Thermal Qualification Services

Thermal Validation You Can Rely On

At Oorja Technical Services Pvt. Ltd., our Thermal Qualification Services are meticulously designed to validate the thermal performance of critical equipment used in controlled environments, sterile manufacturing, and storage. We ensure that all thermal systems consistently operate within defined specifications, maintaining product quality, process integrity, and regulatory compliance.

We offer complete Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services, following cGMP, WHO, and FDA guidelines. Our protocols are fully customized based on the equipment's intended use, client SOPs, and regulatory expectations.

Equipment We Qualify:

We perform thermal qualification and validation services for a wide range of equipment, including but not limited to:

• Autoclaves (B-type, Pre-vacuum, Gravity type)
   
• Dry Heat Sterilizers (DHS)
   
• Depyrogenation Tunnels
   
• Incubators & Laboratory Ovens
   
• Muffle Furnaces
   
• Vacuum Tray Dryers (VTD)
   
• Air Tray Dryers (ATD)
   
• Steam Tray Dryers (STD)
   
• Process Reactors & Water Baths
   
• Refrigerators & Deep Freezers
   
• Shipper Boxes / Transport Containers
   
• Lyophilizers / Freeze Dryers
   
• Steam Sterilizers / Steam Autoclaves
   

Key Features of Our Thermal Qualification:

• Use of high-accuracy, NABL-traceable temperature data loggers
   
• Mapping as per URS (User Requirement Specifications) and risk assessment
   
• Detailed analysis including temperature distribution, maximum & minimum hold times, and thermal equilibrium
   
• Graphical representation with time-temperature profiles
   
• Real-time monitoring with multichannel data acquisition systems
   
• Comprehensive documentation with validation reports aligned with regulatory standards
   

Benefits of Thermal Qualification with Oorja:

• Ensures consistent product quality and safety
   
• Supports regulatory audits with traceable data and documentation
   
• Reduces risk of thermal deviation or non-conformance
   
• Optimizes equipment performance and reliability
   
• Enhances process validation and environmental control
   

With a strong focus on precision, compliance, and technical excellence, Oorja Technical Services Pvt. Ltd. is your trusted partner for reliable thermal qualification of your temperature-sensitive equipment.