ISO 14644 (Clean Rooms)
ISO 14644 standard was first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in clean rooms and clean Zones. The need for wider ranging standards was recognized when clean rooms became more experienced and knowledgeable. The need for a single standard for clean room classification & testing was long felt. The first document of ISO 14644 was published in 1990, after the petition of ANSI and IEST to ISO for new standards. The integrity of manufacturing process is important for any medical device that comes in direct or indirect contact with patient as they can easily come in contact with the remains of microbiological or chemical which are produced within the manufacturing and distribution environment. For the manufacturer of these types of devices, clean rooms are best suited. Clean rooms are very safe and hygienic. In this type of room’s humidity, temperature, pressures are kept within the limits. Clean room ensures that the products are under control and does not contaminate any person. It also reduces the possibilities of risks to the patient.
Benefits of ISO 14644 (Clean Rooms):
- Recognized medical device expertise.
- Active involvement in standards development and implementation.
- Quality system certification
Clean rooms can be very large in size as entire manufacturing facilities can be covered in this room. These rooms can be used for that field which are very sensitive to environmental contamination like semiconductor manufacturing, biotechnology, the life sciences and many other such fields. Air entering the clean room removes all the dust as it is filtered. HEPA (High Efficiency Particulate Air) again circulates the air inside the room constantly and contaminants which are produced inside the room are removed through the help of ULPA (Ultra Low Particulate Air.
People inside the room wear protective clothes such as hoods, face masks, gloves, boots and coveralls. Clean room has such kind of equipments which generate minimum contamination of air. Furniture of clean room is also designed in such a way that it produces minimum of the particles and is also easy to clean.
Clean rooms are used mostly in every industry where small particles can adversely affect the manufacturing process. Size and complexity of the clean room vary from each other. These rooms are used in the industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and department of energy.
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