FlipTop® Tear-Down Seals: The Easy-Open Tear Down Seal Vial Closure
A tear down seal vial closure is an aluminium-plastic seal in which the polypropylene disc is riveted to the aluminium body, so the operator opens the disc, then pulls and rotates it anticlockwise to bring the whole seal off the vial. It is built for fast, repeatable, single-handed opening, which is why the FlipTop® tear-down is used mainly for oral vaccinations and other frequently accessed presentations.
This page sets out what the tear-down seal is, how its riveted disc opens, the sizes Autofits supplies, the dimensional and material specifications, and how it differs from the all-aluminium tear-down seal.
Key takeaways
- A tear down seal vial closure has a polypropylene disc riveted to the aluminium (bridge design); the disc opens, then is pulled and rotated anticlockwise so the whole seal comes off.
- Autofits supplies it in 13 mm, 20 mm and 32 mm, with the 32 mm in a flower (fin) design.
- It is an easy-open closure built for oral vaccinations, emergency drugs and frequently accessed vials.
- It is not the same as the all-aluminium tear-down seal, which has different geometry and no plastic disc.
- Construction is AA8011 aluminium, epoxy lacquer and a moulded polypropylene disc, made under ISO 15378:2017 in an ISO Class 8 cleanroom with 100% camera inspection.
- Supplied Regular, Ready-to-Use (gamma or ETO sterilized) or Ready-to-Sterilize; see the FlipTop seal range and the pull-ring variant.
What a tear-down seal is
A FlipTop® tear-down seal is an aluminium-plastic combination cap in which the polypropylene disc is riveted to the aluminium seal body, designed so the whole seal is torn down and removed once the disc is opened. It belongs to the same aluminium-plastic family as the FlipTop Optima flip-off seal, but it is engineered for the entire seal to leave the vial rather than for a small button to flip up over a retained injection point.
The construction combines a formed aluminium shell, made from AA8011 alloy and coated with epoxy lacquer, which crimps around the vial neck flange and holds the rubber stopper compressed against the glass, with a moulded polypropylene disc that is riveted to the aluminium. Because the disc and the aluminium are joined, opening the disc gives the operator a single grip point to pull the whole assembly. The 13 mm and 20 mm sizes use a bridge design; the 32 mm size uses a flower (fin) design.
How a tear-down seal opens
To open, the operator opens the riveted polypropylene disc, then pulls it and rotates it anticlockwise; because the disc is riveted to the aluminium, the whole seal tears down and comes off the vial. The crimped lower edge of the aluminium releases as the assembly is turned, so the metal, the disc, and the stopper-retaining structure come away together, exposing the stopper or the vial mouth.
The advantage is speed and simplicity. The riveted disc means the operator does not need a separate tab or tool: opening the disc and turning it removes the seal in one continuous motion, which can be done single-handed. In settings where vials are accessed quickly or under pressure, that matters. The torn-down seal is also visible tamper evidence, since it cannot be reseated once removed.
Where the tear-down design fits
The tear-down seal fits products that need fast, repeated, hand-driven access to the whole vial, especially oral vaccinations. It is positioned for routes and settings where opening speed and ease, rather than a small retained injection point, are the priority. For products that need that retained injection point, the FlipTop flip-off range is the better fit.
Specifications and sizing
Autofits supplies the FlipTop® tear-down seal in three sizes. Dimensions below are taken from the Autofits engineering drawings. Match the seal size to the vial neck finish and stopper of the same nominal size.
13 mm tear-down seal (bridge type, aluminium-plastic)
| Parameter | Value |
|---|---|
| External / inner Ø aluminium (D1) | 13.30–13.50 mm |
| Disc Ø (D2) | 14.80–15.40 mm |
| Disc height | 3.70–4.10 mm |
| Aluminium / inner height | 6.00–6.40 mm |
| Total height | 6.80–8.30 mm |
| Aluminium thickness | 0.18–0.22 mm |
| Design | Bridge |
| Max opening force | 30 N |
| Standard packing (per box) | 15,000 (5,000 × 3 bags) |
20 mm tear-down seal (aluminium-plastic)
| Parameter | Value |
|---|---|
| Inner Ø aluminium seal (D2) | 20.00–20.60 mm |
| Outer Ø PP disc (D3) | 22.00–23.00 mm |
| Disc height (H3) | 3.00–4.00 mm |
| Inner aluminium height (H1) | 7.20–7.80 mm |
| Assembled height (H2) | 8.80–9.80 mm |
| Max opening force | 35 N |
| Standard packing (per box) | 6,000 (2,000 × 2 bags) |
32 mm tear-down seal (flower / fin design, aluminium-plastic)
| Parameter | Value |
|---|---|
| External / inner Ø aluminium (D1) | 32.40–33.15 mm |
| Disc Ø (D2) | 35.70–36.70 mm |
| Aluminium / inner height | 13.20–13.60 mm |
| Total height | 14.30–15.30 mm |
| Aluminium thickness | 0.20–0.26 mm |
| Fins | 8 fins (flower) |
Opening force varies with the number and geometry of the bridges or fins. Where a parameter is not listed for a given size, it was not specified on the drawing supplied; it is available on request. Box dimensions are 420 × 270 × 320 mm, and Tyvek bagging is available as an option.
Materials and manufacturing
The tear-down seal is built from pharmaceutical-grade aluminium, food-contact-compliant lacquer, and a moulded polypropylene disc, all produced in-house. Each component is specified against a recognised standard so the closure can be qualified for primary packaging contact.
- Aluminium: alloy AA8011, conforming to EN 15088:2005 with EN 10204-3.1 certification and testing to BS EN 485-2:2008. The alloy is REACH and RoHS compliant.
- Lacquer: an epoxy lacquer coating conforming to 21 CFR 175.300. The aluminium can be double-lacquered and may be pigmented for colour. Seals are available in a wide range of colours, matte or glossy, customised to requirement.
- Polypropylene disc: moulded PP conforming to IS 10910 / IS 10909 and FDA 21 CFR 177.1520 (olefin polymers), with EC 1895/2005 compliance; BADGE, NOGE and BFDGE are not used. In the tear-down design the disc is riveted to the aluminium.
- Manufacturing: the PP disc is injection-moulded in-house on Japanese Toyo machines; aluminium is fully automatically washed to control particles; seals undergo 100% high-speed camera inspection; and assembly is carried out in an ISO Class 8 cleanroom at the 75,000 sq ft Nashik facility (E-13/7/4, MIDC, Malegaon, Sinnar).
Regulatory and quality
The tear-down seal is manufactured to ISO 15378:2017 GMP and follows ISO 8362-6 for aluminium-plastics combination caps, with documented material compliance for pharmaceutical contact. Relevant references and controls are:
- Standards: ISO 8362-6 for aluminium-plastics combination caps, within the ISO 15378:2017 quality framework. Vial necks follow ISO 8362-1.
- Food / drug-contact compliance: lacquer to 21 CFR 175.300 and PP to 21 CFR 177.1520.
- Heavy metals: chromium-VI, cadmium, mercury and lead at not more than 100 ppm total (EN 602, EC 94/62).
- BSE/TSE: free of animal-derived material per EMEA/410/01 rev. 3.
- Quality system and certifications: ISO 9001:2015, ISO 14001:2015, ISO 15378:2017, a Drug Master File (DMF 18100) and CFDA registration (B20200000501).
- AQL: critical defects nil; major not more than 2.5%; minor not more than 4%; tailorable to customer specification.
The complete certification set is on the quality page.
Applications
The tear-down seal suits products that need fast, frequent, hand-driven removal of the whole seal. Typical uses include:
- Oral vaccines: the primary use, where many vials are opened quickly and the riveted disc gives one simple grip-and-turn action.
- Emergency drugs: where opening speed under pressure matters and a tool-free, single-handed removal is an advantage.
- Frequently accessed vials: presentations opened repeatedly across a campaign or shift, where an easy-open closure reduces handling effort.
For oral-dosing presentations opened by pulling a ring, see the pull-ring seal; for a small retained injection point, see the FlipTop flip-off range.
Comparison with alternatives
| Closure | What you remove | Plastic disc | How it opens | Typical use |
|---|---|---|---|---|
| FlipTop tear-down | The whole seal | Yes (riveted) | Open disc, pull and turn anticlockwise | Oral vaccines |
| All-aluminium tear-down | The whole seal | No | Different geometry, no plastic disc | All-metal closure |
| Pull-ring | The whole seal | Yes | Pull aluminium ring, turn anticlockwise | Oral dosing |
| Flip-off | A plastic button only | Yes | Flip the button | Injectable |
Note the distinction from the all-aluminium tear-down seal: that product has different geometry and no polypropylene disc, whereas the FlipTop tear-down on this page is an aluminium-plastic combination with a riveted disc. The two share a name and an opening idea but are different closures. See the direct read-out in pull-ring vs tear-down seals, and the tear-down seal glossary entry for the formal definition.
Forms of supply and ordering
Autofits supplies the tear-down seal Regular, Ready-to-Use or Ready-to-Sterilize, sterilized by gamma irradiation or ETO, with shelf life defined for each form.
- Regular: non-sterile bulk for customers who wash and sterilize in-house. Shelf life is 3.5 years before capping (plus 5 years after capping).
- Ready-to-Use (RTU): assembled in the ISO Class 8 cleanroom, double-lacquered, washed to control particles and gamma sterilized, double-bagged for aseptic areas. Shelf life is 2 years before capping.
- Ready-to-Sterilize (RTS): cleaned and bagged for the customer’s own terminal sterilization.
Sterilization is by gamma irradiation or ETO; Tyvek bagging is available. To confirm the right size, design (bridge or flower), finish, colour and form of supply for your fill line and route of administration, contact the Autofits technical team with your vial neck finish and stopper details.
Frequently asked questions
What is a tear down seal on a vial?
A tear down seal is an aluminium-plastic vial closure in which the polypropylene disc is riveted to the aluminium seal body. The operator opens the disc, then pulls and rotates it anticlockwise; because the disc is riveted to the aluminium, the whole seal tears down and comes off the vial. It is an easy-open closure used mainly for oral vaccinations.
How do you open a FlipTop tear-down seal?
Open the riveted polypropylene disc, then pull it and turn it anticlockwise. The disc is joined to the aluminium, so turning it brings the whole seal off the vial in one continuous, single-handed motion. No separate tab or tool is needed.
What sizes does the FlipTop tear-down seal come in?
Autofits supplies three sizes: 13 mm, 20 mm and 32 mm. The 13 mm and 20 mm use a bridge design; the 32 mm uses a flower (fin) design with eight fins. The 13 mm seal has an inner aluminium diameter of 13.30 to 13.50 mm; the 32 mm seal has an inner aluminium diameter of 32.40 to 33.15 mm.
How is the FlipTop tear-down different from the all-aluminium tear-down seal?
The FlipTop tear-down on this page is an aluminium-plastic combination with a polypropylene disc riveted to the aluminium. The all-aluminium tear-down seal has different geometry and no plastic disc; it is a one-piece metal closure. They share a name and the idea of tearing the seal down, but they are different products. The all-aluminium version is at the tear-down seals page.
What is the tear-down seal used for?
It is used mainly for oral vaccinations, and more broadly for emergency drugs and frequently accessed vials where fast, tool-free, single-handed opening of the whole seal is an advantage. For a small retained injection point, a flip-off seal is the better choice.
Is the FlipTop tear-down seal available sterilized?
Yes. It is available Ready-to-Use, assembled and washed in an ISO Class 8 cleanroom and gamma sterilized (or ETO), double-bagged for aseptic areas, with a 2-year shelf life before capping. It is also available Regular (non-sterile, 3.5-year shelf life before capping) and Ready-to-Sterilize for in-house terminal sterilization.
What standards does the tear-down seal meet?
It is manufactured under an ISO 15378:2017 GMP quality system and follows ISO 8362-6 for aluminium-plastics combination caps. Materials are documented for pharmaceutical contact: lacquer to 21 CFR 175.300, polypropylene to 21 CFR 177.1520, heavy metals at not more than 100 ppm total, and BSE/TSE-free. Autofits also holds ISO 9001:2015, ISO 14001:2015, a Drug Master File (DMF 18100) and CFDA registration.
Related reading
- FlipTop seal range
- FlipTop pull-ring seals
- All-aluminium tear-down seals
- Pull-ring vs tear-down seals
- Tear-down seal: definition
- ISO 8362-6: aluminium-plastics combination caps
- 13 mm vial seals
- 32 mm vial seals
Sources
- ISO: ISO 8362-6:2010, Injection containers and accessories, Part 6: Caps made of aluminium-plastics combinations for injection vials (https://www.iso.org/standard/45831.html)
- ISO: ISO 15378:2017, Primary packaging materials for medicinal products, GMP requirements (https://www.iso.org/standard/70845.html)
- Autofits engineering drawings and FlipTop Seals dossier (internal, on file)
*Last updated: 2026-06-26. This page is general technical and product information, not regulatory or compliance advice; confirm current standard editions, material specifications and requirements with the issuing bodies and with the Autofits technical team for your specific application.*
