Parsolex CGMP manufacturing facility is located in the Purdue Research Park in West Lafayette, Indiana, US. The facility is registered with the U.S. Food and Drug Administration (FDA).
CGMP Manufacturing Facility Technology
The Parsolex production plant for Good Manufacturing Practices (CGMP) is fitted with cutting edge granulation equipment, fluid bed coating and drying, tablet compression, tablet drum coating and capsule weight inspection technologies from Bosch.
The Pilotmix high-shear mixer and Pilotlab fluid bed device are some of the equipment installed at the Parsolex GMP centre. The systems have granulation and precise coating capabilities, including high-shear and spray granulation, as well as fine particle, pellet and micro tablet coating and drying.
To optimise manufacturing efficiency, the plant also has pneumatic material transfer capabilities for closed product transfers. The sophisticated comminuting platforms at the plant further maintain desired proportions of particle size by milling and sifting dry and wet powders.
The facility also features a TPR-200 tablet press, which doubles the production rate of tablet compression by Parsolex while providing flexibility improved yields and fast changeover times. The plant is also fitted with the Solidlab-2 drum coater, a single device, which offers eight functions for a fast and easy scale-up of output parameters for drying, granulation and coating or layering. Also at the facility, the KKE-1700 capsule weight checker provides 100% gravimetric capsule weighing. It further strengthens the plant’s current capsule filling capacity.
CGMP Manufacturing Facility Expansion
Parsolex, a US contract development and manufacturing company, collaborated with Bosch Packaging Technology in November 2019 to provide its CGMP West Lafayette plant with cutting edge pharmaceutical packaging technology.
Through this deal, Bosch Packaging Technology will provide Parsolex with solid dosage manufacturing and pharmaceutical packaging technology and will gain access to the CDMO’s West Lafayette, IN manufacturing facility.
The strategic partnership will allow Parsolex to give its customers access to the most advanced solid dosage technology in tablet coating, tablet compression, granulation, and capsule weight sorting.
The capabilities will further endorse CGMP manufacturing for clinical trial materials (CTM) and commercial drug products for its customers.
Parsolex will also use Bosch’s modular data acquisition systems in its facility’s operating units. The data acquisition systems will optimise statistical process controls by reporting on the development and design of optimal process parameters.
Parsolex also tracks Bosch’s compliance with the software design requirements for good automated manufacturing practise (GAMP 5), which is key to the company’s compliance with 21 CFR Part 11 regulations.
The alliance will help Parsolex to continue its scientific and operational success while tackling more complex challenges affecting its clients in formulating drugs and manufacturing drug products.
Parsolex and Bosch Packaging Technology will also conduct joint research projects to validate Bosch Packaging’s state-of-the-art packaging technology.
The Purdue Research Park
The Purdue Research Park has become a major commercial and economic hotspot in Indiana. The Park spans across more than 725 acres and is the home of several globally renowned service providers to the pharmaceutical industry, as well as many other established pharma companies and innovative start-ups.
The area is well connected to major cities like Indianapolis, Chicago, St Louis and Cincinnati and has connexions to road, bus, rail and air as well as accessibility for trucks.
More about Parsolex
Founded in 2004, the company is now operating as Parsolex GMP Center, Inc., (formerly Purdue GMP Center, Inc. (“PGC”) and doing business as Parsolex. The name “Parsolex” was chosen by it’s employees as the best way to describe the company, as it combines the concepts of partnership, solutions, and excellence.
Parsolex, is headquartered in West Lafayette, Indiana. Both its corporate office and manufacturing facility are located in the technology-focused Purdue Research Park, which is an important hub for commercialisation and economic growth in Indiana.
Parsolex is a world-class contract development and manufacturing organisation (CDMO) that provides analytical, product development, manufacturing solutions and strategic advisory solutions to clients concerned with non-sterile pharmaceutical products for clinical trials, as well as commercialisation.
The companies advanced technical capabilities include formulation and process development, including first-in-human strategies. Also clinical trial material (“CTM”) manufacturing, scale-up, and technology transfer for a wide range of oral solid dosage forms, including tablets, film-coated tablets, and hard gelatin capsules. Further, Parsolex specialises in analytical method development and validation services; ICH stability storage; CGMP warehousing; and CGMP commercial manufacturing.
The organisation also operates an analytical testing laboratory to support long-term stability studies of the International Council for Harmonization (ICH) and CGMP warehousing.