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Liquid distribution system in pharmaceutical production, it is important to eliminate cross-contamination of active ingredients, foreign matters and insoluble particles, reducing or ending pollution of injections by microorganisms and pyrogens and guaranteeing the quality and safety of products; It can ensure the automatic operation of each production sub-process of large infusion, monitor parameters in the production process in real time and give an alarm; it can control temperature of medicine liquids, temperature of injection water and sterilization effect to ensure production quality; at the same time, it can also query the historical data and operation records of all parameters, which greatly improves the automation level of the production process and reduces the possibility of human error.
In the process of producing materials for injection, the cleaning method of the material system can be divided into three modes: manual, semi-automatic and fully automatic.
1. Manual cleaning mode: such as manually remove the filter, filter element and hose which must be disassembled and washed to ensure the cleaning effect; it is an unstable mode, its reproducibility and effectiveness cannot be guaranteed, and the quality risk level is “high”.
2. Semi-automatic cleaning mode: It adopts ultrasonic technology to clean filters and other accessories; it is relatively stable, and its reproducibility and effectiveness can be basically guaranteed, and the quality risk level is “medium”.
3. Fully automatic cleaning mode: It adopts the human machine interface, information exchange and functional contact or mutual influence to realize fixed process methods or procedures to complete liquid distribution equipment or system operations; It uses the CIP/SIP technology; the kind and concentration of cleaning fluids, temperature, flow rate and cleaning time should be basically met to reach the purpose of cleaning; it is stable, its reproducibility and effectiveness can be completely guaranteed, and the quality risk level is “low”.
1. Fully automatic production, which can improve production efficiency and avoid human error.
2. Monitoring data in the production process and giving an alarm, conducive to find problems existing in the production process.
3. Recording production data in real time and allowing people to trace problems existing in the production process.
4. Controlling temperature of cams.
5. Performing quantitative control on the sterilization effect.
6. Controlling peoples’ operating authority to avoid human error.
7. Ensuring the safety of liquid medicine in emergency situations such as gas and power outages.
8. The operation station adopts the combination of local and remote, which greatly improves the reliability and convenience of the system.
9. Using the advanced PAC control technology of the process controller, thus making the control process faster and more reliable.
10. Applying real-time Ethernet bus on site, thus dramatically enhancing the on-site data transmission speed and reliability.