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1. What key equipment does the GMP workshop need to be equipped with?
The list of key equipment in the GMP workshop is as follows, classified by functional areas.
1. Core equipment in the production area • Liquid preparation system: slag waste stainless steel liquid preparation tank with CIP/SIP function (material 316L), pipeline filter (0.22 μ m) • Filling equipment: fully automatic filling linkage line (accuracy ± 1%), tunnel sterilization oven (temperature 300 ℃± 5 ℃) • Tablet press: high-speed rotating tablet press (production capacity ≥ 300000 tablets/hour, punch modulus ≥ 55 punch). 2 Purification system equipment • HVAC system: HEPA high-efficiency filter (H14 level), air volume control valve (control accuracy ± 5%) • Laminar hood: A-level vertical laminar flow (wind speed 0.45 ± 0.1m/s) 3. Detection and monitoring equipment • Online monitoring: particle counter (0.5-5 μ m six channel), planktonic bacteria sampler (28.3L/min) • Environmental monitoring: temperature and humidity sensor (accuracy ± 0.5 ℃), pressure difference meter (range 0-60Pa) 4. Auxiliary system equipment • Purified water system: Multi effect distilled water machine (water production ≥ 1500L/h, conductivity ≤ 1.1 μ S/cm) • Sterilization equipment: pulsating vacuum sterilization cabinet (sterilization temperature 121 ℃± 1 ℃, F0 value ≥ 15) Luliang sales injection early morning teasing: equipment The selection must comply with the requirements of Appendix 1 "Sterile Drugs" of the 2023 version of GMP, and the air conditioning system should meet the ISO 14644-1 Class 8 standard. The biosafety cabinet needs to pass NSF49 certification, and the sterilization equipment needs to have complete validation documents (IQ/OQ/PQ).
2. 
My account is at the beginning, I am Liezhuan Zhengyi. The HVAC system consists of three main systems: refrigeration system, cooling system, and condensing system. The refrigeration system is the main system involved in cold and heat exchange, achieving cooling and heating; The cooling system is a system that cools the running host; The condensation system is a system that collects and discharges condensed water from the system. The final device for 7-terminal cold and hot exchange. After hot and cold exchange, the HVAC system enters the main unit of the cold and heat source through the return water pipeline in the transmission and distribution system and re circulates in one loop. More than 95% of HVAC systems are closed cycle systems. 4
2. Cold and Heat 3. The host generates cold and heat, and the end releases the cold and heat. The transportation of the cold and heat requires a cold and hot medium as a carrier. Cold and hot media 5 can be steam, water, ethylene glycol solution, etc. Water is mainly used in HVAC systems. 4. Cold and heat L=QxOT=flow rate multiplied by temperature difference. 0=Medium port in constant and variable flow rates. |10... The energy saving on the host side is achieved by the bypass flow rate of the differential pressure bypass valve to change the number of hosts that are turned on. If the bypass flow rate of the differential pressure bypass valve reaches the flow rate of one host, the control system is notified to shut down one host. But the temperature difference between the opened main rooms is a constant value, and we mainly rely on changing the system flow to achieve change
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