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GEA Niro

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GEA Niro

GEA Niro is a world leader in spray drying technology and has a long history of serving the pharmaceutical industry.

GEA Niro offers spray drying solutions, spray dryers as well as contract services for the complete development and product-life cycle, from the initial proof of concept tests to full-scale production of clinical trial materials and commercial products under cGMP conditions.

The benefits of pharmaceutical spray drying

  • Improve the bioavailability of poorly soluble APIs
  • Obtain controlled release or taste masking
  • Produce fine powders for inhalation or other applications
  • Improved shelf-life/ease of handling
  • Drying and particle formation in a single step

Spray dryers for pharmaceutical compounds

GEA Niro’s product range includes spray dryers for R&D as well as industrial-scale plants for continuous production of pharmaceutical compounds under cGMP conditions.

The expertise includes technology for processing APIs, excipients and final drug formulations by spray drying, agglomeration, encapsulation and spray congealing.

pic 4
  SDMicro R&D laboratory spray dryer.

At the GEA Niro test centre, test work, spray drying process development and contract manufacturing can be conducted. The test centre includes the GEA Niro pharma test station – one of the most prominent cGMP spray drying facilities in the industry. The pharma test station holds an ISO: 9001 certificate and is approved by the Danish Medicines Agency for production of clinical trial materials. Upon request, permission to produce commercial material can be obtained.

GEA Niro is part of GEA Process Engineering, a business segment of the GEA Group, which also includes GEA Pharma Systems.

For more information please visit www.niro.com or contact us:

GEA Process Engineering A/S
Gladsaxevej 305, P.O. Box 45, 2860 Søborg, Denmark
Tel +45 39 54 54 54
E-mail: pharma@niro.dk

PHARMASD™

The PHARMASD™ spray dryers are designed especially for the production of final drugs. Like the QUALIFIEDSD™, it includes all equipment and instrumentation required for a qualified pharmaceutical production unit, just as all critical instruments are supplied with manufactures’ calibration certificates, and materials in product contact are selected according to cGMP guidelines and delivered with certificates.

PSD-1 drying chamber and bag filter.

QUALIFIEDSD™

The QUALIFIEDSD™ spray dryer is designed for the pharmaceutical industry and includes all equipment and instrumentation required for a qualified pharmaceutical production unit. Critical instruments are supplied with manufactures’ calibration certificates, and materials in product contact are selected according to cGMP guidelines and delivered with certificates.

SDMicro™

The SD-Micro™ is a fully functional small-scale spray drying plant for early stage product development. It allows customers to make tests at the smallest scale possible, and is easy to dismantle for cleaning and fast product switch. It is available with a qualification package for cGMP production.

Spray Dryers for the Pharmaceutical Industry

GEA Niro supplies a range of spray dryers for the pharmaceutical industry, from small units for R&D to large cGMP approved production units.

Clean room with spray dryer.

Spray Drying Process Development and Contract Manufacturing

GEA Niro’s capabilities within spray drying process development helps determine the feasibility of spray drying and addresses basic formulation questions at an early stage of the drug development phase. With GEA Niro’s DRYING KINETICS ANALYZERTM, it is possible to conduct essential tests with only a few ml of material available – thereby at a very early stage.

GEA Niro's test facility includes spray dryers with several capacities and is available for spray drying process development and contract manufacturing in any quantity from a few g/hr to several kg/hr.It is available for production of both non-cGMP samples for technical analysis and product development, and for production of clinical trial materials and commercial production…

VERSATILE-SD™

The VERSATILE-SD™ is a medium-sized spray dryer for non-GMP productions. It is available in several sizes and configurations to match the exact requirements.

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Quick Contact GEA Niro
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