Agidens designs and builds formulation suspension facility for Akorn Pharmaceuticals
Akorn Pharmaceuticals specializes in the development and manufacturing of branded and generic products in alternate dosage forms: injectables, oral liquids, optics, topicals, inhalants, and nasal sprays. Their portfolio of new products offering high potential for the pharmaceutical market required investment in new production technologies. Akorn relied on Agidens’ expertise to design and build their new formulation facility in Hettlingen (Switzerland).
Akorn Pharmaceuticals opted for Agidens because of our strong references in the field of sterile liquid applications (Pfizer, Johnson & Johnson, Merck). Our ability to manage a project from A to Z (mechanical, E&I, and software engineering, including project control) and our agile project implementation were additional reasons to partner with Agidens.
Our solution
Akorn had the process know-how but needed the capabilities of Agidens to translate the complex process requirements into a formulation installation. A strong collaboration between Agidens and Akorn was therefore established in order to achieve all the requirements for manufacturing the various products Akorn needed to produce on the new installation. Agidens proposed a turnkey formulation unit that could be cleaned and sterilized in place. The formulation unit consists of:
Cleaning in Place (CIP) skid
3 heating/cooling skids
3 formulation vessels (40 L, 200 L, & 300 L)
2 product filter skids
Once the engineering phase was completed, the installation was built by our subcontractor (MTS Prozesstechnik AG) and installed on site in Hettlingen under the supervision of Agidens. After the installation, we took care of the commissioning and the qualification process until the handover to Akorn.
Because Agidens was the main supplier for this formulation installation project, we were also responsible for the overall 3D model of the new facility and integration of other process equipment. Agidens coordinated and detailed the implementation of electrical cabinets and other main components, such as the HVAC unit for the cleanroom.
Thanks to Agidens’ in-depth knowledge of pharmaceutical processes, we still support and advise Akorn Pharmaceuticals in their manufacturing processes.
Challenges
- Limited space
Thanks to our technical capability and ‘outside-the-box’ thinking, Agidens managed to design and build the installation within a limited space, while respecting the customer’s requirements.
- Integration of a pharmaceutical wet grinding mill and aseptic isolator
Our in-depth experience as an integrator of both mechanical systems and software helped us to integrate an aseptic isolator and pharmaceutical mill with the formulation unit provided by Agidens.
- Building an automated recipe management structure to facilitate and guide the formulation process
Agidens put in place a recipe management and execution system that allows for future flexibility and optimization. This was done by integrating Siemens WinCC User Archives in combination with generic PLC codes (S88 – Unit Procedures).
Results
Nico Bielawski, Senior Process Engineer at Agidens Life Sciences: “By implementing a recipe management and execution system, Akorn Pharmaceuticals now has better control over their production processes, as well as complete flexibility. In addition, Agidens has optimized the product flow and operator handling by integrating an aseptic isolator and a pharmaceutical mill into the same formulation facility. Finally, our SAT and IQ/OQ package helped to optimize the equipment qualification lead time.”
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