Tear Off
Vial Seals

An Autofits tear-off seal is a one-piece, all-aluminium vial closure whose metal top is torn completely away to expose the rubber stopper. There is no plastic button or disc: the seal is solid AA8011 aluminium crimped over the stopper, so opening it permanently destroys the metal top and leaves clear tamper evidence on every vial.

This page covers what the tear-off seal is, how it opens, the tamper-evidence it provides, full dimensions per size, materials, regulatory position, and how to specify and order it for your fill-finish line.

Key takeaways

• The tear-off seal is all aluminium (AA8011), with no PP disc or plastic top; it relates to ISO 8362-3 (aluminium caps for injection vials), not to aluminium-plastic combination caps.
• It is supplied in 13 mm, 20 mm and 32 mm neck finishes; the 20 mm and 32 mm carry a defined perforation diameter for clean tear initiation.
• Opening means tearing the metal top fully away, which cannot be reformed or reattached, so an opened seal is permanent, at-a-glance tamper evidence.
• It is finished in double-side silver epoxy lacquer as standard, washed and inspected in an ISO Class 8 cleanroom with 100% high-speed camera inspection.
• Available Regular, Ready-to-Use (RTU, gamma or ETO sterilized) or Ready-to-Sterilize (RTS), double-bagged for aseptic areas.
• For the alternative full-removal mechanism, see tear-down seals; for the educational background, see what is a tear-off seal.

What a tear-off seal is

A tear-off seal is the all-metal counterpart to a flip-off seal: a formed aluminium shell that crimps over the rubber stopper to seal the vial, but is opened by tearing the metal top off rather than flipping a plastic button.

The seal is drawn from a single piece of AA8011 aluminium alloy. The skirt rolls under the vial neck flange during capping and compresses the stopper against the glass to form the closure. Across the upper face the metal is perforated or scored so the top can be torn away by hand. There is no moulded plastic anywhere on the part, which is the defining difference from the FlipTop® aluminium-plastic range.

Because the closure is monolithic aluminium, it suits applications that prefer a robust all-metal seal, that need fuller access to the stopper, or that want to avoid plastic components entirely in the closure system.

How a tear-off seal opens

To open, the user lifts the tear tab and pulls the perforated upper section of the aluminium completely away, removing the metal that covers the stopper and exposing it for the needle or for full stopper removal.

During capping, the crimped skirt holds the stopper compressed against the glass: that crimp, plus the stopper, is what keeps the vial sealed. The perforation across the top face defines where the tear runs, so the metal separates cleanly and predictably along a controlled line rather than ragged across the face. Once the top is torn off, it is gone; the remaining skirt stays crimped on the neck, and the stopper is exposed.

This full removal of the top distinguishes the tear-off design from a flip-off seal, which exposes only a small central injection point while the rest of the cap stays in place.

Tamper evidence

Tear-off seals provide intrinsic, irreversible tamper evidence: the metal top is torn and cannot be reformed, so any vial that has been opened is visibly and permanently marked.

There is no way to re-seat a torn aluminium top or to disguise the tear, which makes the closure self-evidencing. A vial with an intact, un-torn top has not been accessed; a vial with a torn or missing top has. This is the same first-line tamper signal that a flipped or missing plastic button gives on a flip-off seal, delivered here through the metal itself. For sterile injectables this supports container-closure integrity expectations and gives the end user a clear visual check before use.

Specifications and sizing

The tear-off seal is supplied in three neck finishes. All dimensions below are transcribed from the Autofits engineering drawings. The 20 mm size additionally carries the opening-force and standard-packing figures from the product dossier; where a value was not specified on the drawing it is shown as "on request."

13 mm tear-off seal

20 mm tear-off seal

32 mm tear-off seal

Seals match vial necks made to ISO 8362-1; confirm your vial finish and stopper before specifying. Other sizes can be discussed on request. Standard box dimensions are 420 × 270 × 320 mm; Tyvek bagging is available.

Materials and manufacturing

Tear-off seals are made entirely from AA8011 aluminium alloy with an epoxy lacquer coating, with no polypropylene disc or plastic component of any kind.

The aluminium alloy AA8011 conforms to EN 15088:2005 and EN 10204-3.1, with mechanical testing to BS EN 485-2:2008, and is REACH and RoHS compliant. The epoxy lacquer coating conforms to 21 CFR 175.300 and is silver on both sides as the standard finish; it can be pigmented for colour identification, available in a wide range of colours, matte or glossy, customised to requirement.

Because the part is a single drawn aluminium shell, there is no PP disc moulding step. The seals pass through fully automated washing to remove particles, then 100% high-speed camera inspection. RTU lots are assembled and bagged in an ISO Class 8 cleanroom. Manufacturing is at the Autofits Packaging Pvt. Ltd. 75,000 sq ft facility in Nashik, India, which also runs Toyo injection moulding for the PP discs used in the plastic-disc closures elsewhere in the range.

Regulatory and quality

Tear-off seals are all-aluminium caps within the scope of ISO 8362-3 and are produced under an ISO 15378:2017 GMP quality system, with food-contact-compliant lacquer and controlled heavy-metal limits.

• Standards: ISO 8362-3 (aluminium caps for injection vials); produced under ISO 15378:2017 (GMP for primary packaging). Vial necks follow ISO 8362-1.
• Lacquer: epoxy coating conforms to 21 CFR 175.300.
• Heavy metals: chromium-VI, cadmium, mercury and lead total max 100 ppm (EN 602, EC 94/62).
• BSE/TSE: the closure is all-aluminium with no animal-derived component; the BSE/TSE-free declaration (EMEA/410/01 rev.3) applies across the materials range.
• Certifications: ISO 9001:2015, ISO 14001:2015, ISO 15378:2017, Drug Master File (DMF 18100), and CFDA registration (B20200000501).
• AQL: Critical = nil; Major = not more than 2.5%; Minor = not more than 4% (tailorable to your specification).

The full certification set is on the quality page.

Applications

Tear-off seals suit injectable and parenteral vials where an all-metal closure or fuller stopper exposure is wanted. Closure choice by drug type is set out on the applications hub, and a plastic-free seal is often specified for veterinary multidose formats. Typical uses:

• Injectable products that prefer a plastic-free closure system.
• Reconstitution and laboratory reagent uses where the stopper may need to be fully exposed or removed, including IV diluent presentations drawn in bulk.
• Applications that value a simple, robust metal seal with clear, irreversible tamper evidence.
• Lines standardised on 13 mm, 20 mm or 32 mm vial finishes.

Comparison with alternatives

See the direct read-out in flip-off vs tear-off.

Forms of supply and ordering

Tear-off seals are available in three delivery forms:

• Regular: clean, bulk-packed seals for in-house washing and sterilization.
• Ready-to-Use (RTU): assembled, washed and sterilized by gamma irradiation or ETO, double-bagged for direct introduction into aseptic areas.
• Ready-to-Sterilize (RTS): processed and bagged for terminal sterilization on your side.

Shelf life is 3.5 years before capping for non-irradiated seals (plus 5 years after capping) and 2 years before capping for RTU. Standard finish is double-side silver lacquer; colours, matte or glossy, are available customised to requirement.

To specify a tear-off seal for your line, share your vial neck finish (13, 20 or 32 mm), stopper, delivery form and annual volume, and the Autofits technical team will confirm fit and supply. Browse the full product range or go straight to tear-off seals.

FAQ

What is a tear-off seal for a vial?

A tear-off seal is an all-aluminium vial closure whose metal top is torn completely away, usually with a pull tab, to expose the rubber stopper. It has no plastic button or disc; the seal is solid AA8011 aluminium crimped over the stopper. Opening it permanently destroys the top, which serves as tamper evidence.

What sizes does Autofits make tear-off seals in?

Autofits supplies tear-off seals in 13 mm, 20 mm and 32 mm neck finishes. The 20 mm and 32 mm carry a defined perforation diameter for clean tear initiation (9.70–10.50 mm and 17.80–18.20 mm respectively). Other sizes can be discussed on request.

Is a tear-off seal tamper-evident?

Yes. The metal top is torn and cannot be reformed or reattached, so any opened vial is visibly and permanently marked. An intact, un-torn top shows the vial has not been accessed; a torn or missing top shows it has.

Does the tear-off seal contain any plastic?

No. The Autofits tear-off seal is made entirely from AA8011 aluminium with an epoxy lacquer coating. There is no polypropylene disc or plastic top. The plastic-disc closures sit in the separate FlipTop® range.

Which standard applies to tear-off seals?

As all-aluminium caps, tear-off seals relate to ISO 8362-3 (aluminium caps for injection vials). They are produced under an ISO 15378:2017 GMP quality system. Aluminium-plastic combination caps, by contrast, relate to ISO 8362-6.

Can tear-off seals be supplied sterile?

Yes. They are available Ready-to-Use, assembled and washed in an ISO Class 8 cleanroom and sterilized by gamma irradiation or ETO, double-bagged for aseptic areas. Ready-to-Sterilize and Regular forms are also offered.

What colours are available?

The standard finish is double-side silver lacquer. The seals can be pigmented for colour identification and are available in a wide range of colours, matte or glossy, customised to requirement.

Related reading

• What is a tear-off seal
• Tear-off seal: definition
• Tear-down seals
• FlipTop® seals
• Flip-off vs tear-off seals
• ISO 8362-3: aluminium caps for injection vials
• Quality and certifications

Sources

• ISO: ISO 8362-3, Injection containers and accessories, Part 3: Aluminium caps for injection vials (https://www.iso.org/standard/33804.html)
• ISO: ISO 15378, Primary packaging materials for medicinal products, GMP requirements (https://www.iso.org/standard/70729.html)
• US FDA: 21 CFR 175.300, Resinous and polymeric coatings (https://www.ecfr.gov/current/title-21/part-175)
• Autofits engineering drawings and FlipTop Seals dossier (internal specification data)

*Last updated: 2026-06-26. This page is general technical and product information, not regulatory or compliance advice. All dimensions are nominal drawing values; confirm current standard editions, your vial finish and your specification with the Autofits technical team before ordering.*