Manufacturing facility expansion
In November 2019, Parsolex, a contract development and manufacturing organisation in the US, partnered with Bosch Packaging Technology to equip its West Lafayette facility with the latest pharmaceutical packaging technologies.
The strategic co-operation will allow Parsolex to provide its clients with access to the latest solid dosage technology innovations in granulation, coating, tablet compression and capsule weight sorting.
The current Good Manufacturing Practices (CGMP) manufacturing facility is equipped with Bosch’s state-of-the-art granulation, fluid bed coating and drying, tablet compression, tablet drum coating and capsule weight checking technologies.
Parsolex CGMP manufacturing facility is in the Purdue Research Park in West Lafayette, Indiana, US and registered with the US Food and Drug Administration (FDA).
The location has air, bus, rail and trucking accessibility and is well-connected to major cities including Indianapolis, Chicago, St Louis and Cincinnati.
The equipment and systems installed at the Parsolex GMP centre include the Pilotmix high-shear mixer and Pilotlab fluid bed device. The platforms deliver granulation and accurate coating capabilities, including high-shear and spray granulation, as well as fine particle, pellet and micro tablet coating and drying.
The facility also has pneumatic material transfer capabilities for closed transfers of product to enhance production efficiency. The advanced comminuting platforms at the facility further ensure preferred particle size distributions by milling and sifting of dry and wet powders.
The plant also includes a TPR-200 tablet press, which increases Parsolex’s tablet compression production rate by two-fold, while offering flexibility, better yields and rapid changeover times.
The facility is also equipped with the Solidlab-2 drum coater, which offers eight functions in a single device to easily scale-up production parameters for drying, granulation and coating or layering.
The KKE-1700 capsule weight checker at the facility offers 100% gravimetric capsule weighing. It further improves the existing capsule filling capacity of the plant.
The capabilities will support cGMP production for clinical trial materials (CTM) and commercial drug products for its clients.
Parsolex will also employ Bosch’s modular data acquisition systems at the operational units of its facility. The data acquisition systems will report the design and development of optimal process parameters to improve statistical control over processes.
Parsolex also monitors Bosch’s compliance with good automated manufacturing practice (GAMP 5) guidelines during software design, which is essential for the company to comply with 21 CFR Part 11 regulations.
The partnership will enable Parsolex to continue its scientific and operational excellence while addressing more complex formulation and drug product manufacturing challenges faced by its clients.
Parsolex and Bosch Packaging Technology will also undertake joint research projects, which will validate the cutting-edge packaging technology of Bosch Packaging.
Parsolex GMP Center (formerly Purdue GMP Center), doing business as Parsolex, is headquartered in West Lafayette, Indiana. It is a leading contract development and manufacturing organisation (CDMO) offering analytical, development and manufacturing solutions to clients dealing with non-sterile pharmaceutical products.
Founded in 2004, Parsolex is equipped with state-of-the-art manufacturing and analytical technologies, formulation design, process development, scale-up, manufacture and packaging for a range of oral solid dosage forms including tablets, film-coated tablets and hard gelatine capsules filled with powder, granule and coated-beads.
The company also operates an analytical testing laboratory to support long-term International Council for Harmonisation (ICH) stability studies and CGMP warehousing. The client base of Parsolex includes leading academic institutions, major hospitals and pharmaceutical companies of all sizes and stages ranging from entrepreneurial ventures and start-ups to established global firms.
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