Does Glove Color Matter?

Not so long ago, the presence of color in a disposable glove indicated a latex-free glove. Nitrile exam gloves were usually some shade of blue. Latex gloves were a natural color, and looked like – well, latex.

But not anymore.

Nitrile exam gloves are now available in a rainbow of colors. Nitrile cleanroom gloves come in colors other than the standard white. And latex gloves are available in colors other than “natural.”

While choice is nice, does glove color matter?

Maybe.

Cleanroom Glove Color

In cleanroom and controlled environments, contamination is a constant concern. Contaminants can come from the glove, other materials, and from the workers.

White cleanroom gloves are the industry standard. Contamination is easier to see on a white glove. White also conveys and promotes the “clean” message to workers.

Color is a glove additive, and additives can react with the product or process. For this reason, less color is preferred. This is also true for white cleanroom gloves, as white is also an added color. Some white gloves contain less dye than others, reducing the risk of unwanted reactions.

While white is the industry standard, there are use cases for a colored cleanroom glove. A blue cleanroom glove may provide more contrast, making it easier for workers to do their job well.

Glove Color in the Lab

Laboratories are frequently faced with the possibility of cross-contamination. This can happen when an employee inadvertently transfers substances from one area of the lab to another on their gloved hands.

Assigning a specific glove color to each area of the lab can help. For instance, blue gloves could be used in one area, and white nitrile gloves in another. Wearing different colored gloves provides supervisors and employees a visual cue. This can help prevent costly errors caused by cross-contamination.

Colored Medical Gloves

Health care facilities often prefer a colored nitrile. This helps staff differentiate between latex and non-latex gloves.

A shade of blue is the traditional nitrile color of choice in medical facilities. But in recent years other colors such as gray, purple, and pink have become common.

Glove color can be useful in identifying glove failure. Double gloving, wearing a dark glove underneath a light colored glove, can help reveal punctures and small tears.

A Rainbow of Dental Gloves

Glove manufacturers that focus on the dental industry have marketed a rainbow of colored and scented nitrile and latex gloves.

Some dental offices like to color-coordinate their scrubs and gloves. Other offices prefer to use a dark blue nitrile exam glove to reduce the visibility of blood. For the dental hygienist, glove selection is most often a matter of personal choice.

Because glove color has become an effective marketing and branding tool, we will likely continue to see new exam glove colors. Glove color choice will still be influenced by the industry, purchasing decisions and cost.

What do you think?  Does glove color matter?

Editor’s Note:  This post was originally published on Dec. 13, 2011 and has been completely revamped and updated for accuracy and relevancy.

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Endotoxin Testing of Surgical and Cleanroom Gloves

Endotoxin Testing of Surgical and Cleanroom Gloves

Endotoxins are large molecules found in the outer membrane of Gram-negative bacteria. If enough of the molecules get into the bloodstream of humans or animals, they produce a variety of inflammatory responses. Symptoms range from fever and septic shock to low blood pressure and respiratory distress.

Gram-negative bacteria are ubiquitous – found in soil, water and living organisms – so avoiding them isn’t an option. Glove testing and manufacturing controls are employed to reduce the risk of transmission during surgery, whether from surgical gloves or other medical devices.

Endotoxin Testing

To lower the risk of infection and possible death, sterile medical gloves and some cleanroom gloves are tested for endotoxin contamination.

Horseshoe-CrabUSP Chapter <85> Bacterial Endotoxins Test. There are 3 methodologies to detect or quantify endotoxins in sterile medical and cleanroom gloves – Gel Clot, Turbidimetric and Chromogenic. All three methods utilize a reagent produced from the lysate of amoebocytes (white blood cells) of the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus.) This test is often referred to as Limulus Amoebocyte Lysate or LAL.

The average contaminant concentration is reported in endotoxin units per device (glove pair.) The FDA has set a limit of 20 EU/device for medical devices that have direct or indirect contact with blood or lymph fluid. Devices that come into contact with cerebrospinal fluid have a much lower limit – 2.15 EU/device.

Contamination Control

To reduce the amount of contamination on their end product, medical device manufacturers need gloves with low endotoxin levels for their employees. Endotoxin contamination on gloves can vary.

In a 2007 study performed by the Malaysian Rubber Board, endotoxin contamination on latex surgical and examination gloves varied widely between brands. The non-sterile examination gloves tested ranged from <8.4 EU/glove pair to as high as 9,632 EU/glove pair. Most of the sterile surgical gloves in the study were generally clean, with most in the minor to moderate contamination range. A few, however, did test much higher than the FDA limit.

These potentially deadly, fragmented remains of bacteria are bioactive and difficult to kill. Endotoxins can adhere to medical implants and devices, even after sterilization.

Thus, endotoxin contamination control is an important part of medical device manufacturing. Glove manufacturers use a variety of technologies and environmental controls to reduce particulate and biological contamination. The most common approach is to package surgical and cleanroom gloves in a cleanroom environment or white room that is regularly cleaned and sanitized, and operated by workers that are gowned and gloved.

Although bacterial endotoxins are everywhere in our environment, thorough testing and diligent contamination control can result in safe medical devices that enhance our lives.

HandPRO9100_LowEndotoxin_post

Glove Testing Demystified – Tensile Strength and Ultimate Elongation

Glove Testing Demystified - Tensile Strength and Ultimate Elongation

Glove material strength and stretch are important factors in a glove’s quality and performance. Medical and cleanroom gloves undergo testing according to ASTM D412 to meet International standards. This ensures you get a glove that is not prone to tear or fail, and has adequate stretch.

What is ASTM D412?

ASTM D412 is one of over 12,000 standards that operate globally under ASTM International. The current version of the standard is D412-06a(2013) Tensile Properties of Vulcanized Rubber and Thermoplastic Elastomers – Tension.

In this standard, glove material is measured for tensile stress (or tension,) tensile strength, yield point and ultimate elongation.

The Tests

InstromIn Test Method A, a die cut “dumbbell” shaped piece of glove material is stretched from either end by a machine at a constant speed until it breaks. The computer on the machine collects the data as the piece is stretched. Once the piece breaks, the sample’s elongation is measured and recorded.

The test is repeated on samples that have been put through the accelerated aging process in heating chambers according to ASTM D573. This test simulates the glove’s physical properties at the end of its shelf life. This is a “worst case” scenario. Many gloves that have been stored properly, in a cool, dry place away from sunlight, heat and humidity, will have better strength and elongation than the “after aging” test results.

Tensile strength is measured in MPa, or megapascals. The minimum tensile strength for latex exam gloves before aging is 18 MPa, and 14 MPa after aging. The minimum tensile strength for nitrile exam gloves is 14 MPa both before and after aging.

The minimum elongation for latex gloves before aging is 650%, and 500% after aging. Nitrile gloves have a minimum elongation of 500% before aging, and 400% after aging.

Typical Performance vs. ASTM Minimums

Most gloves, however, are manufactured with much higher tensile strength and elongation properties than the ASTM minimums. The typical performance of HandPRO® RoyalTouch300™ Nitrile Exam Gloves during its shelf life, for example, is a tensile strength of 28-32 MPa and an ultimate elongation of 520 – 560%.

HandPRO® Cleanroom gloves are also manufactured to exceed ASTM minimums. HandPRO® Series 9100 Clean Class 100 Nitrile Gloves have a typical tensile strength of 27.1 – 31.0 MPa after aging, and a 540-560% ultimate elongation after aging.

Tensile Strength and Elongation in Use

So what do these numbers mean for you when selecting and wearing gloves?

While high tensile strength is preferred, the “highest” number does not necessarily mean “best” performance. Glove manufacturers must carefully balance strength with stretch and comfort. Too high tensile strength will make a glove stiff or difficult to don.

Elongation is important to the performance of the glove. High elongation helps the glove material stretch instead of tear when snagged. A glove with good elongation will stretch and conform to your hand, improving comfort and performance.

Nanotechnology and Your Gloves – Are You Safe?

Nanotechology and Your Gloves - Are You Safe?

A temporary tattoo that monitors blood glucose levels. A new biomaterial that can potentially rebuild worn tooth enamel. A 3D printed titanium jaw implant. It all sounds rather sci-fi, but all of it is made possible by the booming field of nanotechnology.

Nanotechnology is the manipulation of matter on an atomic, molecular, and supramolecular scale to create new materials or devices. There are a vast range of applications from organic chemistry and molecular biology, to semiconductor physics and microfabrication.

By late 2013 there were over 1600 consumer products on the market made possible by nanotechnology, and it is estimated that by the end of 2014, about 15% of all products were impacted by this new and fast growing science.

Engineered Nanoparticles and Worker Safety

With trillions of dollars going to nanotech research and product development, the nanotechnology workforce is also rapidly growing. By 2020 it is projected that there will be a workforce of some 6 million worldwide, with 2 million of that being in the U.S.

Nanotechnology workers handle the tiniest of matter – just 1-100 nanometers. Many of these engineered nanomaterials (ENMs,) also called engineered nanoparticles (ENPs,) have properties unique from their larger counterparts. This brings a whole new set of challenges for worker health and safety.

Materials considered safe at their historical size could become hazardous in their new nano form. Because so much is unknown about the risks associated with ENPs, The National Institute for Occupational Health and Safety (NIOSH) is recommending that all ENPs be considered hazardous. Recently, the International Agency for Research on Cancer (IARC) classified nanosized titanium dioxide (nTiO2) in 2B-group as possibly carcinogenic to humans.

To protect themselves, workers handling nTiO2 wear protective gloves. Is this enough?

Researchers Study ENPs and Gloves

Researchers in Montreal, Canada wanted to know which gloves efficiently protect against titanium dioxide nanoparticles in work conditions. Their study, published last fall, shed some interesting light on the ability of nano-sized particles to get past some trusted barriers.

The study tested two nitrile gloves at different thicknesses identified as NBR-100 (.10 mm thick) and NBR-200 (.20 mm thick,) a latex glove (thickness unknown,) and a non-disposable butyl rubber glove. Each glove was then brought into contact with nTiO2 in water, in propylene glycol, and in powder. The simulated work conditions in the test were equivalent to about 3 hours wearing time for the nitrile and latex gloves, and 7 hours for the non-disposable butyl glove.

“The results are different depending on the glove models and the nTiO2 application mode. Table 1 summarizes the efficiency of all the protective gloves studied against nTiO2.

 

Table 1. Efficiency of protective gloves
NBR-100 NBR-200 Latex Butyl rubber
nTiO2 in water Poor Good Good Good
nTiO2 in PG Good Good Good Good
nTiO2 in powder Weak Good Good Poor

 

In the case of NBR-200, the thickness has a major role as barrier whereas for latex gloves, the chemical composition seems to be the main actor in the efficiency. Some tests are needed to confirm the results obtained with nTiO2 in powder. So we need for further investigations but for the moment, great care must be taken in selecting protective gloves for the handling nTiO2. It is already possible to recommend a frequent replacement of gloves in case of exposure to nTiO2.”

The study also noted that the “micrometer-sized surface features” – pores, cracks and platelets in the gloves – “may facilitate the penetration of nTiO2 through protective gloves.”

Not noted in the study was the gloves’ Acceptable Quality Level (AQL) for holes. Because of the nature of thin-modulus gloves, all nitrile and latex gloves can have pinholes. The FDA requires that medical gloves have a maximum AQL of 1.5 for holes, but the FDA minimum requirement for cleanroom and other non-medical gloves is only 2.5 – meaning more holes. Some cleanroom gloves, however, have a higher AQL than what is required. (All HandPRO brand cleanroom gloves, for instance, are manufactured with the lower AQL of 1.5 required for medical gloves.)

Based on this study, a thick nitrile or latex glove provided better safety than a thin nitrile glove or even a thick butyl glove in the case of nTiO2 in water.

As work in nanotechnology continues to skyrocket, no doubt additional studies will be conducted on other ENPs so that workers can be better protected.


 

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HandPRO Series 2400

HandPRO Series 2400 Clean Class Latex Gloves are 100% natural rubber latex for outstanding strength, stretch and fit. The fully-textured, powder-free glove is 12” long, double bagged, and compatible with ISO 5 and up.

Contact us to request your free sample pack.

Understanding Glove Related Contact Dermatitis

[dropcap]Y[/dropcap]ou may wear disposable nitrile, latex or vinyl gloves many hours each work day.  If your hands develop dry, itchy, irritated areas or blisters, you are understandably concerned.  Wearing gloves and having healthy skin is imperative in your line of work.

Could your gloves be to blame?  In this Q&A article, we’ll help you get the bottom of the types of glove related contact dermatitis, their causes, and how you might find a resolution for your skin condition.

Q.   What is contact dermatitis?

A.   Occupationally related contact dermatitis is a skin condition that can develop from frequent and repeated use of hand hygiene products, exposure to chemicals and glove use. Contact dermatitis is classified as either irritant or allergic.

Irritant contact dermatitis is common, nonallergic, and develops as dry, itchy, irritated areas on the skin around the area of contact.  It is usually caused by an irritant, such as the chemicals commonly used in the manufacture of hand products and gloves.  It can also be caused by water, (including improper hand drying before donning gloves,) soaps, detergents, solvents, acids, alkalis and friction. Diagnosis is made by reviewing the patient’s medical history, current symptoms, and exclusion of Type IV and Type I hypersensitivity.  This is not an allergic reaction.

Allergic contact dermatitis (type IV hypersensitivity) often manifests as an itchy, red rash, sometimes with small blisters, beginning approximately 6 to 48 hours after contact.  Like irritant dermatitis, it is usually confined to the areas of contact.  It can result from exposure to accelerators and other chemicals used in the manufacture of most latex and non-latex gloves.  Diagnosis is made by reviewing the patient’s medical history, current symptoms and by performing a skin patch test.

Q.   What are chemical “accelerators?”

A.   Chemical accelerators are used in the glove manufacturing process to “accelerate” the linkage of rubber molecules in natural rubber latex or synthetic rubber latex, such as nitrile and vinyl. The chemicals transform the liquid rubber into a thin, strong and elastic glove film, and stabilizes the material.

These sulfur-based chemical accelerators (dithiocarbamates, thiurams and mercaptobenzothiazoles (MBT)) cause the majority of skin dermatitis reactions.

Q.   What are “accelerator-free” gloves?

A.   Accelerator-free gloves, like FreeStyle1100, and Scion700 are manufactured using a breakthrough cross-linking technology that does not use chemical accelerators (dithiocarbamates, thiurams and mercaptobenzothiazoles (MBT.)) The result is a thin, soft and stretchy glove that is actually stronger than traditionally manufactured nitrile glove material.

Q.   What does “Low Dermatitis Potential” mean?

A.   This is an FDA approved claim reserved for gloves that have been tested, and are 1) proven free of chemical accelerator residue, 2) will not induce skin irritation, and 3) will not cause any potential sensitization reaction.

Q.   How long should I try accelerator-free gloves?

A.   Each person is unique. Some individuals know within a few hours, while others require an extended trial of several days or even weeks to know if accelerator-free gloves will resolve their hand dermatitis. (Additional samples of FreeStyle1100 are available for individuals needing a longer period of time to evaluate the glove.)

Q.   Is there anything else in a glove that can cause allergic contact dermatitis?

A.   Yes.  Although 90% of glove allergies are caused by accelerators, the remaining individuals may be reacting to other substances sometimes used in the manufacture of gloves, such as lanolin, polyoxypropyleneglycol (a coagulant,) dyes (organic or inorganic,) quaternary ammonium compounds, and preservatives.

Q.  How important is it to resolve contact dermatitis early?

A.   Skin is an important barrier to bloodborne pathogens and disease. Broken skin due to ongoing irritation or allergy puts an individual at higher risk. A chronic skin condition is painful, and could result in an individual having to abandon their career choice.

Q.  I don’t have contact dermatitis. Should I still consider switching to an accelerator-free glove?

A.   Yes. According to NIOSH, “Because the prognosis of occupational irritant and allergic dermatitis is poor, prevention is imperative. This fact is emphasized by one study showing that 75% of patients with occupational contact dermatitis developed chronic skin disease.” (1) With thousands of potentially harmful chemicals being introduced into the workplace each year, it is important to reduce your exposure wherever possible.

References
NIOSH (The National Institute for Occupational Safety and Health,) Allergic & Irritant Dermatitis(1)
CDC (Centers for Disease Control and Prevention) Frequently Asked Questions, Contact Dermatitis and Latex Allergy

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Understanding Cleanroom Glove Classifications

Understanding Cleanroom Glove Classifications

Cleanroom gloves look a lot like exam gloves.  They’re available in nitrile, latex or vinyl materials.  They’re thin, ambidextrous and disposable.  But they have something extra – an ISO number or Class number.  What does this mean?

To understand cleanroom gloves, we need to understand why they are needed.  A “cleanroom” is an environment with a controlled level of contamination – dust, microbes and aerosol particles – to prevent damage to a product during manufacturing.  Think microelectronics, semiconductors, and biotechnology, where a particle 200 times smaller than a human hair can lead to expensive failures and downtime.

Cleanroom contamination is measured by the number of particles by volume of air at a particular particle size.  The air you breath contains about 35 million particles sized 0.5 µm and larger per cubic meter.  The air in a cleanroom will have much less, making the environment “cleaner.”

The First Cleanroom Standards

US FED STD 209E set the first cleanroom standards.  Airborne contaminates were measured as maximum particles per cubic foot. So a “Class 100” environment meant there was an upper limit of 100 particles/ft3, size 5 µm or smaller.  A “Class 10” meant no more than 10 particles/ft3.

US FED STD 209E Cleanroom Standards
Class maximum particles/ft3 ISO
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7.5 3 1 0.007 ISO 3
10 350 75 30 10 0.07 ISO 4
100 3,500 750 300 100 0.7 ISO 5
1,000 35,000 7,500 3000 1,000 7 ISO 6
10,000 350,000 75,000 30,000 10,000 70 ISO 7
100,000 3.5×106 750,000 300,000 100,000 700 ISO 8

The New Standard

In 1999, the US Department of Commerce introduced a new classification system called ISO 14644-1.  This document established the certification requirements for air cleanliness areas, and airborne particulates are measured as particles per cubic meter rather than cubic foot.  So a Class 100 became ISO 5, and a Class 10 became ISO 4. While this new standard officially replaced the old Federal Standard 209-e in 2001, both classification terms are still in use.

ISO 14644-1 Cleanroom Standards 
Class maximum particles/m3 FED STD 209E
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm
ISO 1 10 2.37 1.02 0.35 0.083 0.0029
ISO 2 100 23.7 10.2 3.5 0.83 0.029
ISO 3 1,000 237 102 35 8.3 0.29 Class 1
ISO 4 10,000 2,370 1,020 352 83 2.9 Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1.0×106 237,000 102,000 35,200 8,320 293 Class 1,000
ISO 7 1.0×107 2.37×106 1,020,000 352,000 83,200 2,930 Class 10,000
ISO 8 1.0×108 2.37×107 1.02×107 3,520,000 832,000 29,300 Class 100,000
ISO 9 1.0×109 2.37×108 1.02×108 35,200,000 8,320,000 293,000 Room air

Glove Classifications

While there are no published standards that designate gloves as “ISO 5,” for instance, glove manufacturers understand the importance of maintaining specified particulate levels in cleanrooms.  Gloves are carefully laundered, dried, tested and packaged to ensure a particle count that is compatible with the cleanroom environment where they will be used. So a glove listed as Clean Class 10 or ISO 4 is compatible with a Class 4 cleanroom and up.  A “Controlled Environment” or Clean Class 1000 glove is suitable for ISO 6 and up environments.

 

5 Good Glove Fit Factors

There are many factors to consider when selecting a disposable glove.  After choosing the right glove type and glove material for the task, good fit ranks high on the list.  A properly fitted glove is critical to performing procedures correctly.   A glove that fits properly conforms to the hand, and does not feel too tight or too stiff.   Consider some glove physical characteristics that influence fit.

1.  Glove Length

Glove length is measured from the tip of the middle finger to the cuff.  Exam gloves are typically a minimum of 9” in length, while surgical gloves and some cleanroom gloves are 12” in length to provide more protection.

2.  Glove Width

The width of a glove is one of the most important considerations for proper glove fit.  Gloves are manufactured to specific ASTM glove standards, including palm width.  But there is a fairly wide range within each size.  A medium exam glove, for instance, can vary from 85mm to 105mm in width.   And there is room for overlap, so one manufacturer’s “medium” exam glove could be another manufacturer’s “large” glove.

3.  Finger Length and Width

Finger lengths and widths also vary between product lines from one manufacturer to another.  The finger length and width is largely determined by the formers used on the manufacturing line.  However, the glove material affects the amount of stretch, which affects finger fit.  A super stretchy, low protein latex glove works with the widest range of finger sizes, and could be a good choice for individuals with shorter fingers.  When it comes to nitrile gloves, the formulations range from “some stretch” to “very stretchy,” which affects finger fit.

4.  Glove Material

Glove thickness and stretchability also influences overall glove fit when donned.  If you are accustomed to wearing a “medium” glove in one brand, you may need to try a “small” or a “large” glove in another brand.  If you are trying a very thin glove, you may need to try a smaller size in order to get the proper fit.

5.  Finger Contour

Hand specific gloves with contoured fingers and a natural thumb position are most commonly found in surgical glove lines.  While offering the best fit, these gloves cost more than an examination glove.  Fortunately, ambidextrous nitrile exam gloves (gloves that can be worn on the left or right hand) made from newer, thinner nitrile material, allows the glove to warm and follow the contours of the hand, fingers and thumb to enhance comfort, improve tactile sensitivity, and reduce hand fatigue.

Finding a good fitting glove is essential.  A tight fitting glove can negatively affect fine motor skills, irritate the skin, and lead to hand fatigue.  On the other hand, a glove that fits too loose can cause a person to execute movements awkwardly, and potentially lead to exposure to bloodborne pathogens or hazardous chemicals.  Evaluating a glove’s ability to contour to the hand, and properly fit the width of the hand is key to finding a good fitting glove that you will enjoy wearing.

[note]Each of our HandPRO Exam Gloves offers a unique fit and stretch due to their different compounds.
Click on the glove below to request your sample pack:

AirSoft900 Nitrile Exam Gloves
Cirrus800 White Nitrile Exam Gloves
FreeStyle1100 Nitrile Exam Gloves with Low Dermatitis Potential
HandPRO 400 Latex Exam Gloves[/note]

Green Trends in Dental, Medical and Cleanroom

Green Trends 2013

Dedicated professionals in many industries, from dental and medical to cleanroom manufacturing, have been working to establish company cultures that put the health and safety of their staff and the environment at the forefront.  This includes adopting and promoting “green” technology, products and initiatives that contribute to a healthier world and workforce.

Green Dentistry

According to the Eco-Dentistry Association, green dentistry means reducing waste and pollution, saving water, energy and money, going high-tech and supporting healthy lifestyles.

Here in the U.S. upwards of 1.7 billion sterilization pouches and 680 million patient barriers are dumped by dental offices each year.  Green practices in the dental office include replacing chemical-based and toxic cold-sterilization with steam sterilization methods using FDA-registered reusable pouches and wraps.  Switching to cloth lab coats and reusable cloth patient barriers also helps cut down on waste.

About half of all mercury entering wastewater treatment facilities comes from dental offices.  Installing an amalgam separator in the office can keep mercury out of our drinking water, irrigation and fishing waters.   By switching to digital imaging, other toxins can be eliminated, such as traditional x-ray fixing chemicals and lead foils.

If a product must be disposable because of its nature, such as gauze, gloves and depression trays, these products are increasingly available in recycled or high-count packaging, or are made from biodegradable, compostable material.

Environmentally Friendly Medical

Medical facilities are committed to improving the health of their patients, employees and communities.  Leading the way, Kaiser Permanente launched their Sustainability Scorecard in 2010, a first of its kind green purchasing model.  The Scorecard helps them evaluate the environmental and health impacts of the more than $1 billion in medical products they purchase each year, as well as the companies they purchase them from.

Another major focus in the medical industry is recycling and reprocessing devices for safe reuse.  Hospitals are the second-largest waste producers in the U.S. after the food industry.  Banner Health in Phoenix saved nearly 1.5 million over 12 months by reprocessing operating room supplies such as compression sleeves and open but unused devices.

Manufacturers and suppliers are helping reduce waste by streamlining packaging.  At University of Minnesota Medical Center, Fairview, surgical kits were reviewed.  They found that the operating room packs contained supplies that were never used (and tossed.)  One chemotherapy kit contained 44 items, but only 27 were needed.  By having their supplier change the kit components and swap disposable gowns and linens for reusable ones, they trimmed a pound of trash and$50 in supply costs per procedure.  Hundreds and thousands of procedures later, and it adds up to a whole lot of green – less waste and money saved.

Greening the Cleanroom

Professionals in cleanroom manufacturing industries are greening their workplaces as well.  As with the dental and medical industries, the focus is on waste and energy conservation, as well as products “friendlier” to workers and the environment.

One of the greatest challenges is reducing energy consumption.  The larger the facility, the more energy it uses. “Cleanrooms aren’t very efficient,” says manager Bill Bond, of QinetiQ North America, a contractor that operates cleanroom facilities for Goddard.  “Airflow is always moving, and that takes energy.”

But his team was able to create an energy efficient design that includes computer-controlled sensing systems for lights and particulate counts.  When the particle count reaches higher levels, the fans operate at higher speeds.  Other efficiencies are created by treating just 10 percent of the air to maintain required air conditions, since the other 90 percent is already-filtered air that the system is recycling.

Modern modular cleanrooms feature coved surfaces and smooth transitions, making them easier to clean.  Manufacturers have responded by redesigning wipers and mops to be reusable or use less cleaning solution or solvent.  This is better for the environment as it minimizes the amount of chemicals needed to maintain cleanliness and sterility.

When it comes to clothing and PPE, cleanrooms are working hard to reduce waste and keep their operators safe and healthy.  Rather than toss items like shoe covers and gowns after the first use, many facilities reuse these items as much their critical environment will allow for while still maintaining cleanliness.  When it does come time to dispose of protective clothing, much of it is recycled.  Products like accelerator-free cleanroom nitrile gloves are also a greener choice.  Formulated with fewer chemicals and weighing on average 20% less than older generations of gloves, they are less likely to cause dermatitis in operators and reduce waste.

As technology continues to evolve, and creative and forward thinking individuals continue to spearhead green initiatives, no doubt newer and more environmentally friendly products, processes and facility designs will emerge.

How is your office or facility going green?  Share your comments below.

Cleanroom Gloves – Balancing ESD and Cleanliness

[dropcap]C[/dropcap]leanroom environments in the electronics, nanotechnology and semiconductor industries are especially sensitive to static.  For this reason, the electrostatic discharge (ESD) property of cleanroom gloves worn by workers is an important consideration.

Electrostatic discharge damages the electrical characteristics of a semiconductor device.  It can also cause equipment to malfunction or fail, interfering with the normal operation of an electronic system.

An electrostatically charged surface can also attract and hold onto contaminants – bad news for the cleanroom environment.  Airborne particles can cause defects in a device’s electrical circuitry.

Controlling ESD

Failing to control ESD in a cleanroom can be expensive.  Static electricity damages electronics, leading to increased manufacturing costs and lower production yields, negatively affecting a company’s reputation and profitability.  One way that cleanrooms manage static charge is by using static dissipative materials.

Static dissipative materials fall somewhere between insulative and conductive materials.  There is electron flow through or over the material, but in a controlled fashion, by the surface resistance or volume resistance of the material.  It allows the charge to dissipate, or transfer slowly to ground without causing damage.

Cleanroom Nitrile Gloves Preferred

When selecting gloves for cleanroom applications where static discharge could harm the product, or where static could lead to contamination, nitrile gloves are the preferred choice.

Gloves made from natural rubber latex are inherently static insulative, holding on to a charge and releasing it in an uncontrolled manner, leading to damage.  The surface resistance of nitrile gloves, however, is normally on the border of insulative and static dissipative.  To be considered static dissipative, the glove should have a surface resistance of more than 1 x 105 but less than 1 x 1011 ohms/sq.  The surface resistance test results for a glove can usually be found on the manufacturer’s product information sheet.

Balancing ESD with Cleanliness

Interestingly, the cleaner the glove, the lower the glove’s ESD protection.  Tom Lesniewski and Kenn Yates of the TRW Space and Electronics Group conducted an evaluation of the cleanliness and ESD protective properties of cleanroom materials, including 7 different types of nitrile gloves.

They found a clear trend – as non-volatile residue (NVR) increased, surface resistance decreased.  The surface contaminants on a glove make the glove more static dissipative, especially in higher humidity.

Because there is clear tradeoff between cleanliness and charge dissipation rate, cleanrooms requiring a high level of ESD protection should choose a cleanroom glove only as clean as it needs to be for the ISO level of the cleanroom.

[note]

HandPRO Cleanroom Nitrile Gloves provide the moderate static dissipation needed to protect highly ESD sensitive devices from damage.  The gloves are also very clean, making them a contamination-free solution for cleanrooms requiring low ionic contamination.

Learn more about HandPRO 9100 Clean Class 100 Accelerator-Free Nitrile Gloves for ISO 5 & up.

Learn more about HandPRO 1700 Controlled Environment Nitrile Gloves for ISO 6 & up.[/note]

 

How does a cleanroom glove’s ESD property impact your manufacturing environment?  Share your comments below.

HandPRO1700_CTA

Compounding Pharmacies – Sterile Gloves and Fingertip Sampling Required

The fungal meningitis outbreak caused by contaminated steroid medications made by New England Compounding Center in Framingham (NECC), Mass. has brought about a flurry of articles and blog posts calling for tighter regulations and direct FDA oversight of compounding pharmacies.  Some of the articles make it appear that compounding pharmacies are nothing more than renegade miniature drug companies making HRT medications and other controversial drugs.

While there appear to be some pharmacies that need to be reined in, most compounding pharmacies exist in hospitals.  These pharmacies normally prepare a medication to order, for a specific patient from a prescription.  Independent compounding pharmacies contract with hospitals and clinics to fill their compounded medication needs.  Many feel that NECC crossed the line from a traditional compounding pharmacy to a drug manufacturer with interstate commerce.

At the end of all of the debating and legal haranguing (which won’t end soon,) the primary issue is safety.  So what regulations are in place to help ensure that sterile medications from compounding pharmacies are safe?

USP 797

The U.S. Pharmacopoeia (USP) issued the first practice standards for compounding pharmacies in the U.S. back in 2004.  Chapter <797>, Pharmaceutical Compounding – Sterile Preparations, commonly referred to as USP 797, was updated in 2008, and is designed to cut down on infections transmitted to patients through “compounded sterile preparations” (CSPs).

Compliance

After eight years, how are compounding pharmacies doing on compliance?  A nationwide Compliance Study conducted in 2011 and updated in 2012 shows that although the chapter has done much to improve the quality of CSPs, there is also much room for improvement.

Here is one example, a test called Gloved Fingertip/Thumb Sampling, designed to demonstrate that the compounder can properly don PPE and sterile gloves, and prepare a medication without contamination:

“In 2011, only 30% of hospitals complied with the requirement for all compounding personnel (including supervising pharmacists) to successfully complete at least three gloved fingertip/thumb sampling procedures (success is 0 CFUs for both hands) before being allowed to compound CSPs. This requirement is designed to verify that compounding personnel can properly don sterile gloves without contaminating them . . . in 2012, compliance with this requirement has increased to 36%.” – 2012 USP <797> Compliance Survey

This is certainly a cause for concern.  Skin cells are shed from the human body at a rate of a million or more per hour and these skin particles are laden with microorganisms.  Gloved Fingertip/Thumb Sampling measures both the microorganisms and particles in the controlled compounding environment and on surfaces like gloves.  It reveals poor aseptic technique or improper disinfection of sterile gloves.

Sterile gloves are a requirement in preparing CSPs.  Non-sterile exam gloves treated with 70% IPA have not been proven adequate in preventing contamination.  Eric Kastango, MBA, RPh, FASHP, president and CEO of Clinical IQ, LLC, a health care consulting firm in Madison, N.J., and a member of the 2010-2015 USP Compounding Expert Committee, states “The decision the USP committee made in requiring sterile gloves over nonsterile gloves is that you start with a pair of gloves with zero microbial bioburden and that it’s a very inexpensive way to maintain a state of control and prevent the risk for contamination and infections. It’s critical to make sure we’re giving patients the safest, best opportunity to have the lowest risk for contamination from compounded sterile preparations.”

Enforcement

So who enforces USP 797?  While the FDA regulates the ingredients, it does not regulate practitioners.  Compounders are regulated by a patchwork of state oversight, including Joint Commission and state pharmacy boards.  In general, the FDA has deferred to states in regard to USP 797, but it can investigate allegations of contaminated drugs, as in the case of NECC.

Compounding pharmacies can be sure that they will be coming under increased scrutiny and regulation.  Compliance with USP 797, which requires sterile gloves and a host of other safety standards is imperative.   By doing so, they can ensure the highest quality compounding environment and deliver ever-safer medications to the public.

Resources:

Summary of USP 797 for Compounding Sterile Preparations

 

 

What do you think?  Are compounding pharmacies doing enough to comply with USP 797?  Share your comments below.

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