Sovereign Pharma commissions isolator-based high-volume ampoule filling line

Sovereign Pharma announced the commissioning of its isolator-based filling line as part of its long-term modernisation strategy to transition three of its filling lines to isolator systems. The first isolator line is now fully commissioned and operational in production.

The system places the company among the limited number of manufacturers globally operating fully contained isolator technology for high-volume ampoule manufacturing. The isolator provides a sealed aseptic environment through glove ports, HEPA-filtered air, positive pressure containment, and vapourised hydrogen peroxide (VHP) bio-decontamination. This reduces human contact, identified as contributing to nearly 80 per cent of contamination risks in sterile processing, and supports sterility assurance, consistency, and reduced human error.

The isolator line incorporates online PUPSIT (Pre-Use Post-Sterilisation Integrity Testing), enabling real-time, non-destructive verification of sterilised filters prior to use. This strengthens sterility assurance and product safety.

Sovereign Pharma stated that it is the first manufacturer in India to introduce an isolator-based high-volume ampoule filling line. While isolators are mandated globally for aseptically filled products, the company is implementing this technology for terminally sterilised products as well, aligning with EU Annex 1 and USFDA standards.

The line supports the filling of aseptic and terminally sterilised injectables, expanding the company’s capability and offering faster turnaround, sterility assurance, and process control.

Rishad Dadachanji, Director, Sovereign Pharma, said, “Commissioning our first isolator-based filling line reflects our commitment to placing India at the forefront of sterile injectable manufacturing. We believe in going beyond compliance and setting new benchmarks. With isolator technology enabling high-volume ampoule filling for the first time in India, we reinforce our dedication to patient safety and to delivering uncompromised quality for every client we serve.”

The isolator system supports manufacturing flexibility, including potent compounds and a range of sterile formulations. Sovereign Pharma plans to extend isolator technology across its remaining filling lines under its phased expansion and modernisation roadmap.