In the pharmaceutical industry, hygiene and sterility of process teams are critical factors for guarantee product quality and regulatory compliance. Automated cleaning and sterilization systems, known as CIP (Clean-In-Place) y SIP (Sterilize-in-Place), allow these processes to be carried out without disassembling pipes or equipment, saving time, reducing risks and ensuring the reproducibility of the results.
What is a CIP system?
A CIP system is an installation designed for Automatic equipment cleaning and Pipes In contact with the product. You can use detergent solutions, purified water, rinse water and controlled flow, temperature and pressure sequences to remove waste without manual intervention.
CIP characteristics:
- Controlled and reproducible cleaning.
- Reduction of the line stop time.
- Personnel safety improvement.
- Water savings and chemicals if the design is optimized.
What is a SIP system?
The SIP system is responsible for sterilization on-site of process systems, using clean steam at high temperature (normally between 121ºC and 135ºC). This process eliminates microorganisms and guarantees aseptic conditions, especially critical in the manufacture of sterile products.
SIP characteristics:
- Sterilization without disassembly.
- Reduction of cross contamination risk.
- Validation of the simplest process.
- Integration with automated control systems.
- INTEGRATION OF CIP/SIP SYSTEMS IN PIPES.
In pharmaceutical facilities, pipe systems must be Designed for Facilitate the uniform flow of cleaning or sterilization agents. This implies the use of appropriate slopes for drainage; the hygienic design, such as sanitary fittings and absence of dead sections; and automation by PLCS or SCADA systems to guarantee the control of critical parameters.
Validation and regulatory compliance
Both CIP and SIP systems must be validated according to Good Manufacturing Practice (GMP). Validation includes: protocols Iq, Oq and Pq; the Cycle documentation, as well as the monitoring and traceability temperature, pressure, conductivity, etc.
The implementation of CIP and SIP systems in pharmaceutical pipes guarantees Efficient cleaning and sterilization, safe and according to regulatory demands. In IDI we design and integrate personalized CIP and SIP solutions that ensure the reliable operation of critical facilities.
Do you want to know more? Contact us and help you optimize your cleaning and sterilization systems with quality guarantees and regulatory compliance.