Maintaining the good standing of the modular clean room where your products are created and tested involves following some strict rules and practices.The FDA inspectors will ding you business for faulty practices. With the abundance of regulations, the attitude can become that the regulations are a barrier to production, a nuisance. Here are six easy mistakes for your clean room employees to avoid so your business stays in good standing.

  1. Don’t clean your cleanroom.—Cleanrooms are only allowed a miniscule amount of dust and contaminants for the safety of the product. These contaminants can build up quickly if left untouched. The time spent in cleaning regularly will pay off in the end.

  2. Record some investigations, but not others.—Rather, keep thorough records of everything. Many of the violations reported by the FDA, are because of inadequate records of investigations.

  3. Record results in pencil that way you can always go back and make changes.—Along the same lines as #3, in the record keeping process, only use blue or black ink. If there is evidence of changes to the records, you will be called to account for the changes. Record accurately the first time, everytime in blue or black ink.

  4. If you don’t need records, they can be destroyed immediately.—Keep records for the prescribed amount of time before destroying them.

  5. Filters don’t need to be changed unless visibly dirty.—Insure your clean room is up to snuff at all times. Inadequate or incorrect airflow will create problems and can foster viral growth, contaminating the product. Also, regular monitoring of bioburden is crucial to maintaining the integrity of the product.

  6. Skip the regulation steps you don’t see as necessary.—Don’t skip steps to save time. It will inevitably come back and bite you during an FDA inspection. The steps are there to create a safe environment for your product.

Vigilance will help you to avoid mistakes and get penalized for it. Proper training of your staff and hiring those with not only the knowledge to complete their tasks well, but to do so and be extremely detailed about each step will help in avoiding these mistakes.