Optimized formulation solution
Our customer, a blue-chip pharmaceutical company with plants all over the world, aimed to increase the production of one of their pharmaceutical ingredients at their plant in Belgium. Therefore, the company needed a new and optimized production installation. Agidens took on the challenge and delivered an A to Z solution.
FROM STUDY & DESIGN TO CONSTRUCTION & VERIFICATION
Being an innovative leader in the pharmaceutical market, our customer constantly strives to improve its processes. Therefore they asked Agidens to build an improved and highly automated version of an existing formulation installation. Next to that, the project included the addition of a filling line and a Cleaning in Place (CIP) installation.
We worked together with our customer on a study that analyzed how to improve the existing process. This analysis resulted in a project plan in which Agidens took a wide range of responsibilities.
- Process design and 3D modelling
- Software engineering
- Mechanical engineering
- E&I engineering
- System integration
- Testing (FAT/SAT) & Commissioning
- Verification (IQ/OQ/PQ)
CHALLENGES & SOLUTIONS
Limited space and time
Seeing that the available space for the new installation was limited, Agidens adapted the design of the formulation process, the weighing unit and the filling line.
As in all large-scale projects, timing and flexibility are crucial. A standardized and detailed project approach allowed Agidens to deliver this project on time and within budget.
Some process steps were optimized, and additional instrumentation was added to get a better control over the process and have a better understanding of the process parameters.
- The process concept about the product filters and its SIP, filter testing and use during production was improved compared to the original way of working.
- Additional tools to better control and monitor the addition of ingredients.
- Modifications to, and improvement of bulk sterilization procedure using vacuum, before starting the sterilization.
- Improvement of cooling/heating capacities and controls to have more flexibility in controlling the process conditions for an optimal separation between the different liquid phases.
GMP & STERILITY
Agidens has extensive knowhow of GMP regulations. Our in-house Validation and Compliance team assisted us during design and construction. This way we avoided compliancy issues during commissioning and guaranteed a ‘first time right’ design.
- Construction and workspace organisation
- Re-arrangement of equipment so that a comfortable workspace for the operators is created. All not relevant equipment for operator handling is installed in the technical area. Only the equipment to be manipulated by the operator is installed in the grade C environment
- Skid based concept: pre-assembly in workshop to reduce ‘on site’ construction time and reduce overall construction and installation period.
- Use of disposable bags to collect the finished product.
- Use of steam through connectors as interface between the permanent stainless-steel production equipment and the disposable pre-sterilized product collecting bags.