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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 ...
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.
Aqueous parts cleaning industrial washer. Parts cleaning is a step in various industrial processes, either as preparation for surface finishing or to safeguard delicate components. One such process, electroplating, is particularly sensitive to part cleanliness, as even thin layers of oil can hinder coating adhesion.
A typical mixture is 3 parts of concentrated sulfuric acid and 1 part of 30 wt. % hydrogen peroxide solution; [1] other protocols may use a 4:1 or even 7:1 mixture. A closely related mixture, sometimes called "base piranha", is a 5:1:1 mixture of water, ammonia solution ( NH 4 OH , or NH 3 (aq) ), and 30% hydrogen peroxide.
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.
ISO 29821-2:2016 Part 2: Procedures and validation ISO 29845:2011 Technical product documentation – Document types ISO/IEC 29881:2010 Information technology - Systems and software engineering - FiSMA 1.1 functional size measurement method
This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the ...