Carbono orgânico total (sumário) a verificação de limpeza é um processo essencial na fabricação farmacêutica e em outras indústrias para garantir que as instalações e equipamentos de fabricação estejam limpos e livres de contaminação. Aqui estão as aplicações e benefícios da verificação de limpeza TOC:
Cotonete de validação de limpeza TOC
Applications of TOC cleaning verification
TOC analysis is a popular method for cleaning validation as it enables simple, rapid measurements and can detect all organic substances. TOC analyzers are mainly used for water quality analysis of liquid samples such as tap water, environmental water, and waste water. Installing special accessories makes it possible to measure nitrogen components in liquid samples and carbon components in solid samples. TOC analyzers have recently been introduced not only for pharmaceutical products but also for cleaning validation at cosmetics and food manufacturing sites. They are also used in the manufacturing process and quality evaluation of various medical devices to evaluate the cleanliness of products after cleaning.
The following three methods can be proposed for cleaning validation using a TOC analyzer. The method used depends on the material, tamanho, and shape of the equipment or products subject to cleaning validation.
- Rinse Sampling – TOC Measuring Method
- Swab Sampling – Extraction – TOC Measuring Method
- Swab Sampling – Direct Combustion Carbon Measuring Method
Benefits of TOC cleaning verification
The key Benefit of using TOC for cleaning validation is that it gives a quantitative value of the entire formulation, degradants, and cleaning agents combined for a more comprehensive understanding of cleanliness. Non-specific methods like TOC have more sensitive limits of detection (LOD) as compared to specific methods like HPLC. TOC provides greater sensitivity while also capturing. TOC and conductivity are the most common non-specific methods deployed for cleaning validation, verification, and monitoring.
Other benefits of using TOC for cleaning validation include:
- Universality: The TOC method is universal and can detect all organic substances, which saves time and labor costs for pharmaceutical companies.
- Simple and Rapid Measurements: TOC analyzers are mainly used for water quality analysis of liquid samples and can provide simple and rapid measurements.
- Expandability: Installing special accessories makes it possible to measure nitrogen components in liquid samples and carbon components in solid samples, which makes TOC analyzers versatile and expandable.
- Custo-beneficio: TOC analysis is a cost-effective method for cleaning validation as it can detect all organic substances in a single run.
Para concluir, TOC cleaning verification is an essential process in pharmaceutical manufacturing and other industries to ensure that manufacturing facilities and equipment are clean and free from contamination. The benefits of using TOC for cleaning validation include universality, simple and rapid measurements, expandability, cost-effectiveness, and more sensitive limits of detection.
