An Automated Autoclave Process for Use in Determining Glassware Quality [USP 660] Written by: Amit Gupta Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. The glass container manufacturing process directly results in the quality of glass produced. Certain types of glass are less durable than others and are therefore more susceptible to delamination of the interior of the glass container. If delamination occurs on […] Tweet Like Share
Your Guide to the ATF Bioreactor Sterilization Cycle Written by: Amit Gupta The ATF Bioreactor Cycle is designed to permit the sterilization of hollow fiber filters while housed in bioreactors such as those made by Repligen and Spectrum Labs. This cycle is a relatively new addition to the typical list of sterilization cycles normally found in laboratory autoclaves. Below is an explanation of the ATF Bioreactor Sterilization […] Tweet Like Share
What to Do About Stained Packs After Autoclaving: Common Causes and Affordable Solutions Written by: Scott Mechler In the summer of 2016, Windsor Regional Hospital (WRH) in Windsor, Ontario, was forced to cancel hundreds of surgeries at its Ouellette campus due to a “mysterious sterilization scare.” The strange scare, as reported in numerous media outlets, involved the staining of wrapping materials used to protect sterilized instrument trays during and after autoclaving. Because of […] 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
Survey Results Show Need for Cloud-Connected Autoclaves in Laboratories Written by: Arthur Trapotsis A recent survey of autoclave users (researchers, lab managers, and technicians) shows, unequivocally, that having access to a cloud-connected autoclave can and will boost productivity, as well as improve access to sterilizer data. In an earlier post — The Birth of the Internet of Labs (IoL) — we skim the surface on the benefits of […] Tweet Like Share
Prion Sterilization: Common Challenges Written by: Arthur Trapotsis Transmission of prion diseases through medical equipment remains an ever-present possibility in many laboratories and medical facilities around the world. As such, prion sterilization should not be taken lightly. Facilities that lack prion sterilization equipment and protocols for exposed or contaminated medical instruments not only put lab personnel at risk, but also endanger any future […] Tweet Like Share
Laboratory Autoclave Steam Sterilization Cycles, Part 10: Immediate-Use (Flash) Sterilization Cycle Written by: Arthur Trapotsis There has been much debate around the antiquated term “flash sterilization.” A concerted effort has been made by the Association for Advancement of Medical Instrumentation (AAMI), the Joint Commission (JC) and the Food and Drug Administration (FDA), to clarify the use of flash sterilization, which these organizations now refer to as “immediate use” sterilization. This sterilization cycle is not intended for routine instrument sterilization but only when specific instruments are needed for an emergency procedure. Read more → Tweet Like Share
Why To Autoclave Liquids With a Load Probe Written by: Amit Gupta In our previous Sterilization Cycles post on the F0 Cycle, we briefly reviewed the process for autoclaving liquids with a load probe. This post further discusses the benefits of using a load probe for sterilization validation. A load probe is a temperature sensing probe located inside the laboratory’s autoclave chamber. It is configured such that […] Tweet Like Share
Laboratory Autoclave Steam Sterilization Cycles, Part 9: Air Over-Pressure Cycle Written by: Arthur Trapotsis In the ninth installment of our Steam Sterilization Cycles Series, we explore Air Over–Pressure, another cycle used to sterilize a specific type of liquid load. An Air Over-Pressure Cycle is used to sterilize small liquid loads that are extremely sensitive to evaporation or boil-over in laboratory autoclaves. Typical applications for this cycle include pre-filled pipet tips, small pre-filled vials, loosely capped flasks, foil sealed glassware, or any partially vented containers where even small amounts of evaporation are not acceptable. Read more → Tweet Like Share
Bowie-Dick & Vacuum Leak Tests: Autoclave Sterilization Cycles Written by: Arthur Trapotsis The entire purpose of a laboratory or medical autoclave is to, quite simply, sterilize; however, without the proper conditions for sterility, an autoclave may fall short of its mission. Validation is an essential quality assurance measure designed to ensure that your autoclave operates exactly as intended. There are a number of different ways to validate […] Tweet Like Share
7.12.23 Cordyceps Sterilization: How to Kill “The Last of Us” Parasite → In HBO’s recent adaptation of “The Last of Us,” a popular action-adventure video game, life as we know it is upended by a parasitic fungus that transforms its human hosts into zombies. The culprit? Cordyceps, a real-life genus of fungus which is best known for infecting insects (most famously ants) in much the same manner […]
6.30.23 Top 13 Sterile Processing Mistakes in Hospitals → When it comes to ensuring patient safety in hospitals and ambulatory surgery centers (ASCs), the Sterile Processing Department (SPD) is among the last lines of defense. It’s this department’s sole responsibility to make sure that reusable instruments and devices are properly decontaminated, sterilized, and ultimately safe to use in future procedures — protecting patients from […]
6.22.23 Sterilization vs. High-Level and Low-Level Disinfection [a 3-Point Comparison] → In a 1939 paper, microbiologist Earle H. Spaulding introduced a system for determining which medical devices and instruments needed disinfection and which ones required sterilization. In it, he proposed that critical instruments would need to be subjected to more stringent disinfection protocols than non-critical patient care items. Today, this framework is fittingly known as Spaulding […]
