When a major food ingredient & pharmaceutical excipient producer in Holland wanted to expand lactose production facilities to include over 20 discrete products, they chose Atritor Ltd, Coventry, England as their key supplier for air classifier milling systems. Although 2 standards  of  quality

were required, 1 for food and the other for pharma grade, it was decided that both plants should be built to the same high pharma GMP standards with only one system having to be fully validated for FDA and MCA audit.

Normally, this large Dutch food group would have had a wide range of suppliers to choose from for food grade milling equipment but for this application, with validation   audits  expected  from

both the FDA and at least one of the 'Big 5' pharmaceutical producers, a supplier able to demonstrate both significant food and pharmaceutical experience, including system validation, was an absolute requirement. Atritor Ltd with good foundations in both industries was therefore a strong contender.

Because of the wide range of tablet types and associated active pharmaceutical ingredients - API's - which are combined with excipients, such as lactose, the particle size distributions of such excipients are crucial to the behaviour of the drug, from ingestion to absorption. So, with these criteria in mind, it was important that the customer select a powder processing specialist with the following qualities outlined below.

• Able to supply classifier milling equipment with the latest in classifier design to produce powders with a wide range of particle size distributions



• A trusted track record of supplying powder processing equipment to the pharmaceutical industry and particularly the end user's principal customers



• An understanding of the requirements of GMP process equipment design for the food and pharmaceutical industry



• Associated experience of pharmaceutical process equipment validation to satisfy MCA and FDA expectations



• In-house knowledge of process control automation to supply the latest in PLC and MMI systems to communicate with the customer's DMS system



• Well established experience in international projects combined with a willingness to source from and work with local suppliers preferred by the customer



• A comprehensive test facility where materials could be tested on equipment of the same design - if a smaller scale - as that to be supplied



• A stable, well financed company able to offer secure process guarantees that the equipment and associated systems were correctly sized and specified



• Able to meet the rigorous particle size distribution specifications and associated plant capacities nominated by the customer



• Design capabilities to make the milling units particularly suitable for regular cleaning - with an open body design and CIP facilities