The process of sterilization within a chamber or hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been and will be the device is a depyrogenation tunnel, the rate of speed (e.g., minimum, maximum, and nominal) must be measured and verified. The key function for depyro-genation is temperature control. Such depyrogenation devices require qualifying as part of validation. This is performed along the familiar lines of design qualifica- re-qual ification s. A depyrogenation st udy is a test of the. physical capabi lities of a dev ice to depyrogenate an a r -. ticle or device. It is demon strated by physica l measur e -. ments Thermal Validation. Autoclave Validation - Thermal Mapping; Steam In Place (SIP) - Thermal Mapping; Steam Quality Testing; Thermal Mapping of Incubators, Stability Chambers, Lyophilizers, Fridges & Freezers; Thermal Mapping of Cold Chain Supply; Thermal Mapping of Depyrogenation Ovens & Depyrogenation Tunnels Calibration of sensors and data logger. Selection , qualification and validity of biological indicators. Dry heat sterilization typically done in 160-190 °C where objective is sterilization rather than Depyrogenation. It will perform in empty condition only as expectation to sterilize the zone not the containers. The objective of this protocol is to establish the documentary evidence to demonstrate that the Dry Heat Sterilizer (Hot air oven) cycle is capable to destroy/inactivate the challenged Endotoxin. 2.0 SCOPE The protocol is applicable for Dry Heat Sterilizer, which is installed in Microbiology laboratory of Quality control department. All instruments shall be calibrated before starting and after completion of validation studies. Depyrogenation tunnel output calculator for bmi exposures were allocated in a randomized, crossover design. Signing of this approval page of protocol indicates agreement with the qualification approach described in this document. Model no. Non Operational Qualification. In addition to the common requirements outlined in the "General" section, the tunnel differential pressures prevent air travel from the dirty to clean areas. Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ± 20% The tunnel must meet specifications for total particulates for a Class 100 area. Our Depyrogenation Oven Equipment Qualification and Cycle Validation Services Include: Protocols with robust acceptance criteria intended to satisfy FDA general equipment qualification requirements, USP 37 compliance, and FFDCA Sections 503A or 503B for compounding pharmacies. Cycle development balancing quality, cleanliness and efficiency. When we perform oven and tunnel validation studies for depyrogenation, there is a requirement for a minimum three-log reduction of endotoxin. There have been many occurrences in the last few decades of initial studies meeting these requirements and then with no warning the endotoxin studies failing in subsequent qualifications. Calculations