Isothermal Qualification

Qualification is the process by which it is verified that a piece of equipment or system meets its established specifications and requirements. It is a component of the quality assurance process.

It seeks to ensure that the equipment or system operates correctly and according to the manufacturer's specifications and the user's needs.

Types of Qualification

• Design Qualification (DQ): Verifies that the design of the equipment or system meets the user's specifications and requirements.
• Installation Qualification (IQ): Ensures that the equipment or system is installed according to the manufacturer's specifications.
• Operational Qualification (OQ): Verifies that the equipment or system operates according to its specifications under normal operating conditions.
• Performance Qualification (PQ): Ensures that the equipment or system operates correctly under normal usage conditions and meets user expectations.

Applicable Equipment

• Water Baths
• Stability Chambers
• Ethylene Oxide Sterilization Chambers
• Freezers
• Cold Rooms
• Drying Ovens
• Incubators
• Cooking Pots - Preparation Tanks
• Temperature and Humidity Profiles
• Refrigerators
• Ultra Freezers
• Production Equipment
• Power Plants