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The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain
Contract development and manufacturing organization (CDMO), Idifarma, announced that it 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 fully operational Bosch GKF-702 automatic capsule filling machine is capable of manufacturing 3000 to 42,000 hard capsules per hour. The investment enables Idifarma to support the manufacturing of small-scale clinical and commercial batches as well as simulate industrial production environments during R&D.
The GKF-702 includes a minibowl for small R&D batches, resulting in a more efficient use of APIs and less wastage. The machine also comes equipped with an industrial PC that is 21 CFR part 11 compliant and benefits from a variety of interfaces, making batch documentation easier to access.
Idifarma completed a successful audit by the Spanish Medicines Agency (AEMPS) in June 2017. The CDMO specializes in the development and manufacturing of oral solid dosage forms, with a particular focus on highly potent compounds and niche pharmaceutical products requiring small batches.
In addition to its expanded capsule filling capabilities, Idifarma has also recently invested in new analytical equipment at its Pamplona facility, including an Agilent gas chromatography system and dissolution apparatus, as well as four new Waters HPLCs to support its growing client base.