Keeping the cleanroom in good condition where the production and research are carried out involves following some strict standards and procedures. The inspectors will penalize your business for poor practices. Many people believe that too many restrictions are a burden, a hindrance to progress. In this article, VCR will provide six mistakes the employees should avoid in the cleanroom.

  • Don’t clean your cleanroom.

Cleanrooms are only allowed a minuscule amount of dust and contaminants for the safety of the product. These contaminants can build up quickly if left untouched. The time spent cleaning regularly will pay off in the end.

  • 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.

  • 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, every time in blue or black ink.

  • If you don’t need records, they can be destroyed immediately.

Keep records for the prescribed amount of time before destroying them.

  • Filters don’t need to be changed unless visibly dirty.

Ensure your cleanroom 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.

  • 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.

VCR will help you to avoid mistakes and get penalized for you. 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.

Source: Travis Cleanair

Vietnam Cleanroom Equipment (VCR) specializes in providing clean room equipment for contractors in Vietnam. We provide high-quality products with competitive prices and large quantities nationwide.

For details, please refer to Vietnam cleanroom equipment official website

https://en.vietnamcleanroom.com

Or contact us via hotline: +84 90 123 7008 / +84 90 123 9008 (Whatsapp)

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