Company insight
The big barriers of small batch production
Time to market is key for a pharmaceutical company launching a new therapy or combination product. These programmes tend to be quite extensive, including several clinical trials before receiving, regulatory approval and meeting the patient demand. The ability to react quickly to meet the need of the pharma company’s assembly equipment is paramount. Mikron Automation’s new service is specialised for the small-batch production of injectables. Jean-François Bauer, head of marketing and business development, describes how it operates.
Why would companies want low volumes of injectables? Jean-François Bauer: In the pharmaceutical industry, it’s a journey from the design stage of a medical device to when it’s launched. The process of commercialising a new device requires several steps: design, assembly and testing, such as design verification and potentially clinical trials. These steps are very thorough, and they all need to be validated to ensure there is no risk to patients. Given this, small batches of product must be assembled in order to be validated by the regulatory agencies, such as FDA, before a company can enter the market and scale it up for mass production. Setting up an assembly line for mass production takes on average more than 12 months if you factor in the time to design, build, and commission it. It also demands a high investment of money and personnel, as well as a clean room for certain products. Sometimes processes are still being developed or the design of a medical device
is not fully finalised. This can be particularly challenging if you are in the middle of building a mass-production system and have the potential to significantly impact time and costs. For this reason, an assembly cell made for clinical trials, which runs at a low volume of output and only has automation embedded for critical processes, makes sense.
Are Mikron Automation well-placed to meet low-volume demand? Mikron Automation has been building high performance assembly lines for 50 years, gaining huge expertise in complex processes – our brand is known for quality and precision. We are partners for our customers for the full life cycle of their products, including during the early design phase when small batches are needed for product testing and clinical trials. We developed the Mikron MAIA to serve companies during the clinical trial phase but also to ensure our high- volume expertise is integrated so they can use process equivalency scale up production smoothly with reduced regulatory burden.
Why are injectables well suited for a purpose built, low-volume manufacturing service? Injectables such as pens, auto-injectors and safety syringes all include some standard manufacturing processes that allow for a level of automation in production. The benefit of the Mikron MAIA is that it offers quick changeover tooling and a powerful control software, enabling the assembly of a variety of injectables in a short time.
The Mikron MAIA assembly cell uses advanced control software to allow customers to collect data on the assembly of their product.
All parts feeding is manual, and this mix of manual and automatised processes in low volume assembly is the key to giving companies flexibility to change the design
Medical Device Developments /
www.nsmedicaldevices.com
of their product and produce it rapidly for clinical trials. An additional benefit is that the Mikron MAIA is fully electrically actuated, which means lower energy costs and easy setup. Our advanced control software MOOS, which is the same as in our high-volume line, offers data collection and connectivity capabilities.
When partnering with a company that is launching a new injectable medical device, how do you support the scaling up of production once the final product is ready? In the Mikron MAIA, we have built our process experience on hardware and software elements. In practice, this means each process is built and characterised in the way that the medical device will be assembled in mass production. It also means that when a customer wants to scale up, through process equivalency, all validated processes used in the Mikron MAIA can be reused on the high-volume line with less regulatory burden.
Mikron Automation not only delivers precise assembly solutions, but we also offer pre-production services such as design for assembly (DFA) or design for manufacturing (DFM), proof of principle (POP) as well medical validation support based on GAMP5. Some of our clients require quick use of a cleanroom for the assembly of design verification or clinical trial product and our US site Mikron Corporation Denver has a ISO 7 cleanroom to specifically help these customers with these quality controlled low volume builds. Adding value along the entire product life cycle is part of our strategy to become a long-term partner to customers. ●
www.mikronautomation.com 59
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