Innovative Development of a Roller Press to Comply with Workplace Limit Values Specified by OEB 3 and 4

Description:

IUTA provided analytical support for the further development of a roller press for tableting in the OEB 3-4 classification. Since substance leakage is accepted to a certain extent due to the moderate risk classification, this baseline contamination of the workplace poses challenges for equipment qualification. Often, the spatial conditions required to perform equipment qualifications in cleanrooms or contamination-free environments are lacking.

IUTA has developed mobile test chambers to create a low-contamination environment for equipment qualification, provided the sites have a background level of the active ingredient to be analyzed. These are shown in the figure in a lightweight (left) and compact (right) form.

Furthermore, sucrose was identified as an alternative surrogate substance to lactose. Despite their very similar chemical and physical properties, analytical differentiation is guaranteed, and sucrose can be used with good sensitivity in an environment with high lactose levels for equipment qualification.