Clean in Place System (CIP) Calibration
When it comes to biopharmaceutical organization's involved in manufacturing, having a sterile environment is important to maintain both compliance and product quality. A key piece of equipment in manufacturing is the clean in place (CIP) systems, which keeps the equipment and pipelines cleaned and sanitized between production runs. This minimizes any risk of contamination or cross-contamination. The team of professionals at GL Technologies, as an ISO 17025 company, specializes in equipment calibration and certification services for biopharmaceutical clients throughout California to help our clients continuously meet regulatory compliance and maintain equipment that is working as needed.
To speak with the experts about your clean in place system needs, please fill out our online form or give us a call!
What is a Clean in Place (CIP) System?
A clean in place system, commonly referred to as a "CIP", as an automated cleaning system that is used in the biopharmaceutical industry. The system is designed to clean the interior surfaces of equipment and pipelines without the need to be disassembled. The goal of a CIP system is to remove product residues and other contaminants so the equipment is ready to perform in the next production cycle.
Why is CIP Calibration Important in Biopharmaceutical Manufacturing?
With any equipment or system calibration in the biopharmaceutical industry, accurate results are absolutely important to maintain both product quality and regulatory compliance. CIP calibration involves both verification and adjusting of the system's qualifed "parameters" to guarantee consistent cleaning cycles.
Contamination Prevention
When clean in place systems are properly calibrated, this provides sanitization to the instruments which reduces the risk of product contamination. In the biopharmaceutical industry, even trace amounts of impurities can effect producty quality and overall patient safety with the end product.
Regulatory Compliance
All of the clients with GL Technologies understand how important regulatory compliance with cGMP (current good manufacturing practices) and the FDA are extremely important to comply with. Proper calibration of all instruments, including CIP systems, shows that a company is meeting the standards for product manufacturing that will meet both general inspections and audits.
Process Efficiency
Calibration works to improve the CIP process, providing efficient use of resources including water, cleaning solutions, and energy. When the parameters of the clean in place system are propertly adjusted, flow rates, temperatures, and cleaning cycles are improved and manufactuers have the ability to minimize operating costs through improved processes.
Consistency
With any system in a laboratory, the importance of consistent and repeatable results is important, even with cleaning. The cleaning process maintains batch-to-batch sterilization and consistency for product quality, and achieving reliable validation results.
Calibration Process for CIP Systems
The calibration process for CIP systems in the biopharmaceutical industry involves several steps to verify and adjust the system's performance including:
Documentation Review
During the calibration process for CIP, GL technologies will provide a comprehensive documentation review of the system's operating manuals, maintenance records, and past calibration logs. With the evaluation we will be able to identify any inconsistencies, deviations, or outdated information that may impact the performance of the equipment. The review also checks the organization's adherence to regulations for compliance. With the review, we will be able to establish a foundation for accurate measurements and cleaning performance.
System Evaluation
The system evaluation starts with an inspection of the CIP system's physical condition, which will include tanks, pumps, and instruments. Once the inspection is complete the system's performance is measured and verified by conducting tests on the parameters including flow rates, pressure, and chemical concentration. Any sort of deviation from the needed values are identified and corrected.It also includes an evaluatin of the system's control logic like alarm settings and other safety features so they meet manufacturer's requirements.
Parameter Verification
Parameter verification involves the confirmation of the correct settings and values for the key parameters of the CIP's system's overall operation. This verification includes the flow rate, temperature, concentration of cleaning solutions, and the duration of the cycle. By checking the parameters of these cycles, technicians can show that the CIP system is working as needed to remove contaminants and maintain hygiene standars.
Performance Testing
Performance testing is a fundamental step in the calibration process, the goal is to evaluate the system for accuracy. It involves a series of tests to measure the important parameters like flow rates, chemical concentration, and temperature. By examining and testing the CIP system, technicians will be able to tell if the CIP system meets the predetermined specifications and removes contaminants. Any issues or deviations found during performance testing can be fixed through adjustments or a recalibration.
Documentation
The documentation is the final phase and plays an important role in maintaining consistent performance and regulatory compliance. The documentation should include step-by-step instructions for calibration procedures, including: tools needed, safety precautions, and acceptance criteria. The documentation should also record the calibration results including any measurements and deviations. This will give biopharmaceuticals the ability to troubleshoot any future issues should they occur and provide traceability..
GL Technologies Calibration and Certification
GL Technologies is comprised of a team of professionals with deep knowledge in the biopharmaceutical research and manufacturing industry. We work with clients throughout California for all their equipment calibration and certification requirements to keep equipment perfoming to manufacturer's standards and keep our clients compliant with federal regulations.
To speak with the experts about your clean in place needs, please fill out our online form or give us a call!
To request a quote from GL-Tec, please fill out our online form and we will get back to you promptly.
CLICK HERE TO BEGIN