Extended use of the Mastersizer 2000 at Hexal Pharmaceuticals
Malvern Mastersizer particle size analyzers have been used at the Holzkirchen (Germany)
headquarters of pharmaceutical company Hexal AG for many years. Now their use has been
extended with installations at other facilities within the Hexal group. The systems are
being employed in a variety of different applications, but a key factor in selecting the
Mastersizer 2000 was Hexal's need for comparable results between different facilities,
as well as the requirement to be able to exchange methods easily. This of growing significance
as Hexal prepares for integration into the Sandoz division of Novartis, one of the leaders
within the worldwide market for pharmaceutical generics.
In the past year, Mastersizer 2000 systems have been installed at three Hexal sites: at
Salutas GmbH, one of the most modern pharmaceutical production sites in Europe, manufacturing
more than 5 million tablets and capsules every year; at HEXAL Syntech GmbH, near Dresden,
for use in controlling the synthesis of active substances; and at JENAHEXAL Pharma GmbH,
the site of Hexal's sterile production. At JENAHEXAL, more than 450 different sterile dosage
forms, including injectables, infusions and implants, are produced under GMP cleanroom
The Mastersizer 2000 is a laser diffraction-based particle size analyzer which measures
particle size over an extremely broad range from 0.02 to 2000 microns. Its software-driven
Standard Operating Procedures (SOPs) are designed to simplify method development, allow
global method transfer and ensure that minimal operator intervention is required during
measurements. A SOP-assistant supports the user during the set up of an optimum measurement
method, and SOPs can be transferred from instrument to instrument by email - an important
feature for global operations.
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