A critical step in understanding the biosafety and suitability of containers are the ability to characterize all materials and chemicals that can migrate into the interior of the container system and that can potentially lead to pharmaceutical contamination or degradation. CD Formulation can test the types of containers that need to be evaluated, including plastic bottles, glass vials, stoppers and raw plastics (resin pellets, sheet, etc.).
Fig.1 Drug packaging safety testing.
CD Formulation has a number of regulatory testing procedures to ensure that the composition and function of pharmaceutical packaging are appropriate for the different stages of a pharmaceutical product. CD Formulation has experience using these methods, as well as customer-provided container analysis methods, to perform relevant testing, including:
Plastic Packaging Systems for Pharmaceuticals
Tests include identification, solution appearance, UV absorbance, pH, total organic carbon, bioreactivity tests for polyethylene, polypropylene, polyethylene terephthalate, cyclic olefins and plasticized polyvinyl chloride, as well as chemical safety assessments that can be applied to any type of plastic (extractable testing).
Auxiliary Encapsulation Components
Testing includes pharmaceutical cotton, rayon, pharmaceutical polyester and desiccant testing. Desiccants include bentonite, anhydrous calcium chloride, calcium oxide, molecular sieve, and silica gel.
Packaging Performance Testing
Testing includes moisture permeability testing of bottles and blister packages, as well as UV transmission testing.
Pharmaceutical glass containers come into direct contact with pharmaceutical products. Glasses used for pharmaceutical containers are either borosilicate (neutral) glass or soda lime silica glass. Borosilicate glasses contain significant amounts of boron oxide, aluminum oxide, and alkali and/or alkaline earth oxides. Depending on the intended use, the glass is also classified as Class I, II or III. Appropriate tests are performed depending on the composition and type of glass. Water resistance testing of glass is determined by titrating extracts under defined conditions to detect the amount of alkali released from the glass.
We have many years of experience in container testing.
We can test multiple pharmaceutical packaging combinations.
We can follow a variety of testing procedures including customer specific testing procedures.
We have the ability to provide complete testing services for your entire packaging system, including assessment of pharmaceutical packaging seal integrity and testing for insoluble particles.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.