Rubber packaging component manufacturers

Table 7 Pharmaceutical rubber packaging component manufacturers... 

The polymeric materials usually used to manufacture rigid closures are practically the same as those seen under plastic containers (Section 6.1.3.2). The same impurities are therefore to be expected in these packaging components. On the other hand, though made of polymeric materials, elastomeric closures present a different structure. In the manufacture of rubber, elastomer, the chief component, is combined with other chemicals to produce a material with specific properties that meet target needs, such as its above-mentioned ability to reseal on repeated use. Table 28 lists the common elastomers used in the pharmaceutical industry and their monomeric structures. 

Quality control—The rubber component manufacturer s release criteria and drug packager s acceptance are found in this section. Also recommended is a method to monitor the consistency in composition of elastomeric components such as periodic extraction profiles. 

FDA approved 1998 for use as an accelerator in the manufacture of rubber material (up to 1.5% of weight of rubber) intended for use in all stages of production, processing, packaging and transport of food 21CFR 177.2600. Regulated for use under 21CFR175.105 for components of adhesives. 

Like the one-component polysulfides or polyurethanes, the one-component silicones must be protected from moisture during manufacture and storage. However, package stability of the silicones is superior. If a cartridge is only partially used, the plug of cured rubber which forms in the tip retards further moisture penetration. 

---