About the awards
The CPhI Pharma Awards recognise the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward. The CPhI Pharma Awards celebrate the thinkers and creators driving the industry forward through their innovations, technologies and strategies.
Short Project Description
The modular facility was designed and manufactured by KeyPlants in Sweden, shipped to Kiel (Germany) for Tech Transfer, production trials and process validation and finally shipped to Indonesia for validation batches, commercial production and launch.
Having the new facility initially assembled, commissioned and qualified in Kiel, with the availability of technical experts and process specialists on hand was critical for the success of the Tech-Transfer.
The newly formed production team from Indonesia travelled to Kiel for training, to take over and qualify the new modular units. This reduced the risk of knowledge transfer and simplified the Tech Transfer activities.
With KeyPlants’ off-site modular approach, the facility design and manufacturing could be conducted in parallel with search and preparations at the final site. This further reduced the timeline.
This is a unique solution for rapid deployment of modular, movable facilities.
The novelty is the combination of two innovations:
- Movability: A complete manufacturing facility can be built in one location, further equipped, tested and qualified in another location and then moved again to a final site to begin production.
- Off- site construction: A complete building with clean rooms, process equipment, and utilities.
This solution introduces an innovative Tech Transfer approach by performing the tech transfer activities at the sending unit, in this case Kiel, Germany, to its final destination in Indonesia. In so doing, we were able to derive benefit from the full expertise and knowledge of the people at the current manufacturing site.
– No loss of information, knowledge or experience because the tech-transfer occurs at the sending unit location
– Faster time to market
– Cost and schedule predictability
– Fewer site disturbances and increased safety
– Less impact on daily business and site regulatory requirements (e.g. update of Site Master Plan)
– Flexibility of the facility – expandable and movable
When establishing facilities in new markets, there are challenges to ensuring identical duplication of manufacturing processes, equipment and ways of working, using conventional methods. Distance, local regulations and cultural aspects can be a challenge. Challenges with Tech Transfer often includes loss of information when transferring from distant sending unit to receiving unit.
Establishing new pharmaceutical manufacturing facilities is very time consuming using conventional construction methods.
In summary, the following issues are being addressed with modular, movable facilities:
- Ensuring the quality of a new facility right from the start
- Reducing time to market (to establish local production and launch of an approved product on a new market)
- Efficient Qualification
- Accurate and more comprehensive transfer of knowledge
Competitive advantages compared to conventional methods:
- No need to wait for the final location to start construction
- Rapid deployment of manufacturing facilities
- Overcoming Tech Transfer challenges
- Predictable and competitive cost