Turnkey delivery and validation of a process installation for Pfizer
After a thorough investigation Pfizer selected Agidens to design and build a completely new sterile formulation process at their plant in Puurs. Agidens took the challenge as an EPC contractor and delivered in close cooperation with Pfizer a turnkey solution. From start (conceptual design) to finish (validation of entire the installation), Agidens’ approach was driven to provide the client with a single point of contact.
INTEGRATED APPROACH BY DEDICATED AGIDENS-PFIZER TEAM
Blue-chip pharmaceutical companies such as Pfizer expect their suppliers to work according the highest standards possible. They want a team that can think along, adds know how to the process and guarantees a high quality GMP compliant installation. Therefore, both parties set up a joint project team in which Pfizer engineers added specific product & process know how to the existent process & automation expertise of the Agidens engineers.
This innovative approach with an integrated on-site engineering team resulted in a top-level project performance and allowed one dedicated Agidens-Pfizer team to take up all necessary services involved.
- Joint Project Team (with a single point of contact for the client)
- Conceptual design of the process and the installation
- Basic & detailed engineering (including 3D visualisation)
- Delivery and installation of the entire process chain (tanks, piping, skids, pumps, valves,…)
- Automation (including Software, Electrical & Instrumentation, SCADA, etc.)
- Commissioning
- Validation of all equipment installed
CHALLENGES
Agidens has a long experience in building, automating and maintaining sterile production facilities for pharmaceutical companies. Nevertheless, fully automated projects such as these generate specific challenges. In these cases, it is the flexibility and determination of our teams that make the difference. Several high-level challenges needed to be resolved during the project.
In close collaboration with the client, we took the challenge to draw up the process flow and process chain. A fruitful co-operation and open communication between the engineering departments of both teams allowed us to proceed continuously.
Certification, documentation and traceability of all components in the installation makes project administration a key challenge. The application of internal Agidens standards combined with the standards from the client provided the team with fully approved document files very quickly.
The limited space in which the installation had to be built, required us to prefabricate skids off-site. For the installation of these skids by crane, parts of the roof of the building were removed and reinstalled afterwards.
The limited space in which the installation had to be built, required us to prefabricate skids off-site. For the installation of these skids by crane, parts of the roof of the building were removed and reinstalled afterwards.
DELIVERABLES
Procurement and Construction was an integral part of the project scope. We constructed several skids and connected them on site, to deliver a completely functional installation.
- Solution, suspension and holding tanks, several of which are mobile
- In-line blending system including an in-line mixing device
- Isolator to add products manually
- All software necessary for automation and integration of the process
- CIP/SIP system for various parts of the installation
- SCADA visualisation systems according the Pfizer standards
- Filtering systems in various parts of the process installation
KEY BENEFITS FOR PFIZER
- Engineering, construction and validation by one team facilitates collaboration. The validation team thinks along during construction, thus saving time in the validation phase.
- A single point of contact for the client makes communication easy and fast.
- No liability conflicts between different contractors during the construction process.
- Agidens’ involvement in engineering allows early phase procurement of long term delivery items.
- Joint engineering between Agidens and Pfizer guarantees the pharmaceutical company to keep ownership of the process.
- Agidens is capable of delivering high quality GMP compliant mixing and blending systems.