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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.
Provided the RCA clean is performed with high-purity chemicals and clean glassware, it results in a very clean wafer surface while the wafer is still submersed in water. The rinsing and drying steps must be performed correctly (e.g., with flowing water) since the surface can be easily recontaminated by organics and particulates floating on the ...
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.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Biological indicators may take the form of glass vials of spores and liquid media, or as spores on strips of paper inside glassine envelopes. These indicators are placed in locations where it is difficult for steam to reach to verify that steam is penetrating that area. For autoclaving, cleaning is critical.
Cleaning laboratory glassware is a frequent necessity and may be done using multiple methods depending on the nature of the contamination and the purity requirements of its use. Glassware can be soaked in a detergent solution to remove grease and loosen most contaminations, these contaminations are then scrubbed with a brush or scouring pad to ...
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 ...