According to the U.S. Department of Labor, thousands of employees suffer from eye injuries every year, many of these injuries sustained at work, usually from inadequate eye protection. These injuries can result in blindness and cost over $300 million per year in lost production time, medical expenses and worker compensation.
Potential eye hazards can be found in almost every industry. What causes eye injuries? According to the US Department of Labor, 70% of the total eye injuries are caused by falling objects or sparks striking the eye. 3/5 of these objects being smaller than a pin head but were traveling faster than a hand thrown object. 20% of the eye injuries resulted from contact with chemicals.
To prevent eye injuries, you should always wear effective eye protection. There are three types of eye protection: safety glasses, goggles or a face shield. Safety glasses are the most common. They are designed with side protection and can resist an impact up to 150 feet per second. Safety goggles form a seal around the eyes giving better protection and can come in impact resistant and chemical resistant. Chemical goggles protect the wearer from chemical splashes with hooded or indirect ventilation. Impact goggles have direct ventilation holes and protect against direct impact or large particles. Finally there are face shields which are used in welding and sanding applications. Face shields are a secondary form of protection and must be worn with either safety glasses or goggles. Which type of eye protection is chosen based on the nature and degree of potential hazard the workplace factors and any OSHA and ANSI requirements.
There are three main types of lenses found in eye safety wear. Glass lenses are not easily scratched and can be used around harsh chemicals. They can also be made into a corrective prescription for those who need it. However, they can also be heavy and uncomfortable to wear. Plastic lenses are lighter weight, are good for protecting against welding splatter and are not likely to fog up on your face. However, they are more likely to scratch when compared to glass. Polycarbonate lenses are light weight, protect against welding splatter and are not likely to fog up like the plastic lenses. However they are the strongest lens and have a greater impact resistance then glass and plastic alone.
Protective eye wear goes through a series of tests to verify that it meets the requirements that have been put into place. This includes testing the frames and the lens for durability like flame or chemical resistance, high impact, high mass impact and high velocity impact. High impact will be marked with Z87+. If they are not rated for high impact they will just Z87. Other markings include a V, which indicates photochromic lenses and S which means the lenses have a special tint usually meant for welding or soldering.
Preventing eye injuries through use of safety glasses, goggles and face shields saves money by avoiding injury costs, lost productivity, insurance costs, lawsuits and possible fines. For the worker it avoids catastrophic injury like blindness, pain, lost wages and medical bills. 50% of workers injure while wearing eye protection thought the eye wear had minimized the damage.
CleanPro® offers a wide variety of safety glasses from Pyramex for your eye protection with a variety of lenses tints and lanyards and cords. Click here for details.
CleanPro offers a wide selection of particle counters. But how to do you determine if you need a particle counter or what model of particle counter to purchase? In this article we will go over the basics of particle counters and give you the facts to help you determine which one is best for your cleanroom application.
A particle counter is an instrument that detects and counts particles one at a time. There are three main categories of particle counters, aerosol, liquid and solid, but only aerosol particle counters directly relate to cleanrooms, so we will be focusing on them. Aerosol particle counters determine the air quality by counting and sizing the particles in the air. They are mainly used in cleanroom applications. Since cleanrooms have defined particle count limits, aerosol particle counters are used to test and classify the cleanroom to ensure it is up to standard.
There are two types of aerosol particle counters, optical and condensation. With optical particle counters, the particle passes through a high energy light source, then the amplitude of the light scattered or blocked is measured and the particle is counted. Optical particle counters have several different ways to detect and measure particles. They are light blocking, light scattering, and direct imaging. The light blocking method can detect particles larger than a micrometer in size and is based on the amount of light the particle blocks when passing through the light source. The light scattering method is capable of detecting smaller size particles and is based on the amount of light that is redirected by the particle passing through the light source. Direct imaging uses light emitted by a laser as a source to illuminate the particles passing through and measure the area of the particles, like an automated microscope.
A condensation particle counter counts aerosol particles by first enlarging them and using them as nucleation centers to create droplets in a super saturated gas. Condensation particle counters can detect particles as small as 2nm, which cannot be detected with optical particle counters.
Particle counters come in many different sizes. There is a hand-held form, which is a small self-contained model that is easily transported and used. Hand-held particle counters tend to have a lower flow rate, so they are ideal for cleanroom spot checking and certification of lower volumes of air. Larger portable units have a fixed location and continuously monitor the air 24/7. These portable units have a higher flow rate and are ideal for sampling larger volumes of air.
The first is the size of the particles that you need to monitor. This is determined by the ISO class of your cleanroom. Make sure the particle counters you are looking at can measure all the particle sizes that you need to monitor. For example a particle counter can have a size range of 0.3/0.5/5.0 µm.
The second factor is the flow rate capacity of the particle counter. To do this you will need this formula: Vs = 20/Cnm) x 1000. Vs is the minimum single sample volume per location. Cnm is the class limit for the largest considered particle size specified for the class of your cleanroom. 20 is the defined number of particles that could be counted for class of the cleanroom. This calculates the number of liters of air that need to be sampled in your cleanroom. So for example if you want to have a class 4 cleanroom, the largest size particle is 1.0 µm and can have a maximum concentration of 83 particles/ m3 according to the ISO 14644-1 cleanroom standards. Plug it into the formula for Vs=(20/83) x 1000, and Vs=240.96. So we would need to sample 240.96 liters of air. So if we chose a small hand-held particle counter that had a flow rate of 2 liters per meter that would take about 120 minutes or 2 hours to sample the air. So for this example I would recommend finding a larger portable particle counter with a higher flow rate.
CleanPro offers particle counters from both Kanomax and Airy Technology in both hand-held and portable models. Click here to view all our particle counters.
Cleanrooms are 10,000 times cleaner than a hospital operating room. It takes an incredible amount of technology to achieve and maintain such cleanliness. Huge air filtration systems completely change the air in cleanrooms about 10 times per minute, reducing the changes that there are airborne particles that might harm the product. Keeping the environment clean, however, is only half of the story.
What about the people who work in the cleanrooms? The thousands of people who all wear “bunny suits” to protect products from from human particles such as skin flakes or hairs. A bunny suit is made of unique, non-linting, anti-static fabric and is worn over street clothes. Suiting up is a rather involved process, not to mention that every time you enter and leave a cleanroom you have to repeat the steps below:
- Store personal items
- Discard any gum, candy, ect.
- Remove any makeup with cleanroom soap and water
- Take a drink of water to wash away any throat particles
- Cover any facial hair with a surgical mask or beard/mustache lint-free cover
- Put on a lint-free head cover
- Clean shoes with shoe cleaners
- Put shoe covers on over shoes
- Clean any small, pre-approved items to be taken inside
- Pick up booties
- Sit on “dirty” side of the bench
- Put on one bootie (over shoe cover)
- Swing bootied foot to “clean” side of the bench
- Put other bootie on on the “dirty” side of the bench
- Swing bootied foot to “clean” side of the bench
- Enter main gowning room
- Set aside badge, pager, any other items to be taken inside
- Put on nylon gowning gloves
- Obtain bunny suit and belt
- Put on the bunny suit without it touching the floor
- Put on belt
- Tuck bunny suit pant legs into booties
- Fasten snaps at top of booties
- Attach battery pack to belt
- Attach filter unit to belt
- Plug filter unit into battery pack
- Obtain helmet, safety glasses, and ID badge
- Put on helmet
- Tuck helmet skirt into bunny suit
- Zip up bunny suit at shoulders
- Attach helmet hose to filter unit
- Tighten knob at back of helmet
- Put on ID badge
- Put on pager
- Put on safety glasses
- Obtain disposable scope shield
- Remove protective covering from both sides of scope shield
- Undo front helmet snaps
- Attach face shield to helmet
- Re-snap from helmet snaps
- Examine attire in mirror
- Put on latex gloves
- Enter the cleanroom
Now not all cleanrooms will follow this exact regimen, but it does give you an idea of what is involved for employees entering a cleanroom. Each step gets the user “cleaner” without contaminating the next layer.
When leaving a cleanroom these steps are taken in opposite order and each layer is disposed of properly. Suits, helmets, and goggles can be cleaned and reused or disposed of. Gloves are almost always one time use items, same with hairnets, bouffants, beard covers, and shoe covers; all are one time use items.
CleanPro offers a wide range of gowning products from shoe covers to full suits, we can help you keep the integrity of your cleanroom by supplying high quality, dependable cleanroom garments.
Ultimate Cleaning Equipment for Cleanrooms
The list of industries that incorporate cleanrooms into their manufacturing facilities is growing at a galloping pace. Ever since the cleanroom standards were instituted on behalf of the US Government and NASA (which needed to establish requirements for cleanliness on the production of various items for the Apollo Space project), commercial businesses have seen the benefit to adding to their own manufacturing processes.
Today, electronics, semiconductor, high-tech, biotech, pharmaceutical, medical device, and chemical manufacturers operate cleanrooms – even some progressive food companies use cleanrooms. But, all of the effort and expense involved in creating these immaculate, contaminant-free atmospheres may be wasted if it’s not maintained properly.
The key word for cleanrooms is contaminant. While the contaminant may be a particle of perfectly legitimate, high-quality material, in the cleanroom setting it earns a status no greater than the lowly dirt speck, and it is not tolerated. Maintaining cleanrooms standards required proper cleaning of all floors and surfaces with a HEPA-filtered vacuum.
Nilfisk engineered the first cleanroom-packaged vacuums and originally developed vacuums with HEPA and now ULPA filtration. They are built with corrosion-resistant, stainless steel construction for improved decontamination, sanitation, and validation. Of course they are approved for cleanrooms up to ISO 4 (Class 10).
Proven Performance Advantages
Nilfisk high performance cleanroom vacuums are equipped with oversized, multi-stage, HEPA filtration to ensure that 99.97% of all particles down to and including 0.3 microns are collected and retained. Other advantages also improve efficiency of your operation and include:
Easy-to-Clean Design – Constructed modularly, Nilfisk vacuum components are easy to access for fast cleaning. Nilfisk polished, stainless steel vacuums can be quickly decontaminated with little to no trace of product residue.
Simple Waste Disposal – Many of Nilfisk’s vacuums feature dropout collection conatiners, externally cleaned filters, paper bags, ABS collection tank inserts, and polyliners to make waste disposal safer and faster.
User Friendly Features – Static control accessories, automated filter purging, remote starting, and many other features reduce maintenance steps and hassle for your team.
Interchangeable Engineering – Easily expand your Nilfisk and Nilfisk CFM vacuums’ capabilities to meet your changing needs with our full range of compatible accessories and components.
Contaminate-Free Exhaust – HEPA* and ULPA** filters that are installed after the vacuum’s motor ensure a decontaminated exhaust stream.
Fire/Explosion Protection – To reduce risk when working with dangerous materials, Nilfisk offers electric or air-operated models, specially designed for use in explosion hazardous environments.
* High Efficiency Particulate Air
** Ultra Low Penetration Air
Simply put, every square inch of a cleanroom should be absolutely pristine. Ceiling panels, lighting units, HEPA filtration units, sprinkler heads, walls, glass surfaces, process equipment, piping systems, floors, and manufacturing equipment should all be decontaminated regularly. Even the ambient air must be monitored and maintained at proper levels. HEPA-filtered ventilation systems assisted by preventative measures help manufacturers limit airborne contamination. However, in order to assure environmental purity, regular housecleaning procedures are necessary.
Cleaning with both a HEPA-filtered vacuum and traditional wipe-down methods are standard housekeeping procedures in most cleanrooms. Yet in critical cleaning situations, vacuuming is often the more efficient method because particles are retained inside the machine with little chance of being exhausted into the atmosphere (provided your vacuum has a HEPA-filtered exhaust stream). Vacuuming also eliminates the fiber particles that swabs and wipers may leave behind. In fact, measurements taken in one cleanroom setting found that a dusting system using disposable cloths polluted the space twice as much as using a HEPA-filtered vacuum cleaner.
So what should your cleanroom vacuum include? First and foremost, any vacuum cleaner used in a biotech parenteral cleanroom must be HEPA-filtered to ensure that 99.97% of all particles down to and including 0.3 microns are collected and retained. In addition, it is absolutely critical that the HEPA filter be installed after the motor to filter the exhaust stream. The motor’s commutator and carbon brushes generate dust, and if the exhaust stream is not filtered than the dust will be released into the environment.
A word of caution: not all HEPA-filtration systems are created equal. Make sure the vacuum you select contains a multi-stage, graduated filtration system for peak operating efficiency. A graduated filtration system uses a series of progressively finer filters to trap and retain particles as they move through the vacuum. The largest particles are captured first by coarser filters; smaller particles are then caught and retained by the finer HEPA filters. This multi-stage system protects the HEPA filters from blockage and excessive wear-and-tear, maintaining peak performance. When equipped with an ULPA filter, the system should retain up to 99.99% of all ultra-fine particles, down to and including 0.12 microns in size.
Additionally, the filtration system in your vacuum should use oversized filters, which slow airflow across the larger surface area and optimize the air-to-cloth ratio. This allows the vacuum to easily collect large volumes of debris over extended periods of time with minimal maintenance.
Besides having an exceptional filtration system, any vacuum used in a cleanroom should be constructed of non-particle generating materials. For example, non-porous, stainless steel vacuums – equipped with smooth hoses and attachments – enable personnel to quickly wipe down and decontaminate equipment for faster, simpler sanitization and validation. And it must be specially packaged to prevent contaminates from entering the cleanroom environment when delivered.
Vacuum Tip: Don’t forget to take spill response into account when purchasing a vacuum. At least one of your vacuums should be capable of wet and dry collection.
A cleanroom is an environment that is used for the manufacturing of precision equipment of conducting of scientific research that has a strictly controlled level of contamination. Cleanrooms use specifically designed equipment to control the amount of particles per cubic meter at a specified particle size in the room. In some cases even air temperature and humidity controls are needed.
Regardless of cleanliness class, the air to all cleanrooms is filtered through HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Particulate Air) filters. These filters are rated for 99.99 percent efficiency on 0.3 micron particles (HEPA) and 0.128 micron particles (ULPA). Cleanliness is a function of how much clean air is mixed with the contaminated air in the room. The more clean air, the greater the contaminant dilution, and the higher the level of cleanliness. Cleanrooms also take advantage of another feature of the filters and that is the pleating of the media in the manufacturing process. This pleating effect causes the air passing through the filter to be delivered in a jet stream. The collective results of these multiple air streams produces a column of clean air moving uniformly away from the filter face.
The process within the space generally dictates the temperature range that can be tolerated. If there are non-specific requirements, the human factor will usually guide the selection.
Often overlooked in the design of a cleanroom is the stringent humidity requirement. This can vary, again depending on the process involved. Between 40 to 60 percent is typical with a variation usually not greater than 5 percent.
Walls can be constructed of any non-shedding material that can be wiped down easily and kept clean. Walls can be gypsum board with a seamless coating on metal studs or they can be modular. Modular walls have a tax advantage in they are considered tangible property and can be taken down and moved.
The best cleanroom floors are poured seamless systems, seamless sheet vinyl, epoxy, or vinyl tile in that order. Products that limit dust penetration and can be easily maintained are required.
Most cleanrooms are designed with positive pressure plenums, or ceiling spaces. This requires a special grid system that is usually factory gasketed or it can be a gel system on the more stringent rooms. The grids typically support the HEPA filters, lights, and panels and can weigh as much as 12 pounds per square foot. 12 gauge wire is used to support the grid.
HEPA Filter Units
The heart of any cleanroom design is the filtration that is required. SOme are ducted but the most common are fan powered units. The typical 2’x4′ unit has the capacity of 700 to 800 cfm, with a 1/3 hp motor. Latest designs also include energy efficient watt motors.
Lights are specially constructed for cleanrooms so they are sealed air tight. They also produce heat which must be taken into account. Typical lighting is 70 to 100 foot candles.
While we know what the hardware mentioned above produces in regards to release of microbes, heat, ect. the one element that changes daily is the human element. It has been said that “absolute cleanliness” cannot be maintained with man’s involvement, that robots are the only way to eliminate this source of particulate pollution. Even fully gowned, workers are constantly shedding skin particles. Gowning is required.
Garments can include hair coverings, beard or mouth covering, body covering, shoe covering, and gloves with any combination of the above. Garments should be put on in a gowning room. This gowning room should also be HEPA filtered.
Testing and Certification
Once the room is completed, most specifications call for testing and certification. Some requirements state that the room should be tested annually. Testing is usually conducted by an independent testing agency using the ISO Standards, It is also imperative for the owner to purchase a cleanroom monitor in order to determine the daily status of the room.
Cleanrooms require much consideration, equipment, and supplies. CleanPro, a division of Production Automation Corporation is dedicated to guiding customers through the design process, set-up, and supply maintenance of cleanroom areas. To get started, send us a request for quote and we will work with you to identify and quote the exact type and class you require. CleanPro works with high quality and reputable manufacturers to get you the best materials for your project. CleanPro also carries the furniture and equipment needed to fill your cleanroom; from storage and gowning to laminar flow workbenches and seating. CleanPro can make your cleanroom functional and efficient.
Contact us at 888-903-0333 Monday though Friday to speak with one of our cleanroom experts, or email us at email@example.com. We have also created a Cleanroom Quoting Form to help you get started on identifying what type of cleanroom you require, CLICK HERE to get started.
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A question commonly asked is “What is a clean room?” Generally speaking a “Clean Room” is an enclosed room that has equipment which controls the amount of particulate matter in the air by using air pressure and filters. To meet requirements of a “Clean Room” as defined by Federal Standard 209E and newer ISO Standards, all Clean Rooms must not exceed a particulate count as specified in the air cleanliness class.
What are the room classes?
Standards have changed in the last few years. Federal Standard 209E classified rooms in numbers:
- Class 1
- Class 10
- Class 100
- Class 1,000
- Class 10,000
- Class 100,000
This method is simple, the number assigned to the class is the classification that the room must be designed to. Class 1 was the cleanest. The new ISO14644-1 (or British Standard BS5295) has changed these numbers to simple classes:
- Class 3
- Class 4
- Class 5
- Class 6
- Class 7
- Class 8
Class 3 is the cleanest. The difference? Generally speaking, federal standards are measured in cubic feet and the ISO standards are measured in cubic meters.
What is measured in the air? Class 3, 4, and 5 are based on the maximum number of 0.1 and 0.5 micron particles that are permitted in a cubic foot of air approaching any work operation within the room. Class 6, 7, and 8 are based on the number 0.5 micron particles.
What is a micron? To give you an idea of what is being measured, one micron is one-hundredth the width of a human hair. The smallest particle seen with the naked eye is a 10 micron particle. Clean rooms can control 0.01 and 0.05 particles!
Where do these particles come from? The clean room is under positive pressure, keeping out new particles from coming in. So where do they come from? Micro-organisms come from people in the room and other particulates from the processes in the room. Microbes come from skin cells of humans. We shed our outermost layer of skin every 24 hours, that is 1 billion flakes every 24 hours! One flake is about 35 microns.
Class Limits (Amount of Particles Allowed)
Federal 209B Standards:
- Class 100,000: Particle count not to exceed a total of 100,000 particles per cubic foot of a size 0.5 micron and larger or 700 particles per cubic foot of a size 5.0 micron and larger.
- Class 10,000: Particle count not to exceed a total or 10,000 particles per cubic foot of a size 0.5 micron and larger or 65 particles per cubic foot of a size 5.0 micron and larger.
- Class 1,000: Particle count not to exceed a total of 1000 particles per cubic foot of a size 0.5 micron and larger or 10 particles per cubic foot of a size 5.0 micron or larger.
- Class 100: Particle count not to exceed a total of 100 particles per cubic foot of a size 0.5 micron and larger.
ISO or BS 5295 Standards:
- Class 1: The particle count shall not exceed a total of 3000 particles/m3 of a size of 0.5 micron or greater. The greatest particle present in any sample shall not exceed 5 micron.
- Class 2: The particle count shall not exceed a total of 300,000 particles/m3 of a size 0.5 micron or greater: 2000 particles/m3 of a size 5 micron or greater: 30 particles of a size 10 micron or greater.
- Class 3: The particle count shall not exceed 1,000,000 particles of a size of 1 micron or greater; 300 particles/m3 of a size 25 micron or greater.
- Class 4: The particle count shall not exceed a total of 200,000 particles/m3 of a size 5 micron or greater: 40,000 particles/m3 of a size 10 micron or greater: 4000 particles/m3 of a size 25 micron or greater.
A properly designed clean room must have a high rate of air changes to scrub the room of particulates. A Class 5 room can have an air change rate of 400 to 600 times per hour while a class 7 room can change at 50 to 60 changes per hour.
Testing and Certification
Once the room is completed, most specifications call for testing and certification. Some requirements state that the room should be tested annually also. Testing is usually conducted by an independent testing agency using the ISO Standards. It is also imperative for the owner to purchase a clean room monitor in order to determine the daily status of the room.
CleanPro offers all types of cleanrooms, including mobile options along with monitoring, furniture and garments. Everything you need to start, maintain, or expand an existing cleanroom.
Contact us anytime at firstname.lastname@example.org and let our clean room experts help you find what you need.
Visit our store: www.cleanroomproducts.com
© Jenn Weesies. Feb. 25, 2010
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