November 9, 2021
Temperature and Humidity Monitoring in the Pharmaceutical Industry
There are over 26,000 drug store businesses and pharmacies in the US. The growth of these businesses has been 3% in 2021, and the states where the most pharmacies are present are California, New York, and Texas.
Something that pharmacy business owners have to consider when storing their medications is temperature and humidity monitoring.
The same goes for those who run or own laboratories hospitals, blood banks, and pharmacy vaccine/VFC K-12 universities shipment data centers.
If you run or own any of these businesses, then you want to ensure that you are regulating temperature and humidity correctly. If you don’t know how, this could negatively impact the medications in storage.
Fortunately, in this article, we’ll review the best practices for temperature and humidity monitoring. Read on to learn more.
When it comes to temperature monitoring, there are several requirements and practices that you should use if you’re in the pharmaceutical industry. Some important requirements are set out by the World Health Organization, which is what we’ll first cover in this section.
WHO Temperature Monitoring Requirements
According to the WHO, there are certain optimal conditions you should meet. For one thing, medicines and other stored objects in pharmacies should be stored in areas where the temperature is the same as what the manufacturer indicates.
Additionally, they state that the range of general storage temperature is between 15 degrees and 25 degrees Celsius.
However, be sure that you note the specific requirements of each item you are storing.
This way, you won’t accidentally set the temperature to general store temperature when it should be a different temperature because of the specific items you’re storing.
The Four Types of Temperature Conditions
When it comes to temperature monitoring correctly, it’s important to be aware of the four types of temperature conditions. These include cool storage, room temperature, fridge storage, and cold storage.
Once you understand these, you can store items at the correct temperature according to the manufacturer’s advice.
The definition of cool storage conditions is between 46 and 59 degrees Fahrenheit or between 8 and 15 degrees Celsius. If you’re storing a medicine that requires this temperature, ensure that you set the temperature in the storage area within these ranges.
This is one of the most common storage room requirements for medications because most medications are designed to retain stability at room temperature. For pharmaceuticals, the definition of room temperature is between 68 and 77 degrees Fahrenheit.
Additionally, the definition extends to between 20 and 25 degrees Celsius.
Some medications will require fridge storage conditions. The definition of this temperature type is between 25 and 36 degrees Fahrenheit or between -4 and 2 degrees Celsius. Like room temperature, this is a common temperature storage requirement.
The definition of the cold storage temperature requirement is between 36 and 46 degrees Fahrenheit or between 2 and 8 degrees Celsius. This temperature condition is ideal for inhibiting microbial growth and chemical reactions.
Cold storage is a standard that is ideal for the storage of vitamins and drugs that are highly degradable.
Best Practices Related to Temperature Monitoring
Even though there are many ways you can control the temperature according to pharmaceutical industry standards, heat exposure can sometimes occur in a pharmacy setting. Malfunctioning equipment, heatwaves, and power outages can all cause this.
Fortunately, there are several practices you can use to ensure your temperature monitoring is as effective as possible.
If heat enters a pharmacy, having airflow set at a proper level can dissipate this heat. For this reason, it helps to have vents and windows through which air can flow. Regarding windows, put up screens so insects don’t enter, and keep them open as often as you can.
Additionally, use fans to circulate the pharmacy’s airflow as much as you can.
Another practice you can use to protect medicines from any unexpected changes in temperature is to ensure that they are packaged properly, using the seals and coverings that are suitable for the medications. Don’t open new packages unless it’s necessary to.
Additionally, when containers aren’t in use, ensure that they are sealed properly.
You must have an air conditioner in your pharmacy for days that are particularly hot. Additionally, you should schedule maintenance regular for your air conditioner so that you don’t end up with one that doesn’t work on one of these hot days.
One of the problems with boxes and shelves that are tightly packed is that they can trap heat. This in turn can cause medications to gradually overheat. For this reason, you should place boxes in such a way that there is airflow traveling between them.
Following the Right Temperature Monitoring Guidelines During Transport and Delivery
In the pharmaceutical industry, it’s also important to follow the right temperature monitoring guidelines during transport and delivery. Otherwise, even if you have the proper conditions at your pharmacy, you could end up with negatively impacted medications.
According to the World Health Organization, there are certain requirements you must meet when transporting and delivering medications in vehicles that are temperature-controlled.
One of these is that the temperature must have an accuracy of 0.5 degrees Celsius that is more or less the amount as the required temperature.
Another is that it must be possible to calibrate the temperature against a traceable, certified reference standard. This must occur at least once every year.
Additionally, the person handling the transportation and delivery must provide documentation regarding the temperature that can be accessed and stored.
Also, for each device, the person handling the transportation and delivery must provide a record of temperature with a recording frequency of at least six times each hour.
There must also be a possibility of positioning for the monitoring of positions that are worst-case.
Using a Temperature Monitoring System
Finally, one of the best practices you can use to ensure the maintenance of temperature at the right levels is to use a temperature monitoring system. These are much more effective than monitoring temperature manually.
Instead of having to rely on a recording that can be inaccurate or inconsistent, and only being able to check the temperature during working hours, you can get a more accurate and consistent check of your pharmacy’s temperature.
These systems are automated and will alert you if there are any temperature issues. As a result, your pharmacy’s temperature is being constantly checked and you can fix any issues if they come up very quickly.
The World Health Organization also has optimal conditions related to humidity monitoring. According to this organization, humidity levels that are relative should be a percentage that is 60 percent or lower. By ensuring you meet this requirement, you can store your pharmaceutical items properly.
Best Practices Related to Humidity Monitoring
When it comes to humidity regulation, there are several practices you can use to maintain humidity levels effectively and monitor them. These include having separate sealed areas, preventing moisture migration, and more.
Having Separate Sealed Areas
When it comes to areas where you’re storing medicines that require a low humidity level, you should ensure that they are separate from other areas with ceilings and walls that are sealed off well. You should also use suitable airlocks to separate them from areas nearby that have higher humidity.
Prevention of Moisture Migration
Sometimes, moisture can migrate to the HVAC system you have installed in your pharmacy. Use the strategies needed to ensure that this doesn’t occur, as you don’t want moisture to migrate to your HVAC system.
Removal and Adding of Moisture
When it comes to setting humidity at the right level, there are two actions you have to take once you have the humidity data that tell you whether the humidity has to be higher or lower. One of these is to remove moisture from the air and the other is to add it.
When it comes to the removal of moisture, you can do this with chemical dehumidifiers or refrigerated dehumidifiers.
The right type of cooling media for when you’re dehumidifying includes refrigerant or a mix of glycol mixture and chilled water.
The problem with humidifiers is that they could end up becoming a contamination source (for example, microbial growth). For this reason, when you’re making the area more humid, you should use the right type of means.
For example, you could inject steam into the stream of air.
Before doing this, complete a product-contamination assessment to figure out whether you should use clean or pure steam when completing the humidification process.
Additionally, make sure that you check for chemicals like chelating agents or corrosion inhibitors. These could detrimentally affect the product, so you should not add them to the boiler system.
You should also ensure that whatever humidification system you’re using is well-drained. This is because you don’t want condensate to accumulate in your air-handling system.
In addition to humidifiers, there are other humidification appliances you should avoid. These include water mist sprays, atomizers, and evaporative systems. They also have the potential microbial contamination risk.
Ensure the Surrounding Area Has the Appropriate Features
The area surrounding the area in which you are monitoring humidity should have the appropriate features. For one thing, the duct material shouldn’t add any contaminants to the air that will end up being filtered downstream.
Additionally, you should insulate cold surfaces so that there isn’t any condensation on components that handle the air or in the clean area.
You also shouldn’t install any air filters that are immediately downstream of the humidifiers.
Use the Right Type of Chemical Driers
If you’re using chemical driers, you have to use the right type. These include lithium chloride and silica gel. Note, however, that they are only acceptable if they will not become contamination sources.
If they might, you should avoid using them.
Using a Humidity Monitoring System
It can also be helpful to use a temperature and humidity monitoring system. You can track humidity conditions more easily and effectively with a system like this, and you can also do this securely. You get real-time data access and data measurements that are accurate.
Additionally, you can receive alerts anytime storage conditions aren’t in an optimal state, and you’ll also have access to intelligent alarms. Other benefits include:
- Data logging that is automatic
- The manufacturing process becomes streamlined
- Brand quality maintenance
- Improved productivity
- Data security
You’ll also know exactly when you have to implement solutions for humidity control, and you’ll get data security, simple implementation, and flexible data access. Another benefit is that you’ll be able to produce and access historical data.
Many of these solutions are remote. So in addition to having the most accurate information necessary when you need it, you’ll be able to access this information from anywhere.
This means you can deal with the issue ASAP, even if no one is in to improve the humidity levels.
Technologies such as the humidity transmitter and humidity sensor can also be quite helpful.
Looking for Temperature and Humidity Monitoring Solutions?
Now that you’ve learned about temperature and humidity monitoring in the pharmaceutical industry, you might be looking for temperature and humidity monitoring solutions. In this case, you should look no further than SensoScientific.
At SensoScientfic, we have products that allow you to monitor temperature and humidity.
To learn more about the products we have available, check them out now.