New research highlights exceptional containment performance of the GEA coater
09 Feb 2021
The containment performance of the GEA Coater, described as a “new generation” device capable of both continuous and batch film coating, was assessed during three phases of operation and discussed in a peer-reviewed journal
As containment experts, part of GEA’s responsibility is to ensure that operators are protected during every step of the process when manufacturing pharmaceutical tablets. And, even though the risk of being exposed to airborne particles during tablet coating is relatively minimal, some highly potent active pharmaceutical ingredients (APIs) — even at very low concentrations — have the potential to cause adverse health effects. Therefore, in collaboration with SafeBridge Europe, we tested the containment performance of the GEA tablet coater, which can be used as part of a continuous ConsiGma® 4.0 line, as part of a traditional batch production line and/or as a standalone machine.1
Using tried and tested industrial hygiene measurement techniques and a low toxicity surrogate (mannitol) for the highly potent API, we determined the inherent “containment” ability of the manufacturing equipment during the coating process, disassembly and cleaning.2 For this study, a manual loading operation was performed in a flexible isolator to avoid influencing the results of the measurements. In a production environment, however, loading the tablet cores is done using an automated, contained set-up.
The results of these trials showed that the GEA tablet coater operates in a very contained manner. During the three 2-hour process runs, airborne surrogate concentrations were as low as 4–6 ng/m³ for a 5% formulation. With both product and operator safety in mind, and given that Short Term Time Weighted Average (STTWA) values are expressed in terms of 100% drug load, our conclusion is that the system is capable of operating at an STTWA of 0.5 µg/m³. This makes it suitable for formulations involving highly potent APIs (OEL values less than 1 µg/m³).
The GEA Coater is capable of operating at an STTWA of 0.5 µg/m³
The disassembly and cleaning operations, which involved disconnecting and removing contaminated parts and cleaning them by hand, obviously presented higher exposure levels, up to approx. 100 ng/m³ and 400 ng/m³, respectively, resulting in an operational STTWA of 8 µg/m³.
This level is still within the permissible limits of processing potent compounds (OEL values less than 10 µg/m³) on a system not equipped with cleaning options. The GEA coater can, however, be supplied with automated cleaning systems, such as wetting-in-place or a wash-off-line system, which will significantly reduce both operator involvement during cleaning and the associated exposure risk.
In conclusion, the authors state that this coating technology offers a high level of containment and is suitable for applications involving highly potent APIs. Of course, a case-by-case evaluation should to be done for each API to determine whether the equipment can be used as is or whether any additional safety measures should be implemented. GEA is happy to support you and your team to perform an operator safety risk assessment.
References
1. M.W. Axon, J. Ball and E. Van Strijdonck, “Containment Performance of Semi-Continuous Tablet Coating Equipment,” Chimica Oggi/Chemistry Today 38(6), 45–49 (2020).
2. International Society for Pharmaceutical Engineering, “Assessing the Particulate Containment Performance of Pharmaceutical Equipment,” ISPE Good Practice Guide, 2nd Edition (ISPE, North Bethesda, MD, US, 2012).
