Idifarma approved for EU-GMP commercial capsule manufacturing
A Spanish contract development and manufacturing organisation (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 up 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 specialised 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.
Luis Oquiñena, general manager and co-founder of Idifarma commented: “The latest addition to our facility in Pamplona is a fantastic development for Idifarma, helping us to bolster our manufacturing capabilities and reinforce our position as a specialist CDMO for small-scale niche products in solid oral forms.
“The GKF-702’s modular design will help us to future proof our investment ensuring that we can add real value to our clients’ manufacturing and development projects over the coming years. It is important for us to remain versatile and flexible, however we will continue to focus on specialised low-volume and high potent pharmaceutical products which is a key differentiator for us.”
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.