Pharmaceutical substances and drugs are manufactured in highly regulated industries. Cleaning validation is a step that falls within the scope of quality control (QC). It must be effective and compliant with regulations in order to eliminate the risk of cross-contamination. The aim is to guarantee both the effectiveness of the final product and patient safety.
Context & regulatory requirements of pharmacopoeias
The validation of cleaning water allows the effectiveness and reproducibility of the entire cleaning process to be verified. Thus, the maximum residue levels for cleaning products are predetermined according to the materials and products used. These limits must be met in order to verify the removal of residues and deposits on the surfaces of the equipment used in the production line.
The quality of water—water for injection (WFI), pure water (PW), and highly purified water (HPW)—used to clean pharmaceutical process equipment is subject to preliminary analyses in accordance with regulatory requirements. The European Pharmacopoeia (EP), the United States Pharmacopeia (USP), Good Manufacturing Practices (GMP), and other regulatory standards establish strict guidelines for water quality and analytical instruments.
TOC analysis for cleaning validation
TOC (total organic carbon) is one of the parameters that is rigorously monitored in cleaning validation applications. This analysis ensures that the chemical properties of the water have been maintained throughout the manufacturing process. Water used for CIP that comes into contact with tanks and process and manufacturing equipment must comply with a maximum TOC limit of 500 ppb or 0.5 mg C/L.
TOC analyzers used to test cleaning water must therefore comply with USP Chapter <643> and/or EP 2.2.44 guidelines and achieve a quantification limit of at least 500 ppb. The preferred method used for direct TOC measurement is chemical oxidation with persulfate heated to a high temperature (98°C). This technique ensures specific oxidation of the carbon dissolved in the cleaning water and direct measurement of the TOC value by infrared measurement of the CO2 emitted during oxidation.
Meet regulatory requirements for TOC validation
Ideal for cleaning validation applications in the pharmaceutical industry, the Aurora 1030W TOC analyzer is designed for chemical analysis of water.
Persulfate chemical oxidation & regulatory compliance
The Aurora 1030W TOC analyzer uses the persulfate chemical oxidation method (reactor heated to 98°C). This method allows the detection of material residues and contaminants thanks to its high sensitivity. This is why it is approved and adopted in many regulatory standards for water quality analysis (Standard Method 5310C, USEPA 415.3, USP/EU 2.2.44, ASTM D 4779 and 4839, USEPA-DBPR, USEPA-SPCC, ISO 8245, and NF EN 1484).
Performance and low quantification limit < 0.5 ppm
The measurement range and quantification limit are important parameters to consider. The lower the quantification limit, the more qualitative information the instrument will provide on the presence of pollutants in the tested water.
Installation, training, qualification
A team of service engineers, with nearly 30 years of expertise, will arrive on site as quickly as possible and assist you with all the services necessary to start up the instrument and keep it in working order.
- Basics of the chemical oxidation principle of Total Carbon with persulfate
- Applicable methods
- General operation
- Initial start-up
- Computer connection
- Calibration and control of the instrument
- Sample analysis and study of results
- IQ/OQ/PQ and annual requalification
Physitek Devices recommends using suitable consumables and bottles certified <10ppb delivered with a certificate of conformity. See the store
A key step in the pharmaceutical industry’s quality control workflow, the cleaning validation procedure ensures the traceability and effectiveness of the cleaning methods used in production facilities. This is to provide maximum quality for the products manufactured. The Aurora 1030W TOC analyzer is ideal for meeting these quality and safety challenges in the pharmaceutical industry.
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