At CPHI Milan, GEA launches a new approach to coating technology that removes the guesswork from formulation development and bridges the gap between R&D and commercial-scale OSD manufacturing. Mark Rowland, director of product management, GEA’s Pharma Solids business discusses.
GEA
When GEA introduced its ConsiGma FC Lab coater, the pitch to formulators was straightforward: a flexible system that was designed for the lab but with the added benefit that nothing learned in early development would need to be relearned later. At CPHI Milan this October, the company is set to complete that story with the launch of the ConsiGma FC Flex. The same coating technology has now been adapted for production and built using the same drum geometry as its benchtop counterpart.
For an industry that has spent decades treating scale-up as an unavoidable tax on drug development, the significance of that shared geometry is hard to overstate. Conventional coating technology typically requires formulators to move between fundamentally different pieces of equipment as a product progresses from bench to plant. Each transition brings its own optimisation campaign, its own risk of failed batches and its own revalidation paperwork. GEA's proposition, refined across the ConsiGma platform, is that none of this needs to happen if the underlying process physics never change.
From free-fall coating to full production
The CFC Flex inherits its coating mechanism directly from the lab-scale platform: tablets are separated and spun through a spray zone using a high-speed drum and air-knife combination to receive a succession of individual micro-coats. Each application dries almost instantly before the next is deposited, building a uniform 360-degree film across the full batch in a single pass. This contrasts with conventional coaters where tablets tumble slowly past a spray zone, relying upon tablet-to-tablet contact to distribute the coating fluid.
What changes at production scale is not the process but its throughput. Whereas the lab unit runs 0.5-1.5 kg batches through an 80 mm wheel, the CFC Flex extends the same drum diameter to handle production sub-batches of approximately 9.0 kg. Scale-out is achieved by increasing wheel depth and nozzle count rather than altering the drum itself, so spray flux, product bed depth and process dynamics all stay consistent from lab to plant - and the 6-minute cycle time that has made the lab platform popular for rapid Design of Experiment (DoE) work is preserved. Multiple sub-batches can be run in sequence or in parallel, allowing manufacturers to reach daily outputs of up to 1500 kg while retaining the spray dynamics, coverage characteristics and coating chemistry validated during earlier development work.
That combination, GEA argues, removes one of the more persistent inefficiencies in OSD manufacturing: the point at which a formulation that performs beautifully in the laboratory must be reoptimised, sometimes substantially, to survive contact with a different piece of production equipment. Because the CFC Flex shares its fundamental geometry with the CFC Lab, process parameters are intended to transfer directly, sparing manufacturers a second development campaign and the regulatory burden of demonstrating equivalence between two dissimilar systems.
Why CPHI Milan matters for this launch
As one of the largest gatherings in the pharmaceutical calendar, CPHI draws manufacturing, formulation and procurement specialists from across the value chain — precisely the audience with a stake in whether a lab-to-plant transition can be made less costly and less risky. A production-scale coating platform that claims to eliminate revalidation at the point of technology transfer is the kind of announcement likely to resonate with contract manufacturers and originator companies alike, both of whom carry the commercial cost of delayed launches.
Addressing the coating challenges that matter commercially
The gentleness of the free-fall mechanism, a feature already valued by formulators working with friable or unusually shaped cores at lab scale, carries through to the production platform. Because tablets reconnect with the drum gradually rather than being subjected to sustained mechanical tumbling, attrition and coating damage are reduced (even during the longer batch runs typical of commercial manufacturing). That matters for the growing number of products built on softer, more fragile cores, or on those with irregular geometries that conventional rolling-bed coaters struggle to process without yield loss.
Containment, too, remains central to the platform's appeal. The CFC Flex is designed to OEB4 standards as a baseline rather than a retrofit, with split-valve loading and discharge intended to eliminate operator exposure and the need for specialist PPE when handling highly potent APIs. Furthermore, with the optional WIP/CIP functionality, the machine will be OEB5–6 compatible. As more of the industry's pipeline shifts towards targeted, high-potency compounds, that containment-by-design approach is likely to be as commercially relevant as the throughput figures themselves.
Material efficiency is the other consistent thread. Taking a different approach to coating has, during GEA’s research and experimentation, delivered coating solution reductions of approximately a third compared with conventional processes. This has been achieved by applying thinner, more frequent micro-coats rather than a single thick layer. At production volumes, also confirmed during testing, the commercial case for these efficiencies strengthens considerably: waste reduction that looks marginal on a 1.0 kg development batch becomes substantial when scaled-out to batches measuring hundreds of kilograms.
A more predictable route to market
The real appeal of the CFC Flex for manufacturers is simple: a process that works in the lab should keep working, unchanged and without rework, once it moves to full-scale production. A formulation team that has already characterised its coating process on a CFC Lab unit will be able to hand those parameters directly to a production team running the CFC Flex, without the customary pause for reoptimisation. For an industry in which every week of delay between formulation and launch has a direct cost, a coating platform designed explicitly to remove that delay is likely to draw close attention on the CPHI Milan show floor.
CFC FLEX: THE EVIDENCE BASE
GEA's coating platform has been under continuous development and customer testing since 2010 when the first test centre opened in Wommelgem, Belgium. Facilities in Maryland (US) followed in 2017, with a third test centre added in Tokyo in 2020. Across those three sites, GEA reports more than 100 customer trials, spanning over 200 tablet types and more than 100 distinct coating formulations.
Independent containment testing published in TKS Journal in 2020 measured operator exposure during both wash-in-place and wash-offline procedures on the coating platform, recording total exposure levels of 0.627 µg/m3 (8-hour time-weighted average). These sat comfortably within the threshold associated with OEB4 handling, supporting GEA's claim that the CFC Flex can be specified with containment built-in from the outset rather than retrofitted.
Comparative thickness testing carried out with coatings supplier Colorcon, examining the finished film at the tablet face, edge and band under magnification, found substantially tighter variation across those measurement points than a conventional pan coater running the same formulation. This is evidence, GEA argues, for the uniformity claims that underpin the platform's material-efficiency case.