Commitment
to Quality

Autofits Packaging Pvt. Ltd. manufactures vial seals under four certifications and two registrations, each with a number that can be quoted in a supplier qualification file: ISO 9001:2015 (21.GGCS.IN.091174), ISO 14001:2015 (21.GGCS.IN.140169), ISO 15378:2017 GMP for primary pharmaceutical packaging (21.GGCS.IN.151175), a Drug Master File (DMF 18100) and a CFDA registration for the China market. Every seal passes 100% high-speed camera inspection, assembly runs in an ISO Class 8 cleanroom, and AQL is set at critical nil, major not more than 2.5% and minor not more than 4%, tailorable to a customer specification.

This page sets out the certificates and their numbers, the quality system behind them, the manufacturing controls, and the material compliance position for every component in a finished seal.

Key takeaways

• ISO 15378:2017 is the governing certification: GMP requirements for primary packaging materials for medicinal products, certificate 21.GGCS.IN.151175.
• ISO 9001:2015 (21.GGCS.IN.091174) and ISO 14001:2015 (21.GGCS.IN.140169) cover quality and environmental management.
• A Drug Master File (DMF 18100) and a CFDA registration for the China market support customer filings.
• 100% of seals pass high-speed camera inspection, with minimal human intervention in the inspection step.
• AQL: critical nil, major NMT 2.5%, minor NMT 4%, tailorable to a customer specification.
• Assembly is in an ISO Class 8 cleanroom with fully automated washing; polypropylene discs are moulded in-house on Japanese Toyo injection machines.
• Materials are REACH and RoHS compliant, BSE/TSE-free to EMEA/410/01 rev. 3, with heavy metals held to a maximum 100 ppm total.

Certifications and registrations

All four certificates and both registrations are current and are quoted here with their numbers so they can be recorded directly in a supplier file.

ISO 15378 is the certification that matters most to a pharmaceutical buyer, because it applies GMP principles to primary packaging rather than to a generic quality system. It builds on ISO 9001 and adds requirements specific to components that touch a medicinal product: risk management, validation, contamination control and traceability of the material back through the process. What the standard covers and how it is audited is set out on the ISO 15378 page; what a packaging Drug Master File contains, and how a customer references one in a submission, is covered under Type III Drug Master Files.

These certifications cover the whole vial seal and cap range and the closure recommendations made for each pharmaceutical application. They are also the evidence base a buyer works through when they audit a vial closure supplier, and the same system produces every seal shipped to the companies on the client list.

The quality system

Certification sets the framework; the day-to-day system is inspection, sampling and in-house testing at every stage of production.

100% camera inspection. The plant runs high-speed visual inspection camera systems on the line, so every seal is inspected rather than a sample of them, with minimal human intervention in the check. Camera inspection is what makes tamper-evident features and crimp geometry consistent across a batch, and consistency is what holds container closure integrity once the seal is crimped onto a filled vial.

Acceptable quality limits. Sampling is against AQL: critical defects nil, major defects not more than 2.5%, minor defects not more than 4%. These limits are tailorable, so a customer specification that runs tighter than the standard plan can be adopted for that customer’s parts.

In-house laboratory testing. Beyond the certification requirements, the site runs its own testing procedures. The laboratory conducts checks at every stage of production, from incoming aluminium coil and polypropylene resin through to the assembled seal, to reduce defect rates and prevent contamination reaching the finished component.

Continuous improvement. Daily management meetings and continuing training programmes carry the findings from inspection and laboratory testing back into the process, which is where waste reduction and cost efficiency come from.

Manufacturing controls

Control over the process comes from doing the critical steps in-house rather than buying them in.

Polypropylene discs and buttons are moulded on the site’s own Japanese Toyo injection-moulding machines, so disc geometry, gate quality and the moulded break point that gives a seal its tamper evidence are all controlled internally rather than inherited from a supplier. The plant also builds and maintains its own special-purpose machines, which is what allows tooling and process changes to be made for a customer-specific seal without waiting on an external machine builder.

Washing is fully automated. Assembly of the aluminium shell and the moulded plastic top runs in an ISO Class 8 cleanroom, which is the cleanroom sealing environment required for Ready-to-Use components entering an aseptic filling area. The newer plant, commissioned in 2020, is the line used for customised sealing solutions developed to a specific customer specification.

Three delivery forms come out of that process: standard (non-sterile), Ready-to-Sterilize, and Ready-to-Use. Ready-to-Use seals are washed and assembled in the cleanroom, double-lacquered, sterilized by gamma irradiation or ethylene oxide and double-bagged for aseptic areas. Integrity of the finished, capped vial is verified by the customer using the methods described under container closure integrity testing.

Material compliance

Every component in a finished seal carries a documented compliance position, and the material certificates are issued with the consignment.

Aluminium. Alloy AA8011, conforming to EN 15088:2005, supplied with EN 10204 3.1 inspection certification and tested to BS EN 485-2:2008. It is REACH and RoHS compliant. Why this alloy and temper is the standard choice for vial caps is covered under aluminium grades for vial caps.

Lacquer. An epoxy lacquer coating conforming to 21 CFR 175.300, the US FDA regulation for resinous and polymeric coatings in food-contact use. The lacquer may be pigmented where colour is applied to the aluminium.

Polypropylene. Discs and buttons conform to IS 10910 and IS 10909, to FDA 21 CFR 177.1520 for olefin polymers, and to EC 1895/2005. BADGE, NOGE and BFDGE are not used.

Heavy metals. Chromium-VI, cadmium, mercury and lead are held to a maximum 100 ppm total, in line with EN 602 and EC 94/62.

BSE/TSE. Components are free of materials of animal origin and comply with EMEA/410/01 rev. 3, the EMA note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents. The declaration and what it covers are set out under BSE/TSE compliance.

The facility

Production is at a 75,000 sq ft facility at E-13/7/4, MIDC, Malegaon, Sinnar, Nashik, Maharashtra 422113, India, operated by Autofits Packaging Pvt. Ltd. (CIN U25190MH2009PTC191475), employing more than 300 people. The site houses aluminium forming, in-house polypropylene moulding, automated washing, ISO Class 8 cleanroom assembly, high-speed camera inspection and the quality laboratory. More on the plant and its lines is on the factory page.

Frequently asked questions

Is Autofits ISO 15378 certified?

Yes. Autofits holds ISO 15378:2017, the standard that applies GMP requirements to primary packaging materials for medicinal products, under certificate number 21.GGCS.IN.151175. It is held alongside ISO 9001:2015 (certificate 21.GGCS.IN.091174) for quality management and ISO 14001:2015 (certificate 21.GGCS.IN.140169) for environmental management.

Does Autofits have a Drug Master File?

Yes. Autofits holds Drug Master File 18100, which a customer can reference in a regulatory submission so the packaging component data supports their filing without the detail being disclosed to them directly. Autofits also holds a CFDA registration for the China market; the registration number is listed in the certifications block on this page.

What AQL does Autofits work to?

Sampling is against an AQL of critical defects nil, major defects not more than 2.5% and minor defects not more than 4%. Those limits are tailorable: where a customer specification requires tighter limits, the plan is set to that specification for that customer’s parts. Separately, every seal passes 100% high-speed camera inspection rather than sample inspection alone.

Are Autofits seals BSE/TSE-free?

Yes. Components are free of materials of animal origin and comply with EMEA/410/01 rev. 3, the EMA guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products. Heavy metals are separately held to a maximum 100 ppm total for chromium-VI, cadmium, mercury and lead.

What cleanroom class are the seals assembled in?

Assembly runs in an ISO Class 8 cleanroom, with fully automated washing before assembly. Ready-to-Use seals are assembled in that environment, double-lacquered, sterilized by gamma irradiation or ethylene oxide and supplied double-bagged so they can be taken into an aseptic filling area without an additional decontamination step.

Can Autofits supply material and test certificates with a consignment?

Yes. Aluminium is supplied with EN 10204 3.1 inspection certification against EN 15088:2005 and tested to BS EN 485-2:2008. Compliance declarations for the epoxy lacquer (21 CFR 175.300), the polypropylene (IS 10910, IS 10909, 21 CFR 177.1520, EC 1895/2005), heavy metals and BSE/TSE status are available with the consignment on request.

Related reading

• ISO 15378: GMP for primary packaging materials
• Type III Drug Master Files
• BSE/TSE compliance
• How to audit a vial closure supplier
• The Autofits factory
• The full vial seal and cap range

Sources

• ISO: ISO 15378, Primary packaging materials for medicinal products, Particular requirements for the application of ISO 9001:2015 with reference to GMP (https://www.iso.org/)
• ISO: ISO 9001, Quality management systems (https://www.iso.org/)
• ISO: ISO 14001, Environmental management systems (https://www.iso.org/)
• U.S. FDA: Drug Master Files (https://www.fda.gov/)
• EMA: EMEA/410/01 rev. 3, Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (https://www.ema.europa.eu/)
• Autofits certification records and FlipTop Seals dossier (internal, on file)

*Last updated: 2026-08-18. Certificate numbers and material compliance statements are current at the date shown; request the certificates themselves and the applicable declarations from the Autofits technical team for a supplier qualification file.*