FDA Compliant: Devices for Remote Temperature Monitoring System

The pharmaceutical industry has very strict guidelines to control biological products. Time, temperature, and other variables affect the safety and usefulness of these medicines.

Who keeps track of these variables?

Are they still using a handheld probe and a sheet of paper to keep records?

How does that fit into reporting requirements?

The World Health Organization (WHO) applies HACCP to ensure the quality of vaccines. HACCP stands for Hazard Analysis and Critical Control Points. The Food and Drug Administration (FDA), regulates that biological products are manufactured similarly.

Controlling and monitoring vaccine temperature is necessary.  Only biological products with carefully monitored production and storage can guarantee efficacy.

Read on to learn more about efficient technology for remote temperature monitoring.

Control Every Step

Are you delivering the MMR shot to a school child?

Antibiotics to an outbreak of pneumonia in a senior community?

Platelets to a critically ill patient?

Lives are on the line. It’s why the FDA requires temperature monitoring. It is critical to the safety and efficacy of biological products.

During production, raw cultures require certain temperatures to grow. Other temperatures provide the all-important kill step. Finished products need certain temperatures for preservation. Someone checking the thermometer and writing the temperature down is inefficient.

Every point from manufacture to patient delivery matters. One aspect of vaccine manufacture is maintaining temperatures at certain critical levels

Manual Monitoring vs. Automatic

One aspect of biological product manufacture is maintaining temperatures at certain critical levels. To maintain effectiveness, freeze, refrigerate or store medication in temperature-controlled units. This prevents premature loss of efficacy due to improper storage.

There are different ways to check and control lab temperature. The manual method has many drawbacks. Checking a thermometer and recording the temperature requires personnel.

Personnel should have the training and motivation to do it correctly. The person must also act if the temperature is outside of parameters.

Automatic temperature sensing and recording can improve vaccine production safety.  This method allows for a continuous data stream of temperatures-24 hours a day, 7 days a week, every day of the year.

Remote Temperature Monitoring

Temperature sensing and recording are only part of the picture. Interpreting that data and monitoring still need human intervention. With wireless sensors, data is stored in a cloud-based server. Access is possible via any type of Internet-connected device. Use a reader, smartphone or computer easily.

The responsible person can retrieve the temperature readings from anywhere, at any time. You can send alerts to personnel if the temperature is outside preset limits.  Instant access to temperature data allows for immediate action to remedy the situation.

Wireless sensors have a reliable record-keeping capability. They make it easier to follow FDA regulations. Established FDA guidelines for record-keeping and documentation procedures need certain data on hand. Electronic temperature data is always available and complete, in any format required.

Safe Transport Challenges

Remote temperature monitoring during transport is a concern for many labs. To keep vaccines safe from spoilage during transportation, certain temperature thresholds are established.  The use of wireless sensors helps meet these requirements.

Improving the safety of pharmaceuticals in manufacture and transit is not without challenges. Labs can be a particularly difficult environment for wireless sensors. Metalwork surfaces and reinforced concrete walls play havoc on signals. Harsh temperature and moisture are tough on electronics.

In transit, sensors must upload their information. Wifi access can be sporadic, and difficult to get. Wired sensors create problems of their own. For example, inserting a wire conduit through a wall introduces contamination to an otherwise clean room.

Questions to Ask About Remote Temperature Monitoring

It is clear that wireless remote temperature monitoring is the answer. As you move forward, there are several systems to choose from. Some issues to ask about:

• Cost-effectiveness for the size and scale of my operations?
• Is data accessible from any PC or mobile device?
• Is data secure?
• Are there limits to data storage?
• What are the data logging and reporting capabilities?

Ask about uptime reliability:

• Does the system need downtime or is it 24/7/365?
• Is this an Ethernet-based system?
• Can the system accommodate both wireless and hardwired sensors?
• How many sensors can the base unit support?
• What happens in case of sensor failure or power outage?

Think about personnel:

• Can the system check inventory, dry storage, wet storage, refrigerators, and freezers?
• Notifications via text message, email, or phone call?
• Can one account manage many systems?
• Can the system monitor other variable conditions?
• Humidity, pressure,  water leaks, or power outages?

Depending on the type of biological product, you may need to meet standards for more than one agency.

Find the Best Devices for FDA Compliance

Finding the right combination of accuracy and data recording is a balancing act.  A good choice for compliant temperature monitoring is the system from SensoScientific. It features WiFi sensors for monitoring hot and cold applications from -200˚C to +200˚C.

The system adheres to 21 CFR Part 11 electronic record standards and ISO 17025. Unlike in-house solutions, this is a tested and proven off-the-shelf system. It follows the industry’s most stringent compliance standards. There is no need for expensive infrastructure investment in computers, software, or servers.

There are options for items that need more than temperature control. SensoScientific offers automatic wireless sensing capacity for many variables. Rigorous data protocols protect your information from malicious or deliberate interference.

Ask an Expert Today

Pharmaceutical and health organizations of all types and sizes, choose remote temperature monitoring. Professional groups including the FDA’s own labs, choose SensoScientific. Our technology and support systems maintain thousands of medicines every day.

• Automate manual monitoring activities.
• Alert personnel when conditions are out of parameter.
• Provide documentation with our technology.

Our systems are  100% compliant with all FDA regulations. They provide flexible reporting formats for all other regulatory bodies and medical associations.

Let our experts prove how a SensoScientific system can save you time and money. Contact us today.