A drug product container and package system typically includes more than simply a container and a closure. There can be a number of auxiliary components that are used to support or enhance the system or provide improved protection for the drug product or device is it holding. Common auxiliary support components fall into two key categories outlined in the USP <670> General Chapter as follows:
Cotton Pharmaceutical Coil – Purified cotton is the hair of the seed of Gossypium Hirsutum that is deprived of fatty matter and bleached. It is used in bottles of solid oral dosage forms to prevent breakage.
Rayon Pharmaceutical Coil – A fibrous form of bleached, regenerated cellulose, that is used as a filler in bottles of solid oral dosage forms to prevent breakage.
Polyester Pharmaceutical Coil – a white odorless material used as a filler in bottles of solid oral dosage forms to prevent breakage.
Bentonite – a native, colloidal, hydrated aluminum silicate clay used to remove moisture from air in containers.
Calcium Chloride – an inorganic compound with a chemical compound similar to salt, removes moisture and water vapor from container interiors.
Calcium Oxide – a white, caustic, alkaline, crystalline solid that attracts moisture vapor within a closed containers system.
Molecular Sieve – synthetic porous crystalline alkali-metal aluminosilicates in a beaded form with a tightly controlled pore size.
Silica Gel – Silica gel is silicon dioxide that has been manufactured by the addition of sodium silicate solution to a mineral acid to produce a gelatinous precipitate that is washed, then dehydrated to produce colorless silica gel in a bead, granular, or micronized form in a range of mesh sizes.
Testing requirements for these various support components can be complicated to decipher and in some cases require specialized techniques and instrumentation. With a comprehensive focus on all aspects of container and package system qualification testing, the CS Analytical Team can define and complete an auxiliary component test program that ensures compliance to all regulatory guidelines.