A scientist holding a tray of tubes containing blue liquid

What Are Biological Indicators (Spore Tests)?

Written by: Bill Warren

What Is a Biological Indicator & How Does It Work? A biological indicator is a test system that’s embedded within a process challenge device (PCD) and used to verify the efficacy of certain sterilization processes — such as those that rely on sterilizing agents like steam and vaporized hydrogen peroxide. Biological indicators are also commonly […]

Sterilization Cycle Development

How to Validate an Autoclave: Sterilization Cycle Development

Written by: Scott Mechler

Cycle development is an important part of both the autoclave procurement and validation processes. In previous posts about validation, we explored Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). We also discussed the importance of steam quality testing as part of validating your autoclave, as well as Factory Acceptance Testing. In this post, we provide guidance in developing sterilization cycles and […]


How to Validate an Autoclave: Factory Acceptance Testing (FAT)

Written by: Scott Mechler

A steam sterilizer, whether used for pharmaceutical or laboratory sterilizing applications, is designed to use steam under pressure as the sterilizing agent. When constructed, installed and operated correctly, a steam sterilizer should function properly and sterilize your load. But, how does a sterilizer manufacturer ensure the unit they’ve built is assembled properly and is in […]

steam quality

How to Validate an Autoclave: Steam Quality Testing

Written by: Scott Mechler

The quality of the steam feeding an autoclave is an important factor in steam sterilization. Like time, temperature, and pressure, steam is a critical variable in the success and repeatability of the sterilization process. As such, steam quality should be part of the validation of any steam sterilizer. In previous articles other phases of validation […]

performance qualification

How to Validate an Autoclave: Performance Qualification (PQ)

Written by: Amit Gupta

An autoclave undergoes qualification testing in order to validate and verify that it’s performing consistently and properly. In previous posts, we outlined the first two qualification tests known as Installation Qualification (IQ) and Operation Qualification (OQ). In this post we will review Performance Qualification (PQ) as a final critical step in validating your autoclave. What […]

operational qualification

How To Validate an Autoclave: Operational Qualification (OQ)

Written by: Amit Gupta

Every laboratory strives for consistency and repeatability in its sterilization processes. But this doesn’t come easily. In order to ensure your autoclave operates efficiently it’s critical that you validate the sterilization process and verify that the equipment is working safely and properly. This is known as Operational Qualification (OQ), and it’s one of the most […]

Installation Qualification

How To Validate an Autoclave: Installation Qualification (IQ)

Written by: Amit Gupta

There is an array of qualification tests that can be conducted to validate an autoclave. Many laboratories validate autoclaves by simply using biological indicators (BI’s). For some labs, however, a simple validation with BI’s is not enough and a more elaborate validation process must be followed. These labs typically require installation, operation, and performance qualifications […]