34mm FlipTop® Optima Flip-Off Seal

Name: 34mm FlipTop® Optima Flip-Off Seal
Brand: Autofits

The 34mm FlipTop® Optima is an aluminium-plastic flip off seal for the largest injectable and parenteral vials: an AA8011 aluminium shell crimped over the rubber stopper with a moulded polypropylene button you flip up to expose a central injection point. Total seal height is 15.00 to 16.00 mm, with eight tapered bridges and a glossy top, made to ISO 8362-6. The 34 mm is the largest size in the Optima range.

This page gives the 34 mm dimensions, materials, quality position, applications and ordering. For the full range and design options, see the FlipTop® Optima product page.

Key takeaways

The 34mm Optima is the largest flip-off seal in the FlipTop® Optima range.
Total seal height 15.00–16.00 mm, inner aluminium Ø 33.60–34.00 mm, outer disc Ø 35.50–36.50 mm.
Eight tapered bridges with a glossy top finish.
Aluminium AA8011 with epoxy lacquer; polypropylene button moulded in-house on Toyo machines.
Made under ISO 15378, ISO 9001 and ISO 14001 with a Drug Master File, 100% camera inspected.
Opening force and pack quantity for the 34 mm size are available on request.

What is the 34mm FlipTop® Optima?

The 34mm Optima is the flip-off seal for 34 mm neck vials, used for the largest-volume injectable and parenteral presentations. The deep-drawn aluminium shell crimps under the vial neck flange to compress the rubber stopper against the glass, forming the sterile barrier. The polypropylene button on top is flipped up at point of use to expose a small central area of the stopper for the needle, while the aluminium stays crimped and the seal stays intact.

It is the largest of five sizes in the Optima range (13, 20, 28, 32 and 34 mm). At 34 mm the seal carries eight tapered bridges and a glossy top. Match the 34 mm seal to a 34 mm vial finish and a 34 mm stopper of the same nominal diameter; vial necks follow ISO 8362-1. For the next size down, see the 32mm FlipTop® Optima.

Specifications and sizing

Controlled dimensions for the 34 mm Optima, from the Autofits engineering drawings. The standard shipper box is 420 × 270 × 320 mm.

Property	Value
Nominal size	34 mm
Inner Ø aluminium seal (D1)	33.60–34.00 mm
Outer Ø disc (D2)	35.50–36.50 mm
Disc height	not specified
Inner aluminium height	not specified
Total seal height	15.00–16.00 mm
Aluminium thickness	0.20–0.25 mm
Bridges	8 taper
Top finish	Glossy
Max opening force	available on request
Standard packing (per box)	available on request

The dossier opening-force and packing tables run to 32 mm, so no published 34 mm opening-force or pack-quantity figure is supplied; both are confirmed on enquiry. Top designs are Bridge, Button (intrinsic tamper evidence, with a flower under the button disc) and Flower. Finishes are glossy, matte, embossed or printed, in a wide range of colours customised to requirement.

Materials and quality

The shell is AA8011 aluminium alloy (EN 15088:2005, EN 10204 3.1, tested to BS EN 485-2:2008; REACH and RoHS compliant) with an epoxy lacquer coating to 21 CFR 175.300. The button is polypropylene to 21 CFR 177.1520, moulded in-house on Japanese Toyo injection-moulding machines and assembled in an ISO Class 8 cleanroom. Heavy metals are held to a maximum 100 ppm total and the components are BSE/TSE-free (EMEA/410/01 rev. 3).

Every seal passes 100% high-speed camera inspection. Production runs under ISO 15378:2017 GMP, with ISO 9001:2015 and ISO 14001:2015 certification, a Drug Master File (DMF 18100) and CFDA registration, in the 75,000 sq ft Nashik facility. AQL: critical nil, major not more than 2.5%, minor not more than 4%. See the quality page, ISO 8362-6 and ISO 15378.

Forms of supply

The 34 mm Optima ships Regular (non-sterile), Ready-to-Use (gamma or ETO sterilized, double-bagged for aseptic areas) and Ready-to-Sterilize. 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 pack quantity, minimum order quantities and lead times are available on request.

Applications

The 34 mm Optima is used on the largest-volume injectable and parenteral vials, including diluents, lyophilised products and multi-dose presentations, where colour coding differentiates strengths or where intrinsic tamper evidence is required (the Button design). Browse comparable closures on the 34 mm by-size index.

FAQ

What is the total height of a 34mm flip-off seal?

The 34 mm FlipTop® Optima has a total seal height of 15.00 to 16.00 mm. The inner aluminium diameter is 33.60 to 34.00 mm and the outer disc diameter is 35.50 to 36.50 mm. The aluminium thickness is 0.20 to 0.25 mm.

What is the opening force of the 34mm Optima?

The 34 mm Optima has eight tapered bridges; opening force varies with the number of bridges in the design. A published opening-force figure for the 34 mm size is available on request.

How many 34mm seals are in a box?

The standard pack quantity for the 34 mm size is available on request. Seals ship in a 420 × 270 × 320 mm shipper, and Tyvek bagging is available as an alternative.

Is the 34mm seal available sterilized?

Yes. It is offered Ready-to-Use, sterilized by gamma irradiation or ETO and supplied double-bagged for aseptic filling, as well as Ready-to-Sterilize and Regular. RTU seals are washed and assembled in an ISO Class 8 cleanroom.

What vial does the 34mm Optima fit?

It fits 34 mm neck vials with a matching 34 mm rubber stopper. Match the seal, vial finish and stopper to the same nominal diameter; vial necks follow ISO 8362-1.

Sources

Autofits FlipTop Seals dossier and engineering drawings (working/spec-sheets/)
ISO: ISO 8362-6:2010, Caps made of aluminium-plastics combinations for injection vials (https://www.iso.org/standard/45641.html)

*Last updated: 2026-06-26. This page is general technical and product information, not regulatory or compliance advice; confirm current standard editions and your own specification with Autofits and the issuing bodies.*