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West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma^® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec^® film, RB2 Coating, RSV^® and RUV^® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.

Rubber components are essential for the safe containment and delivery of parenteral drug products. Many rubber formulations used in the pharmaceutical industry are based on halobutyl rubbers. Halobutyl rubbers, typically bromobutyl or chlorobutyl, are made by the halogenation of butyl rubber, which is a copolymer of isobutylene and isoprene (to a smaller extent). Key features of halobutyl rubbers that make them suitable for the pharmaceutical industry are that they typically have lower levels of extractables compared to other rubbers, and they have excellent resistance to permeation by water and oxygen.

Primary packaging components come in intimate contact with drug products – they can affect both drug product and patient safety. Many elastomer components are offered with a FluroTec^® film that serves as a chemical barrier to minimize the migration of compounds from the elastomer into the drug product. FluroTec film comprises an ethylene-tetrafluoroethylene co-polymer (ETFE) – selected based upon flexibility, ability to be laminated to an elastomer, and of course, permeability resistance.

The first thought that you may have when you hear the word “rubber” is natural rubber – a poly-isoprene-based polymer, which has as its origination the latex fluid drawn from rubber trees (most prominently in Indonesia and Malaysia). Although natural rubber has been used in the past for pharmaceutical applications, potential issues with latex allergies resultant from proteins from the original latex, have led to the almost complete adoption of synthetic rubber.

West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).