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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.
Since FDTD simulations calculate the E and H fields at all points within the computational domain, the computational domain must be finite to permit its residence in the computer memory. In many cases this is achieved by inserting artificial boundaries into the simulation space. Care must be taken to minimize errors introduced by such boundaries.
For a first-order PDE, the method of characteristics discovers so called characteristic curves along which the PDE becomes an ODE. [1] [2] Once the ODE is found, it can be solved along the characteristic curves and transformed into a solution for the original PDE.
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.
Stencils are the basis for many algorithms to numerically solve partial differential equations (PDE). Two examples of stencils are the five-point stencil and the Crank–Nicolson method stencil. Stencils are classified into two categories: compact and non-compact, the difference being the layers from the point of interest that are also used for ...
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 ...
In mathematics, a partial differential equation (PDE) is an equation which involves a multivariable function and one or more of its partial derivatives.. The function is often thought of as an "unknown" that solves the equation, similar to how x is thought of as an unknown number solving, e.g., an algebraic equation like x 2 − 3x + 2 = 0.
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.