A clean room is a heavily controlled environment where regulated products, such as dietary supplements, are manufactured. The purpose of the controlled area is to keep contaminants to a minimum in order to create high-quality products. Sources of contamination include:
- Facilities – Walls, floors, ceilings, air-conditioning debris.
- People – Skin flakes, oils, cosmetics, hair
- Tools – Friction particles, emissions, brooms
- Fluids – Particulates, cleaning chemicals, floor finishes
- Products – Silicon chips, general debris
Keeping Contaminates Out
Maintaining a clean room starts with its overall design. They should be designed to maintain an airflow in which a body of air moves uniformly along parallel flow lines. Maintaining proper pressure is vital to reducing the risk of contamination by airborne contaminants. The cleanest areas should have the highest pressure so that no backflow from less clean areas can enter the manufacturing suite. Filtration is also of utmost importance. The installation of a High-Efficiency Particulate Air Filter (HEPA) filters particles as small as 0.3 microns. Other filters have special mechanisms for filtering particles from liquids and gases.
When working in this environment, it is typically required to wear shoe boots, gloves, masks, and head covers. Some environments require even more coverage, such as a jumpsuit. Jewelry and cosmetics, including nail polish, should not be worn. Items taken into the clean room should be carefully screened and cleared by the clean room manager. Anyone who is ill should not enter the clean room.
Cleaning procedures depend upon the the classification of the room but typically involve:
- Cleaning of all work surfaces with disinfecting solutions.
- Removal of all waste.
- Cleaning of all doors, frames, and lockers in the adjacent gowning area.
- Vacuuming or mopping the floors.
- Wiping down walls.
Not all manufacturing facilities are required to utilize a clean room, but even just using clean room practices can minimize contaminates and increase the quality of your products. With InstantGMP MES, you have the ability to log all cleaning activities in the rooms used to produce your supplements online instead of using a paper log that can be easily lost or removed from the facility. Contact us for more details about paperless manufacturing.