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The Products are manufactured at a 35,000 square feet modern manufacturing facility located in Bangalore.
  • We are certified by M/s TUV RHEINLAND LGA PRODUCTS GmbH for  EN ISO 13485:2003+AC 2007 A Quality management system for MEDICAL DEVICESEN ISO 9001:2008 A Quality Management System.
  • The Sterilization process has been validated according to ISO 11135standards and a protocol is established to ensure the process repeatedly delivers Sterility Assurance Level 10-6 (SAL) to the product. A set of 16 Biological indicators(1.5 Bl’s per Cu.Mtr) are sent with each batch of sterilization for routine monitoring of the sterilization process, and then incubated for 48 hours @ 37 degrees before the product is released. All packs have Internal and External chemical indicators for a visual check of exposure to ETO.
  • Pouch Packaging conforms to EN 868 Part 5, and are sourced from a manufacturer who conforms to EN ISO 13485:2003 & EN ISO 9001:2008
  • Packaging Sealing is done by state of the art machines with online printing and the sealing process is validated as per EN ISO 11607-2, and has an integrated system to evaluate critical parameters like Pressure, Temperature and Time and is these are recorded.
  • The medical fabrics are sourced from the best manufactures around the globe and conform to various standards as per product applications as well as specific customer requirements. Some of the standards applied are PB70, EN 13795-3, ASTMF1670 & ASTMF1671, ENISO 11607-1.
  • Our Medical Fabrics undergo Batch/Run Wise Monitoring of Critical Quality Parameters and are documented.

  • The medical fabrics are also subjected to Cytotoxixity and Skin (Dermal Irritation) Tests.
  • Regular Bio-Burden Analysis, Sterility Tests as well as ETO residual tests are carried out.
  • Usage based sealing methods are followed
  • -Ultrasonic Sealing
  • -Impulse heat sealing
  • -Hot Melt Glue
  • -Release Tape
  • -Conventional Stitching
  • All traceability protocols with regard to the product and raw materials are followed.