12 ways to reduce time to market with advanced process simulation

A simulator can be used to qualify the controls of a process before the actual manufacturing start-up of a new drug.

The simulator is used to support complex control qualification and assists with change control by predicting process behavioral changes. It also can facilitate:

• Scale-up or reduce “technology transfer” time from laboratory
• Scale manufacturing to large scale production
• Enable the use of modeling to improve the predictability of bioprocesses.

An often overlooked value of using simulators is to get operators and all technical staff fully trained on the new system before starting the new process.

12 ways advanced process simulation can reduce time to market:

1. Develop a process model to improve predictability
2. Test design strategies
3. Create and test recipes and logic sequences
4. Test emergency sequences which may be dangerous to personnel or equipment
5. Pre-tune control loops
6. Evaluate controls stability
7. Validate permissive logic
8. Qualify graphics displays
9. Test control loops to assist with commissioning
10. Implement qualified controls at the real manufacturing facility
11. Test and validate changes during the post-start-up phase
12. Simultaneously improve operator and technical staff training and effectiveness

Flawless first time start-up?

Simulated control modifications required for start-up and proper operation can be pre-validated before being implemented at the manufacturing site. Customers who have taken advantage of this type of testing and pre-startup training have experienced nearly flawless first-time start-ups. And the elimination of extra validation (design changes and rework) during the start of manufacturing is by itself a common justification for the simulator purchase.

Contact the expert

Tania Simoncelli

Managing Consultant 

Tania Simoncelli has over 17+ years experience in the Pharmaceutical industry.  Currently she holds the position of managing consultant for Schneider-Electric in the Life Sciences, Global Compliance Consulting group .  Her areas of expertise include Project Management, Quality Assurance, Quality Compliance, Equipment/System Validation, Computer Validation and GLP regulations. She is an officer of the PDA Canadian chapter and her aim is to continuously  promote the understanding of compliance regulations and how to apply them in a cost-effective and efficient manner.

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