Zach Sparks is the Manager of Validation Services for Mesa’s Global Service department and has worked in the validation and regulatory compliance fields since 2004. Zach holds a Bachelor of Science in Microbiology from Colorado State University and is certified in Consumer Products & Quality Assurance Microbiology with the National Registry of Certified Microbiologists.

Depyrogination

Validation of Dry Heat Sterilization Processes

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…

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FDA Code of Federal Regulations Title 21, Section 820.75

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,…

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Differentiating Design Validation & Design Verification

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…

Compliance

What is Validation?

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…