A Spanish contract development and manufacturing organization (CDMO) has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.
The new Bosch GKF-702 automatic capsule filling machine, which is capable of manufacturing from 3,000 to 42,000 hard capsules per hour, is now fully operational and will support Idifarma in the manufacturing of small-scale clinical and commercial batches, as well as providing the ability to simulate industrial production environments during R&D.
Successfully audited by the Spanish Medicines Agency (AEMPS) in June, the GKF-702 strengthens Idifarma’s position as a specialized contract partner for the development and manufacturing of oral solid dosage forms, with a particular focus on high potent compounds and niche pharmaceutical products requiring small batches.
The new investment includes a minibowl for small R&D batches, resulting in a more efficient use of active pharmaceutical ingredients (APIs) and less wastage. The machine also comes equipped with an industrial PC (IPC) which is 21 CFR part 11 compliant and benefits from a variety of interfaces which makes the batch documentation easier to access.