Introduction
Denca Controls is well experienced in the unique requirements of the
healthcare sector having worked with several healthcare companies to
provide integrated automated control systems.
Denca uses sophisticated software engineering to provide traceable
electronic documentation in accordance with CFR21 Part 2, as required
for FDA approval. This is particularly relevant to the process
automation needs of the healthcare sector, as the following case study
demonstrates:
Problem
Colgate Palmolive used a manual batch process for adding minor
ingredients to its various healthcare products and needed to improve
traceability on the process in order to achieve FDA approval.
Solution
To ensure full traceability for FDA approval, the batch process had to
be automated and system logged to provide traceable electronic
documentation. Hence Denca's automated tracking system for minor
ingredient additions included the following elements:
- Design of a wireless tag reading system which ensured that each batch was uniquely identified and checked for the right mix of the right minor ingredients, and then tracked to ensure that it was added at the correct point.
- Embedding each batch container with a wireless chip which uniquely identified the batch and its ingredients. The recipe system only accepts this batch at the mixing point and then confirms addition of the correct minor ingredients, logs the details to system, and clears the container's embedded chip ready for re-use.
- Coding the control program for the programmable logic controller (PLC), the SCADA PCs, weigh scales and tag reading system, plus developing an event tracking interface with the plant recipe system.
- Commissioning the full automated tracking system.
Benefits
The automated batch process system with traceable electronic
documentation delivered the following main benefits to Colgate Palmolive:
- technically complex batch process control problem translated into a reliable, simply operated solution
- full traceability in accordance with CFR21 Part 2 was ensured through wireless data tag technology, which allowed Colgate Palmolive to gain FDA approval for the whole production facility
- eliminated batch process errors and hence reduced wastage.
Technical
The automation of the batch process control system was put out to tender
to several companies and Denca was subsequently awarded the contract to:
- provide a detailed electrical & instrumentation design package
- software engineering - configure automation software for PLC, SCADA PCs, weigh scales and tag readers
- develop and code an event tracking interface for the plant's recipe system
- commission the full system.
The batch process control system consisted of the following main elements:
- 8 x DataScan wireless tag reading systems
- 3 x Mettler Toledo Profibus weigh scales
- 2 x InTouch SCADA PCs
- Allen Bradley SLC 500 PLC
- Event tracking interface with client's SQL database recipe system
The above installation provided Colgate Palmolive with an automated batch process control system which was simple to operate, provided full traceability, gained FDA approval, eliminated batch process errors and reduced wastage.
For further details, please contact Alan Brennan on 0151 257 9010
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