Organon installs Werum PAS-X for API production

A Werum Software and Systems product story

Edited by the Processingtalk editorial team Jan 19, 2007

Active Pharmaceutical Ingredient manufacturer Organon has installed Werum PAS-X MES software in their new state-of-the-art API-powder processing production facility in Oss, The Netherlands

Organon, the human healthcare business unit of Akzo Nobel and one of the largest manufacturers of Active Pharmaceutical Ingredients (APIs) worldwide, has finished the installation of the Werum Software and Systems PAS-X MES software in their new state-of-the-art API-powder processing production facility in Oss, The Netherlands.

Mixing and milling as well as a final-product warehouse were combined in this new factory.

Organon uses PAS-X for recipe management, weighing and dispensing, shop floor management, electronic batch recording, and warehouse management.

Throughout all the manufacturing processes PAS-X has replaced paper-based recipes and SOPs by electronic records.

Operators do not only get information about the production processes on screen, but they are also able to give feedback about process parameters by computer.

Mixing and milling are part of the final activities in the overall manufacturing process of Active Pharmaceutical Ingredients.

In this stage the final product is already present in a solid form, usually as a powder.

Depending on customer specifications this powder must be homogenised and milled or micronised to make it yet finer.

In the warehouse final products are received, stored, picked, weighed and either sent to external customers or to other Organon departments.

The primary goal pursued by the implementation of the PAS-X MES system was quality assurance through prevention of mistakes, registration and verification of critical activities and data, acquisition of deviations, and tracking and tracing of batches and equipment.

Moreover, the MES system contributes to an improved efficiency through barcode scanning instead of manual entries; through detailed location tracking so that specific batches can be found and picked more easily; and through more effective creation and maintenance procedures for Master Batch Records by authorised employees.

The installation includes manual or computerised interfaces with various systems, such as ERP, Substance Information System, Document Management System (EDMS), and LIMS.