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Injection moulding (U.S. spelling: injection molding) is a manufacturing process for producing parts by injecting molten material into a mould, or mold. Injection moulding can be performed with a host of materials mainly including metals (for which the process is called die-casting ), glasses , elastomers , confections , and most commonly ...
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.
Injection mold construction is the process of creating molds that are used to perform injection molding operations using an injection molding machine. These are generally used to produce plastic parts using a core and a cavity. Molds are designed as two-plate or three-plate molds, depending on the type of component to be manufactured.
A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
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 ]
Multi-material injection molding (MMM) is the process of molding two or more different materials into one plastic part at one time. [1] As is the case in traditional injection molding, multi material injection molding uses materials that are at or near their melting point so that the semi-liquidous material can fill voids and cavities within a pre-machined mold, thus taking on the desired ...
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.
Micro injection molding is a molding process for the manufacture of plastics components for shot weights of 1 to 0.1 grams with tolerances in the range of 10 to 100 microns. This molding process permits the manufacture of complicated small geometries with maximum possible accuracy and precision. [1]