Clean Rooms, How Clean Are They Really? (Part 2 of 2)
In the last blog, I discussed various types of clean room issues I had experienced with several former companies and suppliers. This blog will focus on additional areas of opportunities for failure if not corrected that could negatively impact the product or your customer’s confidence in your business.
As a medical device manufacturer, the site needs to have the appropriate level of rodent/insect controls throughout the building, not just clean room areas. If the raw materials are infested or the finished goods area have rodents chewing on the boxes, how long before they break into the sterile barriers on the individual packaging? Break and lunch room areas, as well as doors for ingress/egress, should have flying and crawling insect controls to prevent intrusion into any nearby controlled or clean room areas.
One of the favorite areas I like to view are the ceiling tiles above the clean rooms. If I ask a supervisor or maintenance person about the gap(s) between the tiles, I usually hear the room has positive pressure, so only dirty air is leaving the room. If there is enough positive pressure in the room it kind of sounds ok. What the FDA asks is “How do you keep insects out with those gaps?” Answer: ‘We train them only to go through the front lobby and then refuse them a Visitors badge.’ Probably not your best answer. Fix the tiles and eliminate the problem.
Where is your procedure for bringing a room back up to the proper cleanliness level after maintenance services equipment on the weekend or during the week? Remember, if it is not written, it didn’t happen in the eyes of the FDA. Who is verifying the equipment and table areas were properly cleaned before the first shift on Monday AM? How much product would be exposed/scrapped if the outside cleaning company missed the appointment? Is there any danger of maintenance working too closely to open products during the week that could be compromised?
Room pressure… who cares? You should so don’t hold those doors open any longer than they need to be! A properly controlled room should still stay at the appropriate level of positive pressure with all of the doors open at once for 15-30 seconds minimum. If not, they need to have interlocks built in so the positive pressure can never be breached by all the doors being open to maintain the continuous pressure forcing clean air out of your workroom, and never letting dirty air push back into a clean room. Depending on the critical need for your level of cleanliness, there are pressure gauges that can be placed by each entryway and read daily or weekly. There are also continuous reading electronic devices (used in aseptic and pharmaceutical processing) to monitor 24/7 which would indicate an unknown breach of the room to help understand an unexpected bioburden level on a batch of products that failed a sterility test. It’s your site. I would recommend getting the best protection for the least amount of production stoppages you can afford.
Lastly, plastic rolls in a clean room, or ‘White Rooms’. Only buy the type that has a plastic core, or cardboard particulate will continue to release itself as the roller turns over the bar. The static from the plastic will eventually pick up the particles and whatever you are trying to cover may become ‘dirtier’ due to the randomly infiltrated cardboard particles. If you don’t have tight-fitting caps at each end of the roll, your process could be producing potential contaminates at will. Also, the cutting tray on the table should be cleaned of any shavings, metal or other debris each shift. The hardened cutter blade rubs against the softer cutting bar to slice the plastic sheet. This debris maker is of sufficient size to have the static cling of the plastic sheet being pulled over the catch tray debris particles throughout the shifts day in and day out. This last issue nearly shut down a production area of a well-established company I was involved with until the source was found.
Now that you have two blogs with many common, and a few not so common areas to review, check your own clean rooms and don’t let familiarity get into the way of cleanliness for your customer’s sake.