Medical Device Cleanroom | ISO 14644

Cleanrooms are a specially designed environment in every medical industry or food packaging industry etc, to avoid small particles interfering with the manufacturing process.

A clean room is an area where if air also enters then it is been filtered, and the air within the facility is also continuously filtered in order to remove any contaminants that are produced on the inside of the facility.

Cleanrooms level of contamination is controlled, indicated by the number of particles per cubic meter at a predefined particle size. Humidity, temperature and pressure can also be controlled.

The size and complexity of cleanrooms fluctuate reliant on the industries they are to be utilized as a part of, for instance, in the biotech business; more control is required over the environment.

The accessories and specific equipment inside the cleanroom are designed to prevent contamination, including specially designed mops and buckets. And the furniture is built as per the cleanroom environment. Regardless of, it is not perfect for a clean room as the main focus is only on eliminating airborne contaminants.

The key segment of a cleanroom is the High-Efficiency Particulate Air (HEPA) channel where all air conveyed to the room is gone through and particles that are 0.3 microns and bigger in the measure are filtered out. Now and again it might be important for an Ultra Low Particulate Air (ULPA) channel to be utilized, where more stringent cleanliness is required. Individuals, the manufacturing procedure, facilities and equipment produce the contaminants that are filtered through by the HEPA or ULPA channels.

Consistently, more manufacturing procedures and items are being created that make cleanroom generation situations fundamental. This is particularly valid in the screen print industry, where contaminants can infiltrate the manufacturing procedure and negatively affect the nature of the completed print.

Each Cleanroom is designed as per the quality standard of International Organization for Standardization which is applicable to the globe. ISO 14644 is the cleanroom standard established by ISO in 1999 i.e. ISO 14644-1(the first version of cleanroom standard). If you are the medical device manufacturer and want to design cleanroom for your medical device then you need to have QMS of cleanroom(i.e. ISO 14644).

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