USP 660

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 […]

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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 […]

Sterilizer Staining

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 […]

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 […]

Prion Sterilization Common Challenges

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 […]

Laboratory Autoclave Steam Sterilization Cycles, Part 10

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. The Association for Advancement of Medical Instrumentation (AAMI), the Joint Commission (JC), and the Food and Drug Administration (FDA) have all made a concerted effort to clarify the use of flash sterilization, which is now known as immediate-use steam sterilization (IUSS). The particular cycle is not intended for routine sterilization but rather when specific instruments are needed for an emergency procedure.

Compared to traditional gravity or vacuum cycles, which are performed at 250°F (121°C), immediate-use cycles are performed at elevated temperatures of 270°F–275°F (132°C–135°C). As a result, immediate-use sterilization cycles are often shorter than gravity or vacuum cycles, which is where the “flash” in flash sterilization comes from.

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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 […]

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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 →

bowie-dick test

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 […]