Active
implements a weighing system at Boehringer Ingelheim Mexico
Aug/2005
One more Active system, IWS - Integrated Weighing System –
has been implemented successfully at Boehringer Mexico.
Before the implementation, the company used a manual process, where
a weighing equipment known as ID5 was used. The labels and records
were filled out manually, which was consuming time and a batch of
paper. According to Rodrigo Correa, Project Manager: “They
needed validated and reliable systems that would fulfill the regulatory
standards”.
And they found these features in Active system, since it fulfill
the Mexican SSA standards (Health Agency) and the American standard
21 CFR Part11, FDA, and it controls the materials weighing of the
Solids and Liquid Plants. Now, Boehringer can work with electronic
records and signatures, the operations are signed electronically
in accordance with the process and with no need of hand-written
notes. The system also allows to extract a report with all the process
data if is necessary.
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With
this suite there is no risk for errors, for the system does not
allow, for example, that a batch in quarantine status may be weighed
and does not allow the use of materials that have not been approved.
After implementation, planning and construction have been completed,
Active provided the users with theoretical and practical training,
so they may know well the operation’s procedures. According
to Correa, there was a certain resistance, because the controls
were installed and then the users would have to follow rules.
This innovation brought in a cultural change, for now the company
has a system that controls all processes. In just 3 weeks, users
were already fully well-adjusted for the new process, which lasted
around 7 months to be implemented.
Boehringer Solids Plant exports drugs to the United States. Therefore
Active expands its system in the demanding North American market.
In less than one month the Americans will be ingesting drugs are
made through an Active system. The Know How caused Active to stand
out in the international market.
Integrated Weighing System
- Main Benefits
Boehringer Ingelheim has currently a modern system, thus, besides
complying with the regulatory standards, it increased security in
Boehringer’s drug manufacturing, it carried out labeling of
materials with bar code, recording the activities of scales’
checking, cleaning the weighing cabins, the system does not allow
to weigh raw material without cleaning the last weighting, avoiding
so the contamination between materials, electronic checking of batches,
not allowing for using incorrect batches.
Finally, the company streamlined its processes, since the users
do not need to write any more, as they signs electronically the
operation, the system updates the data in the right time, day of
execution, performed operation, who did it and finally, the person
who checked.
For Rodrigo Correa, Project Manager, with this implementation the
risk of errors is practically zero.
Active honors again its values with commitment, sincerity, integrity,
ethics, innovation, partnership and social responsibility. |