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Our goal is to provide a complete GMP & GLP models with a set of ready procedures and manuals which are easy to understand and readily applicable.
All procedures are written with practical instructions and examples.
Intertek’s scientists provide integrated polymer chemical and physical testing, consultancy and formulation support for all types of polymer materials and a range of applications such as aerospace and automotive through to packaging, medical devices and consumer products.
With over 30 years’ experience in polymer chemical testing and a global laboratory network located in Netherlands, UK and Switzerland and the US, we are the partner of choice for many of the world’s most innovative developers and manufacturers of polymers and plastics.
This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.
This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose.
Chemical testing of polymers and plastics is required to ensure that a material is suitable for its intended application.
Polymer chemical testing is used to identify fundamental structural information including as molecular weight, molecular weight distribution and information on branching.
Chemical testing of a plastic or polymer material can be complex but can provide valuable information on the additives used and other substances present which is important when trying to understand material performance.
This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.