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OPTIMISATION OF NEP PROJECT RELIABILITY


The Project

  • Place all of the In-Position Cleaning (NEP process under control: Ensure that automation checks are complete to ensure that all defects affecting cleaning quality are signalled to operators.
  • Optimise installation reliability to minimise the number nonconforming cycles: Check that all sensors and actuators are of adequate size with respect to the process requirements.
  • Implement a QP validation strategy under unfavourable conditions.

The project was addressed in two phases.
In the first phase, modifications were applied to a complete formulation-filling line at the time of production startup.
The second phase, which has not yet been started, will consist of repeating these modifications on an identical formulation-filling line.


Scope of work assigned to Assystem
The first phase of the project was performed by Assystem which deployed, for each cleaning system, the following approach:

  • Identification of critical parameters: Identification of the parameters (and the measurement ranges for these parameters) required to ensure cleaning effectiveness. These parameters were determined on the basis of previous studies and data provided by the supplier.
  • Optimisation of installation reliability: Depending on the specific case, either the automation program was changed or the actuators were replaced. These modifications were then certified in terms of QI/QO.
  • Optimisation of process reliability: All automation programs controlling the NEP cycles were studied and improved, to ensure continual verification of critical parameters and alarms. The study carried out also allowed, wherever possible, the optimisation of NEP cycle time. These modifications were then certified in terms of QI/QO.
  • Implementation of the QP strategy and performance of QP certification: On the basis of the critical parameter study, values for unfavourable cases were established, then the means to achieve these values were determined. QP certification was then performed in collaboration with the customer’s validation team.


Results
 The first phase was successfully completed. Thanks to the methodology proposed by Assystem, it was possible to perform the modifications without affecting production startup.
For production, installation faults are now detected earlier, which allows a reduction in the number of investigations to be carried out.
For validation, the improvements helped the customer to serenely tackle audits.




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