When weather patterns shift from Summer towards Winter, it means one thing for sure, temperatures will shift from the warm side to the cold side. When that happens, the temperatures will be affected in your warehouse as well. For temperature sensitive product and equipment, this can be trouble if the temperature dips too low. That is where Kaye’s environmental monitoring capabilities come in to help you know exactly what is going on with the temperature levels in your warehouse.
We recently discussed this topic with Bill Robertson of VaLogic to learn more about what his company’s plans are for the upcoming winter season.
Kaye - What are your typical dates you target for the winter mapping?
Bill - Typically, we look to perform the winter profile studies starting in late December through March when average daily temperature and relative humidity are at lower points compared to other times of year.
Kaye - Do you have a certain duration and sample rate you follow?
Bill - For warehouse environments, the industry has in great part, standardized seasonal mapping studies to include a minimum a 72-hour study with 15-minute recording intervals. However, it is not uncommon for a client to have a higher sensitivity to any excursion in their environmental controls and require a more extensive mapping study. In such cases, mapping studies will usually extend to a 7-day study but have seen even more rigorous study period at 14 days. As with so many things in our Industry, one shouldn't automatically decide to use a "standard" approach. A well-designed study protocol needs to be fashioned to reflect a deliberate, risk-based approach that best ensures product or raw materials do not become adulterated..
Kaye - What are your typical measurements? Temperature, Humidity, etc.
Bill - Temperature and Relative Humidity are the most typical measurements across the board. Depending on the room design and material risk requirements, other parameters may include environmental monitoring of the space for non-viable particulates and viable counts, and/or differential pressure values across adjacent areas.
Kaye - Are there any major differences for your location when it comes to summer mapping as opposed to winter mapping? Do you take all the same measurements? Same location of sensors?
Bill - One thing is for sure; our industry loves consistency and reproducibility. That holds true for warehouse mapping studies too. The quantity, type of data points, and locations are almost always mirrored from one study to the next. This affords greater ability to normalize data sets and demonstrate the warehouse’s ability to maintain environmental conditions (temp, RH%, etc.) throughout any season.
In summary, the location of your sensors for a warehouse mapping are carefully selected based on risk assessment at the start of mapping exercise. These locations are kept same for both Summer and Winter mapping events. The duration (number of days) and sampling rate are kept identical for both events.
Kaye - Are there standard regulations for this type of mapping by the FDA or another organization?
Bill - Absolutely, and they are very helpful resources. Some of the most relied upon are:
- WHO Technical Report Series, No.961, 2011 Annex 9
Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products, 2011
- USP <1079> Good Storage and Distribution Practices for Drug Products
- ISPE Good Practice Guide: Controlled Temperature Chambers 2nd Edition, December 2021
- PDA Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain, Aug 2011
Kaye - Does real time data play a role in your study?
Bill - Real-time studies can be exceptionally helpful in the earliest stages. Often, we perform scouting studies to determine possible points of concern and demonstrate the facility’s overall state of readiness for the qualification process.
Kaye - Do you normally rent or purchase your equipment?
Bill – Most of our mapping-related equipment is owned by VaLogic. That said, we do augment our in-house assets with rental equipment when tackling a several large projects at once. Having the flexibility to rent equipment to increase mapping capacity is important as many of the mapping studies tend to end up “stacking” because of the seasonal brackets that we need to execute within for summer and winter. We take great measures to ensure any rented equipment meets the same high standards for reliability and compliance as . we have learned the hard way that cheaper is not always better.. Kaye by far develops and maintains their rental equipment assets better than any in the industry, whichh is why they are the only vendor VaLogic will use to support our rental equipment needs.
At Kaye, we offer the equipment that can make the task of monitoring your location much easier to do. If you would like to learn more about our mapping equipment options, please contact us today to get the process started. You can visit us online here: https://www.kayeinstruments.com/contact
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