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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Optima Packaging explains its approach to process design.
Digitalization and Industry 4.0 tools are being employed to improve pharmaceutical equipment and systems. An example of this is Optima Packaging’s Comprehensive Scientific Process Engineering (CSPE) approach to project planning for its fill/finish systems, which uses simulation for mock-up, engineering design, and design review to speed the design process. Three-dimensional models can be experienced using virtual reality to collect input from users early in the design process. The company opened a new facility, the CSPE Center, at its Schwaebisch Hall, Germany site in July 2019 that gives the company space to build, test, and commission multi-story, turnkey, fill/finish facilities. Pharmaceutical Technology spoke withJan Deininger, editor at OPTIMA Packaging Group, about the company’s approach to equipment and process design.
PharmTech: What are some of the parameters you might consider in the design phase?
Deininger (Optima): During the design phase, strength calculations, flow simulations, and determination of the resonance values of individual components support the developers. First, air flow and simulations of vaporized hydrogen peroxide flow support a flow-optimized machine design. In addition, designers use simulation to optimize the line layout, considering factors such as accessibility. Simulation can also be used for preliminary tests, such as setting the stopper.
The CSPE approach minimizes the risks associated with large plant construction projects by conducting a thorough analysis even prior to the design stage. If potential risks based on reliable data gained from comparable earlier projects are identified, they can be proactively countered.
PharmTech: What are some best practices you use for factory acceptance testing (FAT) and site acceptance testing (SAT)?
Deininger (Optima): The CSPE Center is designed so that the entire system-consisting of isolator and filling and closing machine-is brought together in Schwaebisch Hall and can be fully tested and approved on the supplier site under conditions that are as realistic as possible. In the past, in projects without integrated FAT (iFAT), the separately pre-tested plant parts were not combined until they reach the customer’s site. With iFAT, the system components are optimally coordinated as an overall system, which allows reliable performance of qualification work that is similar to the later SAT of the overall system at its destination. The only deviations that might arise later result from special features of the cleanroom environment on the customer’s premises. The systematic exploitation of digital engineering in combination with iFAT significantly reduces the overall project duration.
The entire system is tested before it goes to the customer. This means we carry out smoke studies, leak tests, SCADA [supervisory control and data acquisition] tests, and alarm tests. Also included are interface tests and filling tests under production conditions, sometimes with original or placebo product of the customer. Line safety tests and cycle development also take place. In general, everything can be tested that is later required in installation qualification, operational qualification, and even in performance qualification. By doing this, risks of unexpected delays at the customer site can be reduced to a minimum, and the time to market is reduced as well.