| With growing concerns of interactions between drug products
and container closure systems, pharmaceutical companies desire
an ideal elastomeric closure. Prior to this increased awareness,
the role of elastomeric closures was quite basic. This allowed
pharmaceutical companies to develop standard packaging
components for their portfolio of injectable drug products. The
role of a standard elastomeric closure was limited to confining a
pharmaceutical within a given area (for example, vial or syringe),
maintaining a seal for vials or syringes, and permitting proper
removal of pharmaceuticals via a hypodermic needle.
However,
in recent decades, more demands come from pharmaceutical
companies to their suppliers, including improved compounds and
coatings, more specific closures designs, manufacturing facilities
that are GMP-compliant, and validated wash processes that
comply with the requirements of FDA and EU guidances. This
article discusses the choices pharmaceutical companies are
required to review when selecting an elastomeric closure.
CLOSURE DESIGN
Typically, one of the most fundamental decisions to make
when choosing an elastomeric closure is the geometrical design.
This statement holds true for vial stoppers (includes serum and
lyophilisation stoppers) more than it does for syringe components
(plungers/pistons, tip caps and needle covers). Vial stoppers are
traditionally designed in accordance with ISO standards ISO
8362-2 and ISO8362-5, which promotes compatibility with ISO
standard ISO 8362-1 for vials. |
