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A life science organization’s valuable investments, revenue potential, and reputation reside in the lab--expensive equipment and precious samples must be protected and kept at optimal conditions, while employees must remain well informed and educated on company SOPs to ensure minimal errors occur and risks are mitigated. When the average cost of a drug development program registers between $2.5 and $3 billion it is imperative that every facet of the laboratory is monitored and protected to secure high-cost investments and Intellectual Property (IP).


Without implementing proper monitoring and quality control programs, common errors and failures can occur in a laboratory. Understanding these errors and failures, why they occur and how to perform the proper root-cause analysis is the first step to safeguarding your laboratory.


Common Errors and Failures


Laboratory Equipment


Most life science laboratories contain a wide variety of expensive equipment. Refrigerators, ultra-low freezers, incubators, cryotanks, and bioreactors are just a few types of equipment that are used daily by researchers and lab staff in order to conduct important experiments and store valuable samples and assets. This equipment must be constantly monitored and protected for optimal operation efficiencies.


Equipment errors and failures can damage valuable samples and distort research results, potentially resulting in a failed drug development program. Errors and failures with equipment are bound to occur, but with proper monitoring the downtime, costs and other adverse effects from these events can be substantially decreased. For instance, excessive and prolonged door openings in a refrigerator or ultra-low -80 freezer can lead to hysteresis, ice build-up, and many other issues that ultimately lead to a catastrophic failure. Implementing a solution for monitoring temperature stability and door openings helps predict and prevent these types of errors and failures.


HVAC System


HVAC systems are a pivotal component to ambient laboratory conditions and operations and are often overlooked. Air quality, temperature, relative humidity, and VOCs all have varying effects on many areas throughout a laboratory facility. Having poor quality air or unstable conditions can have a drastic impact on research results. Without monitoring HVAC functionality and quality, organization’s may be subject to undesirable conditions and issues. Proper HVAC monitoring can lead to valuable insights on air quality, laboratory conditions, and inconsistent research results.


A large east-coast based pharmaceutical company recently struggled to determine issues with reproducing consistent and stable research data. Several of their experiments and subsequent data registered at varying levels, despite being performed with stable equipment operating within desired parameters. Leveraging advanced monitoring solutions and in depth data analysis, they were able to determine that it was the HVAC system blowing air either too hot or too cold in the proximity of certain lab equipment at different times of the day when experiments were conducted. Identifying these HVAC issues improved ambient laboratory conditions and fixed this company’s research data reproducibility.


Power Outages


Total, or partial, power outages are more common than people realize and can result in many different types of errors, failures, and losses. These outages often occur after hours when there is no staff onsite to address the issues. When the average cost per power equipment failure is in excess of $350,000 it is important to have a fail-safe, redundant monitoring solution that ensures the proper systems are in place and operating in order to alleviate any issues from the initial power outage.


Monitoring a facility’s backup generator to be certain that the generator has switched on and is providing power to the facility is a key component to minimizing downtime as the operations team works to restore vital building systems, preserve sensitive environments, like vivariums, and protect valuable research samples.


Loss of Samples & Intellectual Property (IP)


Losing samples due to errors and failures can affect organizations immensely. Samples are stored in a variety of equipment that can be prone to errors and failures, unless they are monitored and protected. Preserving sample conditions and being able to replicate scientific research performed on them is pivotal to the drug development process. Losing samples not only sets back research timelines and adds a financial burden to lab operations, but can also lower the morale of researchers who have been running the experiments.


Lost or destroyed samples are detrimental for a life science organization’s ability to bring a viable drug to market. The average value of samples stored in a single unit of equipment is $100,000, making it imperative to ensure that sample storage areas are well maintained and closely monitored.



Audits due to Errors and Failures


Every life science company can expect a FDA audit at least every two years, with audit duration lasting at least five days. These audits can be prolonged or exacerbated in the event that errors and failures are common, especially if the company is unable to produce proper documentation showing why an error occurred and what steps were taken to prevent it from recurring. Significant errors and failures identified during an audit can lead to a FDA Warning Letter and Notice of Violation, and potentially to a full shutdown of a drug development program.


Implementing a robust monitoring solution with automated reporting will help ensure an organization’s preparedness for any internal or external audit. This type of solution also better enables quality control and quality assurance best practices and procedures.


XiltriX Lab Monitoring and Monitoring-as-a-Service


Preventing Errors and Failures


XiltriX is the first and only company to offer a robust laboratory monitoring solution and Monitoring-as-a-Service for life science companies. The XiltriX managed monitoring service leverages over 30 years of life science industry experience--without a failure--monitoring laboratory equipment, conditions and ambient parameters in order to prevent errors and failures in the lab. XiltriX delivers the world’s most robust, advanced monitoring solution, providing predictive analytics for preventive maintenance, as well as improving SOPs and best practices.


The XiltriX Monitoring-as-a-Service package includes implementation, configuration and management of all hardware and software, including all necessary upgrades and updates. The XiltriX Safety Net team manages every aspect of the hardware and software solution, 24/7, so that customers don’t have to dedicate resources to ensure optimal performance. Actively monitoring a variety of building systems, laboratory equipment and ambient environments for deviations from preset parameters and stepping in when a critical failure occurs to provide live support, XiltriX is a trusted partner for any life science organization aiming to minimize errors and prevent catastrophic failures in the lab.

 

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References:

1 DiMasi JA, Grabowski HG, Hansen RA. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics 2016;47:20-33.

2 Information Management for Facilities and Operations, © AIIM 2017 www.aiim.org