Vial Seal Exporter from India
Autofits Packaging Pvt. Ltd. supplies pharmaceutical vial seals and pilfer-proof caps from its plant in Nashik, Maharashtra, to drug makers outside India, and holds an Importer-Exporter Code (IEC 0310003130). The range runs from 13 to 34 mm in FlipTop® aluminium-plastic and all-aluminium seals, plus aluminium ROPP caps from 22 to 38 mm, made under ISO 15378:2017 with a Drug Master File (DMF 18100) that an overseas customer can reference in its own filing.
Key takeaways
- Exporter of record: Autofits Packaging Pvt. Ltd., IEC 0310003130, Nashik, Maharashtra, India.
- Range: FlipTop Optima, Pull Ring and Tear-Down seals (13 to 34 mm), all-aluminium tear-off and tear-down seals, and ROPP caps (22 to 38 mm).
- Certifications: ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017, Drug Master File 18100 and a CFDA registration.
- Dossier data: controlled drawings with critical dimensions, and materials stated for each component, which is what a CTD dossier asks of a primary packaging component.
- Packing: standard shipper box of 420 × 270 × 320 mm; Tyvek bagging available; double-bagged for aseptic areas.
- Delivery forms: Regular, Ready-to-Sterilise and Ready-to-Use (gamma or ETO).
What Autofits supplies overseas
| Product | Sizes | Delivery forms |
|---|---|---|
| FlipTop® Optima flip-off seals | 13, 20, 28, 32, 34 mm | Regular, RTS, RTU |
| FlipTop® Pull Ring seals | 20, 32 mm | Regular, RTS, RTU |
| FlipTop® Tear-Down seals | 13, 20, 32 mm | Regular, RTS, RTU |
| Tear-off seals, all aluminium | 13, 20, 32 mm | Confirmed with the quotation |
| Tear-down seals, all aluminium | 20 mm | Confirmed with the quotation |
| Aluminium pilfer-proof (ROPP) caps | 22, 25, 28, 35, 38 mm | Confirmed with the quotation |
The whole range is on the products page.
What a drug regulator asks about the seal
Most drug regulators that receive dossiers in the Common Technical Document (CTD) format ask the same thing of a primary packaging component: what it is made of, its specification, and its critical dimensions. The ICH M4Q guideline puts this in Module 3, section 3.2.P.7 (container closure system), and section 3.2.P.2.4 covers why the closure suits the product.
The Saudi Food and Drug Authority sets out its dossier content in its Data Requirements for Human Drugs Submission, which follows the CTD structure, and the Egyptian Drug Authority’s CTD quality guideline asks for the materials of construction of each primary packaging component, its specification, and critical dimensions with drawings where appropriate. The drug maker files the dossier; the seal supplier provides the data that goes into it.
| What the dossier needs | What Autofits holds |
|---|---|
| Materials of construction | AA8011 aluminium to EN 15088:2005; epoxy lacquer to 21 CFR 175.300; polypropylene to FDA 21 CFR 177.1520 and EC 1895/2005 |
| Specification and critical dimensions | Engineering drawings with tolerances for every FlipTop, tear-off and tear-down seal size |
| Quality system of the component maker | ISO 15378:2017 (21.GGCS.IN.151175), ISO 9001:2015, ISO 14001:2015 |
| Data the regulator can review without disclosure to the buyer | Drug Master File 18100 |
| Animal-origin risk | BSE/TSE-free to EMEA/410/01 rev. 3 |
| Heavy metals | Chromium VI, cadmium, mercury and lead, maximum 100 ppm total (EN 602, EC 94/62) |
| Chemical restrictions | REACH and RoHS compliant aluminium |
The certificates and their numbers are on the quality certificates page, and the standards behind each line are in the regulatory compliance pack.
Cartons and packing for export
Seals ship in a standard box of 420 × 270 × 320 mm, packed in inner bags.
| Seal size | Seals per box | Bags |
|---|---|---|
| 13 mm | 15,000 | 5,000 × 3 |
| 20 mm | 6,000 | 2,000 × 2 |
| 28 mm | 3,000 | 1,500 × 2 |
| 32 mm | 1,400 | 700 × 2 |
Tyvek bagging is available, and Ready-to-Use seals are double-bagged so the outer bag comes off at the clean-area boundary. Counts for 34 mm seals and ROPP caps are confirmed with the quotation. Freight and storage figures are on the packaging and shipping page.
Shelf life and storage in transit
Non-irradiated seals have a shelf life of 3.5 years before capping, plus 5 years after capping. Ready-to-Use seals have 2 years before capping. Shelf life is what an importer plans stock against, since sea freight and customs clearance add time between dispatch and use.
In practice at Autofits
Every seal shipped overseas comes from the same 75,000 sq ft plant at E-13/7/4, MIDC Malegaon, Sinnar, Nashik, with ISO Class 8 cleanroom assembly, in-house polypropylene moulding and 100% camera inspection. Autofits exhibited at Pharmaconex Egypt 2026 in Cairo. Overseas buyers who audit suppliers before approval can find the plant described on the factory page and the audit steps on vial closure supplier selection.
Frequently asked questions
Does Autofits export vial seals?
Yes. Autofits Packaging Pvt. Ltd. supplies vial seals and pilfer-proof caps from Nashik, India to overseas pharmaceutical buyers and holds Importer-Exporter Code 0310003130.
What certifications does an Indian vial seal exporter need?
Overseas drug makers usually look for ISO 15378, the GMP standard for primary packaging materials, and a Drug Master File they can reference. Autofits holds ISO 15378:2017, ISO 9001:2015, ISO 14001:2015 and Drug Master File 18100.
What information do regulators need about a vial seal?
Under the CTD format, Module 3 section 3.2.P.7 asks for the materials of construction of each primary packaging component, its specification and its critical dimensions, with drawings where appropriate. Autofits holds drawings and material specifications for every seal size it makes.
How are vial seals packed for export?
In a standard 420 × 270 × 320 mm box with inner bags: 15,000 seals at 13 mm, 6,000 at 20 mm, 3,000 at 28 mm and 1,400 at 32 mm. Tyvek bagging is available and Ready-to-Use seals are double-bagged.
Can overseas buyers order ready-to-use seals?
Yes. FlipTop seals are available Ready-to-Use, sterilised by gamma irradiation or ETO and double-bagged, with a shelf life of 2 years before capping.
Sources
- ICH: M4Q, The Common Technical Document, Quality
- Saudi Food and Drug Authority: Data Requirements for Human Drugs Submission, Content of the Dossier
- Egyptian Drug Authority: Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals, 2023
- EMA: EMEA/410/01 rev. 3, Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents (ema.europa.eu)
- Autofits FlipTop Seals dossier, engineering drawings and company records
*Last updated: 2026-11-06. Product and supply information only, not regulatory advice. Delivery terms are confirmed with the quotation.*
