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A container closure system should provide the dosage form with adequate protection from factors (e.g., temperature, light) that can cause a degradation in the quality of dosage form over its shelf ...
This protection is guaranteed by selected container closure systems, whose aseptic packaging performs broad roles like shielding freeze-dried products against water vapour, guarding vaccines from ...
Pharmaceutical waste containers and closure system: Introduction In the intricate world of pharmaceuticals, the disposal of waste is a critical concern that demands meticulous attention and ...
US FDA in its guidance titled ‘Container Closure System and Component Changes: Glass Vials and Stoppers’ conveys recommendations to holders of approved new drug applications (NDAs), biologics license ...
Lee, MA, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM), a Massachusetts fill finish CMO, and Aptar Pharma, a global leader in drug delivery systems, services and active ...
On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass ...