Sovereign Pharma, a contract manufacturing organisation, has announced that it is India’s first manufacturer to commission the use of an advanced isolator-based filling line.
“Commissioning our first isolator-based filling line reflects our commitment to placing India at the forefront of sterile injectable manufacturing,” said Rishad Dadachanji, Director of Sovereign Pharma.
Only a limited number of companies worldwide are capable of operating isolator-based, high-throughput ampoule filling.
The isolator enclosure provides a sealed aseptic environment supported by glove ports, HEPA-filtered air, positive-pressure containment, and vaporised hydrogen peroxide biodecontamination.
Human intervention is estimated to account for up to 80% of contamination risk in sterile processing, and the isolator sharply reduces the need for human intervention.
In this way, the new system will deliver higher sterility assurance, more consistent performance and fewer operator-driven errors.
Sovereign Pharma, which is part of the Dadachanji Group company, produces injectables in ampoules, vials (liquid and lyophilised), pre-filled syringes, and cartridges.
The manufacturer will also now incorporate PUPSIT (Pre-Use Post-Sterilisation Integrity Testing), to enable real-time, non-destructive verification of sterilised filters before use.
While isolator systems are mandated globally for aseptic operations, the company is extending the technology to terminally sterilised products as well.
Their approach exceeds regulatory requirements and aligns with evolving expectations under EU GMP Annex 1 and US FDA guidance.