Using Advanced Glovebox Gloves for Environmental Contamination Protection

Gloveboxes play a key role in protecting products from environmental or human contamination in addition to protecting environments and individuals from workplace Hazards.

Image Credit: Shutterstock/Natalay Mayak

They ensure the containment of critical and sensitive materials and are designed to provide a controlled, enclosed work environment that is separated from workers by a barrier. The environment inside a glovebox is usually pressurized and clean or sterile, either negatively or positively in order to meet the specific needs of the application.

Gloveboxes are utilized widely across a number of industries, from food processing, to pharmaceutical and electronics manufacturing, to nuclear applications and more. In pharmaceutical companies alone, it is usual to find between 30 and 600 glove ports used per site.

Any of three different types of gloveboxes may be employed because of the propensity of sensitive materials utilized in the life sciences as each is designed for the level of cleanliness required or the specific hazards present.

Containment gloveboxes

Containment gloveboxes are designed specifically to protect the ambient environment and operator from the material which is being processed. Normally operated under negative pressure, containment gloveboxes are typically seen in pharmaceutical applications relating to the development of enhancing drugs, neurological pain drugs, oral treatments, nuclear medicine and other potent drugs.

Activities like weighing and dispensing, reactor charging, filter drying, powder transfer, drum charging, dryer discharging, fermenting, centrifuging, sampling, blending, and toxic animal handling are performed in containment gloveboxes.

Isolation gloveboxes

Isolation gloveboxes protect the material being processed from the environment and/or the operator. Typically under positive pressure, isolation gloveboxes are employed in applications like aseptic drug manufacture and filling and the development of parenteral (injectable) drugs.

Functions that are usually performed inside isolation gloveboxes include autoclave interfacing, tablet pressing, powder filling, freeze drying, sterile liquid filling, sterility testing and transferring.

Isolators

An isolator is the third type of glovebox. It combines features of isolation and containment gloveboxes, and includes both negative and positive pressure zones. For life sciences applications, these are utilized in the manufacture of cytotoxic parenteral drugs, biopharmaceutical cancer drugs and some chemotherapy drugs.

They are capable of ensuring an ultra-contained and ultra-clean space for product protection, isolators are utilized to contain some of the most dangerous and toxic materials known to man.

Glove integrity is vital

The gloves which are utilized inside any type of glovebox supply the crucial interface between the interior glovebox environment and the worker. They must maintain a reliable, clean barrier while enabling the worker to carry out manual tasks effectively.1

The integrity of the gloves is critical, so a glove breach is a breach in containment that puts products and/or workers at risk of contamination. Minimizing breaches in the gloves is a significant safety concern in daily operations across life sciences applications, as gloves are the weakest protection point of the glovebox.

While glovebox gloves are available in a range of configurations and materials, the key factor in choosing a glove is the material from which it is constructed. First and foremost, glove material must be approved for utilization among the hazards present, like radiation or chemicals.

Glove material is then chosen based on other application-specific characteristics such as mechanical performance, aging and anti-static properties, FDA compliance and its ability to resist tears or punctures.

The glove should ultimately ensure the greatest possible protection, fit, comfort and tactility needed to perform manual tasks effectively, safely, and efficiently for the duration of its use.

While traditionally, glovebox gloves have been made from CSM and natural rubber latex, recent advances in materials like nitrile provide significantly improved protection, longevity and reliability.

With so many vital factors playing into both the protection of workers and the safety of ultra-sensitive products, it is easy to see why choosing the highest-performing glove is critical to achieve best practices.

This article outlines the differences between innovative and traditional glove materials to help safety managers to choose the most effective, safest, and longest-lasting glovebox gloves.

Preparing gloves for use

When thinking about the overall longevity and performance of a glove, one must consider the various ways the glove is actively used, and also what the glove is exposed to throughout routine operations.

For example, the gloves may undergo sterilization prior to being mounted onto the glovebox when they reach the end-user. In most instances, gloves are washed in a dirty or non-sterile washing room, then wiped down with disinfectants, like 70 percent IPA (isopropyl alcohol), biocides or a combination of the two.

After that, the gloves move into a cleanroom area and sterilization happens either here or when they are mounted onto the port, a process also known as sterilization in place (SIP).

Depending on the application, sterilization and decontamination are obtained through a number of techniques, and could include autoclave with high heat or hydrogen peroxide, or other means of environmental and/or chemical exposure. Based on the type of glove material and the decontamination techniques used, each time gloves undergo sterilization, they are affected to varying degrees.

So, the amount of sterilization cycles a glove can undergo before replacement should be evaluated on an individual basis. Glovebox gloves will be exposed to the rigors of decontamination and sterilization processes as often as required over their service life.

Changing gloves

The frequency with which gloves are replaced varies based on the application and is dependent on multiple factors. These factors include the presence of pinholes or tears - which represent a breach in the barrier, degradation of physical properties due to the sterilization process, and the overall age of the glove.

Over time, gloves degrade as a result of excess stress and strain, exposure to chemicals, ozone, ionizing radiation, ultraviolet light, extreme cold or heat, and general wear. Lastly, gloves may be replaced because of a product batch change, as a means of avoiding cross-contamination.

Employers can increase the longevity of reliable performance and protection offered by the gloves by making informed decisions about the type of glove material utilized. This improves productivity, decreases downtime, and promotes cost savings.

Keys to promoting glove longevity

As a general rule, the glovebox glove should be treated like it is the operator’s skin. While it must be thick enough and strong enough to supply an impenetrable barrier, it must also ensure the elasticity, comfort, and tactility needed to ensure manual tasks can be performed as needed.

Operators should use general precautions to reduce glove replacement, like avoiding direct contact with anything that can puncture, degrade, or tear the glove, like hot or sharp objects or corrosive chemicals. How the gloves are stored can also impact their useful lifespan significantly.

It is vital to avoid storing gloves in the open when they are not yet mounted, as exposure to ultraviolet light and naturally occurring ozone degrades some glove polymers. For the best longevity, gloves should be stored in their original, sealed packaging away from direct light sources until they are to be used.

There are many characteristics specific to different materials that directly affect glove performance beyond these general guidelines. Below is a closer look at the attributes of common glove materials plus brand new offerings and the unique properties they offer.

Glove materials and their properties

Nitrile

Nitrile is a non-solvent based, synthetic, FDA-approved polymer and is the perfect alternative to latex, where the risk of latex allergies is a concern. It has excellent anti-static properties which prevent the buildup of static electricity, nitrile is ideal for utilization with flammable powders and liquids.

Nitrile can withstand multiple autoclave cycles and temperatures of up to 121 °C and does not become sticky like CSM. It can also be sanitized by vaporized hydrogen peroxide (VHP), gamma irradiation, and isopropyl alcohol (IPA) and non-sterile options can also be washed, processed and packaged within a cleanroom environment.

This ensures that before being introduced into the isolator glovebox, the gloves are an ultra-low contamination risk. Nitrile has huge benefits over traditional materials in physical performance with superior puncture resistance, dexterity and user comfort.

It also provides excellent chemical resistance providing more than eight hours of permeation protection against many cytotoxins and the ability to maintain its properties after gamma irradiation. Nitrile meets the requirements of life sciences applications better with significantly enhanced comfort, protection and performance.

Neoprene (Polychloroprene)

Also known as polychloroprene, neoprene is a family of synthetic latex products created by the polymerization of chloroprene. Neoprene gloves deliver very good elasticity and tactile comfort in glovebox applications, though they are not quite as strong as NRL.

Neoprene supplies slightly better chemical resistance over NRL, is somewhat flame retardant, and does not pose an allergy risk to workers, making it a popular choice for glovebox applications. Neoprene ages better than NRL; it withstands a fairly comparable amount of decontamination cycles before needing replacement.

FDA compliant for food processing applications, and provides better chemical resistance against a higher range of chemicals over NRL. Overall, neoprene’s increased chemical resistance without the risk of allergies makes it a more suitable choice for a number of life sciences glovebox applications.

Natural rubber latex (NRL)

Natural rubber latex is an extremely versatile and common glove material employed across a number of applications and industries. An organic compound with highly elastic properties, NRL is prized for its exceptional fit and comfort.

It may safely be utilized in slicing, packaging, filling and capping applications since it meets FDA compliance for food processing. NRL is easy to manufacture and is readily available in a variety of low-cost price points. However, in glovebox applications, NRL does not stand up to multiple autoclave cycles and may age more quickly than other materials.

The largest drawback to utilizing NRL gloves in gloveboxes is the health challenge they pose to a large number of workers who experience allergic reactions ranging from skin irritation to anaphylaxis, which is a potentially life-threatening condition.2

Workers can be affected from direct contact in addition to inhaling airborne latex particles released when someone removes latex gloves.3 While hand dermatitis is the most common condition associated with latex allergies4, reactions can worsen or individuals who were not allergic to latex previously may become sensitized with repeated latex exposure.

Generally, in most applications, NRL gloves supply excellent physical performance but lack of heat and chemical resistance, short glove life, and worker allergies pose sizable threats to widespread glovebox application use.

EPDM+ (ethylene-propylene-diene-rubber)

EPDM+ is a premium FDA-approved material (FDA CFR 21 Positive List), which is designed to withstand repeated autoclave sterilization up to 50 times, significantly decreasing the requirement for glove replacement compared to 6 standard latex, CSM or neoprene gloves.

EPDM+ is resistant against common disinfecting chemicals and hydrogen peroxide solutions, and withstands temperatures up to 130 °C to ensure longevity even after dozens of sterilizations, making it long lasting and durable. EPDM+ is also unique in its double-layer breach detection system.

The dual-tone coloring of the glove – a white outer material covering a black inner layer – enables easy, instant visual integrity inspection. The glove’s white external layer makes it perfectly suited for pharmaceutical applications where visual identification of breaches and contaminants is crucial.

EPDM

EPDM features all of the same advanced qualities in protection, durability, comfort, heat and chemical resistance, and FDA compliance as EPDM+. The EPDM glove does not feature the white outer layer of an EPDM+ glove.

Traditionally, gloves with higher protective qualities are less comfortable to wear. However, EPDM gloves supply not only extreme ruggedness and protection, but also a high level of dexterity, comfort, and tactile sensitivity to enable fine manual tasks and support workers’ muscle activity.

Available in both heavy and medium weights, the increased thickness of heavy-weight EPDM gloves adds durability for heavy duty applications (24 mil/0.6 mm). EPDM resists aging from exposure to UV rays, oxygen, and ozone, lending to the longevity of the material, and EPDM is suitable for disposal by incineration as it is halogen-free.

It is exceptionally suited for semiconductor applications because the glove material is fully conductive, and the dark coloring makes it a perfect solution in the production of dry powders.

CSM (chlorosulfonated polyethylene)

CSM is a synthetic material, and gloves constructed of it provide a combination of extreme chemical protection and excellent comfort, making them perfectly suited for utilization in vital, heavy duty environments.

Available in both heavy and medium weights, their soft, flexible attributes lend to worker comfort and muscle support to improve productivity, while the inherent thickness of CSM gloves enhances their durability and augments the glovebox’s physical barrier.

CSM provides a high level of resistance against concentrated acids and bases like hydrochloric acid, nitric acid, and ammonia, in addition to a number of oxidizing chemicals and alcohols, and can withstand temperatures of up to 120 °C, making it an ideal choice among high heat or flammable solvents.

Their use reduces the frequency of glove replacement and downtime, as CSM gloves provide better gamma and autoclave performance, plus significantly better resistance to aging from exposure to UV and ozone compared to neoprene and latex gloves.

However, the CSM glove’s material will degrade and require replacement after two or three autoclave cycles. CSM glove material is white, making contamination easy to detect, but it does not meet FDA standards.

Overall, CSM gloves provide better product protection and worker comfort, which in turn enables fewer glove changes, greater durability, and excellent performance in high-hazard, heavy-duty environments.

Nitrile, EPDM, EPDM+, and CSM gloves are designed to supply the best level of worker and product protection, together with extreme resistance and durability qualities for long-lasting use. Ideally suited for critical applications, these materials provide a diverse range of solutions tailored for the life sciences industry.

Conclusion

While many variations of glovebox glove materials have served life sciences companies for decades, none have come close to supplying the innovative combination of attributes offered by EPDM+, EPDM, Nitrile, and CSM.

Choosing the best glove for the application is crucial in an industry where a single glove breach can jeopardize overall operations. By selecting high-quality glove materials built for optimum comfort, protection and longevity, and manufactured by a trusted, proven leader, employers benefit from decreased risk and increased productivity – a winning combination in any facility.

Table 1. Source: Ansell

Material Style Number Port size Thickness
(mil/ mm)
Length
(in/ mm)
Hand size
EPDM +    85-600 8” (200 mm) 20 /0.51 31.5/800 L (9.5) - XL (11)
85-601 10” (250 mm) 20 /0.51 31.5/800 L (9.5) - XL (11)
85-602 12” (300 mm) 20 /0.51 31.5/800 L (9.5) - XL (11)
EPDM        85-500 8” (200 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-501 8” (200 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
85-502 10” (250 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-503 10” (250 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
85-504 12” (300 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-505 12” (300 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
CSM          85-300 8” (200 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-301 8” (200 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
85-302 10” (250 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-303 10” (250 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
85-304 12” (300 mm) 16/0.4 31.5/800 L (9.5) - XL (11)
85-305 12” (300 mm) 24/0.6 31.5/800 L (9.5) - XL (11)
NRL          55-100 6” (150 mm) 20/0.51 28/711 8, 9, 10
55-101 6” (150 mm) 30/0.76 28/711 8, 9, 10
55-104 8” (200 mm) 20/0.51 32/813 9, 10
55-107 9” (230 mm) 30/0.76 31/787 8, 9, 10
55-110 12” (300 mm) 20/0.51 32/813 9, 10
55-111 12” (300 mm) 30/0.76 32/813 8, 9, 10
55-113 8” (200 mm) 20/0.51 32/813 9, 10
Neoprene 55-300 6” (150 mm) 20/0.51 28/711 8, 9, 10
55-301 7” (180 mm) 20/0.51 28/711 9, 10
55-302 8” (200 mm) 20/0.51 32/813 9, 10
55-303 8” (200 mm) 30/0.76 32/813 9, 10
55-305 10” (250 mm) 20/0.51 32/813 9, 10
55-306 10” (250 mm) 30/0.76 32/813 9, 10
55-307 12” (300 mm) 20/0.51 32/813 9, 10
55-308 12” (300 mm) 30/0.76 32/813 9, 10

 

Table 2. Source: Ansell

Material Style Number Description Length
(in/ mm)
To fit port size Hand size
Nitrile    GGL15NIT59 Sterile & Clean Nitrile Isolator Glove 840 mm/33” 6 – 8”
152 – 203 mm
L (9.75)
GGL20NIT59 Sterile & Clean Nitrile Isolator Glove 840 mm/33” 8 – 10”
203 – 254 mm
L (9.75)
GGL33NIT59 Sterile & Clean Nitrile Isolator Glove 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
GGL36NIT59 Sterile & Clean Nitrile Isolator Glove 840 mm/33” 12 – 14”
305 – 356 mm
L (9.75)
GGL30NITM9 Sterile & Clean Nitrile Isolator Mitten 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
CGL20NIT59 Non-Sterile & Clean Nitrile Isolator Glove 840 mm/33” 8 – 10”
203 – 254 mm
L (9.75)
CGL33NIT59 Non-Sterile & Clean Nitrile Isolator Glove 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
CGL36NIT59 Non-Sterile & Clean Nitrile Isolator Glove 840 mm/33” 12 – 14”
305 – 356 mm
L (9.75)
CGL30NITM9 Non-Sterile & Clean Nitrile Isolator Mitten 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
GHG15NIT59 Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 6 – 8”
152 – 203 mm
L (9.75)
GHG20NIT59 Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 8 – 10”
203 – 254 mm
L (9.75)
GHG33NIT59 Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
GHG36NIT59 Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 12 – 14”
305 – 356 mm L (9.75)
CHG15NIT59 Non-Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 6 – 8”
152 – 203 mm
L (9.75)
CHG20NIT59 Non-Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 8 – 10”
203 – 254 mm
L (9.75)
CHG33NIT59 Non-Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
CHG36NIT59 Non-Sterile & Clean Nitrile High Grip Isolator Glove 840 mm/33” 12 – 14”
305 – 356 mm
L (9.75)
CHG30NITM9 Non-Sterile & Clean Nitrile High Grip Isolator Mitten 840 mm/33” 10 – 12”
254 – 305 mm
L (9.75)
GSG10NIT80 Sterile Nitrile Sleeve/ Polychloroprene Glove System
Size 8 - BioClean BPZS
System Length
32”/813 mm
10 – 12”
254 – 305 mm
8.0
GSG10NIT85 Sterile Nitrile Sleeve/ Polychloroprene Glove System
Size 8.5 - BioClean BPZS
System Length
32”/813 mm
10 – 12”
254 – 305 mm
8.5
GSG10NITXLMA Sterile Nitrile Sleeve/ Polychloroprene Glove System
Size 8 - BioClean S-BFAP
System Length
36”/914 mm
10 – 12”
254 – 305 mm
8.0
GSL15NITPP26 Sterile Nitrile Sleeve 660 mm/26” 6 – 8”
152 – 203 mm
N/A
GSL20NITPP26 Sterile Nitrile Sleeve 660 mm/26” 8 – 10”
203 – 254 mm
N/A
GSL33NITPP26 Sterile Nitrile Sleeve 660 mm/26” 10 – 12”
254 – 305 mm
N/A
GSL36NITPP26 Sterile Nitrile Sleeve 660 mm/26” 12 – 14”
305 – 356 mm
N/A

 

References

1. American Glovebox Society AGS-G001-2007, http://www.gloveboxsociety.org/PDFs/2007_Guidelines_Table_of_Contents.pdf

2. Mayo Clinic, “Diseases and Conditions: Latex Allergy,”

3. Mayo Clinic, “Diseases and Conditions: Latex Allergy,”

4. U.S. National Library of Medicine, National Institutes of Health, “Workers’ compensation

Acknowledgments

Produced from materials originally authored by Don Cronk from Ansell.

About Ansell

For over a century, Ansell has delivered the most advanced protection solutions to millions of people…at work, at home and in harm’s way.

In 1905, Eric Ansell recognized an opportunity when his employer was looking to dispose of some manufacturing equipment. With this discarded machinery, he founded what was to become the Ansell Rubber Company, initially a balloon & condom company that eventually expanded into surgical, household and work gloves.

In the years since, millions of people have come to rely on Ansell’s innovative products and safety solutions to protect them at home or on the job. The same dedication to quality and innovation that started with Eric Ansell, continues today, as Ansell has grown to serve 25 global industries in 120 countries in ways that shape and protect our modern world.

Ansell is SAFETY. We protect the most valuable asset of any company — its people."

Magnus Nicolin, Managing Director and Chief Executive Officer

 

 


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Last updated: Oct 19, 2020 at 8:42 AM

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