Thermal Validation

Uni Cal Labs Private Limited is a leading specialist provider of validation services. We have grown as a reputable company and offer our services nationally & internationally. As an industry leader we are having more than 10 years / nearly a decade of experience using both thermocouples and thermistors.

The pharmaceutical industry is a highly regulated environment based on research, evidence, record-keeping and validation. Our experience and expertise will give you a clear, compliant and transparent validation package.

The term "Thermal validation" is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for.

Our range of bespoke services to the pharmaceutical, biotechnology and healthcare industries. We specialise in the validation of international standards as per WHO TRS 961, ISO/IEC:60068, HTM 2010.

Validation and Monitoring equipment (Wired & Wireless) are major responsibilities comes under thermal validation. Well maintained and calibrated equipment ensures that it operates at peak performance and complies with regulatory requirements

We are specialises in the qualification of the following equipment:

• Autoclave / Sterilizer Qualification
• Cold rooms, Warehouse and Room Mapping
• Depyrogenation Ovens Qualification
• Lyophilizers Qualification
• Depyrogenation Tunnels
• BOD, Deep Freezers / Walk In Freezers
• Photostability Chember Qualification
• Steam-in-Place Qualification
• Incubators
• Stability Cabinets
• Washer Disinfectors
• CIP Systems
• Dry Heat Ovens
• Furnaces
• SIP Systems
• Ultra Low Freezers

Clean Room, Warehouse, Cold Containers & Cold Room Mapping:

Cold Chain Validation suddenly became a hot topic when the results of a government investigation into Cold Chain distribution compliance were published. The facts release indicated that nearly a quarter (23&precnt;) of all drugs distributed in the USA, are of unknown efficacy. The distribution of these temperature sensitive products in vehicle containers that lacked validated methods of maintaining the correct internal temperature or even the ability to produce a validated history of what the actual conditions were; has rendered these products 'adultered', i.e. of unknown efficacy or safety. Vehicle body internal temperatures; with seasonal variations, can range from a high of 50 to a low of -40 (degrees centigrade). In contrast the mandated internal temperature for distribution containers for standard drugs and medical products is 2 to 8 (degrees centigrade), with much lower temperatures specified for some drugs.

This shocking news has certainly guaranteed that Cold Chain Validation compliance will be top of everyone's audit list, specifically when drug interactions with the end user are considered as critical. The implications of products being damaged and out of specification may induce many companies to replace doubtful goods or even trigger the regulators into initiating product recalls. This problem is expected to create a veritable stampede as distributors scramble to ensure that all the vehicles and containers they used in this essential everyday service, are rendered Cold Chain compliant, as soon as is possible.