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How is the level of clean workshop in pharmaceutical factory divided?
300,000; Maximum allowable quantity of microorganisms: 1000 planktonic bacteria/m3; Application: Pill packaging workshop. ?
65438+ million; Maximum allowable microbial quantity: 500 planktonic bacteria/m3; Application: injection concentration workshop.
10,000; Maximum allowable quantity of microorganisms: 100 planktonic bacteria/m3; Applicable occasions: small-volume injection filling workshop and final treatment workshop of packaging materials in direct contact with drugs. ?
100; Maximum allowable quantity of microorganisms: 5 planktonic bacteria/m3; Application: Filling workshop for large-capacity injections.
Extended data:
The cleanliness of clean workshop and the continuous stability of pollution control are the core standards for testing the quality of clean room. This standard is divided into several grades according to regional environment, purification degree and other factors. Commonly used standards include international standards and domestic regional industry standards. Some well-known purification engineering companies have their own purification indicators higher than international standards, and their purification ability and environmental adaptability far exceed international brands.
Generally, industrial aluminum materials (stainless steel square pass and plastic-sprayed square pass) are used as the frame, and the fan filter screen unit FFU is used for air supply, with anti-static curtains around it and a blind flange at the top to form a closed joint area, and the internal purification level can reach100-65438+100000. It is especially suitable for areas with high cleanliness requirements in the workshop, such as high-precision product assembly areas in assembly line operation areas.
References:
Baidu encyclopedia-clean workshop
References:
Baidu encyclopedia-cleanliness
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