Compliance can be a complicated beast. The regulations in place are required reading for a wide variety of industries worldwide. They’re complicated because regulations regarding compliance don’t often provide specific direction. That’s why guidances are drafted by agencies and industry working groups to help educate companies on how they can comply with the requirements.
One of the guidances for thermal mapping that our services team often follows is published by the World Health Organization. Specifically speaking, the technical supplement to WHO Technical Report Series, No. 961, 2011 on temperature and humidity monitoring systems for fixed storage areas. It’s also what we follow during product development and innovation to ensure that what we have available to customers is compliant to their needs.
This document covers many different aspects of compliance including monitoring and the services that we provide. Today, we’re going to focus on the consideration needed for the system itself. Next time we’ll discuss the features said systems should include.
For now, here are some of the key requirements as written and defined by WHO. We’ll start with the minimum standards for temperature and humidity monitoring including alarm systems and components as well as for the operational management of these systems.
1.1.1 Temperature monitoring systems
Air temperature monitoring systems and devices should be installed in all temperature controlled rooms, cold rooms, freezer rooms, refrigerators and freezers used to store Time and temperature-sensitive pharmaceutical products (Referred to as TTSPPs). Electronic sensors should be accurate to +/- 0.5℃ or better.
1.1.2 Humidity monitoring systems
Humidity monitoring systems and devices should be used in temperature-controlled rooms that are used to store TTSPPs that require a humidity-controlled environment. Monitoring sensors should be accurate to +/- 5% RH.
1.1.3 Alarm systems
Temperature and, where necessary, humidity alarm systems should be linked to the monitoring system(s) with high and low alarm set points. There should be a visual alarm and also preferably an audible alarm, together with automatic telephone dial-up or SMS text warnings to key personnel.
These are the requirements your chosen monitoring system must meet for compliance. Each are met or exceeded by our DicksonOne line. Our replaceable sensors provide accuracies as defined above, and our alarms are second to none. In fact, you can even set up alarms to deliver on escalating terms should they not be addressed in the initial instance. Their flexibility can mean peace of mind, not only for compliance but for ensuring your product and goods are taken care of and any excursions are addressed before they can become a problem.
The next point the document speaks to is Good Storage Practice (GSP) as a regulatory requirement in most countries worldwide. Effective temperature monitoring and associated record keeping is critically important to this in all locations, regardless of size, where TTSPPs are stored.
2.3 Choosing a monitoring system
A monitoring system generally refers to an automated system that simultaneously and continuously records and documents one or more physical parameters (such as temperature and relative humidity) at one or more predefined points. A monitoring system is used to record and document the conditions in various storage areas whilst minimizing the need for manual measuring and recording. Such a monitoring system is increasingly required in facilities storing TTSPPs
2.3.2 Select the basic system type
There are two fundamentally different design options for a centralized monitoring system.
- Hosted system: For small-scale facilities with limited cold chain equipment, such as primary health care facilities and small pharmacies, the most appropriate hosted system will often be a standalone device; typically a simple portable electronic reorder which can be directly read by the person responsible for cold chain equipment.
- Software as a Service (SaaS): The monitoring system hardware (sensors and readers) is installed at the organization’s site, but the software, server, and database are hosted by the system supplier. The data are collected, stored, and managed by the supplier whilst the organization has access to the data through a secure web interface. In this scenario, the system supplier ensures the system maintenance and qualification.
DicksonOne is a SaaS-based system that allows you to store your continuously collected data in the cloud. That data is then accessible via a web portal available via any web-enabled device. Our touchscreens function wonderfully as a single device system, for a number of reasons. For one, your historical data can be viewed at the point of monitoring with the push of a button. For two, it’s easy to scale up should your needs ever expand.
Another important part of choosing a system is to match it to its needed use. Here are a few examples listed out in the WHO document.
2.2.3 Match the system to the needs
Each combination of operator and operation will have different monitoring and reporting requirements.
Large pharmaceutical warehouses: These organizations require reliable and adaptable monitoring systems with hardware that is designed for use on industrial sites. Wireless sensor networks are a suitable technology for these types of facility. Alternatively, hard-wired sensor systems may be used. Regardless of the chosen system, it is essential that it is compatible with the storage environment and can be altered and extended as necessary to suite changing needs. A web-based system, centrally hosted and monitored by the organization is typically used by these types of facilities.
Small-scale pharmacies and laboratories: Pharmacies and laboratories may find it cheaper and more convenient to use an externally hosted SaaS system because of the cost and complexity of the IT and operational requirements needed to support an in-house hosted system. This type of system generally uses wireless sensors, as they are easier to install in smaller facilities than wired systems.
These are just a few examples of industries and categories that have adopted DicksonOne as their preferred monitoring solutions. We’ve also done considerable business, however, with companies in the food industry, medical device manufacturing, logistics and more. In fact, we claim more than 75% of the Fortune 100 as our customers.
The last point we’re going to discuss today is the need for continuous monitoring that provides ease of accessibility to your data in order to ensure you’re always connected should any excursion occur.
2.3.4 Automated continuous monitoring
The monitoring system should preferably be automated and continuous. Installing a real time or nearly real-time data recording system is clearly an advantage. Automated data monitoring provides reliability advantages compared to manual measurements, which rely on human intervention.
Automated monitoring systems provide an array of analytical and reporting functions that can be accessed easily from any connected device (computer, phone, or PDA). Reports based on time, date, activity, input, event type or multiple criteria can then be generated. Data can also be compiled and analyzed over longer periods of time so that trending and risk analysis exercises can be conducted.
We’re proud to say that our cloud-based system, DicksonOne, checks all of the boxes listed above. That makes Dickson a premier choice for your company for monitoring. That’s why, when every point matters, you should always trust the compliance experts.