Surgical gloves, medical gloves, or exam gloves out of a cardboard dispenser box are NOT the same thing as cleanroom gloves. I’ve been in thousands of cleanrooms over my career, and it always shocks me when I see the wrong types of gloves used in life science cleanrooms. The unintended consequences can be disastrous—including increased risk to patients, failed media fills, sterility failures, product recalls, customer complaints, FDA Form 483 observations and warning letters.
Cleanroom Catastrophes Series: Surgical-Medical-Exam Grade BOXED Gloves Are Not Equivalent to Cleanroom Gloves
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First, let’s set the stage.
When working in a medical product cleanroom, gloves provide the barrier between the operator and any surface they touch with those gloves. The moment the glove is on the operator, everything the person touches is a potential transfer method for contamination. The barrier between the human and surfaces must not be compromised or act as a transfer mechanism. When it comes to medical products, US and International cGMPs require the control of microbial AND particulate contamination. Operators use their hands more than any other tool in the cleanroom—touching many things—tools, products, workbenches, etc. Frequent hand sanitization is required. If you're not using a glove manufactured and packaged specifically for this type of use in cleanrooms, you are introducing contaminants into your cleanroom and process. The gloves an aseptic operator wears are intended to be on for the entire time they are in the aseptic area. I want to be very clear—it is much cheaper to buy the correct gloves that are suitably packaged rather than having contamination problems or regulator observations related to operator’s gloves, much cheaper AND easier.
You may think, “Hey, we use gloves labeled sterile, medical, surgical-grade or gynecological -grade so they must be suitable to use in the cleanroom or aseptic area”. However, “sterile” is not the same thing as “clean.” Cleanrooms are environments designed and operated to establish a state of control suitable for the operations caried out inside the cleanroom. Sterile, medical-grade gloves and sterile cleanroom gloves only share one characteristic—they each have five fingers—that’s it.
The three contaminant types we need to manage in a life science cleanroom are particulate, bacteria, and endotoxins
And guess what? Sterile, medical-grade gloves may contain multiple contamination types as they are not made in a cleanroom, are not cleaned prior to sterilization, and are not designed for longer working conditions.
I’ve observed the following real-world practices in life science cleanrooms, and I am here to tell you that these practices can cause serious problems and cost the organization in more ways than one. If any of these practices are taking place in your controlled environment, STOP now and reevaluate the risk vs. cost benefit. I think you’ll agree it’s an easy decision!
We use “medical-grade, surgical or gynecological gloves”, but we spray with sterile 70% IPA to “clean or sanitize” them.
Spraying the glove with sterile 70% IPA may “sanitize” the glove, but it is not sterilizing the glove, nor is it removing contamination that is already present on the glove. These gloves still have particles left over from manufacturing and packaging, which can contaminate your process.
Be aware, “the contaminants in the glove factory (oftentimes half a world away) are arriving in your gowning room” and may be contacting critical products and sterilized garments operators are putting on. Cleanroom gloves are manufactured and packaged in cleanroom suitable packaging to control contamination.
Gloves packed directly in cardboard or fiberboard are a source of particle, microbial, and fungal contamination.
Cardboard or fiberboard are materials that should not get past the loading dock in any medical product cleanroom facility.
Sterile, medical, surgical-grade or gynecological-grade gloves are typically worn for a short time, typically a single procedure and are not intended to be worn for hours with the frequent hand sanitization required in medical product cleanrooms. Undetected pin holes or tears can be disastrous.
A specialty cleanroom supplier vs. a general “lab” supplier will know the difference between a cleanroom glove and a general-purpose PPE glove and assist with the product qualification process.
“It came out of my supplier’s catalog, so it must be okay.”
Widely available from many sources, these exam-grade PPE gloves are selected out of convenience. Buyers and production managers don’t intentionally source the wrong product, they often don’t know the difference
A generic selection process does not account for your requirements for the process performed in the cleanroom. Something so critical as a barrier to operator contact with your product warrants a thorough qualification process.
A specialty cleanroom supplier vs. a general “lab” supplier will know the difference between a cleanroom glove and a general-purpose PPE glove and assist with the product qualification process.
The fiberboard paper glove dispenser is used in the gowning room or cleanroom.
The paper dispenser may introduce bacterial and fungal contaminants, and it definitely introduces non-viable contamination (cellulose fibers) to your cleanroom via the gloves themselves. Under the right conditions (moisture), paper can grow fungus. Is there a fungus among us in your cleanroom? I hope not!
Any paper—notebooks, cardboard, fiberboard, dispensers, etc. not specifically designed for use in a cleanroom should never be in the cleanroom or gowning room, no matter what classification of cleanroom you are in.
Pulling gloves out of fiberboard paper dispenser does not permit proper donning and can lead to contamination. The operator is unable to grasp the glove from the cuff, which is the proper donning procedure. The operator cross-contaminates the palm of the glove with their ungloved hand.
Before you have a contamination event, implement these corrective actions.
The good thing about using the wrong glove is that it's an easy fix. It may take a bit of time to qualify a new product manufacturer and select the glove to meet your technical requirements and operator preference, but an ounce of prevention is well worth avoiding the pound of cure.