Evaluation of the General Solution Compatibility of Polymer Materials Used in Medical Devices such as Syringes

Abstract

Polymeric materials are commonly used in medical devices such as syringes. The plastic materials may interact with drug products contained within the device, potentially affecting the quality of the drug products. These interactions may include leaching, which is the migration of entities out of the material and into the drug product, and binding, which is the migration of substances out of the drug product and into the material. This paper examines the magnitude of leaching and binding for several materials that can be used in syringe parts such as the syringe barrel, plunger, and tip cap.

Identification of chemical species created during γ‐irradiation of antioxidant used in polyethylene and polyethylene‐co‐vinyl acetate multilayer film

“…However, the chain-breaking inability should not be the main reactional scheme. In contrast, hindered aryl phosphites can react with alkoxyl radicals by substitution reactions giving substituted alkylaryl phosphite derivatives and hindered aryloxyl radicals (Scheme 16), which terminates Note: The formations of 30, [63][64][65] 32, 33 [63][64][65][66] the oxidation chain reactions. Phosphite antioxidants are in most cases used in synergy [80] with primary antioxidants such as 2 and 3.…”

Science- and risk-based strategy to qualify prefillable autoclavable syringes as primary packaging material

“…This is in line with the findings of Jenke et al who examined the compatibility of several polymeric (including glass) and elastomeric materials with solution-based pharmaceutical products. 5 The UV absorption profile (210-280 nm) for polypropylene was high and increased with higher pH values. The UV profile for COP and cyclic olefin copolymer (COC)…”

“…(3) the refrigerator capacity that is needed for storage, both in the pharmacy and on the ward; (4) the need for a cold chain for the entire production and distribution process including the need for a validation of this process; (5) the lack of the qualifications of the syringes as containers and (6) the limited capabilities of upscaling the production. A terminally sterilised product is preferred because it provides a much higher level of quality assurance.…”

Evaluation of Physicochemical Parameters of the Leachates of Plastic Biomedical Devices

“…28 There are numerous reports on the leachable, such as metals, DEHP, cyclohexanone and other organic and acidic compounds found in the solution of PVC bags. [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] Heavy metals, such as Cd, Cr, Cu, Fe, Mn, Ni, Pb and Zn leaching in the simulating solvent are known to be present in the commercial plastic products. 13 They affect the normal physiological activities of the cells, when the levels of these metals are found to be above the permissible limits.…”

“…These additives are not chemically bound to the matrix of the polymeric materials and leach out under the influence of physicochemical factors such as sun light, temperature, type of solvents and pH of the stored commodity. [12][13][14][15][16][17][18][19][20][21][22] The plasticizers, initiators and stabilizing additives commonly used in IV bag production to enhance their manufacturability or physical properties can differ in different types or the same type of plastic materials. 23 24 Compounds that include organics, metals and volatile sulphur containing compounds may leach out from the plastic IV infusion containers into the contained solution.…”