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CIP-SIP
Cleaning and sterilisation in place systems
In the pharmaceutical industry, cleaning and sterilisation are critical to ensure product quality and regulatory compliance. CIP-SIP (Cleaning In Place and Sterilisation In Place) systems enable these processes to be performed directly in situ.
In the pharmaceutical industry, cleaning and sterilisation are critical to ensure product quality and regulatory compliance. CIP-SIP (Cleaning In Place and Sterilisation In Place) systems enable these processes to be performed directly in situ.
Clean. Sterile. Ready.
CIP is an automated cleaning process that removes product residues from the internal surfaces of equipment (i.e. product contact parts) through a controlled sequence of rinsing, washing with detergent, and final rinsing. Different types of detergent solutions can be selected according to product characteristics to optimise cleaning.
SIP is an automated sterilisation process that uses saturated steam to eliminate viable microorganisms after cleaning, at temperatures above 121°C. The CIP-SIP unit can be integrated into both liquid and powder filling lines.
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Production Plant
IMA Life
CIP-SIP Highlights
1.
Compliance with ASME BPE for piping and fittings; compliance with FDA regulations, USP Class VI, and ADIF standards for plastic components.
2.
3.1 material certificate according to EN 10204 for stainless steel parts and welding documentation (WPS, WPQR,QW, etc.).
3.
Redundant filtration and in-line pre-use post-sterilisation integrity testing (PUPSIT) and post-use integrity testing of sterile filters.
4.
Different level of integration for Filter Integrity instrument
5.
Verification of proper circuit cleanliness through WFI monitoring system integration (i.e. TOC and conductivity).
6.
F0 method for calculating SIP sterilisation time and guarantee of sterility maintenance after SIP through dedicated sequence.
7.
Redundancy in its control and monitoring instrumentation of critical parameters during SIP cycle.
8.
Process validation through Riboflavin test (CIP) and temperature mapping test (SIP).
CIP-SIP skids are generally integrated with dosing systems using volumetric pumps or time-pressure technology. Dosing systems with peristaltic pumps are typically required in combination with Single Use Systems (SUS). Combined solutions can also be offered (SU dosing circuits with CIP-SIP units).
- Technical Data
- Machine Layout
