Sovereign Pharma has unveiled its new advanced isolator-based filling line, marking an advancement in India’s sterile injectable manufacturing landscape. As part of its long-term modernisation strategy, the company had planned to transition three of its filling lines to isolator-based systems. With this milestone, the first of these isolator lines is now fully commissioned and operational in production.

This cutting-edge system positions the company among the select few globally operating fully contained isolator technology for high-volume ampoule manufacturing. The isolator creates a sealed aseptic environment through glove ports, HEPA-filtered air, positive pressure containment, and Vaporized Hydrogen Peroxide (VHP) bio-decontamination. This reduces human contact, responsible for nearly 80 percent of contamination risks in sterile processing, resulting in higher sterility assurance, improved consistency, and reduced human error.

The new isolator line also features online PUPSIT (Pre-Use Post-Sterilisation Integrity Testing), making Sovereign Pharma among the very few companies capable of executing real-time, non-destructive verification of sterilised filters prior to use, significantly strengthening sterility assurance and product safety.

Sovereign Pharma becomes the first manufacturer in India to introduce an isolator-based high-volume ampoule filling line. While isolators are globally mandated for aseptically filled products, the company is going beyond compliance by deploying this technology even for terminally sterilised products, exceeding regulatory expectations and aligning with evolving EU Annex 1 and the US FDA standards.

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

Speaking in this regard, 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 broad manufacturing flexibility, enabling handling of potent compounds and a wide range of sterile formulations. Sovereign Pharma will extend isolator technology across its remaining filling lines as part of its phased expansion and modernisation roadmap.