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Having remote operations in place is crucial to maintaining good automation practices.
BioPharm International spoke with Casey Snodgrass, market segment leader for Pharmaceutical Sciences at the Hamilton Company; Cynthia Pussinen, vice-president and general manager, Life Sciences and Specialty Chemicals for Honeywell Process Solutions; and Bruce Kane, industry technology consultant for Rockwell Automation, regarding the proper procedures for remote operations when complying with good automation practices.
BioPharm: How practical are remote operations in manufacturing facilities in terms of good automation practices?
Snodgrass (Hamilton): In practical terms, remote operations minimize the number of people that directly interface with the system. This is especially useful when working with hazardous materials or highly infectious pathogens, such as SARS-CoV-2, to limit the number of people with potential exposure to infectious agents spending valuable time with hands-on training, and reduces the amount of personal protective equipment (PPE) used at the facility. To balance this perspective, convenience and practicality often come at the price of complexity. Remote operations may require more extensive programming and project management. The stakeholders need to have a clear vision of the system’s goals, along with an incredibly detailed map of the requirements, including interactions with other equipment and the laboratory information system. A remotely operated system is far different than a stand-alone automation platform for a dedicated workflow.
However, the term ‘remote operations’ can be a bit misleading, because a facility still needs people-let’s call them super users-physically interfacing with a liquid handling system to load tips, consumables, and reagents onto a robotic system, and also providing periodic maintenance and troubleshooting, or error handling response. It is possible to configure an automated system with convenient remote access for users that are trained in creating a job, and at the end of the run, remotely retrieve the data or send samples downstream. Facilities can also link Hamilton’s dissolved oxygen (DO), pH, cell viability, and conductivity sensors to a biocontrol system for remote monitoring and automatic event triggering.
Pussinen (Honeywell): Remote operations in manufacturing facilities are extremely pragmatic, concerning automation practices. A good reference document for the life-sciences industry, authored by the International Society of Pharmaceutical Engineers (ISPE), The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture (1), describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality.
The use of remote operations in life sciences settings will likely evolve rather quickly as the industry seeks to ensure it is able to deliver life-saving therapies to patients around the world, without interruption, in case of natural disasters, inclement weather, pandemics, and/or in other situations where colleagues are not able to be physically present at a manufacturing facility.
Kane (Rockwell): Good automation practices are not exclusive to remote operations, or vice versa. Instead, good automation practices are centered around building quality controls into the manufacturing process. Remote capabilities can serve to enhance this quality. Remote technologies that enable safer, more frequent, and more timely monitoring and intervention into process disturbances are of great value to ensuring product quality. The technologies that allow both interactive, remote, and full remote are well evolved and suited for a wide variety of remote-use cases. We believe that, as the technology continues to evolve and augmented visualization technologies become more robust, there will be an increase in their uses throughout a wide cross section of facilities.
BioPharm: Are remote operations in manufacturing facilities safeguarded?
Pussinen (Honeywell): Yes, absolutely. Customers around the world are also looking for Honeywell to provide remote support in light of restrictions on personnel traveling and entering a site. Honeywell has deployed multiple remote service options to continue providing expert support via remote connectivity to our equipment. These remote options also use the power of Honeywell Forge offerings to proactively detect issues and bring them to the attention of both the customer and a Honeywell expert.
With these three methods, we are able to keep customers safe while also maintaining business continuity. The industries we serve include:
In fact, we have employed these unique technologies within some of our own plants.
Kane (Rockwell): It depends on how the systems are designed, but, yes, modern systems employing current best practices in security, engineering, and safety controls are very safe and secure. There are several perspectives that should be considered when safeguarding remote operations. The most basic safeguard is that connections are secure and not open to attacks or hacks. Following good network design and remote access principles help ensure this safety of communication. Instrument Society of America/International Electrotechnical Commission 62443 also has recommendations for good and secure network design. One should also consider the nature of the remote operations and their impact on local personnel, for example, signaling that indicates equipment is under remote operation.
We recommend something similar to a process hazard and safety review be conducted on any remote operations before implementation to ensure safe operation. For example, some equipment may require a line of sight to visualize that equipment during start up and be able to immediately respond if there is a problem. In order to follow the same intention with a remote-start operation, additional equipment might need to be installed to provide the visual checks in the absence of local operators.
Snodgrass (Hamilton): For those interacting with Hamilton’s workstations on-site, we offer safety features that prevent accidental access to a remotely operated system. Error handling is also a critical safeguard to enable frequent unattended use while preventing major disruptions in the form of unplanned downtime. Hamilton’s systems can automatically recover from many error scenarios and send remote notifications to authorized personnel. For serious issues, some on-site intervention may still be necessary.
BioPharm: What equipment/instruments does your organization rely on when operating remotely?
Snodgrass (Hamilton): Hamilton Robotics has a number of automated liquid handling workstations that can be used in a remote operation, integrated with other devices into larger work cells, and linked to other operations via a laboratory information system. With different platform sizes, configurations and capabilities, it’s easy for biopharma manufacturers to fine-tune a solution specific to their needs. Hamilton Storage offers automated storage systems along with automated cappers and decappers that can further enhance automated workflows in remote operations. In a remote environment, Hamilton’s sensors monitor in real-time whereas many others only provide a before and after snapshot of the activity. By monitoring even tiny fluctuations in real time, users know exactly what’s happening in the process, and make rapid determinations about next steps instead of having to fail an entire batch, which as you can image, is a huge risk for a multi-week process.
Pussinen (Honeywell): Honeywell provides solutions for our customers to support remote operations-cybersecurity is often a critical element, and a variety of solutions and services are available. One such offering, Managed Industrial Cybersecurity Services with security analytics, device management, and regionalized support services helps customers modernize industrial control system (ICS) capabilities while minimizing operational issues caused by cybersecurity incidents.
Additionally available are real-time process supervisory control and data acquisition (SCADA) solutions delivered as a secure and scalable service. A member of Honeywell’s suite of cloud-enabled solutions for operations technology and information technology (OT/IT), SCADA provides cybersecure access and collaboration anywhere, while ensuring regulatory compliance.
Kane (Rockwell): Rockwell Automation is an automation system provider, and in a sense our whole business is about providing remote control to process, whether it be sending a signal to a valve to open across the plant, or around the world. Our business has always been about removing the operator from having to be physically present at the valve to open it. We are using some of the newer and more exciting technologies available for remote operation. Those involve using highly flexible screen sharing capabilities with Thin Manager, a FaceTime-like conferencing with augmented reality and 3D persistent whiteboarding (Chalk). And for sharing work methods and training remotely, we have some unique augmented reality/virtual reality knowledge management systems (Knowledge Capture).
BioPharm: Do you recommend use of remote operations in biopharma manufacturing?
Pussinen (Honeywell): Yes, taking advantage of remote operations is a great way in which to facilitate business continuity when it is not possible to have colleagues physically present at a manufacturing facility, and to allow visibility into one’s operations at a contract manufacturing organization. Given the current day challenges posed with COVID-19, companies increasingly have fewer individuals working at an operating process location, in adherence to ‘stay at home orders.’ In some cases, quarantines of key individuals might impact the availability of skilled resources at the site. In response, Honeywell has issued new software that enables process operations to be monitored or even executed from remote locations outside of the plant facility-in other facilities or from home-depending on specific needs, this might present a very valuable option.
Kane (Rockwell): Remote operations are applicable for use in almost any manufacturing environment. I can’t think of one where it would not be applicable. Provided good engineering and safety practices are followed, there is no reason why remote operations could not be employed. In fact, I can think of a few reasons why remote operations would be preferred: first, a reduction of personnel in an area reduces the sterile load on an area. Second, remote operations support centralized management and resource sharing. And lastly, remote operations allow more timely responses to disturbances.
BioPharm: How do you suggest other organizations implement remote operations into their biopharma manufacturing facilities (e.g., as applies to workflow, day-to-day operations, cleaning/sterilization, etc)?
Snodgrass (Hamilton): This goes along with the best practices, and we already touched on a few of these points. I can’t stress enough just how important planning is, including trying to envision every possible case scenario. For example, it’s not feasible for a user to program a liquid handling workstation in a vacuum, so to speak, and expect that others can begin to use it remotely. Next, make sure to implement error handling protocols and detailed personnel trainings as they are both critical to successful remote operations. Clearly define the workflow and support it through standard operating procedures (SOPs). Obviously, don’t skimp on documentation. By their nature, biopharma companies already have a wealth of documentation to support their audit trails. Scheduling is important; dedicate time for preventative maintenance and for cleaning and reloading the system. Key steps like these can ensure smooth operations in the long run. Consider ways to further minimize risks, like redundant equipment or devices and spare parts, or training in-house service personnel.
Kane (Rockwell): Process hazard analysis, process workflow analysis, and engineering studies. By thinking about how to identify candidate operations for remote control, such as reviewing operations for opportunities to remove local actions and engineering new processes with remote operations. This is a very broad concept to consider, but focus should be on the question, ‘What problem am I trying to solve with remote operations? Is it simply remote operations, or is it inspection or troubleshooting? And will an operator be local or not?’ These are general questions to ask when implementing remote operations into facilities.
1. K.Vaishnavi, Good Automated Manufacturing Practice (GAMP), 225 (2012).
Vol. 33, No. 5
When referring to this article, please cite it as L. Lavelle, "Good Automation Practices for Remote Operations," BioPharm International, 33 (5) 2020.