Certification


EtO:

’s EtO facilities at Bangalore, Edayar, Gurgaon, Tuticorin and Vasai are certified by renowned European bodies (BSI Management systems) for ISO 9001 & ISO 13485 Quality Management Systems requirements.

They have certified the above facilities for the following activities:

Provision of Ethylene oxide sterilisation / bio burden reduction treatment for various commodities & provision of Ethylene oxide sterilisation for Medical Devices in accordance with EN 550 & ISO 11135.

Our Gurgaon facility has obtained a Certificate for GMP compliance from the MHRA (Medicines and Healthcare products Regulatory Agency, London).

Apart from International Certification, we have also obtained local FDA (Food & Drug Administration) / DC (Drug Controller) approval to process medical devices, at Gurgaon, Vasai, Mumbai, Bangalore, Edayar and Tuticorin.


GAMMA RADIATION :

Certified by BSI Management Systems for ISO 9001 & ISO 13485 Quality Management Systems with compliance to EN 552 & ISO 11137, ISO 14001 Environment Management Systems and ISO 22000 Food Safety Management Systems.

This facility is also approved by the DC for sterilisation of medical devices.

’s Gamma Radiation facility has the following International approvals :

  • European Commission to irradiate foods and food ingredients destined for European countries.
  • Assigned a Compliant (C) by Health Canada in accordance to the Food and Drugs  Regulations, Canada.
  • Acceptable in cGMP by the USFDA.

  • The AERB (Atomic Energy Regulatory Board), Government of India, has certified the facility for sterilisation of medical products and spices.

    The DAE (Department of Atomic Energy), Government of India, has also licensed the facility to irradiate food products.


    EtO FORMULATION PLANT :

    Our EtO formulation plant has been certified by Quality Services for ISO 9001 & ISO 14001.

    All our EtO & Gamma radiation facilities have obtained FSSAI licences for processing spices.