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Aluminium Vial Seals Made in India

Autofits makes aluminium vial seals at its plant in Nashik, India, in two constructions: all-aluminium seals with no plastic part, the tear-off (13, 20 and 32 mm) and the tear-down (20 mm), and aluminium-plastic FlipTop® seals, where a polypropylene top sits on the aluminium shell (13 to 34 mm). Every one is formed from AA8011 aluminium alloy with an epoxy lacquer, crimped under the vial neck flange over the rubber stopper, and made under an ISO 15378:2017 quality system with a Drug Master File (DMF 18100).

All-aluminium tear-off vial seals made by Autofits

The aluminium seal range in one table

Seal Construction How it opens Sizes Standard Page
Tear-off All-aluminium, no plastic Aluminium centre torn away along a perforation to expose the stopper 13, 20, 32 mm ISO 8362-3 Tear-off seals
Tear-down All-aluminium, no plastic A perforated section tears down 20 mm ISO 8362-3 Tear-down seals
FlipTop® Optima Aluminium shell with a polypropylene flip-off button Button flips off; aluminium stays crimped 13, 20, 28, 32, 34 mm ISO 8362-6 FlipTop® Optima
FlipTop® Pull-Ring Aluminium shell, polypropylene disc and aluminium pull ring Ring pulled; whole seal comes away 20, 32 mm ISO 8362-6 FlipTop® Pull-Ring
FlipTop® Tear-Down Polypropylene disc riveted to the aluminium shell Disc turned anticlockwise; whole seal comes off 13, 20, 32 mm ISO 8362-6 FlipTop® Tear-Down

Key takeaways

  • An aluminium vial seal is the crimped metal closure that holds the rubber stopper on an injection vial; Autofits makes it all-aluminium or aluminium-plastic.
  • All-aluminium seals: tear-off in 13, 20 and 32 mm, tear-down in 20 mm, both under ISO 8362-3.
  • Aluminium-plastic seals: the FlipTop® range in 13 to 34 mm, under ISO 8362-6.
  • The aluminium is AA8011 to EN 15088:2005, 0.16 to 0.26 mm thick depending on size and design, with an epoxy lacquer to 21 CFR 175.300.
  • Maximum opening force is 30 N at 13 mm, 35 N at 20 and 28 mm and 65 N at 32 mm.
  • Every seal is supplied regular, ready to use or ready to sterilise.

All-aluminium or aluminium-plastic: which suits which vial

Choose all-aluminium when the specification allows no plastic on the vial; choose aluminium-plastic when the vial is entered by needle, colour-coded or has to be opened with a designed, repeatable action.

  • Metal-only specifications. The tear-off seal has no plastic part: the user tears the aluminium centre away and the stopper is exposed. The 20 mm all-aluminium tear-down tears a perforated section down instead.
  • Needle entry, single-dose or multi-dose. The FlipTop® Optima flip-off leaves the aluminium crimped and exposes only the stopper face, so a multi-dose vial can be entered repeatedly.
  • Seal removed entirely, for oral products. The Pull-Ring and the FlipTop® Tear-Down come off the vial completely; Tear-Down is used mainly for oral vaccines.
  • Colour coding and print. Both constructions can be colour-coded through pigmented lacquer, but a polypropylene top holds colour, embossing and print more cleanly; see the colour range.

Aluminium-plastic seal vs aluminium seal sets the two constructions side by side, and flip-off vs tear-off compares the two most common designs.

All-aluminium tear-down vial seals made by Autofits

The aluminium: AA8011 alloy and lacquer

Every Autofits seal is formed from aluminium alloy AA8011, conforming to EN 15088:2005, supplied with an EN 10204 3.1 certificate and tested to BS EN 485-2:2008. The alloy is soft and ductile enough to roll under a glass neck flange without cracking, which is the property a crimp seal depends on. It is REACH and RoHS compliant.

The aluminium is coated with an epoxy lacquer conforming to 21 CFR 175.300, which may be pigmented for colour; ready-to-use seals are double-lacquered. Heavy metals (hexavalent chromium, cadmium, mercury and lead) are limited to 100 ppm in total to EN 602 and EC 94/62, and the seals are BSE/TSE-free to EMEA/410/01 rev. 3. How alloy and gauge choices affect a vial cap is explained in aluminium grades for vial caps.

Aluminium seal dimensions

From the Autofits engineering drawings, all dimensions in millimetres. Values not on a drawing are confirmed with the quotation.

Seal and size Inner Ø (D1) Perforation or disc Ø (D2) Total height Aluminium thickness Bridges
Tear-off 13 mm 13.20 to 13.60 Confirmed with the quotation 6.90 to 7.70 Confirmed with the quotation 2
Tear-off 20 mm 20.00 to 20.60 9.70 to 10.50 (perforation) 7.40 to 8.00 0.16 to 0.20 2
Tear-off 32 mm 32.40 to 32.60 17.80 to 18.20 (perforation) 13.00 to 13.60 Confirmed with the quotation Confirmed with the quotation
Tear-down 20 mm (all-aluminium) 20.50 to 20.70 12.90 to 13.20 (perforation) 7.50 to 8.50 0.18 to 0.22 2 taper
FlipTop® Optima 13 mm 13.36 min 14.99 max (disc) 7.62 to 8.38 0.16 to 0.20 6 taper
FlipTop® Optima 20 mm 20.22 min 23.14 max (disc) 9.02 to 9.91 0.16 to 0.20 6 taper
FlipTop® Optima 32 mm 32.10 to 32.90 35.50 to 36.50 (disc) 14.30 to 15.50 0.21 to 0.25 12 taper

Full dimensions for every FlipTop® size, including 28 and 34 mm, are on the sizing guide and each size page.

FlipTop Optima aluminium-plastic flip-off seals made by Autofits

Packing, delivery forms and shelf life
Standard packing per 420 x 270 x 320 mm box 15,000 at 13 mm, 6,000 at 20 mm, 3,000 at 28 mm, 1,400 at 32 mm
Bags Standard inner bags; Tyvek available
Delivery forms Regular; ready to use (washed, assembled in an ISO Class 8 cleanroom, double-bagged, gamma or ETO sterilised); ready to sterilise
Shelf life before capping 3.5 years regular, plus 5 years after capping; 2 years ready to use
Order quantity and lead time Confirmed with the quotation

In practice at Autofits

Autofits Packaging Pvt. Ltd. makes its aluminium and aluminium-plastic seals in one 75,000 sq ft plant at MIDC Malegaon, Sinnar, Nashik, Maharashtra. Seals are washed on a fully automated line, assembled in an ISO Class 8 cleanroom and pass 100% high-speed camera inspection, and the polypropylene tops of the FlipTop® range are moulded in-house on Japanese Toyo machines. The quality system is certified to ISO 15378:2017, ISO 9001:2015 and ISO 14001:2015, with a Drug Master File (DMF 18100) and CFDA registration. Release AQL is critical nil, major 2.5% maximum and minor 4% maximum. Certificate numbers are on the quality certificates page.

Frequently asked questions

Who manufactures aluminium vial seals in India?

Autofits Packaging Pvt. Ltd. manufactures aluminium vial seals at its plant in Nashik, Maharashtra: all-aluminium tear-off seals in 13, 20 and 32 mm, an all-aluminium tear-down seal in 20 mm, and the aluminium-plastic FlipTop range in 13 to 34 mm. The plant is certified to ISO 15378:2017 and holds a Drug Master File (DMF 18100).

What aluminium is used for vial seals?

Autofits forms its seals from aluminium alloy AA8011, conforming to EN 15088:2005, with an EN 10204 3.1 certificate, tested to BS EN 485-2:2008 and REACH and RoHS compliant. It is coated with an epoxy lacquer to 21 CFR 175.300. The aluminium is 0.16 to 0.26 mm thick depending on the size and design.

What is the difference between an all-aluminium seal and an aluminium-plastic seal?

An all-aluminium seal is one piece of metal: it is opened by tearing the aluminium, and nothing plastic is left on the vial. An aluminium-plastic seal adds a polypropylene button or disc on the aluminium shell, which gives a designed opening action, such as a flip-off button, and a cleaner surface for colour and print. Both seal the vial the same way, through the aluminium crimp.

Which standard covers aluminium vial seals?

ISO 8362-3 covers aluminium caps for injection vials, which is where the all-aluminium tear-off and tear-down seals sit. ISO 8362-6 covers caps made of aluminium-plastics combinations, the FlipTop range. The vial neck the seal fits is defined in ISO 8362-1.

What sizes do aluminium vial seals come in?

The all-aluminium tear-off is made in 13, 20 and 32 mm and the all-aluminium tear-down in 20 mm. The aluminium-plastic FlipTop Optima covers 13, 20, 28, 32 and 34 mm. The size matches the vial neck finish, not the fill volume.

Can aluminium seals be supplied sterile?

Yes. All Autofits seals are supplied regular, ready to use or ready to sterilise. Ready-to-use seals are washed, assembled in an ISO Class 8 cleanroom, double-bagged and sterilised by gamma irradiation or ETO, with a 2-year shelf life before capping.

Related pages

Sources

*Last updated: 2026-11-06. Dimensions are from the Autofits engineering drawings; confirm your specification with the quotation.*


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