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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 ...
[3] [4] BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophthalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, [1] parenteral medicines, [5] and several other liquid or semiliquid medications, [6] with ...
Internet pharmacies mail the prescribed drugs to the customer; boxes or mailing envelopes are used. Child resistant packaging is often required on the unit packs; if requested, a pharmacist is allowed put drugs in a bottle with easy open features. Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets.
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 ...
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 ]
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
In microbiology, sterility assurance level (SAL) is the probability that a single unit that has been subjected to sterilization nevertheless remains nonsterile.. It is never possible to prove that all organisms have been destroyed, as the likelihood of survival of an individual microorganism is never zero.
Grand River Aseptic Manufacturing (GRAM) is a clinical and commercial sterile manufacturing contractor to the pharmaceutical industry. It has lyophilization , terminal sterilization, analytical, microbiological testing services.