Commitment
to Quality
At Autofits, quality is at the core of everything we do. Our manufacturing facility meets stringent international certification standards, including ISO 15378:2017 GMP for primary pharmaceutical packaging, ensuring that each product reflects our commitment to excellence. With decades of expertise in crafting Special Purpose Machines, we continuously refine our tools and processes to stay at the forefront of quality and innovation
Our newest plant, established in 2020, allows us to develop customized sealing solutions tailored to meet specific industry needs. We specialize in standard, ready-to-sterilize, and ready-to-use seals, solidifying Autofits’ position as India’s leading manufacturer of flip-top seals. Those certifications cover the whole vial seal and cap range, and the closure recommendations we make for each pharmaceutical application.
Zero Defect Assurance
Exceeding Certification Standards
Continuous Improvement & Training
Quality
Certifications
ISO 9001:2015
ISO 14001:2015 EMS
ISO 15378:2017 GMP
DMF Certificate
CDFA Certification
Autofits makes every vial seal under an ISO 15378:2017 quality system, the standard that applies GMP to primary packaging materials for medicinal products, and checks it at four points: incoming material, automated washing, ISO Class 8 cleanroom assembly and 100% high-speed camera inspection. Sampling follows AQL limits of critical nil, major not more than 2.5% and minor not more than 4%, and those limits can be tightened to a customer's specification.
This page describes how the system works on the shop floor. The certificate numbers and material declarations are kept on the quality certificates page.
Key takeaways
- Quality system: ISO 15378:2017 GMP for primary packaging, alongside ISO 9001:2015 and ISO 14001:2015.
- In-house moulding: polypropylene discs are moulded on Japanese Toyo injection machines in the plant.
- Washing: fully automated, to remove particles before assembly.
- Assembly: in an ISO Class 8 cleanroom.
- Inspection: 100% of seals pass high-speed camera inspection, with minimal human intervention.
- AQL: critical nil, major not more than 2.5%, minor not more than 4%, tailorable.
What ISO 15378 adds to a quality system
ISO 15378 takes the requirements of ISO 9001 and adds GMP for components that touch a medicine: risk management, contamination control, validation and traceability. A general quality certificate says a company manages its processes; ISO 15378 says it manages them in the way a drug maker's own GMP expects of a primary packaging supplier. Autofits holds certificate 21.GGCS.IN.151175. What the standard requires, clause by clause, is on the ISO 15378 page, and how it differs from ISO 9001 on ISO 9001 vs ISO 15378.
The four control points
| Stage | What happens | What it controls |
|---|---|---|
| Materials | AA8011 aluminium to EN 15088:2005 with EN 10204 3.1 certification; epoxy lacquer to 21 CFR 175.300; polypropylene to FDA 21 CFR 177.1520 | The seal starts from specified, certified material |
| Moulding and forming | Discs moulded in house on Toyo injection machines; aluminium shells formed and lacquered | Disc geometry and the break point that gives the seal its opening and tamper evidence |
| Washing and assembly | Fully automated washing; assembly in an ISO Class 8 cleanroom | Particles and contamination before the seal is packed |
| Inspection and release | 100% high-speed camera inspection; AQL sampling | Every seal checked, every batch sampled against fixed limits |
Materials
Every component is bought to a stated specification. The aluminium is AA8011 alloy conforming to EN 15088:2005, supplied with EN 10204 3.1 inspection certification and tested to BS EN 485-2:2008. Why this alloy is the standard for vial caps is covered under aluminium grades for vial caps.
Moulding and forming
The polypropylene disc is moulded in the plant rather than bought in, so its geometry and the moulded break point are controlled by the same quality system as the rest of the seal. That break point is what makes a flip-off seal open the same way on every vial, and it is how the Optima Button design carries its tamper evidence. The process from coil to finished seal is set out in aluminium-plastic seal manufacturing.
Washing and cleanroom assembly
Components are washed on a fully automated line, then the shell and disc are assembled in an ISO Class 8 cleanroom. For Ready-to-Use seals, the aluminium is double-lacquered and the packed seals are sterilised by gamma irradiation or ethylene oxide and double-bagged for aseptic areas. What a cleanroom class means for a closure is on sterile vial sealing.
Inspection and release
Every seal passes high-speed camera inspection on the line, with minimal human intervention, so inspection covers 100% of production rather than a sample. On top of that, each batch is sampled against AQL limits:
| Defect class | Acceptance limit |
|---|---|
| Critical | Nil |
| Major | Not more than 2.5% |
| Minor | Not more than 4% |
The limits are tailorable: where a customer's specification runs tighter, that customer's seals are sampled to it. Consistent geometry from batch to batch is what keeps the crimp, and so container closure integrity, the same on every filled vial. How a batch is traced back through these steps is covered in seal batch traceability.
Laboratory testing and improvement
The plant's own laboratory checks seals at each stage of production, from incoming aluminium and resin to the assembled seal. Daily management meetings and continuing training take what inspection and testing find back into the process.
Certificates in brief
Autofits holds ISO 9001:2015, ISO 14001:2015 and ISO 15378:2017, Drug Master File 18100 and a CFDA registration. Materials are BSE/TSE-free to EMEA/410/01 rev. 3, REACH and RoHS compliant, with heavy metals at a maximum 100 ppm total. The numbers, scope and declarations for each are on the quality certificates page, and the standards each seal is built to are in the regulatory compliance pack.
Frequently asked questions
What quality system does Autofits use?
Autofits works under ISO 15378:2017, the standard that applies GMP to primary packaging materials for medicinal products, certificate 21.GGCS.IN.151175, alongside ISO 9001:2015 and ISO 14001:2015.
How are Autofits vial seals inspected?
Every seal passes 100% high-speed camera inspection on the line, with minimal human intervention, and each batch is sampled against AQL limits of critical nil, major not more than 2.5% and minor not more than 4%.
Can AQL limits be set to a customer specification?
Yes. The AQL limits are tailorable, so where a customer's specification is tighter, that customer's seals are sampled to it.
What cleanroom class are Autofits seals assembled in?
Assembly runs in an ISO Class 8 cleanroom, after fully automated washing.
Are the plastic discs made in house?
Yes. Polypropylene discs are moulded in the plant on Japanese Toyo injection machines, so disc geometry and the break point are controlled by the same quality system.
Related reading
- The vial seal and cap range
- The Autofits factory in Nashik
- Type III Drug Master Files
- BSE/TSE compliance
- Container closure integrity testing
- How to audit a vial closure supplier
- Seals by pharmaceutical application
- Companies Autofits supplies
Sources
- ISO: ISO 15378, Primary packaging materials for medicinal products, Particular requirements for the application of ISO 9001:2015, with reference to GMP (iso.org)
- Autofits certification records and FlipTop Seals dossier
*Last updated: 2026-11-06. Certificate copies and declarations are supplied on request.*
