Introduction
To reduce human error and potential quality risks in production greatly, a reliable CIP system and SIP is employed to reduce/ eliminate residual materials in water system or liquid mixing system so as to effectively remove organic matters required by microbial reproduction, control microorganism pollution in equipment to a certain level and realize repeatability and effectiveness required by GMP. For injection liquid mixing system, the washing method can be divided into three forms:
1. Manual cleaning: such as manual disassembly of filter, filter element, hose, etc., by which cleaning effect can be guaranteed. But this belongs to unstable handling method, thus repeatability and effectiveness cannot be guaranteed.
2. Semi-automatic cleaning: ultrasonic technology is used to clean filter and other accessories. It belongs to stable handling method and can basically ensure repeatability and effectiveness.
3. Fully automatic cleaning: the automatic man-machine interface control system transfers perfect manual cleaning process to automatic program, controls the CIP system to finish cleaning of liquid mixing tank body, delivery pump, filter and pipeline automatically with stability, effectiveness and repeatability.
Performance Characteristics
1. Cleaning in Place
CIP system is designed, manufactured and accepted in strict accordance with related requirements in Pharmacopoeia of The People's Republic of China 2010, Steel pressure vessels and Steel welded atmospheric pressure vessels.
CIP nozzle is designed as extension type. When the nozzle is not used, it is retracted into vessel till flush with vessel wall to reduce interference to operation. During CIP, cleaning fluid is pumped to the nozzle and the air-to-open controller pushes the retracted nozzle to the CIP operating position. After in position, the nozzle is driven hydraulically to rotate and spray the surface of the whole equipment. The hydraulic pressure during operation can be 20-80 PSIG. When CIP is finished, air-to-close remote position adjuster retracts the nozzle to the original position.
The nozzle has two types, long type suitable for vessels with thin and thick walls and common type. Besides, it has two control modes, i.e. air-to-open and air-to-close. This kind of retractable nozzle does not need to be mounted and moved before and after cleaning, exerting no influence to operations, to ensure proper position of the nozzle all the time and adapt to PLC control easily. It can be used for insulated pipelines and is resistant to corrosion of CIP cleaning fluid. The system is provided with a visual nozzle position display to ensure complete cleaning.
CIP system process flow
Basic process flow of CIP system is as follows: preliminary cleaning – cyclic heating- cyclic washing- terminal washing- sterilization- pressure maintaining. Operation condition of the system is monitored in real time, data are recorded and kept and functions of self-test, interlocking and alarm are available to prevent pollution to other systems during cleaning.
2. Steaming in place
Requirements of SIP moist heat sterilization:
1). Saturated steam has the strongest penetrability and the relation between temperature and pressure of saturated steam is the most stable. During condensation, the released heat is transferred to items to be sterilized, which will be heated and trigger hydration of microorganism to accelerate death of microorganism.
2) The solution preparation system has to bear pressure of inner steam, of which the safety must be guaranteed.
3) The solution preparation system is provided with steam jacket and thermal insulation to control temperature.
4) The solution preparation system shall be provided with a proper steam trap at a specified position to ensure smooth drainage of all condensate water in the tank and pipelines.
5) The solution preparation system shall be set up with a temperature control point and a pressure control point at the specified position.
6) The solution preparation system is equipped with a cyclical timer and pressure stabilizer.
7) The liquid mixing system shall be designed by sectional sterilization based on customer's requirements.
Key factors of steam sterilization include
In design of steam sterilization, gravity displacement, pre-vacuum process, pulse process or drainage are usually adopted to drain cold air inside the system in sterilization cycle since cold air may force temperature reduction for parts to be sterilized and prevent steam from penetrating the whole surface of the objects under sterilization, thus reducing heat exchange efficiency of steam and objects under sterilization. The design of steam sterilization cycle depends on volume, structure and layout of the system to be sterilized, which may affect drainage effect of cold air. So emptying, intermittent pulsing or flow-through method can be selected to satisfy different needs and the scope of temperature and F0 value can also be determined at the same time.
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