Dry Heat Ovens
Autoclave / Sterilizer Qualification Services
Dry heat ovens are critical for processes requiring high-temperature sterilization and depyrogenation of heat-stable materials. At Vashishta Engineering Services, we specialize in validating dry heat ovens to ensure they consistently deliver sterile, pyrogen-free products and components.
Our Validation Approach
Our qualification process includes:
Heat Distribution Studies
Mapping temperature uniformity across the oven chamber to identify hot and cold spots.Heat Penetration Studies
Assessing heat transfer into representative product loads to ensure all items reach required temperatures.Microbial and Endotoxin Challenge Tests
Using biological indicators (B. subtilis) and endotoxin challenges to verify sterilization and depyrogenation efficacy.Bioburden and Pyroburden Determination
Evaluating initial contamination levels to establish appropriate process parameters.Filter Integrity Testing
Ensuring HEPA filters maintain integrity to prevent contamination during cooling cycles.Performance Qualification (PQ)
Demonstrating consistent performance under routine operating conditions.