What Are Biological Indicators (Spore Tests)? Written by: Arthur Trapotsis 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 […] Tweet Like Share
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 […] Tweet Like Share
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 […] Tweet Like Share
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 […] Tweet Like Share
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 […] Tweet Like Share
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 […] Tweet Like Share
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 […] Tweet Like Share
5.14.26 Consolidated Selected as Small Business Manufacturer by the University of California → What Set Us Apart Throughout the RFP process, Consolidated stood out for our: Relationship with UC, which predates this agreement, with many campuses already standardized on our autoclaves Low cost of ownership through non-proprietary parts and third-party service models, including local service Built-in water- and energy-saving features Support for both in-house and generator steam Custom […]
12.10.25 Introducing SterilSteam Sampler, The Steam Condensate Sampler for AAMI ST108 Compliance → Released in 2023, AAMI/ANSI ST108 establishes water quality requirements for water used in the cleaning, rinsing, disinfection, and sterilization of reusable medical devices. In addition to these requirements, ST108 mandates quarterly testing of steam condensate quality to ensure incoming steam does not stain instruments or pose a risk to patient safety. To help healthcare facilities […]
11.6.25 AAMI ST108 & Critical Water for Autoclaves: What ASCs Need to Know → A major step forward in patient safety, ANSI/AAMI ST108 establishes new minimum water quality requirements for water used in the cleaning, rinsing, disinfection, and sterilization of reusable medical devices. Despite providing guidance on water quality management for sterile processing, ST108 has also created confusion, especially regarding test protocols, water treatment, and critical water requirements. In […]
