Modular movable filling facility

When Swiss pharmaceuticals manufacturer Ferring Pharmaceuticals wanted to increase its presence on the Indonesian market, it contacted KeyPlants in mid-2018 to design and build a modular facility for aseptic filling of pre-sterilised containers, and the project was completed and on site, including commissioning, qualification, and technology transfer, in December 2019. 

Establishing facilities in new markets using conventional methods often raises obstacles to ensuring the identical duplication of manufacturing processes, equipment, and ways of working. Risks include loss of information when transferring from a distant sending unit to a receiving unit. Establishing new pharmaceutical manufacturing facilities is also very time consuming using conventional construction methods.

In addition to addressing these issues, modular, movable facilities can add value by ensuring identical manufacturing processes, which can greatly reduce or avoid entirely the need for costly and time-delaying clinical studies, thereby streamlining the regulatory approval process. 

Taken together, these advantages make modular, off-site manufacturing a rapid, cost effective and low-risk solution for pharmaceutical companies planning to build identical production facilities across Europe, the U.S. and elsewhere. It is also an efficient solution for companies intending to establish local production in developing countries with limited access to engineering and process expertise.

These are some of the reasons Ferring and KeyPlants chose a modular, off-site manufacturing approach for the project to establish a facility in Indonesia for filling pre-sterilised containers. KeyPlants designed and built the facility, which includes formulation, filling, packing and quality control, in Sweden. KeyPlants then shipped the facility to Kiel, Germany, for technology transfer.

Ferring’s newly formed production team from Indonesia then travelled to Kiel for training and to take over and qualify the new modular facility. Following production trials and process validation, KeyPlants shipped the facility to Indonesia for production and launch.

Having the new facility initially assembled, commissioned and qualified in Kiel, with Ferring’s technical experts and process specialists on the scene, reduced risk to the knowledge transfer process and simplified technology transfer activities. KeyPlants’ off-site modular approach, which allowed the facility design and manufacturing to be conducted in parallel with search and preparations at the final site, significantly shortened the timeline.  

By performing the tech transfer activities at the sending unit, in this case in Kiel, Germany, Ferring was able to benefit from the full expertise and knowledge of its staff at the current manufacturing site. This resulted in no loss of information, knowledge, or experience. 

Off-site, modular manufacturing of facilities offers significant cost, speed, quality and safety advantages over conventional construction, including:  

• rapid deployment of manufacturing facilities, reducing time to market,
• cost and schedule predictability,
• fewer site disturbances,
• ability to ensure the quality of a new facility right from the start
• increased safety,
• less impact on daily business and site regulatory requirements (e.g., update of Site Master Plan), and
• flexibility of the facility – expandable and movable
• no need to wait for the final location to start construction
• overcoming technology transfer challenges and ensuring accurate and more comprehensive transfer of knowledge and
• predictable and competitive cost.

The CPhI Pharma Awards shortlisted KeyPlants’ project for aseptic filling for Ferring in Indonesia in the category Excellence in Pharma: Manufacturing Technology and Equipment. The CPhI Pharma Awards celebrate the thinkers and creators driving the industry forward through their innovations, technologies and strategies.