Facility

Our facility is comprised of four independent manufacturing suites, three Ampoule lines, one Vial line, (with a lyophilizer) and a dedicated machine for Ready-to-Fill Syringes and Cartridges. The suites are equipped with dedicated AHUs, pre and post autoclaves, integrated washing, depyrogenation, filling and sealing lines, camera inspection systems, labelling and final packing machines.

Between the four manufacturing suites, Sovereign Pharma is geared to manage the end-to-end production of its products, starting from primary packaging materials, all the way to the exit of its finished goods.

Area Classifications

Manufacturing Areas

Facility dedicated for diluents : Grade D
Aseptically processed products : Grade C

Filling and Sealing Areas

Facility dedicated for diluents : Grade A/C
Aseptically processed products : Grade A/B

Washing and Sterilization Areas

Grade D

Features

  • Box in Box type model with directional layout and segregated man-material movement.
  • Provision of cool/cold storage areas for intermediate as well as finished goods.
  • Dedicated areas for sampling and dispensing of raw materials with segregated MAL and PAL.
  • The facility has 100% power back up and critical areas are connected to an UPS.

Washing and Depyrogenation line
  • SAP, LIMS, QMS and DMS have been implemented.
  • Highly equipped QC Laboratory with three sterility rooms.
  • Segregated LAL and Micro testing rooms with dedicated PALs.
  • Stability chambers covering all major zones, temperatures and humidity conditions.
  • Walk in incubators for environmental monitoring and sterility testing/media fills.