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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 ...
However, if gloveboxes are very meticulously designed, thoroughly disinfected (e.g., using sporocides) and carefully operated by well-trained aseptic processing personnel to prevent introduction of microbial contamination, it is possible to obtain some degree of increased sterile product protection versus the simple traditional LAF hood.
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
Microorganisms growing on an agar plate. Sterilization (British English: sterilisation) refers to any process that removes, kills, or deactivates all forms of life (particularly microorganisms such as fungi, bacteria, spores, and unicellular eukaryotic organisms) and other biological agents (such as prions or viruses) present in fluid or on a specific surface or object. [1]
Asepsis is the state of being free from disease-causing micro-organisms (such as pathogenic bacteria, viruses, pathogenic fungi, and parasites). [1] There are two categories of asepsis: medical and surgical. [ 1 ]
Barriers to the ability of healthcare workers to follow PPE and infection control guidelines include communication of the guidelines, workplace support (manager support), the culture of use at the workplace, adequate training, the amount of physical space in the facility, access to PPE, and healthcare worker motivation to provide good patient ...
BFS-packaged eye drops for single use. Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed.
21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. [3] The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products.