When designing a cleanroom, the choice of ceiling components, particularly the lighting, plays a critical role in determining the overall effectiveness of your controlled environment. Cleanroom lighting is imperative for successful contamination control, ensuring visibility, maintaining precision, promoting safety, and adhering to compliance standards. Color temperature and lumens are crucial factors in choosing cleanroom lighting to ensure compliance with standards and requirements.
You must follow strict rules for cleanroom lighting to keep your space safe and clean. Cleanroom lighting fixtures help stop contamination and protect people working in the cleanroom. You need to use well-known standards like ISO 14644, GMP, and FDA rules when picking or putting in lighting. These standards tell you how many particles are allowed and how clean your workspace should be.
Understanding the unique requirements for cleanroom lighting is crucial because it helps address specific challenges, avoid serious problems, and find effective solutions. This ensures that environmental standards are maintained in sensitive spaces.
ISO classifications are based on international standards that regulate acceptable cleanliness standards in a cleanroom. International Organization for Standardization ISO 14644-1 provides guidance for acceptable air quality levels within the specific clean room ISO classes. A cleanroom’s class is determined by the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air.
A clean room, in my mind are a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. In this blog I will attempt to explain the necessary characteristics of a regulated company clean room not producing potent chemicals or active or hazardous biologicals. If there are significant containment requirements, the requirements would be outside the scope of a “simplistic” blog like this. In a pharmaceutical sense, clean rooms are those rooms that meet the code of GMP requirements as defined in the sterile code of GMP, i.e. Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidance as required by local health authorities.
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