13 May, 2011 -- GEA Niro in Denmark has one of the major Pharmaceutical Spray Drying - spray drying under cGMP conditions - facilities worldwide. The facility, which was first opened as a demonstration plant to support sales of Pharmaceutical Spray Drying installations, is offering spray drying process development and contract manufacturing of pharmaceuticals or pharma-grade products. This allows customers to work on product formulations, test the feasibility of a spray drying, and conduct tests and clinical trials without the need for early investment in a plant or spray drying expertise. The facility is one of the largest of its kind, making it suitable for large-scale production under cGMP conditions.
Over the years GEA Niro’s facility has been extensively used for contract manufacturing with customers taking advantage of both the technology available at the facility, its capacity and the expertise of the GEA Niro technicians on site. Both big-pharma companies, CROs and small start-up companies have used the facility to evaluate Pharmaceutical Spray Drying and optimise processes before entering the production phase. Customers requiring short-run or low volume production have been able to perform their entire production run at the facility, with others investing in a plant for higher volume production only when the process was well established and the product ready to be marketed. In each case GEA Niro’s customers have been able to optimise the product, save money, delay capital expenditure and potentially bring products to market 1 – 2 years faster than would otherwise have been possible.
No two projects are alike, but GEA Niro’s vast expertise in spray drying technology has allowed the company to solve many problems. Examples include not only powder engineering - getting the right properties into each particle, but also solving critical issues like keeping the exact temperature of feeds during storage, mixing and atomization, sterile filtration - both batch-wise and in-line, powder cooling and post drying, etc.
The GEA Niro PTS is a fully equipped cGMP spray drying facility. It includes two GEA Niro PHARMASDTM spray dryers: a PSD-1 spray dryer, which is a small scale unit suitable for initial tests and productions of small quantities; and a PSD-4 spray dryer for larger-scale productions. Both spray dryers are closed cycle type dryers (e.g. use Nitrogen as drying gas) and are suitable for most kinds of solvents, including water.
GEA Niro is recognised as a pioneer in the use of spray drying for pharmaceuticals and pharma-grade products. As well as its role as a R&D facility, the PTS is rapidly taking up its place as a trusted contract manufacturing plant that benefits from both the most recent technology and the expertise to bring out its best.
Pharmaceutical Spray Drying Spray drying is a fast and gentle way to produce free-flowing powders and a process that allows a very precise particle formation. The drying takes place in seconds and at temperatures preserving the product’s activity. Spray drying can be applied in pharmaceutical production to obtain several benefits, including increased bioavailability, controlled release or taste masking and aseptic production. It can also be applied for production of fine powders for inhalation or other applications. It can be applied in the production of APIs, excipients as well as of solid dosage formulations of final drugs.
About GEA Niro
GEA Niro is a world leader in spray drying technology and has a long history of serving the pharmaceutical industry. The supply includes laboratory scale spray dryers for R&D and spray dryers for full-scale production under cGMP conditions. GEA Niro also offers assistance with spray drying process development and cGMP contract spray drying. The expertise includes technologies for processing API, excipients and solid dosage formulations by spray drying, agglomeration, encapsulation and spray congealing.
All editorial enquiries to:
Steve Jordan
The Words Workshop Ltd
26 Swanwick Lane, Broughton, Milton Keynes, MK10 9LD
Tel: +44 1908 695500
Email: steve@thewordsworkshop.co.uk
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All business enquiries to:
Michael Wahlberg
GEA Niro
Gladsaxevej 305, DK-2860 Soeborg
Denmark
Tel: +45 3954 5454
Email: Michael.Wahlberg@geagroup.com
Web: www.niro.com
