Thermal Mapping in the  Pharmaceutical Industry?

Thermal Mapping in the Pharmaceutical Industry?

Thermal Mapping or Thermal Validation is the method of validating or qualifying equipment and storage facilities, e.g., warehouses, storage facilities, refrigerators, freezers, incubators, cryo-apparatus, autoclaves, depyrogenation ovens and tunnels, lyophilizers, photostability chambers, SIP systems, etc., that you claim will maintain a defined temperature range or profile during their intended use and operation.  Thermal mapping determines if the facility or equipment will maintain the temperature range you claim under your actual conditions of use.

If you are in the pharmaceutical, biotechnology, or healthcare industries, you need to have properly maintained, calibrated, and validated equipment and facilities, not just for regulatory compliance but for reliable and profitable operations. You need to do thermal mapping of your temperature controlled equipment.

What are the tests performed during thermal mapping?

You want to do a risk assessment before you do the thermal mapping so you can identify all of the tests you need to do based on your risks.  You identify the required tests for your thermal validation study based on your risk assessment.

Common tests for refrigerators, freezers, and incubators include

  • Temperature Distribution Test (Empty Chamber)
  • Temperature Distribution Test (Loaded Chamber)
  • Pull-down Tests
  • Door Open Tests
  • Power Loss Tests
  • Alarm Tests
  • Recovery Time Tests

Common tests for Autoclaves, Dry Heat Ovens, Depyrogenation Lines, Pasteurizers, etc., include

  • Temperature Distribution Test (Partial Load)
  • Temperature Penetration Test (Loaded)
  • Pull Down Tests
  • Accumulated Lethality (Fo and FH) Tests

Other tests to consider based on your risk assessment include

  • Compressor Switch Over Tests
  • Compressor Failure Tests
  • Fan Failure Tests
  • Emergency Generator Cutover Tests
  • Routine Use Tests

How is Thermal Mapping done?

Thermal mapping involves the placement of an array of pre-calibrated temperature, temperature and humidity, or temperature and other parameter data-logging sensors in pre-defined locations within the enclosed space or the equipment.  You start the data-logging sensors and run the tests specified in your approved thermal validation study protocol.  You want to run the thermal validation study long enough to go through the planned defrost cycles for your equipment.  If you are mapping warehouses or facilities, you may want to consider mapping studies in both a hot, dry summer month and in a cold, wet winter month to show that no matter what the weather conditions your facility meets your specifications.  After the thermal mapping study, the sensors are post-calibrated to assure that the sensors are still operating as you expect.

How long does thermal mapping take?

A thermal mapping study takes one to two weeks, including the time to prepare and approve the protocol, pre-calibrate the sensors, the actual testing, and the post-calibration of the sensors.  Typical thermal mapping study execution times are in these ranges.

  • Temperature-controlled units (run duration or 24-72 Hours)
  • Warehouse/Dry Storage Facility (1 Week)
  • Cold Storage (24 Hours to 1 Week)

Results

The thermal mapping output is temperature (and other parameters) versus time report at each location.  The thermal map is a temperature (and other parameter) data plot for each location over time.   The final study report demonstrates that your equipment or facility can meet your specifications when you operate it as you intend to operate it.

PSC Biotech is the right thermal mapping service

If you need thermal mapping services, calibration services, and state-of-the-art wireless or wired equipment to do thermal mapping validation of your equipment and/or facility, contact PSC Biotech. Our thermal mapping experience and supply of calibrated state-of-the-art wireless and wired sensors can meet all your needs for thermal mapping.

Thermal Mapping in the  Pharmaceutical Industry?

Revolutionize Your Business with State-of-the-Art Validation Equipment

The life sciences industry validates and monitors everything.  The life sciences industry continuously collects validation and monitoring data.  The life sciences industry adopts the latest technologies.   The life sciences industry automates.  The life sciences industry needs state-of-the art validation equipment.  PSC has state-of-the-art validation equipment for your needs.

Promising Rewards

To make sure your business stays at the forefront of the industry – you must have the equipment to validate, monitor, and support your operations. The market around is full of businesses that constantly diversify their portfolios, and brave startups are coming after you to steal your thunder.  If you don’t maintain compliance, someone else will step right in and take it away.

In challenging times like these, the benefits of new devices can be a differentiator for your business. More important than buying a specific solution – is using trusted solutions that enable you to work more efficiently.

The Kaye Validator ® 2000 simplifies the process of thermal validation, particularly under extreme conditions such as autoclaves and dry heat ovens or ultra-low temperature freezers.  The Kaye Validator reduces the time needed to set up a thermal validation.

Wireless temperature, temperature and humidity, and other monitors from Lives International, Ellabs, and Cryopak can provide you with almost unlimited flexibility to validate and monitor environmental conditions for any equipment or facility.

Instruments like these enable you to stay competitive in an ever-changing market. But operating a business in an industry that is so prone to an upheaval can feel daunting at times.

It always feels like you’re on the brink of change!  Because you are!

Heightened Industry Standards Means Never Ending Validation

The life sciences industry continues to improve and heighten the current Good Manufacturing Practice standards.  You need to adapt to and adopt the latest standards just to remain compliant.  This means adopting improved technologies and improved levels of performance in your validation programs.

Cleanrooms are crucial to many life science operations.  CLiMET® monitoring and validation equipment gives you the state-of-the-art tools to show and maintain environmental compliance..

CLiMET’s stainless-steel exterior, ease of use, and touch-screen LCD interface  make environmental validation and monitoring a lot easier.  Oh yes, they are also incredibly portable.

We know the future.  Higher standards.  Never ending validation and monitoring.  A constant drive to improve performance and control costs while maintaining and improving the quality and reliability of our products, processes, and facilities.  If you don’t do it, your competition will leave you behind.

Cost-Effectiveness: Renting Can Be Better Than Owning

Even though the industry is moving at a blistering pace, owning validation equipment can be too much of a financial commitment for an average consumer. If your needs change, buying a device and watching it slowly go obsolete can be a devastating experience.

We recommend you consider renting validation equipment.  Renting gives you flexibility and cost control.  You rent what you need, when you need it, for as long as you need it.

The Bottom Line

Your business stands to gain from the exciting technological advancements to meet the needs of the life sciences industry.  Selecting the right equipment for your business can be a challenging task.  Let our skilled professionals help you to choose the right equipment and adopt the best operational practices. We understand that choosing the right validation equipment can save you both time and money.

PSC can provide you with state-of-the-art equipment.  We also excel in commissioning and qualifying validation equipment anywhere in the world. If your business has validation equipment needs, contact us today or click here to learn more.