Mesa Laboratories : What You Need to Know to Choose an Excellent Cold Chain Management System

Effective cold chain management is crucial in ensuring temperature-control for pharmaceuticals. With today's easy access to mail-order pharmaceuticals, it's imperative for a cold chain system to be resilient during any delays or challenges that might occur, such as problems with customs or equipment breakdown. Cold chain management ensures the protection and compliance of your products throughout the shipping process - right into the consumer's hands.

There are several factors to consider when choosing a cold chain monitoring system, but the most important consideration is how well will the system will meet your specific needs and the needs of your facility. The system must be customizable and flexible to ensure ease and efficacy for your facility to implement and for your staff to use. When the system is being utilized across departments, the equipment and software must be able to adapt to each department's needs to guarantee prime usefulness and adoption.

The system should accurately and reliably monitor temperature, humidity and other critical parameters. Automatic and on-demand reporting must also be readily available in order to meet accreditation guidance, client requirements and/or industry standards.

What good is the data you have if you can't provide meaningful reporting and timely responses to inquiries?

Perhaps most important to any cold chain monitoring system? Its capabilities when an alarm situation occurs. An effective system adapts how it alerts by departments, piece of equipment, time of day, day of the week, condition parameters, delivery method and escalation protocols. These can mean the difference between immediate and appropriate action and interaction, and coworker frustration and product loss.

So, how do you choose the best cold chain monitoring system?

We've created a list of things you must consider in your decision-making process. The end goal is that you will choose the system that best meets your organizations' needs - now and moving forward - to better protect what is most vulnerable to you.

1). Sensor Battery Life

The typical duration of life for batteries used within a cold chain monitoring system may seem like a minor detail, but the way that the system utilizes batteries and how they are maintained and replaced can dramatically impact cost of ownership, especially if a service call is required for replacement.

Things to consider:

• What type of batteries are required?
• Are the sensor batteries user replaceable?
• What is the life of the sensor batteries?

2). Calibration

Most governing bodies are increasing their requirements when it comes to traceable calibration

of sensors used within a cold chain monitoring system. Suppliers vary greatly in that some do not offer a NIST-traceable certificate with new sensors and some also require on-site calibration as a yearly 'add on' service.

Things to consider:

• What is the annual calibration process and cost?
  • Can calibration be accomplished by the user?
  • Is a certification of sensor calibration provided with the initial installation?
  • Is a NIST-traceable certificate of calibration provided?

3). Network and Server Requirements

Depending on the architecture of the facility/department, organization-wide Wi-Fi strength and specific IT requirements, there are a number of different ways in which a cold chain monitoring system can be configured and installed. Often times, a system should be customized to reflect the specific attributes of your application in order to achieve the most usefulness and reliability from your monitoring system.

Things to consider:

Does the system have both a 900MHz and Wi-Fi option for system communications?

• If 900MHz, does the system provide both Repeaters and Ethernet based Access Points?
• Can the system be installed on a local server or is it cloud based?
• If local, is a dedicated server required? Can it be installed 'virtually' on an existing Hospital server?
• How does the system accommodate remote site installations?
• How does the system protect against interference with medical equipment and other devices?
• Is the system Web-based, providing remote access over the internet?
• If the network experiences an outage, how does the system compensate?
• Does the system hardware have integrated system back-up/buffering capabilities of the hardware

components?

• Are network status reports and/or diagnostic tools available with the system?

4). Sensors

The eyes and ears of any monitoring system, the sensors themselves are vital to any critical

parameter being monitored. As the last line of defense, the accuracy and reliability of the sensors is

vital to the effectiveness of any monitoring program.

As most systems are priced 'per point', it is important to understand the situations where an

individual sensor can monitor multiple parameters. Because of the multitude of situations that you

may want to monitor, it is also very important that the system's sensors can accommodate a variety

of parameters, locations and equipment. This planning will not only ensure that your current needs

are met, but it will also prepare for system expansion should this be necessary in the future.

Things to consider:

• What is the maximum number of sensors accommodated by the system?
• Do the sensors have two-way communication with the server?
• Do the sensors come with the ability to also monitor Door Open/Closed?
• Do the sensors have internal memory? How much/how long?
• What other types of sensors are available?

1. Temperature and Humidity
2. Ultra Low Temperature (-80°C)
3. CO2
4. Differential Pressure
5. Dual Temperature (top and bottom of combination units)
6. Liquid Nitrogen with Dry contact alarm status
7. Motion for Platelet Rotators
8. Temperature and Door Open/Closed Status
9. Dishwasher (hot water line)
10. Power/network outage

• Can a single sensor monitor multiple values, such as Temp & Humidity; Temp & Motion; Temp &

Door Open/Close?

• Does the system meet the Pharmacy's USP 797 requirement for Differential Air Pressure

Monitoring?

• Are the sensors water-resistant?
• How is the system performance impacted upon loss of connectivity or system failure?
• Is there a sensor 'low battery' alarm?
• How does the system provide notification during communication loss with a sensor?
• Can you place a sensor in a 'repair' status to prevent unnecessary alarms?

5). Alerting

The way that a system can alert its users to conditions outside of desired parameters varies greatly

from system to system. Often times, different departments are responsible for separate pieces of

equipment located in the same area and will need completely different alerting and alert escalation.

This functionality can be quite complicated, and it is necessary to understand if the system will meet

the needs of every department head and technician required to be in the loop on your equipment.

Things to consider:

• Does the system offer alert escalation?
• Can alert escalation be 'looped'?
• Can the system program a different alert escalation path for each sensor based on the time of day

and day of the week for non-24/7 areas?

• How many levels of escalation can be programmed for each event?
• Is there a local visual and audible alarm available?
• How does the system document corrective action?
• Can alert notification be programmed to respond based on the temperature exceeding the

temperature parameter and also a time parameter?

• Does the system have an 'alert threshold' which will give the unit a chance to recover in the event

of an out-of-range situation (e.g. door opened)?

• Does the system offer an alarm suppression feature which will allow for the flexible scheduling of

alert suppression based on customer requirements?

• Does the system provide for departmental control of alarm limits under their control?
• Does the system alert if a component should fail like a Sensor, Repeater or Access Point?
• Does the system provide continuous System Status of Health (SOH) monitoring with automated

alerts?

• If a component of the system should fail, is there a feature to identify the exact point of failure?

6). System Warranty Life

There are great variances in what is covered from system to system. Make sure you are comparing apples to apples when reviewing the warranty for continuous monitoring systems as the terms of the warranty can have a major impact on cost of ownership over time.

Things to consider:

• How long is the product warranted after initial installation?
• Are there any additional fees related to work done under warranty?

7). Service and Support

In order to get the most out of any continuous monitoring system, training and ongoing support are of utmost importance. From professional installation and installers to responsive after-the-sale service and support, this is the true measure of a professional solution and partnership. You need to be confident that the system you choose will be fully supported for years to come and that the organization you work with is structured so as to be able to meet your needs in a timely fashion.

Things to consider:

• Is complete system installation and setup provided by the manufacturer?
• What are your Service and Extended Warranty options?
• Are software upgrades provided as part of the service contract? How is the software upgraded?
• Is system training provided as part of the installation?

8). Reporting and Compliance

Preparing the data for various reports should not only be simple, it should be automatic! Many systems now offer the flexibility to automatically produce and print/save reports on a daily/weekly/monthly basis and are fully customizable based on your needs and preferences. You can also create very different reports based on departmental needs and any particular regulatory requirements. Systems can be configured to require input from those receiving the alarm so that it is documented that they acknowledged the event. Any action can be documented as well, keeping your facility in compliance and your documentation complete.

Things to consider:

• Does the system provide centralized administration and global administration of a single

database?

• Does the system provide for departmental control of alarm limits under their control?
• How are users, equipment and alert notification grouped within the system?
• Does the system meet the stringent requirements of Blood Banks including:

1. Calibration with NIST Traceability
2. Alarm check
3. Validation IQ/OQ
4. Temperature monitoring of upper & lower sections of Blood Bank Devices

• Is the system FDA 21 CFR Part 11 compliant?
• For Blood Bank/Transfusion Medicine applications (e.g. frequency of temperature determinations,

frequency of reporting to application software, if dual probes), is delta difference between the two

customizable for alerts?

To protect your assets, Mesa Labs offers cold chain monitoring services. From data logging and asset monitoring, to temperature and transport mapping, qualification, validation and package design and testing - we are there with you every step of the way. Feel confident that your products haven't been compromised with accurate, reliable asset monitoring.