Vial Seal Resources: Specifications, Compliance and Ordering

The Autofits resources section brings together everything a buyer needs before an enquiry: the product catalogue, dimensions, colours, datasheets and packaging specifications; the compliance pack and certificates; and the order quantities, lead times, samples and quotes. Each resource is a page built from the Autofits engineering drawings and product dossier, with the reference tables on the page itself, ready to read or print. Where a value is typical rather than fixed, the page says so, and the controlled drawing for a part comes with its quotation.
Key takeaways
- Ten resources in three groups: specifications, compliance and ordering.
- Specifications cover five vial seal lines in 13 to 34 mm and aluminium ROPP caps in 22 to 38 mm.
- Compliance covers ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017 certification, Drug Master File DMF 18100 and the standards the range is built to.
- Ordering covers typical MOQ, lead times, samples and what a custom quote needs.
- No downloads to chase: every table is on the page, and certificate copies are supplied on request.
- One contact route: every resource ends with a list of what to send to contact Autofits.
Specifications
Start here to confirm that a seal exists in your size, fits your vial and ships the way your plant needs it.
| Resource | What it answers | What is on the page |
|---|---|---|
| Product catalogue | Which lines and sizes does Autofits make? | Every seal line and ROPP cap size, with D1, total height and pack per box |
| Seal sizing guide | Will this seal fit my vial neck and stopper? | Full drawing dimensions by line and size, bridge counts, opening force, neck standards |
| Seal colour chart | What can be coloured, and how is a shade matched? | Colour options by line, matte and glossy finish, US rules on cap colour, the matching sequence |
| Technical datasheets | What is the full specification for one line? | Materials, dimensions, opening force, packing, delivery forms, shelf life and standards per line |
| Packaging and shipping specs | How do the seals arrive? | Seals per box, the 420 × 270 × 320 mm box, bagging, double-bagging, freight planning figures |
Compliance
Use these two to open a supplier qualification file and to map your specification to the standards behind the range.
| Resource | What it answers | What is on the page |
|---|---|---|
| Regulatory compliance pack | Which standards apply to the seal, the stopper, the vial and the sealed product? | Every standard with what it requires and how the range relates, linked to its explainer |
| Quality certificates | Which certificates and declarations does Autofits hold? | ISO certificate numbers, DMF 18100, CFDA registration, BSE/TSE and heavy-metal declarations, AQL |
Ordering
Use these three once the part is chosen, to plan quantities, trial the seal and ask for a price.
| Resource | What it answers | What is on the page |
|---|---|---|
| MOQ and lead times | How much must I order and how long will it take? | Typical MOQ for standard and custom seals, lead times by delivery form, MOQ in boxes |
| Sample request | Can I trial the seal first? | What can be sampled, typical quantities, what to specify and how to evaluate |
| Custom seal quote request | What does a quote for a custom seal need? | The full quote specification, a copy-ready block and what comes back with a quotation |
Which resource answers your question
| If you are asking | Go to |
|---|---|
| Do you make a 32 mm tear-off seal? | Product catalogue |
| What is the inner diameter of a 20 mm flip-off seal? | Seal sizing guide |
| Can the disc be matched to our brand colour? | Seal colour chart |
| What is the shelf life before capping? | Technical datasheets |
| How many seals are in a box? | Packaging and shipping specs |
| Does USP <381> apply to the aluminium seal? | Regulatory compliance pack |
| What is your ISO 15378 certificate number? | Quality certificates |
| What is the minimum order for a custom colour? | MOQ and lead times |
| Can we get 20 mm samples for a capping trial? | Sample request |
| What do you need to quote a printed seal? | Custom seal quote request |
The range these resources cover
All ten resources describe one range from one plant.
| Item | Detail |
|---|---|
| Vial seal lines | FlipTop Optima, FlipTop Pull Ring, FlipTop Tear-Down, tear-off, tear-down |
| Vial seal sizes | 13, 20, 28, 32 and 34 mm |
| Pilfer-proof (ROPP) caps | 22, 25, 28, 35 and 38 mm, with EPE, latex or PVC liners |
| Delivery forms | Regular, Ready-to-Sterilize, Ready-to-Use (gamma or ETO) |
| Capacity | More than 2.4 billion seals a year; around 250 million aluminium pilfer-proof caps a month |
| Quality system | ISO 9001:2015, ISO 14001:2015, ISO 15378:2017; DMF 18100 |
| Plant | Autofits Packaging Pvt. Ltd., 75,000 sq ft facility at MIDC Malegaon, Sinnar, Nashik, India |
Published values and typical values
Seal dimensions, opening forces and pack quantities come from the Autofits engineering drawings and product dossier; a value not published for a size is marked “on request”. Order quantities, lead times and sample sizes are typical and confirmed on enquiry, and pilfer-proof cap dimensions and carton counts are typical and confirmed with the quotation.
The pages are written to be printed from a browser, so a buyer can keep a copy in a shortlisting file. A printed page is a reference, not a controlled document: the controlled drawing and specification for a part are issued with its quotation, and those are the documents to attach to a purchase specification.
What to send with any enquiry
Whatever the resource that brought you here, the same core details move an enquiry fastest.
- Product line, design and size
- Vial and stopper drawings, or the supplier part numbers
- Colour, finish and any print or emboss artwork
- Delivery form and bagging
- Quantity per size and colour, and annual volume
- Destination country and the documents you need
Contact Autofits with the list above. Each resource page adds the details specific to its own question.
Frequently asked questions
Can I download Autofits catalogues and datasheets as PDFs?
The catalogue, datasheets and other resources are published as web pages rather than PDFs, so the tables you read are current. Each page can be printed from a browser. The controlled record of any part is its drawing, which comes with the quotation.
Where do the numbers on these pages come from?
Seal dimensions, opening forces, pack quantities, materials and shelf life come from the Autofits engineering drawings and product dossier. Order quantities, lead times and sample sizes are typical values, and pilfer-proof cap dimensions and carton counts are typical, all confirmed on enquiry.
How do I get copies of Autofits certificates?
Certificate copies and material declarations are supplied on request. The certificate numbers for ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017, the Drug Master File number and the declarations available are listed on the quality certificates page, together with what to send when asking for copies.
Which resource should I start with?
Start with the product catalogue if you are still choosing a seal, the sizing guide if you have a vial and need to confirm the fit, and the compliance pack or certificates if you are opening a supplier qualification file. Ordering resources follow once the part is chosen.
Is there a form to request samples or a quote?
There is no separate sample or quote form. The sample request and custom quote pages each list exactly what to include, and the details are sent through the Autofits contact page. The custom quote page also has a copy-ready block to paste into an email.
Related reading
- Product catalogue
- Seal sizing guide
- Regulatory compliance pack
- MOQ and lead times
- Custom seal quote request
Sources
- Autofits engineering drawings, FlipTop Seals dossier and company brochure (https://autofits.com/wp-content/uploads/2024/07/Autofits-Brochure.pdf)
- ISO: ISO 15378:2017, Primary packaging materials for medicinal products (https://www.iso.org/standard/70729.html)
- ISO: ISO 8362-6:2010, Caps made of aluminium-plastics combinations for injection vials (https://www.iso.org/standard/52806.html)
*Last updated: 2026-09-15. Seal values on the resource pages are transcribed from Autofits engineering drawings and the product dossier; commercial terms and ROPP cap values are typical and confirmed on enquiry.*