Search results
Results from the WOW.Com Content Network
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
Aseptic sampling is the process of aseptically withdrawing materials used in biopharmaceutical processes for analysis so as not contaminate or alter the sample or the source of the sample. [1] Aseptic samples are drawn throughout the entire biopharmaceutical process ( cell culture /fermentation, buffer & media prep, purification , final fill ...
Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness. In cases such as changes in synthesis of the drug substance, changes in composition of the finished product, and changes in the analytical procedure ...
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.
For example, sterile equipment and fluids are used during invasive medical and nursing procedures. [11] The largest manifestation of such aseptic techniques is in hospital operating theaters, where the aim is to keep patients free from hospital micro-organisms. [12] Packaged, sterilized surgical instruments
Process analytical chemistry (PAC) is the application of analytical chemistry with specialized techniques, algorithms, and sampling equipment for solving problems related to chemical processes. It is a specialized form of analytical chemistry used for process manufacturing similar to process analytical technology (PAT) used in the ...
The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be ...