EXTON, Pa.—West Pharmaceutical Services Inc., a global manufacturer of containment and delivery systems for injectable medicines, has developed a new elastomer formula for two of its stoppers that the company said increases reliability and safety in the packaging, containment and transport phases.
In addition, the company has launched a new line to its established AccelTRA component program, AccelTRA Select, which offers new configurations of stoppers and a 1-3 mL uncoated plunger, all in a 4031/45 elastomer formula, West said.
A company spokeswoman said customer input drove much of the design of the 4040/40 formula used in the LyoTec stoppers, available in 13 and 20 millimeter sizes.
"Customers are looking for elastomers that are compatible with a brand portfolio of current drugs that also address the tightening regulatory requirements for the future," she said.
Using design principles that minimize by-product formation, the spokeswoman said the 4040/40 formula stoppers reduce extractables and particulates in whatever medicine or biomedical product they are containing.
"These are two key customer challenges that we focused on during the development of the new 4040/40 formulation," she said.
Extractables, which can contaminate the product, mostly are generated by interaction between the biomedical products and their packaging over time, usually under extreme conditions such as the presence of strong solvents or elevated temperatures, according to the company. Extractables also can be caused by gamma-irradiation.
Specific extractables of concern include bromo oligomers, the spokeswoman said.
The AccelTRA Select line, which features new configurations of stoppers and a plunger all in a "new-generation" 4031/45 elastomer formula, is designed to improve the packaging and delivery process for generics customers, according to West.
This line, which West hopes to expand in 2020, offers both serum and lyo stoppers in 13 and 20 mm sizes, along with a 1-3 mL uncoated plunger.
"These new elastomer product offerings reflect West's deep commitment to innovation based on customer insights," said Karen Flynn, senior vice president and chief commercial officer with West Pharmaceuticals. "We aim to simplify their journey with drug packaging and delivery systems and help bring much-needed injectable medicines to patients more quickly and efficiently."