Industrialisation of a Dry Powder Inhaler – A Challenging Task


  

Harald Grün

 

 

Balda Medical GmbH & Co. KG

Bergkirchener Str. 228, DE-32549 Bad Oeynhausen, Germany

Tel: +49 5734 5132021   Fax: +49 5734 5132111
Email: hgruen@balda-medical.de

 

  

Biography 

 

Harald Gruen has a Master degree in Business Economics from the Private University of Business Economics from Zurich, Switzerland, and a Master degree in Plastic Engineering from the University of Applied Sciences from Darmstadt, Germany.
 

He joined George Fischer Piping Systems GmbH Germany, in 1994 as a Product Manager for Industrial Piping Systems.

In 1997 he changed to the Head Quarter of George Fischer Piping Systems Ltd. in Schaffhausen, Switzerland. As a Market Manager Life Science he was worldwide responsible for the market development of High Performance Plastic Piping Systems for PW (Purified Water) and WFI (Water for Injection) in the Pharmaceutical and Medical Device Industry.

In 2001 he joined Createchnic AG as a Vice President Medical Devices and member of the Management Team. He was responsible for the Strategic Development, Marketing, Project Management, Production and Quality Management of the Business Unit Medical Devices. In April 2005 he took up his current position at Balda Medical GmbH & Co. KG as a Director Sales & Marketing responsible for the Strategic Development, Acquisition of new projects and all Marketing Activities in the Pharmaceutical Industry, Medical Device Industry, Diagnostic and Beauty Care Industry.

 

Company Profile

 

Balda Medical is the specialist within the Balda group for the development, production and assembly of devices for the Medical Device Industry, primary packing for the Pharmaceutical Industry, disposables for the Diagnostic and packing for the Beauty Care Industry. Balda Medical was founded in 2002 as part of a diversification strategy of the Balda AG.

Core Competences of Balda Medical are the development of new Devices, the industrial engineering of complete automated production processes, the production of precision tools, the production of single plastic parts by injection moulding including clean room production, the surface decoration of single parts or Devices, the manual or automatic assembly of complete complex Devices and the qualification and validation of the complete development and production process.

 

Balda Medical has been certified according to DIN EN ISO 13485:2001 and manufactures in clean rooms according to ISO class 8 and EU-GMP class C.

 

Balda Medical offers the complete expertise from the development to the validation of Devices, e.g. for lancing devices for diabetes care, inhalers for respiratory diseases or packaging for the healthcare industry.

 

 

 

 

 

 

Abstract

 

Since several years the market for dry powder inhalers is growing constantly.

 

Worldwide there are about 600 million patients who have Asthma bronchiale or COPD (chronic obstructive pulmonary disease). In the past patients mainly used MDI ‘s (meter dose inhalers) to control the disease.

 

Since several years dry powder inhalers are more and more used because they are easy to use and studies have shown that the absorption of fine particles by the lungs is better than by using MDI ‘s with aerosols.

 

Since 2004 Balda Medical GmbH & Co. KG produces the AeroflyerTM dry powder inhaler which is sold by several generic companies.The industrialisation of the inhaler was a quite challenging process.

 

After the clinical trails Balda Medical had to review the whole concept of the device production including design to manufacture, tolerance analysis and the selection of medical grade polymers for the production of the parts.

 

Several parts were analysed and optimised by mould flow studies and intensive tests before they were approved for production.  

The single parts are produced in multi cavity tools in a clean room in Bad Oeynhausen. The assembly of the inhaler is done manually by a partner. Before the device is delivered to the filling company the dose conformity and the trigger value is tests according to the specifications by a trigger threshold measurement device (DUSA). Several tests have shown, that the AeroflyerTM inhaler can compete with common inhalers and is quite accepted by the patients