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Pharmaceuticals
“Using Wonderware,
Roche seamlessly
integrated the solution
into the corporate
network & still satisfied
the stringent
requirements
of the FDA.”
IndustrialSQL Server, InTouch
Roche Diagnostics Optimizes
Operations and Satisfies FDA
Regulations with Wonderware
Production and Performance
Management Solution
Uwe Drücker, Managing
Director, Drücker
Steuerungssysteme GmbH
by Wonderware GmbH
Company Overview
Roche Diagnostics GmbH - Mannheim, Germany
Roche Diagnostics is ranking no. 1 in the worldwide
market of diagnostica.
At the plant in Mannheim approx 6,500 employees
research, develop and produce diagnostica for the
business areas “Diabetes Care” and “Centralized
Diagnostics.”
As one of the world’s leading medical
diagnostics manufacturers and a global
leader in the healthcare industry, Roche
Diagnostics GmbH continually improves
its manufacturing processes and sustains
an exceptional commitment to high
product quality and safety.
Roche is an innovator in the healthcare
field, which continually increases its
manufacturing capabilities to provide
the industry with pioneering products
for the prevention, diagnosis, evaluation
and monitoring of diseases. To accommodate a recent increase in demand
for its diabetes care and diagnostic
products, the company established a
new rack-packing line at its facility in
Mannheim, Germany. The Mannheim
plant serves as the worldwide headquarters for Roche’s research, development and manufacturing operations.
Although based in Germany, Roche
diagnostics has many customers in the United States. Therefore, complying
with U.S. Food and Drug Administration (FDA) regulations is standard operating procedure for Roche. To meet the FDA’s exacting standards - as well
as to achieve even greater operational efficiency and enhance its process
monitoring and auditing capabilities - Roche Diagnostics implemented a
Production and Performance Management Software Solution from
Wonderware, a business unit of Invensys Systems, Inc.
Ensuring that its processes could be validated according to FDA 21 CFR Part
11 regulations was a critical factor in the implementation of Roche
Diagnostics’ Wonderware solution and furthermore an important factor in
the design and operational phases of the project implementation.
“Selecting components for this new solution was a complicated task that
required consideration of several requirements,” said Uwe Drücker,
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Overview screen
Managing Director of Drücker Steuerungssysteme
GmbH. “Most importantly, our engineers needed to
evaluate and select a solution that was not only easy to
use, but was able to support the FDA’s compliance for
a high level of data integrity. With both of these capabilities well in hand, maintaining the safety and quality
of our manufacturing line was much simpler.”
As part of the Wonderware Production and
Performance Management Software Solution, InTouch
human-machine interface (HMI) software now gives
Roche comprehensive, real-time visualization capabilities
for monitoring and control of the plant floor. In addition, the high-performance IndustrialSQL Server historian combines the power and flexibility of a relational
database with the speed and compression of a realtime system. Both software products empower Roche
to meet its business and operational objectives while
meeting the FDA’s exacting regulatory requirements.
On the new rack-packing line, vials of diagnostics are
individually selected from pallets, sorted and joined
together to make a rack pack. The packs are then
transported to a rotary table for further processing.
Labels are applied and a camera verifies that the matrix
bar code is correct and properly positioned. After an
additional camera checks the vials and caps for the
correct color, the pack goes into the final packing
stages.
From start to finish, the manufacturing process is initiated,
controlled and monitored by company operators using
Wonderware software.
The InTouch software’s easy-to-use interface maximizes operator efficiency on the plant floor by guiding
operators step-by-step through the process. They no
longer have to select from a multitude of screen
options. FDA guidelines require manufacturers to
maintain complete traceability of product data.
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IndustrialSQL Server, InTouch
To comply with these requirements, Roche Diagnostics
has to substantiate every step of its processes, indicating
which operator completed a task and when the activity took place. Leveraging the InTouch HMI’s user management features as well as those provided by the
Microsoft Windows 2000 operating system, Roche
could design strong security into the Mannheim plant
without exposing the operating system to the user.
“One of the benefits of using this approach is that user
management isn’t performed just on a standalone
system, but rather as part of the enterprise-wide security system,” said Uwe Drücker. “Using this method of
operation, the company can easily incorporate and
re-use the plant’s existing operating system user models.
In addition, the InTouch software’s easy-to-use controls
and consistent interfaces enable the Mannheim
operators to keep the rack-packing line running at
optimum efficiency.
“Not only does this simple integration save us valuable
time, but we are able to see a positive return on our
investment. We experience end-to-end security using a
single user management system rather than employing
Product Data Management with Audit Trail
several costly proprietary solutions.”
Operators of the new rack-pack line log on via InTouch
screens that authenticate and authorize them to perform certain actions depending on their access level.
Activities on the process line can include day-to-day
operations such as creating or editing product and
process data; initiating, pausing or stopping a batch; or
editing user profiles. Operators working directly on the
line must confirm their actions by entering their user
name and password. This secure login technique not
only helps the company meet FDA traceability requirements but makes the manufacturing and processing
lines tamper-resistant.
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The Wonderware software enables time-stamped
electronic signatures that link each operator to a specific
action. The signature and any other relevant data are
then logged in the Wonderware IndustrialSQL Server
historian database to generate a comprehensive audit
trail. These audit trails can easily be viewed and printed by authorized supervisors or managers at any time.
Further preserving data integrity, the information and
electronic signatures cannot be altered or deleted resulting in an FDA-approved, tamper-resistant repository.
In addition, the Mannheim plant operates a redundant
system for high availability and data integrity. Physically
separated from the master system, this standby system
continually synchronizes its data with the master
IndustrialSQL Server, InTouch
system. In the event of a master system failure, this
handshake synchronization method detects when the
primary process is down and automatically switches
into the master mode, creating a failsafe capability. This
seamless integration of the corporate network also
makes all data available for enterprise-wide analysis.
“Using Wonderware’s standard components, our
company was able to seamlessly integrate the solution
into the corporate network and still satisfy the stringent
requirements of the FDA,” said Uwe Drücker. “Not only
did our plant achieve validation, but we were able to
extend the Wonderware solution to quickly implement
and validate a second vial-packing line based on the
rack-pack design.”
Aside from the pressures of satisfying FDA requirements,
the growing threat of bioterrorism and product
tampering is always a critical concern for pharmaceutical companies like Roche Diagnostics. Therefore, the
security features provided by the Wonderware
Production and Performance Management Solution
give Roche a high level of assurance that it can track
and maintain quality throughout each step of its
manufacturing and packaging process.
The Mannheim plant’s achievements and Roche
Diagnostics’ commitment to monitor its entire process
from start to finish using Wonderware’s innovative
software solution only reinforce Roche Diagnostics’
position as a world-class manufacturer of products for
diabetes care and centralized diagnostics.
Batches Management
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