ISO 13485 & CE Certified Plant

Infrastructure

State-of-the-art ISO Class 7/8 cleanroom facilities, high-precision extrusion & injection moulding lines, and batch-validated sterilisation systems engineered for global healthcare standards.

Class 7 & 8 CleanroomsControlled particle & environmental sterility
Full Process IntegrationGranule-to-carton controlled manufacturing
36+ Years MasteryPrecision engineering in Ahmedabad since 1988
100% Quality AuditedBatch-wise release & EO residue testing
Manufacturing Excellence

World-Class Production Facility & Cleanroom Infrastructure

Situated in Vatva, Ahmedabad, Gujarat, our manufacturing facility operates under rigorous quality management systems conforming to ISO 13485:2016 and EU MDR directives for single-use medical devices.

Quality Management & Verification

End-to-End Quality Engineering Standards

Our vertically integrated infrastructure eliminates dependence on third-party sub-assembly, guaranteeing full batch traceability and international regulatory compliance for hospital buyers.

Cleanroom Environmental Monitoring

+

Controlled room air quality is maintained continuously to uphold strict particle counts, humidity levels, and microbiological limits across operating shifts.

  • Continuous air exchange via high-efficiency particulate air (HEPA) filtration systems
  • Positive differential pressure controls to eliminate external contaminant entry
  • Microbiological surface and settle-plate monitoring on a daily schedule
  • Strict gowning, air-shower, and hygiene compliance protocols for technical personnel

Raw Material Integrity & Traceability

+

Every batch of medical-grade polymer undergoes rigorous raw material verification prior to releasing to extrusion or moulding departments.

  • 100% medical-grade, non-toxic, non-pyrogenic resin compliance (ISO 10993 tested)
  • Verification of raw polymer Certificates of Analysis (CoA) for melt-flow index and purity
  • Complete lot traceability from virgin resin intake to sealed export cartons
  • Phthalate-free, DEHP-free, and latex-free material options available for sensitive clinical uses
Mediplus India manufacturing unit powered by sustainable solar energy
Sustainable Operations

Eco-Friendly Manufacturing & Clean Energy

In addition to strict medical quality standards, our Vatva facility integrates sustainable energy solutions to lower the carbon footprint of medical device production.

  • Solar-powered manufacturing: Rooftop solar PV installation providing renewable energy for cleanroom lighting and extrusion lines.
  • Low-emission sterilisation: Advanced EO gas recovery systems ensuring minimal environmental discharge.
  • Zero-waste polymer recycling: Non-clinical runner plastic recycled into non-medical industrial applications under strict segregations.
  • Export-grade eco packaging: Compact carton engineering reducing volumetric shipping waste and container space requirements.
Global Partnership & B2B Solutions

Interested in OEM Manufacturing or Factory Audits?

We welcome international distributors, procurement agencies, and OEM partners to inspect our cleanrooms, review technical files, or request custom private-label production schedules.

Send an Inquiry