CIP and SIP systems in Pharmaceutical Industry

Pharmaceutical industries use water for production, reconstruction or synthesis of the pharmaceutical products. The raw water entering the pharmaceutical industry will often need treatment to meet the high-grade specificationsfor the different purpose of the industry. As hygiene is one of the essential parts of food processing, cosmetics and pharmaceutical industries and hence correct cleaning of all the elements is required.Clean-in-Place (CIP) and Sterilization-in-Place (SIP) systems are anessential part of any pharmaceutical industry which believes to deliver quality products.

Until 1950s, closed systems were disassembled and then cleaned manually. This used to consume a lot of time for industries which needed frequent cleaning. The advent of CIP (Clean-in-Place) has really benefitted such industries.CIP systems in the pharmaceutical industry is a method which is used to clean the inner surface of pipes, filters, vessels, types of related equipments, and associated fittings, without the stress to disassemble them. CIP was started as a manual process which involved a balance tank, a centrifugal pump and connection to the system which is to be cleaned. The industries that use CIP, saves a lot of time and labor force. Also, their products posses a less chemical exposure risk to people. Over the years, CIP has evolved to include fully automated systems that contain programmable logic controllers, sensors, heat exchangers and specially designed spray nozzle systems.

SIP (Steam-in-place/Sterilization-in-place)system in pharmaceutical industry is responsible for continuous steaming the areas of the product contact, including all the vessels, flow paths and sample ports. SIP is performed after CIP cleaning. This can be done by reducing the bio-burden or by killing the harmful materials/substances at the end of the batch. A typical SIP system will ensure that all the areas that are being steamed need to be exposed to live steam for adequate quality of time, to ensure the desired ‘kill’ effect. The sterile process requires sterile plants. In the pharmaceutical industries, SIP is done in all cases by using saturated steam at a pressure of 1 bar. The process is done by blowing out the whole system with sterile air and in the case of process vessels, the cooling system is activated through the jacket.

After the sterilization process is ended, all the sensitive components have should be checked for their proper functionality and integrity. The steam system should be able to measure and control steam temperature, pressure and the flow of the steam in order to ensure adequate steaming. Constant temperature measurement is required in order to  meet the temperature needed. The SIP is usually carried out with the steam, which is supplied by the steam generator though chemical sterilization is also possible. SIP kills the harmful micro-organisms that may have survived CIP or in the place where CIP isn’t performed.