As temperatures approach nearly 100°F throughout much of the country this weekend, many of us will seek relief poolside, at the beach, or at our favorite indoor air-conditioned venue.
Figure 1: Temperature outlook for this weekend shows many parts of the country will be close to 100°F.
And with many offices and laboratories empty for the weekend, HVAC or building management systems settings may be adjusted for energy conservation. While well-intentioned, it may cause extreme environmental conditions at your site that are not aligned with the Food and Drug Administration/Purpose Office of Regulatory Affairs (FDA/ORA) laboratory facilities guidelines. These are critically important as they help establish environmental conditions so that sample handling, instrumentation, analytical testing, and calibrations are not adversely affected or invalidated. Section 6.1.2 of the document outlines the need for laboratory climate control. It’s best practice to follow manufacturer’s specifications regarding storage and operational conditions, but there are also guidelines for working conditions (20-25C and 35-50% relative humidity) for your staff. Section 6.1.3 also lists lighting guidelines of 80-100 foot candles or 861-1076 lux for working conditions. Again, it’s best to follow manufacturer’s guidelines, especially when working with photosensitive materials.
Fortunately, there is an easily deployable solution which will provide consistent environmental monitoring and actionable insights for your team. Internet of things (IoT) equipped environmental sensors, Element-As, placed in various work environments have shown temperature, humidity, and light all trend upwards over the course of the first seven months of the year. See Figures 2-4. Notice how the often all three environmental parameters exceed the recommended FDA/ORA guidelines (highlighted in red) during the summer months.
Figure 2 - Noticeable temperature creep from January 2019 to July 2019
Figure 3 - Noticeable humidity creep from January 2019 to July 2019
Figure 4 - Noticeable light creep from January 2019 to July 2019
So what’s the big deal? We know it gets hot and humid in the summer, and we enjoy longer hours of daylight after what seems like endless dark winter days (especially here in New England). Well, one of the most costly, undesirable consequences of environmental variability in the lab is scientific irreproducibility. As you may already know, many biological processes are sensitive to temperature, humidity, and light, so it’s important that these parameters be maintained at consistent levels in the lab.
We’ve come across a few strong case studies/examples where environmental parameters have impacted scientific reproducibility. The first involves irreproducible results from an HPLC system at Sunovion Pharmaceuticals. The team noticed that the instrument readouts were inconsistent. They initially attributed the inconsistency to an instrument problem. However, when the manufacturer concluded that the system was in proper working order, the Sunovion team started exploring other parameters. The team placed a small environmental sensor, Element-A, in the vicinity of the HPLC, and they were able to find a relationship between instrument readouts and the temperature readings in the vicinity of the instrument. Ultimately, the team attributed the HPLC variability to hot or cold air blown in the direction of the instrument by the building HVAC system. This troubleshooting was facilitated by the use of the Elemental Machines Connected Platform that automates continuous environmental data collection.
While temperature variability was the root cause behind inconsistent HPLC data, humidity can also adversely affect scientific reproducibility. Liquid handlers, such as pipettes, are vulnerable to performance variability when humidity changes. For example, liquid handlers can underdeliver fluids by up to 35% in low humidity environments. Additionally, electrostatic discharge can also damage internal electronics, resulting in erratic readings/displays. On the other end, high humidity environments can also result in equipment performance issues due to corrosion.
Light variability in the lab throughout the year can impact bench work results as well as animal study results. Photosensitive materials, such fluorophores and dyes, play a critical role in illuminating biomarkers. Degradation of these materials could happen faster in the summer months as these materials are usually both light and temperature sensitive. Lastly, light variability is also important for pre-clinical drug studies involving animals, often mice. It’s recommended that mice are exposed to light cycles of 12-14 hours followed by dark cycles of 10-12 hours to reduce stress. Longer daylight hours in the summer should be accounted for in animal housing rooms.
In order to create work environments set up for success, it’s important for facility, operations, and quality team members to understand the type of scientific development that takes place that their facilities and then determine whether environmental variability that could be impacting the outcome of the studies. So, before you head out for the weekend, start the conversation with your colleagues. If you would like more information on how to automate continuous environmental data collect at your site(s), download our Environmental Monitoring E-Guide.