Tear Down ​
Vial Seals

An Autofits tear-down seal is an all-aluminium vial closure that is opened by tearing a perforated section of the metal down and removing it to release the seal from the neck. It contains no polypropylene disc and no plastic top: it is solid AA8011 aluminium crimped over the rubber stopper, so opening it permanently deforms the metal and leaves clear tamper evidence.

This page covers what the all-aluminium tear-down seal is, how the tear-down mechanism opens, the 20 mm specification (the size for which Autofits holds full drawing data), materials, regulatory position, and how it differs from the aluminium-plastic FlipTop® Tear-Down.

Key takeaways

• The tear-down seal described here is all aluminium (AA8011), with no PP disc; it relates to ISO 8362-3 (aluminium caps for injection vials).
• It is opened by tearing a perforated section of the metal down, which releases the seal so the whole closure comes off and the stopper is fully exposed.
• Full drawing dimensions are held for the 20 mm all-aluminium tear-down; other sizes are available on request.
• It is not the same product as the FlipTop® Tear-Down, which is an aluminium-plastic closure with a PP disc opened by twisting anticlockwise.
• Standard finish is double-side silver epoxy lacquer, washed and 100% camera-inspected, available Regular, Ready-to-Use or Ready-to-Sterilize.

What an all-aluminium tear-down seal is

A tear-down seal is a one-piece aluminium closure that crimps over the rubber stopper to seal the vial and is opened by tearing a perforated band of the metal down so the seal can be lifted away.

The seal is drawn from a single piece of AA8011 aluminium alloy. Its skirt rolls under the vial neck flange during capping and compresses the stopper against the glass to form the closure. A perforation across the metal defines the tear path. There is no moulded plastic component anywhere on the part, which is the defining difference from the aluminium-plastic tear-down in the FlipTop® range.

Because the closure is monolithic aluminium, it suits applications that prefer a plastic-free seal, that need the stopper fully exposed after opening, and that want irreversible tamper evidence built into the metal itself.

How the tear-down mechanism opens

To open, the user starts the tear at the perforation and pulls the metal section down and around, which breaks the controlled bridges and releases the seal so the whole closure lifts off the neck, exposing the stopper.

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, together with the two taper bridges on the 20 mm part, defines where and how the metal separates so the tear runs along a controlled line rather than tearing unpredictably across the face. Once the perforated band is torn down and the bridges break, the seal is released and the stopper is fully accessible.

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

Specification and sizing

Full engineering-drawing dimensions are held for the 20 mm all-aluminium tear-down seal, given below. All values are nominal drawing figures.

20 mm tear-down seal (all-aluminium)

Other sizes of all-aluminium tear-down seal are available on request; share your vial neck finish and we will confirm fit and supply. Seals match vial necks made to ISO 8362-1. Standard box dimensions are 420 × 270 × 320 mm; Tyvek bagging is available.

Materials and manufacturing

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

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 standard; 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

All-aluminium tear-down seals are 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).

The full certification set is on the quality page.

All-aluminium tear-down vs FlipTop® Tear-Down

These are two distinct products and should not be confused when specifying.

If your application needs the riveted PP disc and anticlockwise twist-off action (common on oral-use products), see the FlipTop® Tear-Down. For the all-metal tear-down described here, continue below.

Applications

All-aluminium tear-down seals suit injectable and parenteral vials where a plastic-free closure and full stopper exposure are wanted. The applications hub maps drug type to closure, and the plastic-free construction is often specified for veterinary multidose vials and research reagent presentations. Typical uses:

• Injectable products that prefer a closure system free of plastic components.
• Uses where the stopper must be fully exposed or removed after opening.
• Applications that value a robust metal seal with clear, irreversible tamper evidence.
• Lines standardised on the 20 mm vial finish (other sizes on request).

Tamper evidence

Tear-down seals are intrinsically tamper-evident: the perforated band and bridges are torn and the metal deformed on opening, so an opened vial is visibly and permanently marked and the seal cannot be re-seated.

A vial with the band intact and bridges unbroken has not been accessed; a vial with the band torn down 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, which supports container-closure integrity expectations for sterile products.

Forms of supply and ordering

Tear-down 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 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 an all-aluminium tear-down seal, share your vial neck finish (20 mm or other on request), 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-down seals.

FAQ

What is a tear-down seal in pharmaceutical packaging?

A tear-down seal is a vial closure opened by tearing a perforated section of the seal down and removing it to release the closure from the neck. The Autofits all-aluminium version is solid AA8011 aluminium crimped over the stopper, with no plastic disc, so opening it permanently deforms the metal and leaves tamper evidence.

What sizes are available?

Autofits holds full engineering-drawing dimensions for the 20 mm all-aluminium tear-down seal (D1 20.50–20.70 mm, perforation 12.90–13.20 mm, height 7.50–8.50 mm, thickness 0.18–0.22 mm, two taper bridges). Other sizes are available on request.

How is the all-aluminium tear-down different from the FlipTop® Tear-Down?

The all-aluminium tear-down is one-piece aluminium with no plastic and is opened by tearing a perforated band down. The FlipTop® Tear-Down is an aluminium-plastic closure with a PP disc riveted to the aluminium, opened by working the disc then pulling and rotating anticlockwise to remove the whole seal; it is mainly used for oral vaccinations.

Does the all-aluminium tear-down seal contain plastic?

No. It is made entirely from AA8011 aluminium with an epoxy lacquer coating. There is no polypropylene disc or plastic top. The plastic-disc tear-down is the separate FlipTop® Tear-Down.

Is a tear-down seal tamper-evident?

Yes. The perforated band and bridges are torn and the metal deformed on opening, so an opened vial is permanently and visibly marked. The seal cannot be re-seated, which makes the closure self-evidencing.

Can tear-down 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.

Related reading

• Tear-off seals
• FlipTop® Tear-Down (aluminium-plastic)
• Tear-down seal: definition
• What is a tear-off seal
• ISO 8362-3: aluminium caps for injection vials
• ISO 15378: GMP for primary packaging
• 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.*