Name: Gowning for a Cleanroom Space and Donning for a Biological Safety Cabinet
Uploaded: 2023-03-17T12:20:00
Description: Watch this Scientific Journal Video about Gowning for a Cleanroom Space and Donning for a Biological Safety Cabinet at JoVE.com

The video outlines the step-by-step procedure for properly donning personal protective equipment (PPE) in a cleanroom environment, specifically transitioning through ISO-8 and ISO-7 anterooms. It emphasizes hand sanitation, glove decontamination, and the correct way to wear sterile coverings before entering the biological safety cabinet.

gowning for a cleanroom space and donning for a biological safety cabinet

Microbial Control and Monitoring Strategies for Cleanroom Environments

Implementing a strong microbial monitoring program through environmental monitoring (EM), process monitoring, and product sterility testing is a regulatory requirement for current good tissue practices (cGTP) and current good manufacturing practices (cGMP) in cellular therapy laboratories1. Additionally, the United States Food and Drug Administration (FDA) expects that the laboratory performing the quality control (QC) testing of the product should also employ facilities and controls comparable to those used for aseptic filling operations2. 
This protocol has four main sections: 1) Aseptic practices, including personnel gowning, cleaning, and staging of materials; 2) EM, including viable air and surface cultures and non-viable particle air monitoring; 3) process monitoring, including settling plates and gloved fingertip sampling; and 4) product sterility testing via the compendial United States Pharmacopeia (USP) &lt;71&gt; method3 or the NIH Alternative Sterility Testing Method4. When used together, these measures can be an effective method for ensuring that a facility remains in a state of control.
The techniques described here are not novel; however, current standards from regulators and professional organizations lack detail, which has led to an absence of microbial monitoring or the implementation of non-standardized practices, particularly in academic centers where on-site manufacturing and product sterility testing are emerging at a rapid rate1,5,6. This protocol can be used as a guide to create a microbial monitoring and control program that meets regulatory requirements when used in conjunction with end-user validation and risk assessments.

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies  

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Clinical microbiology labs are being increasingly asked to assist with sterility testing as cellular therapies emerge as frontline treatment options. This project aims to provide clear instructions for implementing microbial monitoring and testing strategies applicable to any CGMP setting with a particular focus on academic and clinical laboratories. Gold standard microbial testing and CGMP relies on traditional culture-based methods, which are slow.While newer technologies exist, implementation is often limited by the regulatory requirement to conduct rigorous end-user validations to demonstrate non-inferiority. We hope that future work will help establish newer technologies into the mainstream for CGMP testing. There is no standardization between programs in CGMP.While a regulatory framework is provided, microbial monitoring and testing strategies are unique to each facility and rely on a risk-based approach and end-user validation. This can be confusing for establishing new CGMP programs in the clinical setting. Our group aims to bring awareness of CGMP to the clinical setting.We have published large-scale studies highlighting the advantages and pitfalls of blood culture systems for sterility testing as well as review articles demonstrating major differences between the clinical and CGMP microbiology labs and areas for consideration if implementing sterility testing in the clinical setting.

Watch this Scientific Journal Video about Gowning for a Cleanroom Space and Donning for a Biological Safety Cabinet at JoVE.com

Gowning for a Cleanroom Space and Donning for a Biological Safety Cabinet  

To begin, change into long-sleeved scrub top or short-sleeved scrub top with non-sterile sleeves, full-length scrub pants, and cleanroom shoes with shoe covers on. Sanitize hands with an alcohol-based hand sanitizer, and don non-sterile gloves, a beard cover if applicable, and a non-sterile bouffant. Remove the shoe covers, and step onto the tacky mat in front of the International Organization for Standardization or ISO-8 anteroom door.After discarding the shoe covers, decontaminate the gloves and door handle with 70%sterile isopropyl alcohol before entering the ISO 8 anteroom. Gather a sterile hood, face mask, coveralls, boot covers, and safety glasses. After decontaminating the gloves again, don safety glasses and stage the materials onto a clean surface.Don a new pair of non-sterile shoe covers over the dedicated cleanroom shoes, step onto the tacky mat, and enter the secondary ISO 7 anteroom, remaining on the dirty side of the demarcation line. Don the sterile hood and the sterile coverall, ensuring the neck of the hood is tucked inside the coverall to create a complete seal. Don the secondary sterile boot covers and decontaminate the gloves between each donning step before entering the ISO 7 space.To don into the biological safety cabinet, don sterile sleeves over the coverall, using thumb loops if present. Don sterile gloves over the existing gloves, ensuring the cuff of the glove extends over the sterile sleeve before entering the biological safety cabinet.

Research

JoVE Journal

Bioengineering

A well-validated and holistic program that incorporates robust gowning, cleaning, environmental monitoring, and personnel monitoring measures is critical ...