Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle…
Section 820.75 of the FDA Code of Federal Regulations Title 21 defines the Process Validation requirements of 21CFR820.70 – Production and Process Controls. The Process Validation requirements include: Validation of the production process is required if the final results of a process cannot be verified by subsequent inspection or testing. The validation testing and results,…
Design Validation frequently gets confused with Design Verification – they are quite different processes, though. With verification, you’re making sure that the product meets the requirements identified by customers and regulations. Validation is where you actually build a functioning version of the product to make sure it performs as expected. In Section 820.3(z), the FDA…
There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…
