Advanced security and surveillance technologies can greatly support risk management within biopharma. Biopharma operations rely heavily on maintaining a safe and efficient environment. By leveraging these technologies, biopharma companies can optimize their processes, minimize downtime, and promote a healthier workplace. Here’s how.
The role of security within biopharma is evolving. While traditional asset protection and harm prevention remain core objectives, security must now support broader risk management goals.
Security and surveillance systems have, in fact, become integral to business success. The data they produce and guardrails they enforce pertain to a host of factors spanning business continuity, product quality, R&D integrity and assurance, workflow efficiency, and time-to-resolution. That is because proper risk assessment and management touches every stage of a product’s lifecycle or workflow.
The types of risks identified by this process can be split into three categories:
- Security threats: Dealing with things like physical security, theft, and sabotage.
- Process threats: Preventing any compromise to the integrity of vital processes such as contamination or degradation of a sample.
- Efficiency threats: Minimizing downtime, time-to-resolution and troubleshooting, even workflow optimization.
Biopharma is an industry that is particularly vulnerable to risk. In dealing with organic matter, the challenges it faces are, arguably, even more sensitive than in traditional pharmaceutical manufacturing and R&D. Lab environments must be maintained, sample integrity ensured even through lengthy transport, tests completed before samples degrade, and protected health information (PHI) handled appropriately. Companies routinely deal with hazardous materials and controlled substances which must be carefully managed. All the while test subjects, patients, and staff alike add opportunity for human error or abuse.
As a multi-billion dollar (USD) industry, achieving even the most incremental of efficiencies or improvements to loss prevention can result in enormous savings. Which is why many of the world’s leading biopharma organizations are enhancing their risk management with advanced surveillance and security systems.
Two segments within biopharma that benefit the most from this kind of support are test manufacturing and clinical trials.
Mitigating risk in test manufacturing: tailored solutions
Test manufacturing faces many of the typical security challenges you’d expect, with the need for robust access controls, biometric authentication, evidence documentation, messaging and alert systems. However, biopharma systems must also account for a variety of additional factors beyond a typical set up.
Systems must be tailored to specific environments. Dry powder chemical stores, for example, are zone/division 2 hazardous areas. In areas such as these where explosions can occur, not only do the access controls and provisions need to meet much higher standards, but the surveillance hardware within the rooms themselves must also be suitable. There can be no risk of any sparks, be they within the cameras, door controls, or from a person’s cell phone.
Similarly, biopharma environments demand cleanliness. The regular use of powerful chemical detergents to sanitize surfaces and surroundings is common practice, and so equipment – including surveillance hardware – must be made of stainless steel or other inert materials to protect against corrosion.
Protecting processes and driving efficiencies
Within the test manufacturing processes themselves we also find ample opportunity to support risk mitigation strategies using surveillance technologies. Support can come from both real-time actionable events to prevent incident escalation as well as retrospective analysis to inform and refine risk strategies.
Real-time events might include monitoring for temperature changes, for example. We want to build in redundancies to processes like these. Having a video feed, equipped with analytic capabilities, monitoring an analogue thermometer provides a reliable, automated, secondary system ready to alert staff to any unexpected temperature swings.
Likewise, pipes or equipment may leak. Bottles may not be filled properly, or products may fall off conveyer belts. Machines could malfunction, fires start, and evacuations need to be sounded. As soon as any of these happen staff need to know.
The same principles also apply to driving efficiency. Test production often employs large portions of automated laboratory equipment and robotics. These machines are finely calibrated to make hundreds, if not thousands, of precise movements, often at speed. When something goes wrong having footage that can clearly illustrate why it has happened can drastically improve time-to-resolution and downtime.
But once again, solutions must be tailored to the use case. Cameras need to be an appropriate form factor, made with suitable casing materials, mountable, and able to cater for vibrations and high-speed movements. Also, machines may be left on overnight with little-to-no lighting, so cameras must account for this too.
In fact, almost all process incidents, be they mechanical or even spillages, slips and falls, can be reviewed using video footage and after-action summaries, allowing for the refinement of preventive measures. You could even go as far as to heat mapping usage areas, allowing you to spot outliers such as sample carts left in inappropriate (uncooled) areas and prevent sample degradation.
Supporting clinical trials
Clinical trials are a melting pot of risk and unpredictability. First and foremost, you have the meeting of federally controlled substances with a higher risk patient cohort. This demands specific safeguards to ensure the safety of not only the subjects but also that of the staff administering the trial. Naturally, biopharma organizations have thorough screening processes to help identify potentially problematic applicants, however, the risk remains.
Facial recognition technology can assist with identifying those on federal watch lists and offenders, while tracking and alert technologies such as loitering detection can help identify wrong doers in high value/risk locations such as drug storage.
However, it is not only malicious behavior that must be monitored. Trial participants must be constantly observed to guarantee the integrity of the trial as well as for health and safety reasons. They may display symptoms like coughing or wheezing that can be identified with acoustic monitoring solutions. Slips, trips and falls may occur, especially when feeling dizzy or weak. AI driven analytics can support here too, automatically alerting staff when a fallen person is identified. Some trials even require compliance to specific routines or behaviors. All of which must be checked and validated to ensure its success.
Privacy and data protection
Work in biopharma almost invariably involves protected health information (PHI). As well as active testing processes that track samples associated with a person, patients and staff routinely volunteer sensitive data. The handling and storage of this data, including that generated by surveillance systems, must comply with the security and data handling requirements of the appropriate regulation, be that HIPAA, GDPR, or any other form of PHI legislation.
Technologies such as privacy masking (for faces or text), audio analysis that only sends metadata instead of audio streams, and thermal imaging that doesn’t capture identifiable features, can help meet privacy standards. While hardware and systems must natively complement your compliance strategy and meet the ISO 9000 standards family for quality management.
