Tamper Evident Vial Seal Manufacturer in India

FlipTop Optima Button type tamper evident vial seal

Autofits makes tamper evident vial seals in Nashik, India in three FlipTop designs: Optima flip-off in 13, 20, 28, 32 and 34 mm, Pull Ring in 20 and 32 mm, and Tear-Down in 13, 20 and 32 mm, with an all-aluminium tear-off seal in 13, 20 and 32 mm for a plastic-free closure. Each has a feature that breaks or comes away the first time the vial is opened and cannot be put back. The Optima Button design carries intrinsic tamper evidence from a 12-stem flower moulded under the button disc, and every seal is 100% camera inspected under ISO 15378:2017.

The three tamper evident designs

Design	How it shows the vial was opened	Sizes
FlipTop Optima, Bridge and Flower types	The plastic top snaps at its moulded break point and cannot be reseated; the aluminium stays crimped	13, 20, 28, 32, 34 mm
FlipTop Optima Button type	Intrinsic: a 12-stem flower moulded under the button disc is disturbed when the button is lifted	13, 20, 28, 32, 34 mm
FlipTop Pull Ring	Once the polypropylene disc is detached the whole seal comes away: pull the ring, open anticlockwise	20 mm (bridge), 32 mm (flower)
FlipTop Tear-Down	The disc is opened, then pulled and rotated anticlockwise so the whole seal comes off	13, 20, 32 mm
All-aluminium tear-off	The metal top is torn away at the perforation and cannot be reformed	13, 20, 32 mm

Choose the Button design when tamper evidence is the main requirement, because the flower is part of the closure geometry rather than a side effect of opening. Where the whole closure has to leave the neck in one visible action, Pull Ring and Tear-Down do that, and they are the usual choice for oral presentations.

Dimensions by design and size

From the Autofits engineering drawings. All dimensions in millimetres; values not carried on a drawing are shown as on request.

Design and size	Inner Ø alu (D1)	Outer Ø disc (D2)	Total height	Alu thickness	Bridges or fins
Optima 13 mm	13.36 min	14.99 max	7.62 to 8.38	0.16 to 0.20	6 taper
Optima 20 mm	20.22 min	23.14 max	9.02 to 9.91	0.16 to 0.20	6 taper
Optima 28 mm	27.60 to 28.20	30.10 to 31.10	11.06 to 12.06	0.17 to 0.23	8
Optima 32 mm	32.10 to 32.90	35.50 to 36.50	14.30 to 15.50	0.21 to 0.25	12 taper
Optima 34 mm	33.60 to 34.00	35.50 to 36.50	15.00 to 16.00	0.20 to 0.25	8 taper
Pull Ring 20 mm	20.00 to 20.60	22.00 to 23.00	9.00 to 10.00	0.18 to 0.22	6 taper bridges
Pull Ring 32 mm	32.15 to 32.40	36.20 to 36.60	14.30 to 15.30	0.20 to 0.26	8 fins (flower)
Tear-Down 13 mm	13.30 to 13.50	14.80 to 15.40	6.80 to 8.30	0.18 to 0.22	Bridge
Tear-Down 20 mm	20.00 to 20.60	22.00 to 23.00	8.80 to 9.80	On request	Bridge
Tear-Down 32 mm	32.40 to 33.15	35.70 to 36.70	14.30 to 15.30	0.20 to 0.26	8 fins

Maximum opening force is 30 N at 13 mm, 35 N at 20 and 28 mm and 65 N at 32 mm, varying with the number of bridges. Standard packing per box (420 × 270 × 320 mm) is 15,000 seals at 13 mm, 6,000 at 20 mm, 3,000 at 28 mm and 1,400 at 32 mm; Tyvek bagging is available. Per-size detail is on the 20 mm seals and 32 mm seals pages, and tear-off dimensions on the tear-off seal page.

Key takeaways

Tamper evidence is a one-way feature: once the button, ring, disc or metal top is disturbed it cannot be reseated.
The Optima Button design carries intrinsic tamper evidence, with a 12-stem flower moulded under the button disc.
Tear-Down and Pull Ring take the whole seal off the neck in one action.
Tamper evidence and container closure integrity are separate jobs: the crimp holds the sterile barrier, the tamper feature only shows opening.
Supplied Regular, Ready-to-Use (gamma or ETO sterilised) or Ready-to-Sterilise, double-bagged for aseptic areas.

What makes a vial seal tamper evident

A vial seal is tamper evident when opening it destroys a feature that cannot be restored by hand, so anyone handling the vial afterwards can tell it has been entered. The seal does not prevent opening; it makes opening visible.

That comes from two places. The crimped aluminium skirt is rolled under the vial neck flange during capping and cannot be lifted and reseated without visible deformation. On top of it, each design adds a break point of its own: a moulded scoreline on a flip button, a riveted disc that lifts the whole seal, or a perforation in the metal top. A seal whose geometry or aluminium thickness drifts across a batch breaks unevenly, and an uneven break is harder to read, so consistency of manufacture is part of the tamper evidence. How the mechanisms work in general is explained in how tamper evidence works on vial closures.

Tamper evidence is not container closure integrity

Tamper evidence shows whether a vial was opened. Integrity keeps the contents sterile, and comes from the stopper held in compression by the crimp. Flipping the button on an Optima seal gives tamper evidence without breaking the sterile barrier, because the aluminium stays crimped. Integrity is verified separately, by the methods in USP General Chapter <1207>, covered under container closure integrity testing.

Materials and quality

Shells are AA8011 aluminium alloy to EN 15088:2005, supplied with EN 10204 3.1 certification and tested to BS EN 485-2:2008, REACH and RoHS compliant, with an epoxy lacquer coating to 21 CFR 175.300. Polypropylene buttons, discs and rings are moulded in-house on Japanese Toyo injection machines to IS 10910 and IS 10909, FDA 21 CFR 177.1520 and EC 1895/2005, with BADGE, NOGE and BFDGE not used. Heavy metals (chrome-VI, cadmium, mercury, lead) are limited to 100 ppm total to EN 602 and EC 94/62, and components are BSE/TSE-free to EMEA/410/01 rev. 3.

Combination seals are made to ISO 8362-6; all-aluminium seals relate to ISO 8362-3. Production runs under ISO 15378:2017, ISO 9001:2015 and ISO 14001:2015, with a Drug Master File (DMF 18100) and CFDA registration, in the 75,000 sq ft Nashik facility. Assembly is in an ISO Class 8 cleanroom, washing is fully automated, and every seal passes 100% high-speed camera inspection. AQL is critical nil, major not more than 2.5% and minor not more than 4%, tailorable. Certificate numbers are on the quality page.

Forms of supply

Tamper evident seals ship Regular (non-sterile), Ready-to-Use or Ready-to-Sterilise. Ready-to-Use seals are washed and assembled in the ISO Class 8 cleanroom, double-lacquered, sterilised by gamma irradiation or ethylene oxide and double-bagged for aseptic areas. Shelf life is 3.5 years before capping for non-irradiated seals, plus 5 years after capping, and 2 years before capping for Ready-to-Use.

Colour, finish (glossy, matte, embossed or printed) and marking are set per order, which is how most sites combine the tamper feature with strength coding; the options are on the customizable seals page. Pull Ring seals are often marked for oral use. Order quantity and lead time are confirmed with the quotation.

Applications

Tamper evident seals are specified wherever the closure has to be checkable before use: multi-dose vaccines, high-value oncology products, and emergency drugs held on trolleys, where an intact seal is the only routine audit check. Match the seal to the vial neck finish first, using the size hub or the serum vial seals page, then choose the design by opening action.

Frequently asked questions

Who makes tamper evident vial seals in India?

Autofits Packaging Pvt. Ltd. makes tamper evident vial seals at its plant in Nashik, Maharashtra: FlipTop Optima flip-off seals in 13 to 34 mm, FlipTop Pull Ring in 20 and 32 mm, FlipTop Tear-Down in 13, 20 and 32 mm, and all-aluminium tear-off seals in 13, 20 and 32 mm. Production runs under ISO 15378:2017 with a Drug Master File (DMF 18100).

What is a tamper evident vial seal?

A tamper evident vial seal is a crimped aluminium or aluminium-plastic closure with a feature that breaks or detaches irreversibly the first time the vial is opened. The crimped aluminium skirt cannot be lifted and reseated without visible damage, and the plastic button, ring or disc on top gives way at a designed break point, so a user can see before use whether the closure is intact.

Which vial seal design gives the strongest tamper evidence?

The Optima Button design carries intrinsic tamper evidence: a 12-stem flower is moulded under the button disc, so the evidence is part of the closure geometry rather than a consequence of the opening action. Where the whole closure has to visibly leave the neck, the Pull Ring and Tear-Down designs remove the seal in one action instead.

Is tamper evidence the same as container closure integrity?

No. Tamper evidence shows whether the vial has been opened; container closure integrity keeps the contents sterile and sealed. Integrity comes from the rubber stopper held in compression by the crimped aluminium and is verified by package-integrity testing. Flipping the button on a flip-off seal gives tamper evidence without breaking the sterile barrier, because the aluminium stays crimped.

What sizes are tamper evident vial seals available in?

Autofits makes them in 13, 20, 28, 32 and 34 mm. Optima covers all five sizes; Tear-Down covers 13, 20 and 32 mm; Pull Ring is made at 20 mm as a bridge design and 32 mm as a flower design; all-aluminium tear-off covers 13, 20 and 32 mm. The size refers to the vial neck finish, not the fill volume.

Sources

ISO: ISO 8362-6, Injection containers and accessories, Part 6: Caps made of aluminium-plastics combinations for injection vials (https://www.iso.org/)
ISO: ISO 15378, Primary packaging materials for medicinal products, GMP requirements (https://www.iso.org/standard/70729.html)
USP: General Chapter <1207>, Package Integrity Evaluation, Sterile Products, in the USP-NF (https://www.usp.org/)

*Last updated: 2026-11-06. This page is general technical and product information, not regulatory or compliance advice; confirm current standard editions, material specifications and your own specification with the Autofits technical team and the issuing bodies.*