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Aseptic Processing

Aseptic Process Development

Many new drugs and devices require new manufacturing processes which need specialist design and development expertise, especially in the area of aseptic processing and sterile manufacture.  It is important to choose a partner who can support the total life-cycle of your product;  who can design and manufacture the appropriate type and scale of equipment, from bench-top and lab-scale equipment for R&D and early clinical manufacturing, through to pilot-scale and full-scale production lines for high-volume production.  The ability to scale up production without changing the core process is an essential factor to consider in pharmaceutical and medical device manufacturing and is typical of our approach and design philosophy at 3P.  With any new drug or medical device, there are a number of key objectives to fulfil, which will typically apply across the 3 key work-streams of ‘Drug’, ‘Device’ and ‘Manufacturing Process’.  The diagram below helps to illustrate this. 

The first objective is to develop and de-risk the core aseptic processes involved in manufacture.  From a machine perspective, it is important to specify and design equipment which will provide agility and flexibility to quickly accommodate changes in the properties of the drug (e.g. viscosity of liquids, powder flow properties etc) and in the design of the primary drug container (PDC) itself (e.g. size, shape, material selection etc).  As well as being flexible, the machine solution must perform aseptic processes that can be measured, with ability to define and record Critical Process Parameters (CPPs) and with capability to explore tolerances and sensitivities of the process in order to ensure that necessary process control is defined and understood.

The second objective is to demonstrate to your customers and the regulatory authorities  that you know how to manufacture your product;  Being able to demonstrate this know-how using process-representative equipment is invaluable to build confidence, secure regulatory support, produce samples and ultimately sell your product (drug and/or device) to the market.  Typically we design and manufacture aseptic equipment which can be installed in existing hard-wall or soft-wall isolators, providing cGMP manufacturing capability from the earliest stages in the project.

Once a new drug and device has been proven and interested customers are on-board, the third objective is to industrialise as fast as possible, with a view to supply the required volumes and ramp-up capability to the market.  This is where the earlier efforts in defining a robust and scalable aseptic process will pay off.  Previous quality thinking in how to scale-up core processes can be applied, enabling confident, fast-track design of automation and the manufacture of production machines.   

Once manufacturing capability is in place, the fourth objective is to ensure that production capacity can match market demand.  Previous consideration and planning regarding ‘scaling up’ (increasing the throughput of an aseptic manufacturing process) versus ‘scaling out’ (multiplying the number of machines or production lines) can be implemented.  In addition, earlier-stage thinking will have considered the potential requirement to quickly and cost-effectively introduce new product variants (e.g. different drug doses, device derivatives), on the same machine platform, without needing to buy new machines.

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