How to Achieve Spotless Pharmaceutical Clean Room Standards Approved by the FDA

How to Achieve Pharmaceutical Clean Room Standards Approved by the FDA

Whether for processing pharmaceuticals or for creating tech products, clean rooms are essential to many modern production facilities.

When trying to abide by U.S. Food and Drug Administration standards, it's vital to know the regulations and the details contained therein. Contaminants can be introduced during every step of production to make sure you know clean room standards before you even plan your facility.
Here are some basics.

Understanding the Regulations

Requirements for clean rooms are more than just generic or general standards and practices. They're actually part of a regulated set of rules regarding good manufacturing practices. Current Good Manufacturing Practices or CGMP regulations involve the manufacture of biological products.

These products and drugs produced by manufacturers are regulated by the Code of Federal Regulations. The CGMP for Finished Pharmaceuticals provide information about clean rooms from 21 CFR 600 through CFR 680. These give important requirements for biological products.
The FDA has regulations that regard compliance. Regulations specifically about drug products supersede more general CFR 210 and CFR 211 regulations.

Clean Room Requirements

There are some strict environmental controls that start with the planning and construction of any clean room. It's vital to have clean air standards in your clean room. If you don't start by building for a clean air system using the right filters, it's hard to achieve a clean room.

There should be a monitoring system for your clean room. A separate and adequately-sized room to control humidity, air pressure, temperature, and dust should also have the ability to control microorganisms.

There are regulations requiring that you use an air filtration system. Ensure that you follow written procedures to prevent contamination by cleaning and sanitizing surfaces and equipment. This is the only way to ensure that you achieve the standards of cleanliness required for a clean room.

Maintaining Clean Air Levels

If you're looking for instructions for collecting air samples to measure particles in your room, refer to ISO 14644. The standard here will dictate the concentration of air particles. There are specific sizes and thresholds for clean air that should be maintained.

Air samples must be taken during different occupancy states. There should be a sample right after your room is built, before you use it. There should also be tests taken when the room is being unused as well as when it's operational.

The maximum limits for concentration of particulates in the air is set via ISO classes 1-9. Maximum limits are set by occupancy, size of the room, and the concentration of the room.

How to Achieve Clean Room Standards

The FDA has guidance that it sets out to help manufacturers meet the standards for clean room regulations. Every action that is performed in a room has the potential to result in airborne particulates. Even a motionless person can add 100,000 particles per minute to a room.
Clean room standards are going to prohibit certain kinds of items and certain activities. There will be no jewelry allowed and no fast motions. On top of that, there will be special suits that must be worn.
Make sure that you save space for a gowning room that users of your clean room can suit up in. There should be an interlocking door to go through after suiting up.

Check out our guide for classes that could get your staff up to speed.