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[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 ...
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
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 ...
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.
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.
Solopharm company was established in 2010. [2] The owner and director of Solopharm company is Russian businessman Oleg Zherebtsov.In August 2014 – launch of injection and infusion solution lines by the innovative technology Blow-Fill-Seal accepted in the world as the most perfect technology for production of sterile solutions with opportunity to use aseptic filling or finish sterilization. [3]
Sterile pre-filled medications Nephron states that is has more than 20 years of sterile pharmaceutical manufacturing experience and produces those products from an outsourcing facility.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]