Sterile injectable manufacturing is increasingly moving towards automated, closed systems that reduce contamination risk and support faster, more reliable production. RABS, isolators, robotics and real-time monitoring are helping manufacturers meet strict regulatory expectations while improving flexibility for biologics, vaccines and oncology products.

Aenova Group’s Latina site in Italy operates two complementary sterile filling lines. Its high-speed oRABS line supports high-volume vial and prefilled-syringe campaigns, while its isolator line offers greater flexibility for vials, syringes and cartridges across clinical and commercial batches.

The site’s contamination-control strategy aligns with EU GMP Annex 1 and combines facility design, monitoring, cleaning, simulations and operator training. Process improvements in prefilled-syringe filling have also reduced needle residue, improved fill-weight consistency and increased filling speeds by up to 30%.

By combining advanced barrier technologies with process expertise and skilled operators, Aenova Latina supports scalable sterile manufacturing for sensitive, high-value medicines.

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