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Vial (revision 1)

Old revision·09:00, 23 Jul 2024·CounterfeitCato

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Vial
FunctionPrimary container for injectable and lyophilised products
Usual materialType I borosilicate glass
ClosureElastomeric stopper with crimped aluminium ferrule
Common neck finishes13 mm and 20 mm
Common sizes for research peptides2R and 6R
Topic infobox · conventions

A vial is a small container, conventionally of glass, closed by an elastomeric stopper retained under a crimped metal ferrule. It is the standard primary package for injectable products and for lyophilised solids, including the great majority of peptides distributed for research use. The vial, its closure and its seal are treated in pharmaceutical practice as a single functional unit — the container closure system — because none of the three performs its function without the others.[1]

The container has three simultaneous duties. It must contain the product without contributing to it, which constrains the chemistry of both glass and elastomer; it must exclude micro-organisms and, for many products, moisture and oxygen, which is a matter of seal integrity rather than of material; and it must permit withdrawal by needle without loss of that integrity, which is why the closure is a penetrable elastomer rather than a screw cap.[2][1]

References

  1. ^ a b United States Pharmacopeia, General Chapter <1207>, "Package Integrity Evaluation — Sterile Products" (informational), with subchapters <1207.1> to <1207.3>. USP–NF, current revision.
  2. ^ United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.