At a time when the pharmaceutical industry is entering a new transformational phase, the promise that automation, robotics and concomitant digitalization hold is getting more and more recognition. The transition has long reached manufacturing, and now it seems to be the turn of microbiological quality control. In the interview also published in this issue we talked about the benefits for manufacturers of automation in QC, which include higher productivity, full data traceability, and a reduced risk of disruptive and costly root cause analyses. This article sheds light on the requirements for facilities and the capabilities of some prototypes that are turning into standardized solutions.
Making a facility suitable
When investing in a new manufacturing facility, it is worth taking likely future requirements into account. A facility designed from the onset to be suitable for automation and robotics leaves manufacturers with more options in the future. It is worth noting that while some robots will be fixed to one place over their entire lifetime, others must move between locations, either regularly or at intervals.
Among the things to consider when designing an automation-friendly facility are to level the flooring, avoid slopes and steps, and dimension corridors to allow the movement of robots. Doors that open and close automatically and large enough locks with no physical obstacles to overcome should be installed. If the facility access covers multiple levels the elevator should be sufficiently sized, and Wi-Fi must be made available for the transfer of data. Although it should be possible to adapt an existing facility, there should be no operation during conversion, and the total costs would be higher.
Mobile environmental monitoring
Automation solutions for different QC workflows will differ considerably. Environmental monitoring, for example, poses specific challenges. There are usually several locations for air monitoring, so we made sure that the automated air sampling robot we developed with several customers in the pharmaceutical industry can move autonomously to the different sampling points after initial loading. The platform with robotic arms contains instruments for viable and for non-viable air sampling in grade C and D cleanrooms, as well as packs of consumables. The fully functional prototype allows automatic sequential sampling of all accessible air sampling points but also removal of the sampling instruments for manual operation at difficult-to-access points. As robotic arms cannot grasp objects as flexibly as human hands, consumables and accessories had to be adapted. For example, single-use air sampler heads were developed to avoid the need for manual decontamination between testing points, a procedure that stainless steel heads require. To further raise the level of automation in environmental monitoring testing, we are currently working on automated handling in gloveless isolators and automated counting of colonies on plates.
Any robotics solution like the above must take the nature of microbiological testing into account, in particular to avoid contamination from the environment and between samples. For example, particle emission resulting from moving parts was minimized, and any movement of robotic arms over opened plates avoided. Undisturbed air flow was a further consideration.
High-throughput, automated bioburden testing
An automated solution for bioburden testing, on the other hand, need not be mobile. Any stationary system must be installed far enough from walls and other installations to allow cleaning and disinfection. Like all QC hardware for use in controlled areas, it should be designed without sharp edges and porous materials to ensure easy cleanability.
In cooperation with a leading global pharmaceutical company and engineering partners, we have developed a stationary prototype for a fully automated bioburden testing workflow. In 12 hours, its integrated Milliflex Oasis® pumps can perform 240 filtrations, based on a mix of 70% water testing and 30% complex protocols. It involves liquid handling, pipetting and dilution systems, a membrane integrity check and transfer station, a decontamination chamber as well as storage, handling and waste management features. Like the air monitoring prototype, we have developed specialized consumables that have been adapted for secure robot handling.
Standardized solutions in the making
As it is not feasible to devise each automation solution individually to specifications, we plan to develop our prototypes into fully integrated, standardized machines that can plug into any manufacturer’s superordinated lab ecosystem. Automation modules will be incorporated into a mobile unit or dedicated cabinet with several compartments. They will comprise robotic arms, automated hardware and robotic-friendly consumables, designed to collectively reduce human intervention, increase productivity and improve sustainability. Automatic, real-time data capturing will ensure data traceability and regulatory compliance. For our solutions, we will offer a full spectrum of dedicated maintenance and training services, using new technologies to ensure fast response times.
Pharmaceutical manufacturers will ultimately take their decisions based on operational and financial criteria. They will scrutinize an automation solution to find out if it is robust and if the throughput will be sufficiently high. They will calculate whether the investment pays off fast enough and if the total cost of ownership is right. We are aiming to fully meet the industry’s expectations when our standardized solutions go to market.
Learn about Merck’s strategy of developing automation and robotics solutions to build the smart QC laboratory of the future.
Author Details
Anne Weeks, Commercial Applications Specialist- BioMonitoring MilliporeSigma, Burlington, MA, USA, An affiliate of Merck, KGaA Darmstadt, Germany; Anke Hossfeld, Director Marketing, Automation & digitalization – BioMonitoring, Merck Life Science KGaA, Darmstadt, Germany.
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 27, No. 7Nov/Dec 2024Pages: 34-35
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