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How multifaceted, risk-based solutions maximize efficiency, speed, and quality
Author: Susan Cleary, Director of Product Development
The consequences of contamination in pharmaceutical manufacturing go far beyond compromising patient and consumer safety. Lost revenue due to slowdowns and contaminated supplies, fines from regulatory entities such as the U.S. Food and Drug Administration, and reputational damage are just some of the repercussions of drug contamination.
During the 2021 ISPE Annual Meeting, FDA Commander Tara Gooen Bizjak highlighted sustainable compliance – or an aim for companies to “continually operate above the bar” of Current Good Manufacturing Practice (CGMP) compliance rather than surrendering to periodic infractions – as an emerging global compliance issue, according to REDICA Systems.
The COVID-19 pandemic has placed an added spotlight on contamination control in the context of vaccine manufacturing. Not only do expedited timelines and large-scale production efforts leave companies more vulnerable to errors, but absenteeism – another consequence of the pandemic – can interfere with documentation, thus further undermining data integrity, according to Gooen Bizjak.
And yet, despite the increasing pressure for companies to prioritize safety and efficiency within their manufacturing processes, existing data shows a steady increase in FDA warning letters since 2005.
Meeting accelerated deadlines, gathering data and remaining competitive, all while adhering to regulatory guidelines might seem like an impossible balance to strike.
As Director of Product Development here at Novatek, I’m delighted to share some good news for pharmaceutical companies:
Contamination is preventable. However, doing so requires careful planning, consideration, and an investment in preventive measures such as process automation which is one of the most effective.
In this blog post, I’ll explore factors that contribute to external and internal contamination, why it’s important to have an automated, risk-based contamination control strategy, and the elements of a multifaceted contamination control program.
Sources of contamination range from external causes such as physical (particles from the environment) or biological (viruses and bacteria), to internal, which includes cross-contamination and other residues when equipment is improperly sanitized between uses.
The elements contributing to contamination are:
- Facility design
- Cleaning process
- Production process
- Air handling
An effective contamination control Strategy (CCS) is all-encompassing; in other words, it takes into consideration any possibility for contamination of your product throughout the manufacturing process. By incorporating risk management principles, and using risk tools such as failure mode and effects analysis (FMEA) or risk-based inspection software, programs can accurately prepare for and protect against a range of contamination risks.
To mitigate risks, however, companies must continuously monitor a stream of reliable and accurate data surrounding their manufacturing processes. What’s more, regulatory entities now expect companies to trend their data in order to monitor and ensure process control, and to identify weaknesses in their operations.
With ever more stringent regulations, run-of-the mill paper-based data collection processes are not enough to meet the demands of today’s regulatory environment.
Too often, companies fall victim to human error and fail to trend their data in a timely manner, or even worse, fail to collect critical samples altogether.
That’s where automation comes in.
By incorporating automation into pharmaceutical manufacturing processes, companies can improve efficiency, integrate the supply chain, and achieve global compliance while decreasing the cost.
Read on to learn how Novatek has woven automation into the elements of an effective contamination control strategy.
An effective contamination control strategy contains the following three components:
- Environmental monitoring (EM)
- Cleaning Validation (CVM)
- Water & Utility Monitoring (UM)
As seen in the list above, many of the contributors to contamination are external. Therefore, to reduce risk of contamination from outside sources, each source must be evaluated, validated, and controlled.
Environmental monitoring enables companies within the pharmaceutical industry to spot and control contamination threats in real-time. By maximizing quality control and incorporating automation into sample collection, data management, sample processing and tracking, trending and reporting, Novatek’s Environmental Monitoring software and EM Mobile enable companies to easily confirm when processes are complete, or determine when vital steps have been missed.
Another component of a successful contamination control strategy is ensuring cleanrooms are properly cleaned and disinfected to prevent contamination from a previous product, microorganisms, cleaning agents, and any residue.
Cleaning processes must be validated in terms of temperature, concentration, contact time, and the manner in which they are used. To this end, Novatek’s Nova-Cleaning Validation software ensures product integrity by reducing risks of cross-contamination and residues that exist within a dynamic production environment, all while adhering to industry guidelines and regulations.
The quality of your finished product depends greatly on the quality of materials used in pharmaceutical production, especially water, gases, and HVAC. Water systems must account for contamination that can take place during distribution, such as adhesion and biofilm formation, and HVAC and gases must be appropriately filtered and monitored.
Therefore, when it comes to water and other utility systems, sampling, testing, data collection, and pattern recognition is crucial for a quality product. Because utility systems require unique sampling both continuous and discrete, and testing processes, Novatek’s Water & Utility Monitoring Management Software enables companies to manage these features in addition to the environmental monitoring data.
With regulatory pressure increasing on a global scale and vaccine manufacturing and drug development top of mind in light of the COVID-19 pandemic, the stakes are higher than ever for pharmaceutical companies to effectively monitor for, address, and reduce the risk of product contamination.
By moving beyond traditional, paper-based processes and automating environmental monitoring, cleaning validation, and water & utility monitoring, pharmaceutical companies can spend more time optimizing efficiency and safety.
Using Novatek’s modular software design, companies can bring products to market sooner, resulting in what matters most: faster treatment delivery for patients.
It’s easier than you think. Learn more about how Novatek is bringing business ready, compliant solutions to pharmaceutical companies to embrace change through holistic contamination control solutions. https://ntint.com/product-suite/contamination-control/