News Release Werum Software & Systems AG, 9/12/2006
Production of Parenteral Drugs at Bayer HealthCare
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News Release
September 2006
Werum provides PAS-X MES for the Production of
Parenteral Drugs at Bayer HealthCare
Expanded deployment of PAS-X in Leverkusen, Germany
Lueneburg, Germany, September 12, 2006 – Bayer HealthCare is now
using Werum Software & Systems’ PAS-X software to run its parenteral
drug manufacturing at its Leverkusen, Germany site, further expanding
the domain of Werum’s MES product suite at Bayer. Since 1999, Bayer
has successfully relied on PAS-X to control the production of such
successful solid drug products as Ciprobay®, Avelox®, Levitra®, and
Adalat®.
Parenteral drugs are sterile preparations that reach the target tissues or
the bloodstream by way of injection, infusion, or implantation without
passing through the gastrointestinal tract. Parenteral drugs are subject to
particularly stringent quality requirements regarding their microbiological
and particulate purity.
At its production plant for parenteral drugs, Bayer HealthCare
manufactures pharmaceutical solutions and fills them in bottles, ampoules,
flexibags, or vials on various production lines. Depending on the
substance in question, additional production steps may follow the bottling
and sealing operations: sterilization, heat treatment, freeze drying, visual
inspections, or further packaging. All in all, Bayer HealthCare’s parenteral
drug products are shipped from the facility in approximately 30 different
types of packaging.
The PAS-X system is in charge of the recipe creation and manual
weighing steps of the principal base ingredients, using two weighing
cabins (Mettler-Toledo ID 30). Additional ingredients of the respective
solutions are weighed and added through the subordinate PCS 7
distributed control system (DCS) by Siemens (mainly by in-tank
dispensing). The solution manufacturing and filtration processes are
controlled by the MES and/or the DCS.
PAS-X offers paperless electronic workflows for executing the
manufacturing orders and safely guides the operators through the
individual processing phases. All manufacturing steps and reports are
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News Release Werum Software & Systems AG, 9/12/2006
Production of Parenteral Drugs at Bayer HealthCare
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documented in compliance with regulatory requirements. In conjunction
with a barcode system (using both stationary and mobile scanners),
PAS-X also facilitates the tracking of the material flow.
Moreover, the MES can calculate key performance indicators based on the
comprehensive information available in the PAS-X system, such as order
data (materials, batches, or production units), order-specific indicators
(yields, losses, actual and planned machine speeds, etc.) and the times for
configurable events or actions (utilization, malfunctions, downtime, etc.).
Werum Software & Systems is a leading supplier of Manufacturing Execution
Systems for the pharmaceutical and biopharmaceutical industry worldwide.
Twelve of the world's top 20 pharmaceutical companies use Werum's product
suite PAS X to run their manufacturing business. Outstanding PAS X features are
the functions ensuring compliance and boosting performance. The modular
system suite includes components for Production Planning and Scheduling,
Master Batch Record Management, Electronic Batch Recording, Weighing and
Dispensing, Material Flow Control and Tracking, Equipment Integration,
Warehouse Management, Quality Management, and Performance Management
based on KPI Analysis. Werum’s solutions and services range from software
consulting, creation of functional specifications, and software development to turnkey delivery of integrated and validated Manufacturing Execution Systems.
Founded in 1969, the IT company employs more than 250 people in its
headquarters in Lueneburg, Northern Germany, the regional offices in West and
Southwest Germany, and the subsidiary in Parsippany, New Jersey, USA.
Contact:
Volker Mensing
Werum Software & Systems AG
Tel. +49 (0) 4131 8900 - 689
Fax +49 (0) 4131 8900 - 20
mensing@werum.com
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