Single-Use Systems Part 2: Responding to a dynamic drug production landscape

By Eric Rentsch, Product Marketing Manager, Fluid Handling

Drug production requires an agile processing platform

Success in the dynamic world of modern drug production requires an agile processing platform that maintains quality and mitigates risk while keeping costs relatively low. Furthermore, unpredictable natural disasters and tumultuous markets exacerbate the dynamic nature of the drug production market by creating demand spikes and wreaking havoc on supply chains—pharmaceutical production facilities must be able to adjust quickly and effectively all while keeping compliant.

Challenges to upscaling

Batch processing is very common at existing facilities but not well suited for these quick changes as it utilizes large tanks that must be cleaned and sterilized according to cGMP. This procedure not only steals valuable processing time but requires plant foot-space and energy input. Additionally, the capital and resource investment required to scale-up these facilities in order to meet demand is steep as most of the equipment is a permanent part of the brick-and-mortar building structure. Future-proofing your process is then critical, but what does one look for? An easily adaptable and modular process system and methodology are needed to meet these changing market needs. It should be a multiproduct platform and easy to scale-up production in weeks, not months.

Single-use technology is the core of modular process systems

Modularity in the process design is essentially future-proofing it. By using a system of standardized disposable components, modular systems can achieve the requirements laid out. These disposable components range from traditional consumables like fittings and tubing to industry newcomers like pH probes and non-invasive flow meters. They are all usually integrated via pre-fabricated fluid path assembly which is where the benefits start to really add up.

By designing a prefab assembly for your drug production process, it reduces the risk of human contamination while saving on installation and assembly time on the floor or lab bench. These assemblies are ordered in bulk or scheduled “blanket” orders which smooth out the supply chain and usually benefit from a quantity discount. The prefab assemblies constructed to the design owners’ specifications and handled by professionals to ensure a consistent and safe product. Most companies that offer prefab assemblies will also offer gamma irradiation services and provide documentation assistance to comply with federal regulations.

Masterflex^® offers modular solutions

Masterflex is the only supplier to offer a modular pump, fluid path consumables and sensors, as well as custom pre-fabricated assemblies. Masterflex pumps accept numerous pump technologies such as peristaltic (of course), piston, PTFE diaphragm and Quattroflow to accommodate any shift in production need—and they are very easy to install. Masterflex Single-Use makes it quick and easy to create and integrate an entire fluid process path into a single comprehensive design because it eliminates multiple sourcing for critical components which can lead to supply chain delays and complicated scheduling which can mean a lower quality product, or worse, no product at all.

Read Single-Use: What your should know, Part 1