Temperature & Humidity Mapping Validation

Temperature mapping validation is a critical process that involves a detailed analysis of temperature distribution within a controlled environment. It ensures that all areas maintain the required temperature levels consistently over time. You need it to verify that your equipment, such as refrigerators, freezers, and storage units, are performing correctly and maintaining the integrity of your temperature-sensitive products throughout their shelf life or during processing.

The frequency of temperature mapping can depend on several factors, including the type of equipment, the criticality of the stored materials, and regulatory requirements. Generally, it's recommended to perform temperature mapping annually, upon installation of new equipment, after significant changes to the facility or equipment, or after a major repair. However, Quantus can help establish a schedule that fits your specific operational needs and compliance requirements.

Yes, Quantus has the expertise and the technology to conduct temperature mapping on a wide range of equipment, from standard laboratory refrigerators and freezers to ultra-low temperature freezers, Controlled Temperature Units (CTUs), incubators, ICH stability chambers, and large-scale warehouse storage units. Our services are adaptable to any temperature-controlled equipment you use.

Quantus differentiates itself with rapid deployment of off-the-shelf templated protocols for quick service delivery, the flexibility to work with both OEM and customer-generated protocols, and the ability to customize protocols for unique customer equipment and processes. Moreover, our commitment to delivering final reports within two weeks sets us apart in terms of efficiency and customer service.

Absolutely. Quantus' temperature mapping services are designed to meet the most stringent regulatory standards, ensuring compliance with FDA guidelines, GMP requirements, and other international standards. We provide comprehensive documentation and support to make sure your validation processes are audit-ready.