There is a delicate balance involved in cleaning a pharmaceutical plant. Throw it off and you can be shut down for days at a time
In previous blogs, we covered the ideal amount of maintenance and ways to put the brakes on obsolescence. Today we will discuss the best ways to keep your facility clean. Pharmaceutical facilities, especially those manufacturing biological products or sterile dosage forms, present considerable cleaning challenges. They must be: designed to be cleanable and maintained, tested for cleanliness, and cleaned thoroughly.
Ensure surfaces can withstand cleaning agents. Designing for cleanliness is perhaps the easiest part of the puzzle. Why? Because the FDA requirement is for smooth, non-porous surfaces which are inherently resistant to the cleaning chemicals used, such as sporicides. Sporicides are a combination of acid and hydrogen peroxide and are very acidic oxidizers, designed to penetrate the tough cell walls of spores. But they are very corrosive to metals such as aluminum and carbon steel that might otherwise be used. Avoid use of these materials, and stick to stainless steel, plastics, painted gypsum board, and epoxies. These materials will resist corrosion and not deteriorate with repeated use of sporicides.
Floors can be rubber or epoxy or another resistant finish, but keep in mind that they will degrade over time and require refinishing or replacement.
Floors should be as smooth as possible but still slip-resistant. Too many abrasive particles in floors (despite what your safety officer says, you can have too much abrasion) will cause cleaning mops to shed particles, which can end up adulterating your products. Floors can be rubber or epoxy or another resistant finish, but keep in mind that they will degrade over time and require refinishing or replacement. If there is an unidentified stained area on the floor that resists removal despite the best efforts of your staff, it is time to refinish the floor rather than have an FDA inspector enter the room and wonder what contaminated the floor. It is impossible to determine if a surface is cleaned once it is stained.
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Windows represent the opposite sort of problem. When they are properly cleaned with a phenolic disinfectant cleaner, the window glass will appear streaky as if there is a cloudy film residue. Do not be tempted to have this rinsed off, as the film has disinfecting properties and shows that the room has been properly cleaned. Frequently, contractors or vendors will suggest use of painted aluminum trim around windows or lights as a cost-saving alternative to stainless steel. Resist this temptation, as painted aluminum will invariably lose flakes of paint that can adulterate product and expose the raw aluminum surface to sporicides. This will cause very small gray particles of aluminum oxide to shed into the clean room and adulterate your product.
Vendors will also suggest use of hollow steel doors for cleanrooms, which must be painted and the paint will, of course, flake off. The door will also trap sporicides and corrode from the inside out. Fiberglass doors, despite their initial higher cost, are a much better investment. Fire alarm pull stations are often installed with red painted steel by contractors who do not know better and should be avoided for the same reasons.
Spend the time to write a procedure that gives all the details of how each room is to be cleaned.
Over time surfaces will degrade, especially caulked joints, and require replacement. The caulk should be replaced by a skilled tradesman with FDA food-grade caulk. Avoid the cost-savings represented by having latex caulk installed by the cousin of the security guard, as the results will degrade very quickly even if by some miracle the initial finish is good. Degraded caulk joints are the most common defect seen in older pharmaceutical plants, in my opinion.
Acoustical tile drop ceilings are very common in pharmaceutical plants but should not be used in cleanrooms unless they are faced with vinyl. They are otherwise too porous to be cleanable. They must also be gasketed and/or clipped into place, because the cleaning mop will otherwise dislodge the tile and allow whatever horrible flora (mostly spores) present above the tiles to fall into the cleanroom and be distributed throughout the facility, shutting down production for days at a time.
If you have bad environmental monitoring (EM) testing results, you must address the issue. You cannot have bad EM and just write deviations to cover up the problem. If you do, your staff will lose pride in their workplace and ask why they should bother to keep it clean since there appears to be no consequences. The corrective action for bad EM is not to just clean it again—there must be an investigation that uncovers a true root cause so that a repeat performance can be avoided.
Hire a company that knows how to clean this type of space. This will not be the cheapest company that your services procurement department can find. This will be a company that you pay more for because they avoid making mistakes out of ignorance and have experience in following strict written procedures. Plus, they already work for other pharmaceutical companies and have references to prove it.
Cleaning a pharmaceutical plant is a part of the business that combines technical requirements with people skills.
Spend the time to write a procedure that gives all the details of how each room is to be cleaned. This includes the sequence of rooms, starting from the farthest away, and include what part of the room to start with (hint: farthest from the door so you do not walk through the area that was just mopped). The floors, walls and ceilings must remain wet for the required amount of time according to the manufacturer’s instructions. No matter how good this company is, occasionally you need to have someone else watch what they are doing to verify the correct techniques are still being followed. Otherwise you may find that the cleaning company is simply spraying with sporicides (the fastest cleaning method but only supposed to be used when necessary). If used daily, sporicides will cause the building steel and HVAC ductwork to severely corrode!
Cleaning a pharmaceutical plant is a part of the business that combines technical requirements with people skills. It is essential that a technically correct program is executed by competent staff proud of their facility. Ignore either part of the equation and your pharmaceutical plant will suffer the consequences.
This is the third part in a four-part blog series that will explore best practices for maintaining pharmaceutical manufacturing facilities in light of changing regulations and shifts in product development. For more on this topic, don’t miss Doyle’s presentation on October 30 at the 2019 ISPE Annual Meeting & Expo in Las Vegas.
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