Understanding Pharmaceutical Temperature Mapping

Published by Patrick Famisaran on

pharmaceutical temperature mapping

Preserving and maintaining drugs and medicines is vital in the pharmaceutical business. There are efforts and innovations to streamline pharma operations. Despite these advancements, drug manufacturers suffer a significant loss each year. These losses come from temperature control failures. Limiting these losses requires a comprehensive approach to pharmaceutical temperature mapping. The regular mapping activity can reduce loss to revenue. It can also negate risks in administering harmful quality drugs.

Why is Pharmaceutical Temperature Mapping Important?

Different kinds of medicine need specific temperatures. These are constant conditions during manufacturing, transit, and storage. When temperature conditions deviate beyond the acceptable range, the chemical or biological properties will degrade, affecting the efficacy of the drugs.

Because of such importance, investments in cold chain storage are increasing. There is also an increase in awareness of the importance of environmental mapping. Standard operational protocols such as temperature mapping protect the product quality. It also ensures customer safety.

A thorough temperature mapping will ensure monitoring accuracy. It is also a proper maintenance practice for the facility. Moreover, mapping ensures compliance with regulations. Administering correct pharmaceutical temperature mapping highlights pharmaceutical safety. This credibility will increase profits in the long run.

Steps in Temperature Mapping

There are several approaches to temperature mapping. The steps provide practical solutions to any monitoring concerns. In principle, it outlines a general guide to a comprehensive pharmaceutical temperature mapping.

1. Understanding Regulatory Requirements

Pharmaceutical Temperature Mapping using AKCP Wireless sensor
Photo Credit: www.geminimetrology.com

The authority for all healthcare products in the United States Pharmacopeia (USP). It provides standards to all pharmaceutical stakeholders. Included in the guidelines are regulatory standards about:

  • dietary supplements
  • food supplements
  • over-the-counter medicines
  • prescription drugs
  • vaccines

The USP also provides guidelines for drug storage and shipping practices. Best accounts temperature ranges specific to refrigeration. Example of the temperature standards are:

  • Room temperature: 20 to 250 C
  • Controlled room temperature: 20 to 250 C
  • Cool storage: 8 to 150 C
  • Refrigerated storage: 2 to 80 C
  • Freezer storage: -25 to 100 C

Some products need a different storing protocol. These are medications sensitive to light and humidity. Safe handling of such drugs is in the protocol from USP.

2.Establishing Mapping Strategy

There is a regulatory guide for pharmaceutical temperature mapping. But implementing the whole monitoring activity is an iterative process. This requires careful checkpoint and analysis before conduct. There are many considerations in etching out a mapping strategy. As such, analysis of factors should first ensure before moving forward:

  • Identify Areas to Watch
Strategic Pharmaceutical Temperature Mapping
Photo Credit: www.pharmout.net

Different storage areas are strategic locations of temperature sensors. There are pharma rooms that are necessary points of monitoring. Will sensors be in the center? Does it need one sensor for each cold chain compartment? Can placing the sensors suffice in corners alone?

Careful mapping of sensors throughout the cold chain makes for holistic temperature mapping. The locations are benchmark areas that provide the general temperature condition. Hence, the need for careful identification.

  • Determining Risk Factors That May Affect Mapping

Certain variables can impact storage systems. These variables influence temperature conditions. Some examples are:

  • Weather conditions
  • Changing climates
  • Areas with sunlight exposure
  • Areas with airflow restriction
  • Number of windows and doors
  • Heating and air conditioning (HVAC) systems
  • Room structure

Factoring in these variables in the whole strategy will help better temperature reading. It ensures precise temperature reading and accurate figures for analysis.

3. Performing Temperature Mapping

When it is high time to conduct the mapping itself, considering certain factors is necessary. These are preventive control strategies that will mitigate any chance of monitoring failure. And often, these strategies are simple.

  • Proper Equipment to Use

Equipment can dictate the monitoring outcome. Sometimes, we revert to cost-efficiency in incorporating this mapping equipment. While it is best to consider cost, it is vital to check for accuracy ratings. Cheaper alternatives may compromise the whole mapping as a result.

AKCP Wireless Temperature Sensor for Pharmaceutical Temperature Mapping
AKCP Wireless Temperature Sensor

Included in equipment use is integrating backup systems. When advised that 2-3 sensors are enough, a couple more for backup is better. It can sustain mapping operations for more extended periods. Opting for battery-powered sensors is a form of backup as well. Reliance on electric-powered ones can be detrimental, especially in a worst-case scenario. 

Again, when choosing a piece of equipment: PRECISION, ACCURACY, and SUSTAINABILITY.

  • Testing

Conducting a comprehensive mapping entails more than environmental conditions. It also analyzes all other critical factors in pharmaceutical temperature mapping. This refers to:

  • Load testing
  • Uniformity testing
  • Recovery testing

Load testing is specific to temperature-controlled storage systems. This tests containers, compartments, or refrigeration devices that load medications and vaccines. Load testing measures the impact the storage system has on pharmaceuticals. Moreover, testing requires simulated checks on equipment breakage. It accounts for material make-up and shipment cooling also. These are some of the considerations in load testing.

Uniformity testing tests the standard and constant temperature condition.  This is especially relevant in a specific pharmaceutical storage room. Considering the variables, uniformity testing checks the extent of risks. These are risks brought about by sunlight exposure or airflow changes. At length, these factors are significant determinants of fluctuating temperatures.

Recovery testing checks the temperature return period. It gauges how long cold storage will go back to its standard temperature range. Because of many variables affecting temperature, temperature regulation is critical. Refrigerator door opening alone will affect temperature conditions. It will be a problem if the equipment cannot return to the proper temperature range.

  • Installing the System

The next step is to install the mapping system. This will only ensure after accounting all factors involved in pharmaceutical temperature conditions. Following the identified areas for mapping, sensor installation is vital. It should be in the best location to check a wide temperature range. They should cover the area that is vulnerable to changing temperature. But, place some sensors in the stable areas as well. This will serve as your control. It will ease out troubleshooting in case of different readings. 

Location variations are also suggested. Sensors should be near the products. As such, it should be at different heights also. Airflow is a factor in temperature fluctuations. The need to check the upper and lower areas in the room is essential. 

  • Calibration and Maintenance

Again, the name of the game in temperature mapping is precision and accuracy. So, the necessity of equipment calibration is crucial. Calibrations should meet regulatory standards. 

Maintenance procedures should be regular. Because pharmaceutical is an iterative process, it requires routine maintenance as well. This regular maintenance activity will augment the mapping needs. It can also cover some temperature indicators along the way. 

Reliable Mapping Solutions

It is always a good practice to conduct regular temperature mapping. In a pharmaceutical setting, consistent monitoring will determine vaccine and drug quality. Temperature mapping is imperative to anyone who manufactures, transports, and stores pharmaceutical products. 

Retrofitting a pharmaceutical facility with complementary monitoring solutions is an operational development. This is an essential consideration in a pharmaceutical operation. A robust monitoring capacity can be a competitive advantage in the industry. Incorporating monitoring tools into the whole mapping strategy will strengthen business operations.

Sensors are the primary mapping tool in pharmaceutical monitoring. There’s a wide array of sensors in the market. But calibration checks and regulatory compliant sensors are suitable investments. An example, AKCP provides temperature monitoring. As a solutions provider, its sensors are 2x NIST traceable, calibrated temperature sensors

AKCP solutions can provide a holistic temperature mapping relevant to any monitoring needs. AKCPro Pharma-Mon Server is capable of temperature tracking and other monitoring standards such as:

  • access control system to check and secure laboratory doors and medical refrigerators
  • temperature monitoring facilitating real-time graphs and alerts
  • air quality checks for pharma cleanrooms and sterile environment

These capacities fortify the whole pharmaceutical temperature mapping. It will provide good evidence support for regulatory reporting. In time, it will streamline all variable checkpoints relevant to standard temperature maintenance. 

The Next Step for Pharmaceuticals

AKCPro Server Access

Companies will spend more than $21 billion in cold chain services by 2024. This is according to BioPharma Cold Chain Sourcebook. Investment in pharmaceutical cold chains solidifies the need for a complementary monitoring solution.

One significant driver of monitoring solutions is data collection. While data should be precise and accurate, there are other considerations in monitoring.

  • Real-time data access
  • User platforms
  • Digital reports
  • Remote troubleshooting
  • Granular visibility

This is especially important when transporting pharma products. There are innovative sensors that are capable of offloading data to a user platform. Software with user access enables better monitoring capabilities.

The results of temperature mapping are subject to analysis and verification. It is then compared to the regulatory standards for compliance. As such, data access is an integral part of this process. Any chokepoint from gathering the data will be a hassle. It also negates potential monitoring risk. 

In the end, extensive investment in the cold chain requires innovative monitoring solutions. But innovation should equate to convenience. A good temperature mapping solution can provide simple steps and easy-to-understand reports. When done right, this will take out any complexity.  It will pave for a better mapping operation.

Reference Links:

https://www.pharmout.net/understanding-temperature-mapping/

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