In order to meet the standards of the new version of GMP, the production automation of pharmaceutical industry has been more and more widely used. Especially, the preparation automatic control of pharmaceutical factories becomes increasingly urgent; based on production automation trends in the pharmaceutical industry, our company self-developed a preparation automatic control system, which can achieve preparation automation and online CIP cleaning and online SIP disinfecting of the whole system, and achieve online integrality detection of the microporous membrane filter element.
Taking the 300L concentrated preparation for an example, the corresponding volume of the dilution tank is 800L. Concentration tank configuration: lower stirring-magnetic stirring, and the reducer is German "SEW" reducer, with motor power of 0.75KW; tank bottom pneumatic diaphragm valve of DN32; electric heating respirator, 5 " × 1-filter PTFE filter, 0.22μm; digital thermometer interface-aseptic flange type; digital level gauge interface-aseptic flange type; sampling valve interface-aseptic flange type; quick manhole, integrated light endoscopy, diaphragm pressure gauge, safety valve with bursting discs; seat valve with steam inlet angle, pneumatic ball valve with condensate water outlet ; and several quick interfaces-flow meter with liquid inlet.
Dilution tank configuration: Dilution tank is the crucial preparation tank, with a direct impact on the quality of the preparation, so the configuration requirements are relatively high. The dilution tank should be equipped with a weighing system, foreign import, METTLER-TOLEDO weighing modules, and its specifications of CWC-1.5 stainless dynamic loading modules including weighing display; low stirring-magnetic stirring, and the reducer is German "SEW" reducer, with motor power 1.5KW; tank bottom pneumatic diaphragm valve of DN32; Electric heating respirator, 5 "× 1-filter PTFE filter element, 0.22μm; digital thermometer interface-aseptic flange type; PH meter interface-aseptic flange type; sampling valve interface-aseptic flange type; quick manhole, integrated light endoscopy, diaphragm pressure gauge, safety valve with bursting discs;  seat valve with angle steam inlet, pneumatic ball valve with condensate water outlet; and several quick interfaces.
Preparation, CIP cleaning and SIP disinfecting of the whole preparation system are automatically controlled by PLC program, and some parameters are printed out by the printer; determine whether the preparation system is correct, and whether CIP cleaning and SIP disinfecting is qualified by parametric analysis and accordingly determine whether the whole system is sterile and safe.
A conductivity meter is installed at the bottom of the preparation tank, to determine the cleaning degree of the tank and the pipes by conductivity value; It is noteworthy that distilled water conductivity is 0.05-0.1μs/cm, purified water conductivity of 1.0-10μs/cm; if clean with purified water, then the cleaning degree take purified water conductivity range as standards; if clean with distilled water, then the cleaning degree take distilled water conductivity range as standards; the pipe cleaning process also needs conductivity meter to control, and observe the displayed conductivity value of the pipeline in cleaning process, compare with the conductivity range of distilled water and purified water to analyze the pipe cleaning degree.
The disinfecting temperature of the whole system should be taken into consideration in SIP disinfecting process, so a stainless steel dial thermometer is installed at the bottom of each tank and determine the disinfecting temperature of the tank and piping according to the displayed thermometer value; saturated steam temperature for disinfecting is 121 ℃, with a continuous disinfecting at that temperature for 30 minutes. The pure steam is transformed into condenser water in the process which will be drained by pneumatic diaphragm valves at the bottom of the tank and pneumatic diaphragm valves on the pipe and diasostic pneumatic ball valves.