Sovereign Pharma has commissioned its first isolator-based filling line as part of a long-term modernisation plan to upgrade three of its filling lines to advanced isolator systems. The newly commissioned line is fully operational and marks a major milestone in the company’s shift toward next-generation sterile manufacturing.

With this launch, Sovereign Pharma becomes one of the few global manufacturers to operate fully contained isolator technology for high-volume ampoule production. The isolator creates a sealed aseptic environment using glove ports, HEPA-filtered air, positive pressure, and vapourised hydrogen peroxide (VHP) bio-decontamination. By significantly reducing human intervention—widely recognised as the source of nearly 80 percent of contamination risks—the system enhances sterility assurance, consistency, and process reliability.

The line also features online PUPSIT (Pre-Use Post-Sterilisation Integrity Testing), which allows real-time, non-destructive verification of filter integrity before use. This capability strengthens product safety and supports regulatory compliance in critical sterile operations.

Sovereign Pharma noted that it is the first Indian manufacturer to introduce an isolator-based high-volume ampoule filling line. Although isolators are mandatory internationally for aseptically filled products, the company is extending this technology to terminally sterilised products as well, aligning with evolving global standards such as EU Annex 1 and the USFDA’s expectations.

The new line is designed to handle both aseptic and terminally sterilised injectable products, expanding production flexibility while enabling faster turnaround times and more robust process control.

Rishad Dadachanji, Director at 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 platform also supports the handling of potent compounds and a wide range of sterile formulations. Sovereign Pharma plans to roll out isolator technology across its remaining filling lines as part of its phased expansion and modernisation roadmap.