The new containment system for research and development activities aced the factory acceptance test (FAT) and is now ready to be installed in Aprilia.
The containment project developed for Angelini S.p.A. started from the customer need to strengthen their research and development activities in the field of Fine Chemicals for their new manufacturing plant based in Aprilia, which is at the forefront in the development and manufacture of custom small-molecules, advanced intermediates and active pharmaceutical ingredients. This is a cutting edge, cGMP and ISO compliant plant, approved by both AIFA and FDA. Its annual production capacity hits 140.000 litres.
Given the kind of activity and the potentially high toxicity level related to the involved materials, the paramount focus of this project was on superlative flexibility and ultimate protection for the operator.
Our answer was an HC-IS series containment system, GMP compliant, which can assure a top level operator protection from highly potent active pharmaceutical ingredients (HPAPI). A perfect synergy between design and manufacturing strategies boiled down to a remarkably stringent containment level and a certified class 2 tightness, according to ISO 10648-2 regulations.
“Our containment systems were chosen by such an institution as Angelini S.p.A. which makes everyone at Tema Sinergie very proud.
In detail, my engineering staff and I are extremely satisfied of this outcome.
It was such an exciting collaboration, and we’re particularly grateful to Dr. Guido Furlotti – Synthetic Product & Process Lab Manager, whom followed the whole project development, and attended the FAT.”
(Massimiliano Carriero – Head of the Barrier Isolation System Business Unit)
After this delicate acceptance phase we’re ready for the next step. Now heading to Aprilia, to the Angelini Fine Chemicals laboratories and their division specialized in small molecules for the Group brands, which also offers development and production services for international pharmaceuitical industries and biotech companies.