Customizable Pharma Seals and Vial Caps

Custom pharma seals: flip-off vial seals in several colours and finishes with embossed aluminium, beside pilfer-proof caps

Autofits makes customizable pharma seals in Nashik, India: FlipTop vial seals from 13 to 34 mm and aluminium pilfer-proof (ROPP) caps from 22 to 38 mm, with the colour, print, emboss, liner, delivery form and packing set to the buyer’s specification. The crimp and fit dimensions and the material specification stay on the controlled drawing, so a custom seal keeps the qualification of the standard one.

What can be customised

Option	Choices	Product line
Colour	A wide range of colours, customised to requirement, on the polypropylene disc and the lacquered aluminium	FlipTop seals and ROPP caps
Print	Text or marks printed on the aluminium surface or the disc of a seal, or on the cap	FlipTop seals and ROPP caps
Emboss	Embossed finish on the polypropylene disc	FlipTop seals
Finish	Glossy or matte disc; plain, printed or chamfered cap	FlipTop seals and ROPP caps
Liner	EPE, latex or PVC, chosen by application	ROPP caps
Delivery form	Regular, Ready-to-Use (gamma or ETO sterilised), Ready-to-Sterilise	FlipTop seals
Packing	Standard bags and box, Tyvek bagging, double-bagging for aseptic areas	FlipTop seals
Size	13, 20, 28, 32 and 34 mm seals; 22, 25, 28, 35 and 38 mm caps	Both
Top design	Bridge with groove, bridge without groove, button, flower; pull ring; tear-down	FlipTop seals

The colour range is browsable on the seals by colour page, and the colour-coding convention and matching process are on the seal colour chart. ROPP liner choices are compared on the ROPP cap liners page. Order quantity and lead time for a custom specification are confirmed with the quotation.

Key takeaways

What can change: colour, print, emboss, finish, liner (ROPP caps), delivery form, packing, size and top design.
What stays fixed: the crimp and fit dimensions and the material specification on the drawing.
Two product lines take customisation: FlipTop aluminium-plastic seals (and the all-aluminium tear-off seal) and aluminium ROPP caps.
Colour comes from the moulded disc and a pigmented lacquer, so it is part of the seal rather than a label.
Ready-to-Use custom seals are assembled in an ISO Class 8 cleanroom, sterilised and double-bagged.

What “custom” covers on a pharmaceutical seal

A custom seal is a drawing-controlled seal with a buyer-specified appearance, marking and supply format, not a new closure mechanism. Buyers usually customise to tell products apart, to carry identification such as a company mark or a “for oral use” instruction, or to receive seals in the form their line needs. The engineering reasoning behind what can and cannot be changed is set out in custom vial seal manufacturing.

Two product lines can be customised:

FlipTop aluminium-plastic vial seals, in the FlipTop Optima range at 13, 20, 28, 32 and 34 mm, plus Pull Ring and Tear-Down designs, and the all-aluminium tear-off seals.
Aluminium pilfer-proof (ROPP) caps for bottles, at 22, 25, 28, 35 and 38 mm, covered on the pilfer-proof caps page.

Standard or custom: deciding what to change

Start from a standard design and change only what solves a problem you actually have.

If you need to	The option that does it	Worth knowing
Separate strengths or products in one plant	Disc colour, optionally a contrasting aluminium colour	Colour conventions are not standardised across markets, and in the US a black cap and ferrule are reserved for concentrated potassium chloride; see seal colour coding
Carry a company mark or product identifier	Printing or embossing, placed to suit the market	Check each market’s labelling rules first. For injectables sold in the US, USP General Chapter <7> keeps the top surface of the cap overseal and ferrule blank unless a cautionary statement is required; lot numbers and similar marks can go on the side of the ferrule
Warn against injection of an oral product	Printed instruction on a Pull Ring or Tear-Down seal	Pull Ring seals are often marked for oral use; a cautionary statement of this kind is what a top-surface print is for
Help a camera inspection system find the seal	High-contrast colour against the vial and label	Confirm contrast on your own vision system during trials
Go straight into an aseptic filling area	Ready-to-Use delivery, double-bagged	Sterilisation and release are part of the delivery schedule
Fit a different bottle neck on an oral liquid line	ROPP cap size and liner	Confirm against the bottle drawing

Colour matching and artwork

Send a physical reference or a sample of the current seal for colour, and vector artwork for print or emboss. Colour on a FlipTop seal comes from the moulded polypropylene disc and, where specified, a pigmented epoxy lacquer on the aluminium, so it is built into the part rather than applied as a label. Matte and glossy finishes change how a colour reads, so approve the colour on a sample in the finish you will order.

For print and emboss, the artwork is approved before production, and that approval is part of the delivery schedule, so the time your team takes to approve counts towards delivery.

Materials and quality

Customisation leaves the material specification unchanged. The aluminium is AA8011 conforming to EN 15088:2005, REACH and RoHS compliant. The epoxy lacquer conforms to 21 CFR 175.300 and may be pigmented for colour. The polypropylene disc conforms to 21 CFR 177.1520, and BADGE, NOGE and BFDGE are not used. Heavy metals are held to a maximum 100 ppm total and components are BSE/TSE-free. Every seal passes 100% high-speed camera inspection, and release follows an AQL of critical nil, major not more than 2.5% and minor not more than 4%, which can be tailored to the customer’s plan.

Forms of supply and packing

Custom seals are supplied in the same three forms as standard ones: Regular, Ready-to-Use (gamma or ETO sterilised, assembled in an ISO Class 8 cleanroom and double-bagged) and Ready-to-Sterilise. Standard packing is 15,000 seals per box at 13 mm, 6,000 at 20 mm, 3,000 at 28 mm and 1,400 at 32 mm, in a 420 × 270 × 320 mm box. Tyvek bagging can be specified. Non-irradiated seals carry 3.5 years of shelf life before capping; Ready-to-Use seals carry 2 years.

What we need to quote a custom seal

A complete specification gets a complete quotation the first time. Send:

product line and size, from the seals by size index or the cap range;
top design, colour reference and finish;
print or emboss artwork, if any;
liner, for ROPP caps;
delivery form and packing;
annual volume, first order quantity and destination country.

Send it through the contact page. The same list, with notes on each item, is on the custom seal quote request page.

How this works in practice at Autofits

Design and development are in-house at the Nashik plant, and the polypropylene discs are moulded on Toyo injection machines in the same 75,000 sq ft facility, so a disc colour change does not depend on an outside moulder. Standard designs are held for a fast start, and customisation is made to requirement. The quality system is certified to ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017, with a Drug Master File (DMF 18100).

Frequently asked questions

What can be customised on a pharmaceutical seal?

On a FlipTop vial seal you can specify the colour, printing, embossing, a matte or glossy finish, the delivery form, the packing, the size and the top design. On an aluminium pilfer-proof cap you can also choose the liner (EPE, latex or PVC) and a plain, printed or chamfered finish. The crimp dimensions and material specification stay on the controlled drawing.

Who makes customizable pharma seals in India?

Autofits Packaging Pvt. Ltd. makes customizable vial seals and pilfer-proof caps at its plant in Nashik, Maharashtra, under an ISO 15378:2017 quality system with a Drug Master File (DMF 18100). The polypropylene discs are moulded in-house, so colour, print and emboss are set at the plant.

What order quantity applies to custom colour vial seals?

The order quantity for a custom colour, print or emboss is confirmed with the quotation, because it depends on the product line, the size and the combination of options. A complete specification, listed above, lets the quotation state it the first time.

How long do custom printed seals take?

Lead time is confirmed with the quotation. For printed or embossed seals it includes the artwork approval step, so the time your team takes to approve the artwork counts towards delivery. Ready-to-Use supply also includes sterilisation and release.

Can you match a specific colour for a vial seal?

Yes, colours are customised to requirement across a wide range, matte or glossy. The most reliable way to match is to send a physical colour reference or a current seal. Approve the colour on a sample in the finish you intend to order, because matte and glossy surfaces make the same colour look different.

Does changing a seal’s colour or print need requalification?

Changing only colour, print or emboss on the same drawing leaves the sealing dimensions and materials unchanged, which usually limits the work to the drug maker’s own change control and a check of appearance and machinability. How the change is classified is the drug maker’s decision under its quality system and market rules. A different size or design needs capping trials.

Sources

Autofits FlipTop Seals dossier, engineering drawings and company brochure
eCFR: 21 CFR 175.300, Resinous and polymeric coatings (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175/subpart-C/section-175.300)
eCFR: 21 CFR 177.1520, Olefin polymers (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-177/subpart-B/section-177.1520)
ISO: ISO 15378:2017, Primary packaging materials for medicinal products (https://www.iso.org/standard/70729.html)
USP-NF: General Chapter <7>, Labeling, section on ferrules and cap overseals (https://www.usp.org/)
U.S. FDA: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, May 2022 (https://www.fda.gov/media/158522/download)

*Last updated: 2026-11-06. This page is general technical and product information, not regulatory or compliance advice; confirm the specification and your market’s labelling rules with the Autofits technical team and the issuing bodies.*