Explanation of construction standards for 100,000-level gmp clean workshops
Biopharmaceutical companies request GMP's policy to ensure the establishment of a scientific and rigorous environment, skills, operation and management system for the production of sterile medicines, to maximize the elimination of all possible, potential biological activity, dust, pyrogen pollution, and output High-quality, safe-to-clean pharmaceutical products. What we call biopharmaceutical purification engineering-GMP clean plant engineering solution plan and pollution control skills are one of the first means to ensure the successful implementation of GMP;
Through in-depth research on the production environment of biopharmaceutical customers and the accumulation of engineering experience, we understand the key to understanding the environmental control of the biopharmaceutical production process; energy saving is the priority of our system plan; what we do best is to give customers compliance with GMP and Fed 209D , ISO14644, IEST, EN1822 international standard request, together with the environmental solution plan of the latest energy-saving skills; we can provide the GMP whole plant plan planning-people flow logistics purification plan, clean air conditioning system, clean decoration system; Hydropower, ultra-pure gas pipelines, clean room monitoring, protection systems and other devices supporting services;
The gmp workshop refers to the workshop that meets the requirements of the gmp quality and safety management system. The production workshop was inspected by the Drug Supervision Bureau. The cleanliness reached 100,000-level pharmaceutical production specifications, and the 100,000-level purification workshop specifications. The number of air dust particles per cubic meter does not exceed 35.2 times 100,000. 15-20 times per hour, suitable for production occasions with low air cleanliness.
The 100,000-level purification workshop selects skills to deal with as follows:
1. It is necessary for the air-conditioning system to purify the air-conditioning system through three stages of primary, intermediate and high-efficiency filtering treatment. Ensure that the air sent into the room is clean air, which can dilute the polluted indoor air.
2. Ensure a certain pressure in the room to prevent the clean room air from being disturbed by the outside air. Generally, the industrial clean room requires a pressure difference between 5-10pa between indoor and outdoor.
3. It is necessary to construct the envelope structure to ensure excellent air tightness, and to construct a surface that is lubricated, does not produce dust, does not accumulate dust, and does not leak. GMP workshops usually have 10,000 levels, 100,000 levels and 300,000 levels, of which 100,000 levels (filling, inner packaging) and 300,000 levels are the most. The 100,000 levels are much more clean than the 300,000 levels. See attachments. Monitoring project skills require monitoring methods to monitor frequency.
Temperature 18 ~ 28 ℃ (100,000 grades, 300,000 grades) jgj71-90 1 time / shift humidity 45 ~ 65% (100,000 grades, 300,000 grades) jgj71-90 1 time / shift ventilation times Level ≥15 times / hour jgj71-90 1 time / month 300,000 levels ≥12 times / hour static pressure difference ≥5pa (different cleanliness between clean rooms (areas) jgj71-90 1 time / month ≥10pa (clean Room (area) and outdoor)
≥5pa (between clean room (area) and non-clean room (area))
Dust particles ≥0.5μm ≥5μm gb / t16292-1996 1 time / season 100,000 class ≤3500000 pieces / m3 ≤20000 pieces / m3
300,000 class ≤10500000 pcs / m3 ≤60000 pcs / m3
Plankton 100,000 levels ≤500 pcs / m3 gb / t16293-1996 1 time / seasonal settlement bacteria 100,000 levels ≤10 pcs / dish gb / t16294-1996 1 time / week