Manufacturing Facility
  • Modern clean rooms with micro - organism controlled environment.
  • Well established procedures to ensure manufacture as per CGMP ( Current Good Manufacturing Practices ).
  • Modern laboratory with technological advancements for ensuring the quality of incoming raw materials right up to the finished products.
  • Highly restricted entry procedures.
  • Clean Room for Inspection and packaging area are maintained with "Class 10,000" air conditioning facilities (with hepa filters) to eliminate micro organisms.
Process Control in Detail
  • Highest grade of raw materials are carefully selected and tested to ensure compliance with standards required for use in medical devices.
  • Strict in-process and quality control tests are conducted at every stage of compounding, dipping, leaching and packing.
Every individual catheter is subjected to 100% inspection for the following :
  1. Surface Smoothness
  2. Smooth and Evenly Formed Drainage Eye
  3. Rounded And Smooth Tip
  4. Funnel Strength at Bifurcation
  5. Gauge (dimensional Specification)
  6. Balloon Symmetricity
The following biological reactivity tests are conducted from renowned laboratories for ensuring the complete elimination of Urinary Track Infections (UTI) :
  1. Bio-compatibility tests
  2. Sterility tests
  3. Cyto-toxicity tests
  4. Intracutaneous irritation tests (The reports will be made available on request)