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Pharmaceutical dosing systems are widely used in pharmaceutical production and biotechnology, and it is important to use safe and reliable cleaning techniques to remove residues from pharmaceutical dosing systems. CIP (Clean In Place) refers to the method of cleaning the dosing system under closed conditions without disassembling the pharmaceutical dosing production equipment, compared with the traditional COP (Clean Out of Place) method. , CIP cleaning method can be repeatedly verified, save operating time, improve production efficiency, save labor, safe and reliable, save cleaning water, adjustable cleaning procedures, environmental protection and energy saving, easy installation and operation, modular production and factory Advantages such as acceptance testing. 
Analysis of the application of CIP workstation in the pharmaceutical industry
Cleaning principle
The main principle of cleaning is to apply thermal, mechanical and chemical energy to the residue on the surface of the device, and the cleaning of the device is achieved by the combination of these energies. Temperature, mechanical action, chemical action and time are the four basic elements in the cleaning process. For the purpose of cleaning, the above four elements are indispensable and mutually complementary and complementary.
Temperature: Studies have shown that for every 10 °C increase in temperature, the chemical reaction rate will increase by 1.5 to 2 times, and the cleaning rate will increase accordingly. Appropriate increase of temperature helps to save cleaning time. When the temperature exceeds 80 °C, the cleaning time is basically unchanged. Therefore, considering the comprehensive energy consumption and cleaning effect, the CIP program often selects 60~70 °C as the standard cleaning temperature.
Mechanical action: The mechanical action of cleaning is mainly achieved by flow and pressure, and the cleaning process in the turbulent state can effectively remove system residues. The cleaning effect is closely related to the selected cleaning ball. At present, in the conventional dosing system, the rotating ball washing and the tangential water washing ball have been widely promoted in the pharmaceutical engineering industry due to various advantages such as economy, energy saving and water saving.
The cleaning effect is closely related to the dead angle of the system. The cleaning verification of the dead angle shows that the proper increase of the system flow rate has a significant effect on the cleaning effect; at the same time, the smaller the system dead angle control, the lower the required cleaning flow rate. In order to ensure a good cleaning effect of the pharmaceutical dosing system, companies must strictly abide by the "3D dead angle principle". For example, the biopharmaceutical industry often adopts a multi-pass valve design concept with no dead ends to effectively eliminate system cross-contamination. In engineering, the cleaning flow rate is generally controlled at 1.5~2m/s, and the cleaning flow experience value is generally 4~12L/min/m2 (surface area in the tank).
Chemical action: Properly increasing the concentration of the cleaning agent can effectively shorten the cleaning time or make up for the shortage of the cleaning temperature. At present, the cleaning agents used in pharmaceutical dosing systems are mainly divided into two categories: acidic cleaning agents and alkaline cleaning agents. The alkali detergent has a good removal effect on the high-protein-containing soil; the acid-based detergent has a good effect on the stubborn scale which the alkaline cleaning agent cannot remove, and the acid-based detergent has certain corrosiveness to the metal. It needs to be neutralized in time and rinsed with water after use.
Time: In the case of ensuring the cleaning effect, shortening the cleaning time is essential for improving production efficiency. The cleaning time depends on many factors such as dirt properties, chemical action, mechanical action, temperature, dead angle and surface polish. For example, electrolytically polished cans save cleaning time. The cleaning time required for each dosing system will vary and the actual cleaning time required will be confirmed during the PQ (Performance Confirmation) phase.
CIP workstation application
The CIP system was first applied in the dairy industry in the United States in the 1950s. In 1955, the CIP system was combined with an automated control system to effectively solve the stability and reproducibility of the cleaning effect, which has been widely promoted in the pharmaceutical industry. The CIP workstation is a fixed online cleaning device that uses touch operation mode, automatically adjusts cleaning time, cleaning agent concentration, cleaning temperature, cleaning flow rate and other parameters. All operations can be recorded for easy authentication.
According to the number of workstation tanks, CIP workstations can be divided into single tank CIP systems, dual tank CIP systems and multi-tank CIP systems. Pharmaceutical companies can choose a reasonable combination of actual needs.
According to the way the cleaning agent is used, the CIP workstation can be divided into a single batch using a CIP system and a reusing CIP system. The single-batch CIP workstation's cleaning agent is ready to use, completely eliminating the cross-contamination caused by cleaning agents, and has been favored by most pharmaceutical companies, such as fermented biological products, lyophilized preparations and blood products. Tank CIP workstations are widely used. In aseptic bulk pharmaceuticals, chemical medicines, and traditional Chinese medicine sterile preparations, the risk of cross-contamination of products caused by cleaning is relatively small, and some enterprises will also choose three or more tanks of CIP system for online cleaning of liquid dispensing systems. In order to save operating investment such as cleaning agent and cleaning water.
CIP workstations recommend professional 3D design software for modular design and guided assembly. The modular design is conducive to factory performance testing, saving floor space, beautiful and easy to operate, fully in line with the American ASME BPE design philosophy. The distribution frame system of CIP workstation is mainly composed of the following components: cleaning fluid storage tank, final water storage tank, CIP supply pump with frequency conversion control, heat exchanger and heating adjustment device, sampling valve, diaphragm valve, pipeline fittings, Temperature sensor, pressure sensor, conductivity sensor, cleaning agent concentration sensor, concentrated acid and concentrated alkali dosing device, online monitoring instrument, backup valve and its integrated control system, CIP workstation should record the following important indicators: cleaning agent concentration , CIP flow, CIP pressure, final conductivity, cleaning agent temperature and cleaning time. The CIP return pump can also be integrated into the distribution frame according to actual needs. A framework system for a typical CIP workstation practiced by the author.
The cleaning process of standard CIP workstations mainly includes pre-flushing, cleaning agent circulation cleaning and final showering. Practice has shown that increasing the aseptic compressed air purging process can effectively save cleaning time and cleaning water. The 2010 version of the Good Manufacturing Practices (2010 version of the GMP Code) clearly states in Appendix 1: Sterile Drugs: The final water spray of a sterile drug preparation system should meet the quality standards for water for injection. The CIP workstation can automatically determine the end point of the system cleaning through the loop conductivity sensor.
CIP workstation combined with process analysis technology (PAT) has become a very mature online cleaning method in the pharmaceutical industry. With the official promulgation of the new GMP and the new Pharmacopoeia, China's pharmaceutical industry has stricter requirements on the design, installation and product quality of the dosing system. CIP workstations will be more widely used in domestic dosing system cleaning.
Analysis of the application of CIP workstation in the pharmaceutical industry
[China Pharmaceutical Network Technology News] CIP system was first applied in the dairy industry in the United States in the 1950s. According to the number of workstation tanks, CIP workstations can be divided into single tank CIP systems, dual tank CIP systems and multi-tank CIP systems. Pharmaceutical companies can choose a reasonable combination of actual needs.