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Why Us?

The products are manufactured at modern manufacturing facilities having Controlled Enviromental Conditions & Process Specific Cleanrooms
  • The Sterilization process has been validated according to ISO 11135 standards 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 BI'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. The internal chemical indicators are peel off labels with batch & production details, printed on them, in order to transfer them to patient records for traceability.
  • Pouch Packaging conforms to EN 868 and are sourced from a manufacturer who conforms to EN ISO 13485 & ISO 11607 - 1
  • 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 have an integrated system to evaluate critical parameters like Pressure, Temperature and Time and these are recorded. To ensure traceability protocols are met.
  • The medical fabrics are sourced from the best manufacturers around the globe and conform to various standards as per product applications as well as specific customer requirements. Some of the standards applied are AAMI PB70, EN 13795, EN ISO 11607 etc.
  • Our Medical Fabrics undergo Batch/Run Wise Monitoring of Critical Quality Parameters and are documented.
  • The medical fabrics are also subjected to Cytotoxicity and Skin (Dermal Irritation) Tests.
  • Residual tests for Ethylene Oxide, Ethylene Chlorohydrin & Ethylene Glycol as per ISO 10993-7
  • Sterility Tests done as per ISO 11737-2
  • Bioburden Analysis done as per ISO 11737-1
  • Usage based sealing methods are followed
Ultrasonic Sealing
Impulse heat sealing
Hot Melt Glue
Adhesive Tapes
Conventional Stitching
  • All traceability protocols with regard to the product and raw materials are followed.
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