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 […] Tweet Like Share
Consolidated Introduces First-Ever Remote Validation Service Written by: Arthur Trapotsis If you are the owner or operator of a laboratory or medical autoclave, it’s in your best interest to ensure that your unit is operating at optimal performance levels at all times. To that end, it’s important to validate your autoclave, both upon initial installation and on a routine basis. In this blog post, we’ll […] 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
10.21.24 How to Start an Ambulatory Surgery Center (ASC) → If you’re a physician who’s considering opening their own ambulatory surgery center (ASC), you’re in good company. MCG Health reports that, of the 5,800 ASCs on record in the U.S. in 2023, 95% were at least partially physician owned and 52% were solely physician owned. The incentives for physicians are clear: ASCs offer greater autonomy […]
10.15.24 The Different Types of Autoclaves [& How to Choose the Right One] → Steam sterilizers — also known as autoclaves — are an essential piece of equipment in any laboratory, research, or healthcare setting, ensuring sterility for important equipment and instruments. Autoclaves are available in a wide array of designs, each tailored for specific applications, ranging from small-scale laboratory sterilization to large-volume industrial processes. Choosing the right autoclave […]
9.30.24 Horizontal vs. Vertical Autoclaves: 6 Key Differences and Benefits → If you’re looking for a new autoclave for your facility, chances are you’ve considered several options during your search for the right one. When it comes to the question of whether a vertical or horizontal autoclave is the right fit for your lab or medical facility, understanding their key differences is crucial. To help you […]
