Second ampoule filling line added

The new line sits within the existing sterile manufacturing suite and operates under Grade A unidirectional airflow at the point of fill, with the immediate surroundings maintained at Grade B, in line with EU/WHO GMP cleanroom classification. Fill, seal and in-process weight checks are integrated so that each ampoule is prepared, dosed and closed within a single protected airflow envelope, limiting operator intervention at the critical zone.

“The second line adds sterile capacity without changing the aseptic standards or batch-level traceability applied to every ampoule we release.”

Bringing the line into routine use followed a structured qualification exercise. Installation, operational and performance qualification (IQ/OQ/PQ) were completed against predefined acceptance criteria, and aseptic performance was confirmed through media fills and process qualification runs before the line was released for commercial batches. Supporting utilities — Water-for-Injection, HVAC and compressed gases — were verified as part of the same programme.

Practically, the second line increases throughput and gives production planning a degree of redundancy: scheduled maintenance or changeover on one line no longer halts sterile output. Every unit continues to carry the same batch-level identification and Certificate of Analysis discipline, so the added capacity does not dilute traceability. Release remains subject to Qualified Person sign-off following review of the Batch Manufacturing Record and finished-product testing.

Quality-control coverage is unchanged in scope. Finished ampoules from the new line are subject to the same tests applied across the range, including sterility (USP <71>), bacterial endotoxins (USP <85>) and particulate matter (USP <788>), with results recorded against each batch. The expansion is an increase in capacity, not a relaxation of control.