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Tubular Glass Vials (USP Type I)

Type I borosilicate vial, injection vial, 2R–100R · CAS —

Packaging USP Type I / EP Type I, hydrolytic class I CoA per lotDimensional reportHydrolytic resistance testExtractables study summary

For injectables, the vial is part of the container-closure system and therefore part of the filing. Dimension tolerances, hydrolytic resistance and the cosmetic defect standard all have to be agreed in writing before the first shipment, because a 0.2 mm deviation changes the stopper seal.

We supply nest-and-tub format with a dimensional report per lot and an extractables study summary. Amber and printed options are available; printing requires artwork approval and adds two weeks to the lead time.

Identity

Catalogue no.BP-PKG-010
HS code7010.90
SynonymsType I borosilicate vial, injection vial, 2R–100R
Product linePharmaceutical Packaging
CategoryGlass Containers

Release specification

Catalogue standard below. For a supply agreement we release against your dossier specification; send it with the enquiry and the CoA will be built around it.

ParameterSpecification
PurityHydrolytic resistance class HGA1 (Type I)
Related substancesNo visible alkali leaching after autoclave test
Sizes2R, 4R, 6R, 8R, 10R, 20R, 30R, 50R, 100R
MaterialBorosilicate glass 5.1 / 7.0
Tolerance±0.20 mm on body OD (agreed per size)
FormatNest & tub, ready to fill
SterilityNon-sterile; validated washing before fill

Application

Injectable drug products — lyophilised powders, small-volume liquids and vaccines.

Packaging, storage & logistics

Standard packagingShrink-wrapped nest-and-tub, 100–300 pcs per carton
Minimum order50 000 pcs
Lead time20–35 days
Storage conditionsStore in original packaging, dry, away from direct sunlight
Shipping documentsInvoice, packing list, CoA, SDS, certificate of origin; DGM/IATA declaration where applicable

Pack sizes available — pick one to prefill the enquiry

1 000 pcs10 000 pcs50 000 pcs100 000 pcs

Documentation provided

  • CoA per lotLot-specific, with the test methods cited
  • Dimensional reportIssued with each lot on request.
  • Hydrolytic resistance testIssued with each lot on request.
  • Extractables study summaryContainer-closure extractables data supporting your CMC section

Need the DMF open part, a sample CoA or an audit pack before you can qualify us? Ask on the enquiry form — we send those documents before any commercial discussion.

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