Thermal Validation
Precision Thermal Validation Services by Vashishta Engineering Services
Vashishta Engineering Services is a premier provider of thermal validation solutions for the pharmaceutical, biotechnology, and medical device industries. With over 20 years of industrial experience, our team of expert validation professionals ensures that your temperature-controlled processes and equipment operate with unwavering reliability, accuracy, and compliance.
We specialize in qualifying equipment that is critical to product sterility, stability, and efficacy, providing you with the documented evidence required for stringent regulatory audits.
Why is Thermal Validation Critical?
Thermal validation is not a luxury—it is a regulatory necessity. It provides the documented proof that processes involving extreme temperatures (e.g., sterilization, depyrogenation, incubation, storage) consistently perform as intended. This is fundamental to:
Ensuring Product Safety: Eliminating microbial and pyrogenic contamination.
Guaranteeing Product Efficacy: Maintaining the stability and integrity of drugs and materials.
Meeting Regulatory Compliance: Satisfying requirements from agencies like USFDA, EMA, WHO, and PIC/S.
Mitigating Risk: Protecting patient health and your company’s reputation by preventing costly recalls or audit observations.
Our Compliance Framework
Our validation protocols and executions are meticulously designed to comply with all major global standards, including:
USFDA: 21 CFR Part 210, 211, 820
EU GMP: Annex 1 and Annex 15
International Standards: ISO 17665 (Sterilization), ISO 13408 (Aseptic processing)
Indian Regulations: Schedule M