Container closure systems light protection

Primary container-closure system-related data will need to cover storage, transportation, and use. The choice of materials of construction, their description, and the ability of the container-closure system to protect from moisture and/or light will need to be considered. The compatibility of the container-closure and its contents will need to consider sorption, leaching, and safety. The performance of the container-closure system will also need to be considered in terms of dose delivery from any associated device that is to be supplied as part of the product. Container-closure components will require adequate specifications covering description, identification, critical dimensional tolerances, and test methodology (including pharma-copeial and noncompendial methods). More data are likely to be required for liquid or semi-liquid products than for solid dosage forms. In the latter, product stability data and container-closure system specifications may suffice. 

Protection (by each component and/or the container closure system, as appropriate) light exposure, reactive gases (e.g., oxygen), moisture permeation, solvent loss or leakage, microbial contamination (sterility/contamer integrity, increased bioburden, microbial limits), filth, other... 

Because it is chemically inert, impermeable, strong, and rigid, glass has FDA clearance and is the ideal container for most drug products. With the proper closure system, it provides an excellent barrier to practically every element except light. Opaque jars are used to protect light-sensitive products and are available as porcelain white or dark green or amber in color. Commercially available empty ointment jars vary in size from 0.5 ounce to 1 pound. 

---