Cleanroom wipes and gloves undergo LAL and Agar Overlay Analysis when testing for pyrogen and endotoxin levels. These tests ensure that cleanroom materials such as wipes or PPE do not introduce bacteria or pathogens into a cleanroom manufacturing process. This post details the methodology, historical relevance, and modern cleanroom solutions for pyrogen-free and low-endotoxin gloves and wipes.

Biological Contamination – Pharmaceuticals – Sterile Compounding – Lifesciences

Medical device and pharmaceutical cleanroom environments must address environmental exposure to bacteria, fungi, or viruses. Each common tool, material, or surface is capable of retaining microbiological artifacts, some inert, others parthenogenic.

Medical Devices, Pharmaceuticals, and Healthcare Wipe Contamination

In medical device and pharmaceutical cleanroom environments, providers must address environmental exposure to bacteria, fungi, or viruses. Repeated sterile outcomes are critical for applications such as sterile compounding, but also for test and research environments in laboratories and test facilities.

Every surface and tool is subject to a pragmatic and well-documented cleaning regimen that requires aggressive sterilants and certifiable products such as EPA registered, one-step disinfectants.

Example Wipedown Method for a Biological Safety Cabinet

Decontaminating critical tools or surfaces requires a multistep process with hyper-clean wipes, disinfectant agents, and sterile rinse water.

What are Pyrogens and Endotoxins?

Pyrogens

Pyrogens include endotoxins which are derived from Gram-negative bacteria. Non-endotoxin pyrogens result from chemicals or microorganism-derived substances (source).

Endotoxins

“Bacterial endotoxins, also known as lipopolysaccharides, are a fever-producing by-product of gram-negative bacteria commonly known as pyrogens”. (Source)

Endotoxins are toxins released after the destruction of a host cell. Some endotoxins are classified as pyrogens. Pyrogens are molecules that produce fever.