MDTL offers Thermal Validation studies  as per the applicable standards  and can also create individual customized testing strategies.

Thermal validation of medical equipment is a critical process to ensure that the equipment functions within specified temperature ranges, particularly when it comes to devices that come into contact with patients or are used to store sensitive biological materials. This validation process helps verify that the equipment operates safely and effectively under various environmental conditions. Here are key considerations for the thermal validation of medical equipment:

Validation of steam and hot-air sterilisers according to EN, ISO, VYR, further of freezers, thermostats, incubators (including CO2 incubators), refrigerators, chamber cooling plants, etc. Temperature map, stability study, heat penetration in material, verification of probes, steam quality, pressure, CO2 level, RPM, etc.

Certainly, the transportation and storage validation, as part of the broader thermal validation process, is crucial for ensuring that medical equipment remains safe and effective throughout its lifecycle, especially during transportation and storage. Here are key considerations for transportation and storage validation:

Temperature Mapping during Transportation:

Conduct temperature mapping studies during the transportation of medical equipment to assess the temperature variations the equipment might experience during transit. This is especially important for sensitive devices or those with temperature-sensitive components.

Cold Chain Validation:

For medical devices requiring temperature control within a specific range (e.g., vaccines, biologics), perform cold chain validation. This ensures that the product remains within the required temperature range from manufacturing through transportation to storage and eventual use.

Validation of Storage Conditions:

Validate the storage conditions for medical equipment to ensure that the designated storage areas maintain the required temperature and humidity levels. This is critical for devices with electronic components, biologics, or other temperature-sensitive materials.

Temperature Monitoring Devices:

Use temperature monitoring devices during transportation and storage to continuously monitor and record temperature conditions. These devices should be calibrated and provide real-time data to ensure that any deviations can be addressed promptly.

Duration of Transportation and Storage:

Consider the expected duration of transportation and storage when conducting validation studies. Longer durations may require more robust packaging and temperature control measures.

Simulated Transport Studies:

Conduct simulated transport studies in controlled environments to replicate the conditions the equipment may experience during actual transportation. This allows for a comprehensive assessment of the impact on the equipment.

Risk Assessment:

Conduct a risk assessment to identify potential risks associated with transportation and storage, and prioritize mitigation strategies based on the criticality of these risks. By systematically validating transportation and storage conditions, medical equipment manufacturers can enhance the overall reliability and performance of their products, contributing to patient safety and regulatory compliance.

Temperature Mapping Equipment:

MDTL offers Temperature Mapping Equipment studies  as per the applicable standards  and can also create individual customized testing strategies. Different medical devices may have varying thermal requirements. Classify the equipment based on its intended use, and consider factors such as the type of materials it handles, the patient interface, and any temperature-sensitive components.

Performance Qualification (PQ):

Perform PQ studies to validate that the equipment operates effectively within specified temperature ranges under normal operating conditions. This involves testing the equipment with controlled temperature variations.

Installation Qualification (IQ) and Operational Qualification (OQ):

Prior to PQ, conduct IQ to ensure proper installation of the equipment and OQ to verify its operational capabilities. These qualifications set the foundation for subsequent thermal validation steps.

Worst-Case Scenarios:

Identify and test worst-case scenarios where the equipment may be exposed to extreme temperature conditions. This ensures that the equipment remains safe and effective even under challenging circumstances.

Temperature Sensors and Monitoring:

Use calibrated temperature sensors to accurately measure and monitor temperatures. Establish a robust system for continuous monitoring during normal operations and integrate alarms for temperature excursions.

Calibration of Equipment:

Regularly calibrate temperature monitoring equipment to ensure accuracy in measurements. Calibration certificates for instruments used in validation should be up to date.

Validation in Real-World Conditions:

Consider real-world conditions in the validation process, including factors like room temperature variations, humidity levels, and potential interference from nearby equipment.

LIST OF EQUIPMENTS THAT WE CERTIFY, QUALIFY AND VALIDATE:

• Sterlilizers
• Hoods
• Laminar airflow cabinets
• Biological safety cabinets
• Biological isolators
• Premises with controlled air cleanliness
• Sterilization tunnels
• Thermostats
• Freezers
• Fridges, incubators
• Chamber fridges
• Chamber incubators
• Stability chambers
• Heating surfaces
• Fermenters
• Centrifuges
• Filtration stations
• Aerosol filtration
• Heating, ventilation, and air conditioning systems (HVAC)
• Compressed air systems (cleanliness)
• Continuous monitoring systems
• Decontamination systems
• Cleanroom garments and fabric (particle release)
• and many others

Thermal validation is an integral part of ensuring the quality and safety of medical equipment, especially when it involves the well-being of patients or the storage of temperature-sensitive materials. Following established guidelines and standards is essential for regulatory compliance and maintaining the efficacy of medical devices.