impervious, free from cracks and crevices, and non-shedding so they can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.

USP Chapter <797> SCA

Observation 3

As already quoted above, USP <797> talks about sealing cracks and/or crevices in the ceiling tiles, which need to be smooth and easily cleanable so as to “minimize spaces in which microorganisms and other contaminants can accumulate.”