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Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...
The RCA clean is a standard set of wafer cleaning steps which need to be performed before high-temperature processing steps (oxidation, diffusion, CVD) of silicon wafers in semiconductor manufacturing. Werner Kern developed the basic procedure in 1965 while working for RCA, the Radio Corporation of America.
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Environmental Technology Verification (ETV) consists of the verification of the performance of environmental technologies through testing using established protocols or specific requirements. [1] This process is carried out by qualified third parties, and several ETV programs are being run worldwide.
Temperature of the cleaning solution. Elevating the temperature of a cleaning solution increases its dirt removal efficiency. Molecules with high kinetic energy dislodge dirt faster than the slow moving molecules of a cold solution. Concentration of the cleaning agent. A concentrated cleaning solution will clean a dirty surface much better than ...