Sterility and precision,
engineered by design.
Accredited for critical healthcare supplies.
Our regulatory foundation guarantees that every consumable is fully licensed, audited, and cleared for clinical operations. We conform exclusively to the highest medical device production frameworks.
ISO 13485:2016
Certified for the design, development, and manufacture of sterile and non-sterile critical care medical devices. Outlines strict guidelines for risk management, raw material sourcing, and validation of sterile processes.
CDSCO Approved
Fully licensed and approved by the Central Licensing Authority, Ministry of Health and Family Welfare, Government of India. Certifies that our manufacturing facility, cleanrooms, and entire device range comply with national bio-safety and therapeutic standards.
Class 10 Cleanroom Standards
Biological purity is locked in at the point of molding. Our 15,000 sq.ft manufacturing facility is centered around strict particulate atmosphere controls.
Environmental Particulate Control
Operating strictly under Class 10 cleanroom specs, limiting environmental particulates to guarantee that raw consumables are kept in sterile integrity prior to final packaging.
HEPA Filtration & Pressure Loops
Equipped with high-efficiency particulate air (HEPA) terminal filters. Positive pressure air differentials prevent particulate intrusion from entering the workspace.
Strict Gowning Airlocks
Personnel enter only through dedicated dual-door gowning airlocks. Full protective overalls, masks, and head coverings are required to prevent human bio-burden contamination.
In-House Making & Packaging
From polymer extrusion and custom molding to final assembly and primary blister packaging, the entire making and packaging sequence is completed in-house within the Class 10 envelope.
Four loops of validation.
Before any consumable leaves our dispatch bays, it must successfully clear all physical, biological, and sterility verification logs.
Sterilisation Validation
Validated terminal sterilization parameters (Gamma Irradiation / Ethylene Oxide) conducted to reach a Sterility Assurance Level (SAL) of 10⁻⁶.
LAL Pyrogen-Free Assays
Strict batch-level Limulus Amebocyte Lysate (LAL) testing to verify that all clinical fluid-path devices are strictly non-pyrogenic.
Visual & Physical Inspections
100% manual inspections under magnification loops alongside laser micrometer tests verifying material wall-thickness down to the micron.
Full Traceability Log
Every product carton is logged with a unique batch number, linking it to raw polymer material certificates, manufacturing shifts, and QC approvals.
Require specifications or distribution terms?
We work closely with verified distribution partners. Procurement teams and regional distributors can request detailed device specifications, technical files, or regional supply terms.