ALBANY, N.Y., Oct 30 (Bernama-GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading global research, development and manufacturing organization, today announced the completion of a $4 million investment to upgrade its two API aseptic suites in Valladolid, Spain. The investment aligns with the latest EU GMP Annex 1 standards and reinforces Curia’s longstanding commitment to regulatory excellence and product quality. Annex 1 provides general guidance for the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products, applying the principles of Quality Risk Management (QRM) to prevent microbial, particulate and endotoxin contamination in the final product.
The enhancements support upgrades to Valladolid’s infrastructure and technology. Curia used innovative tools to take advantage of new possibilities derived from the application of an enhanced process understanding. The bulk of the investment was dedicated to updating the site’s equipment, including the installation of new isolators, along with modernizations to HVAC, pharmaceutical panels, automation, sterilization in place and general utilities. Transitioning to a fully closed system was the primary driver of these upgrades, with the goal of supporting process and product safety and preventing microbiological contamination at every step of production. Additionally, ergonomic improvements for operators were key to increasing operational safety, along with the implementation of additional automatic controls in line with stricter data integrity policies, as described in 21 CFR Part 11.