Brand-new cGxP formulation unit for Akorn Pharmaceuticals
Akorn Pharmaceuticals, a pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals, wanted to scale up their TheraTears formulation production. They confided in Agidens, and we did not disappoint. Our multidisciplinary teams came together and provided a turnkey solution existing of two 2000 L vessels and one 400 L solution vessel, both integrated and automated in the new process. To top it off, Akorn adopted the Agidens Safety Plan as the new Master Safety Plan.
As Akorn’s existing filling device for TheraTears – eyedrops to restore, cleanse and nourish the eyes – was unable to get a higher output, they asked Agidens to deliver a solution to expand the Thera Tears formulation production to 4000 litres. We integrated a completely new cGxP compliant formulation unit, with in-line SIP station, that fully fitted the requirements, established a new SCADA standard at the Hettlingen site, and reinforced the CIP capacity with an additional parallel installation – all this with an eye on IoT implementation.
A complex but rewarding project that fits our turnkey portfolio.
Scope of the project
- Advice and consultancy
- Process design and engineering
- Software engineering
- Mechanical engineering
- E&I engineering
- Safety engineering
- Automation and system integration
- Testing and commissioning
- DQ, IQ, and OQ
Challenges & solutions
- Maximum flexibility in preparation and production of new medicines
Agidens set up a recipe management and recipe execution that allows future flexibility and optimization. This was done by integration of Siemens WinCC User Archives in combination with generic PLC codes (S88 – Unit Procedures).
- Generating correct batch reports during parallel execution of multiple batches.
Integration of unique batch IDs into each message, alarm or event in order to use it as a report filter.
- The mixing times were very long, which could have an impact on the two-day schedule for the batches: one day formulation and one day filling of the process.
We did a combination of certain types of mixers to reduce the mixing time and to realize the ideal workflow of two days.
- Lack of space and lots of activities at the same time.
The limited space in which the installation had to be built, required us to prefabricate the skids off-site. We teamed up with local subcontractors to bring all the materials in by crane trough a small window.
- Standardization for future projects
We aligned multiple on-site standards and US tender standard for all disciplines, resulting in an overall aligned concept, design and technical approach for current and future projects.
- On-site Safety Plan
The Agidens Safety Plan is now adopted as the Master Safety Plan at Akorn’s Hettlingen site.
- Pre SAT/SAT and IOQ
By combining our start-up knowledge, standard test approach and IOQ experience, we managed to fit the total approach within the Akorn IOQ approach.
- More efficient mixing
Due to our excellent relation with our mixing supplier, we managed to pull out the complex top mixers and replaced them by magnetic bottom mixers. By combining high shear and standard mixing, the production time was reduced by hours.