Commissioning and qualification (C&Q) are terms and processes synonymous with the Good Manufacturing Practices (GMP) of biotechnology and pharmaceutical therapies, but the challenges associated with time consuming and costly traditional C&Q process are not to be understated. Virtual commissioning provides Life Sciences companies with the agility and ability to react quickly without compromising quality - 2 of the keys to success in the changing dynamics and challenges of the pharmaceutical manufacturing landscape.
Integration and qualification tests done manually, late in the engineering process and on site, using the actual physical plant or line that needs to be controlled, delays the start of production. With a virtual twin of the manufacturing line, the commissioning, integration and qualification processes can be simulated prior to construction of the pharma manufacturing line, bringing the plant online sooner and getting medicines to patients faster.
The challenges associated with GMP commissioning and qualification are many but the most notable of them is completing this mandatory activity as effectively and quickly as possible. Life Sciences companies strive to quickly deliver flexible, GMP compliant lines with the required level of performance, to fully trained operators - without stopping production. But, relying on manufacturing equipment, often from third parties, with little visibility and discovering problems late in the process all hinder their ability to quickly introduce new equipment lines and deliver more personalized batches of new therapies, more often.
With Dassault Systèmes Line Virtual Commissioning experience, you can simulate and create a virtual twin of your entire system, which can be tested and validated even before being implemented in the real physical plant, thus, saving you time and money. With Line Virtual Commissioning you can:
- Get an overview of the system as soon as possible: allowing the ability to modify the process and the physical plant in the virtual world before implementation
- Create and manage dedicated component libraries for pharmaceutical processes
- Test and validate the control system of production lines and equipment in automatic and manual mode, including virtual plant behavior simulations
- Support high level test process, including generation of GMP compliance documentation for the development of the simulation model
- Iterate quickly to find the best alternative & reuse the simulation model as Operator Training Systems for simulation of stress situations
40% Reduction of commissioning time
15% Reduction of total time-to-market
80% Deviation reduction - Re-engineering
40% Risk reduction of test batch loss
25% FTE reduction