As a manufacturer of materials testing machines, ZwickRoell offers cleanroom-compatible testing machines that meet the strict requirements for testing in cleanrooms. Standards and guidelines for materials testing in cleanrooms ISO requirements and cleanroom classifications Cleanroom-compatible materials testing machines Applications Certificate FAQ Request a consultation.

Table 1 specifies the particle concentration at various particle sizes within the nine ISO classifications. The use of Table 1 ensures that the particle size ranges appropriated for different classes are better defined.

Source: DIN Standards Committee NHRS. This standard combines the classification of air cleanliness based on the particle concentration of the cleanroom with the suitability of equipment for use in cleanrooms and associated controlled environments.

This standard specifies a methodology for evaluating the cleanroom suitability of equipment for example, machines, measuring instruments, processing equipment, components, tools for use in cleanrooms and associated controlled environments with respect to airborne particle cleanliness as specified in ISO This guideline provides information on planning, generating, maintaining, restoring and verifying the cleanliness of equipment and air handling units.

Requirements, procedures and detection methods therefore depend on the specific use of the cleanroom and the possible contaminants. The guideline includes a standardized procedure for the qualification of equipment and air handling units for cleanliness controlled environments.

Source: VDI Guidelines. The ISO standard describes the requirements on cleanrooms and associated controlled environments. Depending on the size and number of particles present, a classification is made according to different cleanroom classes:.

ZwickRoell is the first manufacturer of cleanroom-compatible testing machines that meet the strict requirements for materials testing in cleanroom environments.

The zwickiLine materials testing machine was further developed to meet these requirements. In a force range of 0. All relevant tests can be conveniently performed with the powerful, flexible, yet cost-effective zwickiLine testing machine.

With its wide range of equipment options, the zwickiLine meets all the necessary requirements while producing reliable test results. The technical properties of the cleanroom-compatible materials testing machine zwickiLine Z2.

It provides sophisticated possibilities for applications with increased test requirements. Results from materials testing in cleanroom environments are transferred to the testXpert testing software. With the traceability option integrated in the software, the regulations of FDA 21 CFR Part 11 can be met according to the ZwickRoell white paper.

ZwickRoell is not just an excellent partner for testing in cleanrooms, we also serve many other areas in the medical and pharmaceutical industry. Testing in cleanrooms is particularly important in the medical and pharmaceutical industries. The cookie is used to store the user consent for the cookies in the category "Analytics".

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Advertisement Advertisement. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. Cleanroom manufacturers and product suppliers have already begun developing materials and supplies to meet the requirements outlined in USP Included in the USP tools are mats and mops that are fabricated to meet the stipulations of ISO class 5 or Class The cleanroom supply industry has been following USP guidelines in hospitals and pharmaceutical applications with the understanding of the growing need for the use of the USP guidelines.

Like most of the products for cleanrooms, cleanroom mats come in several styles, sizes, materials, designs, and configurations, with each type fabricated to perform a special function. Cleanroom mats are made to assist in maintaining the sterility and integrity of the cleanroom environment by protecting the floor and collecting dirt from footwear.

The different types of mats include sticky, carpeted, footbath, anti-fatigue, anti-microbial, and disposable. Sticky cleanroom mats, also known as adhesive mats, are made from layers of polyethylene sheets that have a specially treated pressure sensitive adhesive on the upward exposed side of the mat.

When workers enter the cleanroom walking over a sticky mat, it grabs dust and dirt on the soles of their shoes. A footbath cleanroom mat has a disinfectant solution and rubber scrapers that remove contaminants from footwear.

The mats are capable of holding one gallon of cleaning solution, which is typically a chlorine or quaternary solution. The mat immerses the treads and sides of the soles of footwear.

Anti-fatigue cleanroom mats are an ergonomic floor mat that is designed to relieve leg strain when it is necessary to stand on a hard surface for an extended period.

This type of mat reduces fatigue that causes poor circulation. Operators are prevented from experiencing fatigue and kept comfortable.

Anti-microbial mats, also known as contamination control mats, have an antimicrobial agent that prevents the growth and spread of bacteria.

The antimicrobial compound is applied to the top and bottom of the mat as well as its fibers. Cleanroom shoe cleaners are used to control contamination from dust and particles on shoes.

They are motorized cleaners with brushes that clean all sides of shoes and footwear. Cleanroom shoe cleaners can clean shoes up to six inches wide and can be adjusted to clean smaller width shoes.

Attached to a cleanroom shoe cleaner is a vacuum system that draws the removed dust and particles into a dust bag with the dust filled air from the cleaner discharged through a HEPA filter.

For the protection of users, cleanroom shoe cleaners have a slow starting torque that builds after shoes are placed in the cleaner. For a cleanroom to retain its ISO classification, the workers in the room have to be attired in coverings that meet the stipulations of the classification.

The basic requirements of cleanroom garments are that they be lint free and non-shedding. Every class of cleanroom has a list of approved apparel to meet the level and standards of the cleanroom.

The most restrictive requirements necessitate the wearing of goggles, bouffant hats, hoods, footwear coverings, face masks, and exceptionally sensitive hygienically clean gloves. Types of cleanroom apparel include gowns, coveralls, frocks, coats, aprons, shirts, pants, shoes, footwear covers, sleeves, and hoods.

A material is considered to be sterile if it has had all loose particles, threads, fabric, and lint completely and entirely removed. Sterile garments are made from materials that block particles, contaminants, and non-hazardous splashing.

SMS is a nonwoven fabric that combines spun bond and melt blown. This type of material has exceptional durability and strength whether it is wet or dry and is highly resistant to fraying or unraveling. The melt blown portion is softer and pliable and adds a more pleasant texture to the material since spun bond fabrics tend to be stiff, rigid, and uncomfortable.

Any environment can produce ESDs. In a cleanroom, they can be damaging and negatively impact cleanroom processes. ESD fabrics prevent and protect against ESDs that are normally produced by clothing.

Microporous material is made of nonwoven, laminated, breathable microporous film, which is an excellent barrier against biological infective agents.

Regardless of the lamination, the nonwoven side of the material has a soft feeling. The features of microporous materials are protection against liquid and blood penetration, a high moisture vapor transmission rate MVTR , abrasion resistance, and an antistatic property.

Chemical resistant materials are capable of withstanding exposure to a wide range of chemicals such as bases, solvents, and acids. Each type of fabric is resistant to a certain and specific type of chemical.

For example, nylon is resistant to acetone but can be damaged by water. Included in chemical resistant materials are Arkema, Baden aniline and soda factory BASF , Solvay, nylon, and polyvinylidene fluoride PVDF to name a few. FR materials do not easily catch fire or melt when exposed to fire or some ignition source.

The two types of FR materials are inherently flame resistant fabrics and those that have been chemically treated.

Inherently flame resistant materials or fabrics have a chemical structure that makes them naturally resistant to fire. A chemically treated fabric has had a flame resistant chemical applied to the fabric.

For a fabric to be classified as flame resistant, it has to meet the stipulations of the American Society for Testing and Materials ASTM standard F, Standard Test Method for Evaluation of Flame Resistant Clothing for Protection Against Flash Fire Simulations Using an Instrumented Manikin.

Any flame resistant fabric must be disposed of if it becomes damaged. A biohazard resistant material is a variation of microporous film technology, and it protects against particles and non-hazardous liquids. To qualify as a biohazard material, the fabric must be able to protect against contaminants, plants, animals, and various byproducts.

There are four levels of biohazards:. As with all cleanroom apparel, aprons are designed to prevent pollutants from contaminating the space. They are resistant to spills from acids, alkalis, and different types of chemicals.

They have long sleeves with elastic cuffs to block splashes from striking the arms of the wearer. The basic requirements of cleanroom bouffant caps are that they be lightweight, cool, and non-lint producing. In most cases, they are made of polypropylene and have a floss style elastic cover band.

Bouffant caps are normally a one time disposal product that are immediately disposed of after use and come in materials that meet the class of the cleanroom in question. Cleanroom suits or coveralls are considered in the determination of the materials that can be handled by technicians in a cleanroom.

First, the type of material a suit is made of sets the limits to what the wearer can work with. One of the main differentiations between cleanroom suits is whether they can be used with biohazard or chemical.

Though biohazard and chemical are clear distinctions, suits are further divided by the severity of the materials, with some suits resembling equipment for space travel.

In some cases, cleanroom suits are one use and disposable due to the types of materials being handled. Biohazard suits are divided according to how dangerous the biomaterial is. They are ranked and categorized from basic resistance to suits capable of existing in a highly toxic environment for several hours.

Biohazard materials are divided into four levels: A, B, C, and D. Level A is the most severe and level D is the least severe. Level A biohazard suits are designed for spills and cleanups since they have air tanks to keep the user from breathing in disaster fumes.

At the most severe, cleanrooms may have coveralls as pictured below with boots, a hood, gloves, and a mask. Non-sterile coveralls are worn over everyday clothing to prevent the spread of lint from clothing and particles. They have the same function as biohazard coveralls without the stringent requirements.

Included in non-sterile coveralls are a hood, footwear coverings, full body suit, and gloves. Since the purpose of a non-sterile coverings is to control particulate matter and lint, coverings for the face are not necessary. Some styles of non-sterile coveralls do not include coverings for footwear, hands, and the head.

Chemical and virus suits are designed to deal with acids, chemicals, viruses, and bloodborne pathogens. They can be used as regular apparel for exceptional protection in cleanrooms that are handling acids and caustic chemicals or kept as emergency equipment.

For extra protection, chemical and virus coveralls have taped seams to form an extra seal against leakage. Depending on the needs of the application, chemical and virus coveralls can be sterile or non-sterile. Nomex® is an exceptionally strong material that was developed by the DuPont Corporation.

When Nomex® is exposed to intense heat, its fibers thicken and carbonize by absorbing the heat energy. Due to this characteristic, Nomex® will not melt, drip, or combust.

The molecular structure of Nomex® prevents electricity from flowing through it when it is exposed to arcing electrical currents. Though Nomex® is a highly resilient and durable material, it is expensive and only necessary in unique and unusual conditions. It is available in all forms of cleanroom garments from frocks, hoods, and coveralls to gloves and foot coverings.

Tyvek® is another DuPont product that is designed for cleanrooms. The material of Tyvek® provides a barrier against particles, contaminants, and non-hazardous material splashes. It is a nonwoven and lightweight fabric that is produced using a flash spinning process.

The serge seams do not have raw edges but include extra stitching for a strong, stress resistant seam. Tyvek® cleanroom garments come in coveralls, frocks, lab coats, hoods, boot covers, and bouffant caps. Cleanroom foot coverings are worn over shoes to prevent contamination of the environment by particulate matter.

As with all forms of cleanroom fabrics, foot coverings are lint free and do not shed. They come as sterile and non-sterile booties and simple shoe coverings. The difficulty in shoe coverings is the wide variety of styles, types, and materials that are available. The materials used to produce shoe coverings include Tyvek®, polypropylene, CPE plastics, latex, and polyethylene to name a few.

The quality of the materials of foot coverings must meet the ISO classification of the cleanroom. Masks are not a necessity for every cleanroom and are only required in medium to extremely strict conditions.

The types of masks can vary between heavy duty types designed to filter the air to types that prevent the inhalation of fumes from cleanroom processes.

The varieties of cleanroom masks include ear loop, four tie, pouch, and visor. Ear loop masks are a standard type with two elastic bands that stretch over the ears.

A four tie mask is a surgical style that ties in the back of the head. A pouch style mask is a non-sterile mask that has extra material around the mouth and nose to provide a larger breathing space. A visor mask comes with an attached shield at the top and can be four tie or ear loop.

Additional preventative measures for cleanroom masks are cleanroom mask dispensers. They hold masks in a sanitary container with a lid to prevent contaminants and dust particles from getting to them.

Depending on the type and the requirements of the cleanroom, mask dispensers can be wall mounted or free standing. They are made of clear plastic and are single-use. Cleanroom hoods are worn over the head to keep unclean matter from hair from contaminating the environment.

Hoods come in several varieties, with those that cover the whole face with the exception of the eyes and others that fit under the chin and cover the sides and back of the head. The purpose of hoods is to be used in sterile cleanrooms that are rated at class ISO 4 and ISO 5. The types of gloves used in a cleanroom vary according to how they are shipped and packaged.

For high classification cleanrooms, gloves have to be individually packaged in a sterile plastic bag and free of powders or other packing materials. Packing of gloves in cardboard is not permitted since cardboard particles can be introduced to the cleanroom.

Typical materials used to produce cleanroom gloves include nitrile, latex, neoprene, polychloroprene, and polyisoprene. An essential part of cleanroom gloves is a tight and secure fit such that the gloves are not loose and fit like a second skin.

The class of gloves fit the class of the cleanroom with types designed for non-sterile and sterile environments.

In exceptionally restrictive cleanrooms, normal everyday clothing may not be worn even under coveralls. For the comfort of workers, manufacturers purchase intersuits that are worn under coveralls to meet the requirements of the cleanroom. Much like coveralls, intersuits are non-lint producing and are sealed by elastic material at the wrist and ankles.

Once a worker is in their coveralls with gloves, foot coverings, and a mask, they are completely sealed from the air and environment in the cleanroom. The cleaning of cleanrooms involves the use of several specialized products.

Cleanrooms are classified according to their particle count as defined in ISO and microbial counts as defined in ISO Further requirements and regulations are outlined by the Federal Drug Administration FDA and the European Union EU.

A major step toward meeting the various regulations is the use of well defined cleaning techniques as well as acceptable cleaners and disinfectants. Cleaners and disinfectants use a wide spectrum of ingredients and compounds designed to clean and sanitize cleanroom surfaces.

Bacteriostatic disinfectant cleaners inhibit the growth of bacterial cells. They do this by blocking the metabolic action of bacterial cells by targeting the protein synthesis.

The process does not kill the cells but prevents them from procreating and replicating their DNA. The use of a bacteriostatic disinfectant controls and regulates the growth of bacterial cells but does not eliminate the bacteria. Continued use of bacteriostatic disinfectants will eventually lead to the extinction of bacteria.

Bactericidal disinfectant cleaners are antimicrobial cleaners that treat and kill bacteria. These compounds attack microbes by affecting their cell walls, lipids, enzymes, and protein synthesis. The disruption of the cell structure and blocking of the formation of new cells kills the cells, preventing any further growth.

The work of bactericidal cleaners is irreversible and is used to completely sterilize cleanrooms. The resulting effect is a hygienically and antiseptically clean environment. Antibacterial cleaners stop the growth of bacteria and prevent it from entering an environment. They include ingredients that get embedded in surfaces to create an environment where bacteria cannot live.

They are effective against a wide range of bacteria and other contaminants. Antimicrobial cleaners function much like antibacterial cleaners but go much further in the destruction and prevention of bacterial growth. When an antimicrobial cleaner is introduced into the environment, it offers longer lasting protection and removes contaminants that may enter the environment.

A sporicidal cleaning agent destroys bacterial and fungal spores.