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Successful process handling with CSPE

Sterile filling and freeze-drying processes for pharmaceutical applications often require a combination of filling line, isolator, and freeze dryer. This combines different process steps and technology, which not only have to be coordinated, but also controlled, tested, and qualified together.

Security through integration

The "Comprehensive Scientific Process Engineering" (CSPE) is  a clearly defined, holistic process that provides complete system integration. The process starts as early as the design phase with a complete view of fill-and-finish systems, isolators, and freeze dryers. With the help of optimized engineering, the process ranges from digital planning and simulations to cycle development and functional testing with integrated Factory Acceptance Testing (iFAT) and validation.

What sets CSPE apart from classic project management is that rather than testing fill-finish equipment separately from isolators and freeze-dryers, it is all designed and tested as one complete system. The software and automation concepts, for example, are uniformly designed for the entire line. The decontamination cycle is not only planned but developed and validated in-house. And instead of adapting to changes at the customer's expense, the system is tested in advance under real operating conditions.

The approach has proven itself. Plants that have utilized CSPE show more consistent behavior during commissioning and reduced risk of rework, downtime, or delays during the qualification phase.