Pharmacopoeias.Many pharmacopoeias include standards for plastic containers and closures.
Plastic materials used in medicine and pharmacy may give rise to adverse effects, either by direct contact of the plastic with tissues or by indirect contact (for example, when a solution stored in a plastic container, such as a disposable syringe, is injected). Adverse effects may also arise among workers through handling the materials or by inhaling fumes during manufacture. Pure polymeric plastics appear to be of low toxicity, though carcinogenic effects have been produced by some on prolonged implantation. However, some monomers are toxic, as may be substances added during manufacture to impart specific physical properties. These additives include plasticisers added to reduce brittleness, ultraviolet-ray absorbers to prevent degradation by light, and antoxidants and lubricants which are sometimes needed for satisfactory processing. Monomer residues or additives can leach out from the finished plastic materials and have been the main causes of adverse effects. These may include haemolysis of blood cells, thrombosis, hypersensitivity reactions, precancerous changes, and local tissue necrosis. Silicone particles have been shed from dialysis tubing resulting in hypersplenism, pancytopenia, and occasionally in the production of a granulomatous hepatitis. See also under Vinyl Chloride, Methylmethacrylate, and Polytef, below.
Published May 08, 2019.