EQUIPMENT VALIDATION

EQUIPMENT VALIDATION

a. CO2 INCUBATOR VALIDATION

CO2 incubator validation is a documented process to ensure an incubator consistently maintains the precise and stable environmental conditions required for cell culture. Aero Biotechniques is equipped with world class incubator CO2 analyzer and temperature and RH datalogger to provide the most accurate validation and calibration in the industry.

b.AUTOCLAVE VALIDATION

Autoclave validation is the documented process of confirming that an autoclave consistently sterilizes equipment and materials to the required sterility assurance level (SAL). This involves proving that critical parameters like temperature, pressure, and time are achieved uniformly throughout the load by using a combination of chemical and biological indicators. Validation ensures the autoclave is safe, reliable, and meets regulatory standards like those set by the FDA. Aero Biotech provide complete autoclave validation solution, some of our customers include pharmaceutical and bsl3 laboratories across India.

c.ETO VALIDATION

ETO validation (Ethylene Oxide validation) is the documented process of proving that an EO sterilization cycle consistently and reliably kills microorganisms on medical devices and other products, ensuring they meet sterility standards (like ISO 11135) through physical (temperature, humidity, EO levels) and biological (microorganism kill) testing, typically involving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases. Aero Biotech provide complete ETO validation service solution.

d. CENTRIFUGE VALIDATION

Centrifuge validation is a documented process to prove a centrifuge consistently performs as expected for specific applications, ensuring accuracy, quality, and compliance, especially in regulated fields like clinical labs and geotechnical engineering, involving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to check speed, temperature, vibration, and sample integrity (like preventing hemolysis) against set standards. Aero Biotech provide complete validation service for Centrifuge.

e. COLD ROOM THERMAL MAPPING

Cold room thermal mapping is the process of placing temperature sensors (data loggers) throughout a cold storage area (like a warehouse, fridge, or freezer) for a set time to record temperature variations, identify hot/cold spots, and ensure the entire space consistently stays within required temperature ranges, crucial for quality compliance in pharmaceuticals, food, and vaccines. It's a validation step to prove the storage unit's fitness for purpose, ensuring product safety and efficacy. Work is performed as per ISO, WHO and other international standards, at Aero Biotech we provide complete thermal mapping solution.

f.DEEP FREEZER THERMAL MAPPING

Deep freezer thermal mapping is the process of strategically placing calibrated temperature sensors (data loggers) inside a freezer to measure temperature distribution over time, identifying "hot" or "cold" spots and verifying the freezer consistently maintains precise, uniform temperatures for sensitive items like pharmaceuticals, vaccines, and food, ensuring product safety, quality, and regulatory compliance. It's a crucial part of equipment qualification, involving planning, sensor placement, data collection, analysis, and reporting to prove the freezer's fitness for its intended use. Aero Biotech provide mapping services as per standards like ISO, WHO etc.