Decontaminating N95 Masks with Steam Sterilization

Written by: Amit Gupta

Can N95 Masks be steam sterilized for reuse?  This article attempts to answer this question by giving a review of the current literature and taking a closer look at N95 filter types and materials of construction. The ability to autoclave N95 masks would be ideal because autoclaving is a proven sterilization process and existing autoclave […]

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 […]

Laboratory, GLP, and GMP Steam Sterilizers

What Is the Difference Between Laboratory, GLP, and GMP Steam Sterilizers?

Written by: Amit Gupta

“What is the difference between a GMP and a non-GMP (i.e. GLP and/or basic lab research) steam sterilizer?” The sales and engineering teams here at Consolidated Sterilizer Systems get this question a lot. Many clients mistakenly believe that Good Manufacturing Practice (GMP) requirements are universal to all steam sterilizers used in pharmaceutical or biotechnology facilities. […]


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 […]


Sterilization 101: How Does a Laboratory Autoclave Work?

Written by: Amit Gupta

Steam sterilization is an important process, one that is performed in every laboratory. In this article, we will explore the history of steam sterilization, how a sterilizer works, and emerging trends in sterilizer design. An Introduction to Steam Sterilization Terminology The terms steam sterilizer and autoclave are synonymous and can be used interchangeably. That said, […]

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 […]


Autoclave Chamber Material: Stainless Steel vs Nickel-Clad

Written by: Amit Gupta

Current, state-of-the-art laboratory autoclave chambers are manufactured using stainless steel. In the past, autoclave manufacturers constructed sterilizers using nickel-clad, a highly corrosion-resistant material. The industry has shifted due to the rising cost of “cladding” over the last 10-15 years, heading in the direction of primarily 316L stainless steel. Why should you care? Because while stainless […]

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 […]