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Valutek case Studies [Cleanroom Catastrophes]

Surgical-Medical-Exam Grade BOXED Gloves Are Not Equivalent to Cleanroom Gloves

Authored by Morgan Polen

Overview

Surgical-Medical-Exam Grade BOXED Gloves Are Not the Same as Cleanroom Gloves

In the controlled environment of a medical product cleanroom, gloves serve as the crucial barrier between operators and the surfaces they touch. Once those gloves are on, every touch becomes a potential source of contamination. This barrier is non-negotiable; it must remain uncompromised to meet the stringent requirements of US and International cGMPs, which mandate the control of both microbial and particulate contamination.

Operators heavily rely on their hands within cleanrooms, using them for a multitude of tasks, from handling tools and products to working at benches. Regular hand sanitization is a mandatory practice. However, using gloves not specifically designed and packaged for cleanroom use poses a grave risk, introducing contaminants into the cleanroom and jeopardizing the entire process.

The consequences of such oversight are far-reaching, with potential disasters including increased patient risk, failed media fills, sterility failures, product recalls, customer complaints, FDA Form 483 observations, and warning letters. In this case study, we delve into the critical importance of glove selection and compliance within the cleanroom, highlighting the dire consequences of neglecting this essential component of aseptic and non-aseptic operations.

If you're not using gloves manufactured and packaged specifically for cleanroom use, you risk introducing contaminants into your cleanroom and processes. 

 

Problems

The BIG 3 You Don’t Want In Your Cleanroom

The three contaminant types we need to manage in a life science cleanroom are particulates, bacteria, and endotoxins.

Sterile, medical-grade gloves may contain multiple contamination types because:


  • They are not made in a cleanroom.
  • They are not cleaned prior to sterilization.
  • They are not designed for longer working conditions.
 

The observed real-world practices in life science cleanrooms underscore the importance of recognizing that these actions can result in substantial problems and financial burdens for the organization.

If any of these practices are presently underway within the controlled environment, it is highly advisable to cease them without delay and initiate a comprehensive evaluation of the associated risk versus cost benefits. It is anticipated that upon evaluation, the decision to discontinue these practices will be regarded as a straightforward and prudent course of action.

This case study discusses the critical importance of managing particulates, bacteria, and endotoxins in a life science cleanroom environment, and underscores the necessity of addressing potential sources of contamination associated with sterile, medical-grade gloves with real-world practices.

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