Ensuring Consistent Performance in Controlled Environments
At Indivirtus Healthcare Services Pvt. Ltd., our Temperature Mapping and Validation services ensure the thermal performance of autoclaves, depyrogenation tunnels, cold rooms, and warehouses. Using calibrated data loggers and high-resolution systems, we deliver regulatory-compliant validation for WHO, EU GMP, and FDA standards.
Our services include temperature mapping protocols, sensor placement, data logger deployment, deviation analysis, and comprehensive validation reports, ensuring thermal compliance for critical equipment and environments.
Accurate temperature mapping ensures product integrity, regulatory compliance, and patient safety by identifying hot/cold zones and validating controlled environments.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led validation solutions, providing regulator-ready documentation to support compliance and audit-readiness.
At Indivirtus Healthcare Services, our Temperature Mapping and Validation services are led by certified validation experts with global regulatory expertise. We design customized protocols, deploy calibrated data loggers, and analyze data to map thermal performance across autoclaves, tunnels, cold storage, and warehouses.
Our approach ensures regulator-ready validation, aligning with WHO TRS 961 Annex 9, EU GMP Chapter 3 & 5, US FDA cGMP 21 CFR Part 211, and ISPE Good Practice Guide for Controlled Temperature Chambers.
Temperature Mapping Protocol: Customized plan for thermal validation.
Sensor Placement Plan: Strategic mapping for accurate data collection.
Calibrated Data Logger Deployment: High-resolution data acquisition.
Graphical and Tabular Data Reports: Clear insights into hot and cold zones.
Deviation and Excursion Analysis: Detailed evaluation of temperature variations.
Comprehensive Validation Report: Regulator-ready documentation.
Calibration Certificates: Verification of data logger accuracy.
Our Temperature Mapping and Validation services align with stringent global standards, ensuring your environments are audit-ready and compliant with international expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and product safety.
Our Temperature Mapping and Validation services are essential for pharmaceutical and biotech companies ensuring thermal compliance. Ideal for autoclaves, depyrogenation tunnels, cold rooms, and warehouses, our solutions support global markets. Key use cases include validating new storage facilities, ensuring compliance for FDA/EMA audits, and maintaining product integrity in cold chain logistics.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical and biotech companies, delivering expert-led validation solutions backed by certified professionals with global experience. Our services ensure regulator-ready outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, robust thermal validation, driving regulatory success and product integrity.
We validate autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouses to ensure thermal uniformity and compliance.
Sensor placement follows a risk-based approach using grid layouts to cover corners, center points, and critical locations for accurate thermal profiling.
Yes, we provide pre- and post-study calibration certificates for all data loggers, traceable to national/international standards.
Our final reports include detailed graphical outputs such as time-temperature plots, zone heat maps, and summary tables for easy audit interpretation.
Our reports comply with WHO Annex 9, EU GMP, US FDA, and ISPE guidance for good storage and distribution practices.
Our services include customized protocols, sensor placement, data logger deployment, graphical reports, deviation analysis, validation reports, and calibration certificates.
Pharmaceutical and biotech companies validating autoclaves, tunnels, cold storage, or warehouses benefit from our tailored solutions.
Our services align with WHO TRS 961 Annex 9, EU GMP Chapter 3 & 5, US FDA cGMP 21 CFR Part 211, and ISPE guidelines, ensuring global compliance.
Clients receive protocols, sensor plans, data reports, deviation analyses, validation reports, and calibration certificates.
Yes, our services are tailored to your specific equipment, storage systems, and regulatory requirements, ensuring compliant solutions.
We provide comprehensive, regulator-compliant reports and documentation to ensure seamless audits and compliance with global standards.