Cleanroom suitability describes the suitability of a machine, operating utility, material, etc. for use in a cleanroom, where air cleanliness and other parameters are controlled by way of technical regulations in accordance with ISO 14644. [1]
Cleanroom suitability is a subdomain of cleanliness suitability and primarily describes the particle emission behavior of a machine or operating utility (test piece).
The aim of cleanroom suitability tests is to determine the suitability of machines and operating utilities (air conditioning, venting, etc.) for use in cleanrooms. The tests must be carried out using measurement techniques as particle emission behavior cannot be adequately assessed by the naked eye or similar means. No metrological tests are required if there are obvious flaws in machines and operating utilities, such as rust or the presence of porous or completely unsuitable materials (wood, etc.).
Tests to assess the cleanroom suitability of a machine or operating utility using measurement techniques are performed in a cleanroom in order to be certain that the particles detected are emitted from the test piece. The test cleanroom has to be at least one class cleaner that the desired suitability of the test piece, otherwise it would not be possible to relate the particles detected to the test piece in question. An exception to this is when determining the suitability of a test piece for use in Class 1 cleanrooms in accordance with DIN EN ISO 14644-1: such tests have to be carried out in a Class 1 cleanroom because no other cleanroom classes are defined which are better than this. The test cleanroom must have a low-turbulence airflow (often known as laminar in this context) in order to prove high air cleanliness classes and also accurately locate particle sources.
Particle counters are utilized as measurement devices in order to determine particulate contamination with regard to geometrical size, quantity, distribution, chronological progression and location.
The cleanroom suitability of a material describes its particle emission behavior. However, as particle emission from materials can only be assessed under stress conditions, model tests on material pairings have proved to be valuable in order to obtain reproducible, comparable results. Particle emission behavior tests have to be carried out under the same conditions as for machines and operating utilities, and optical particle counters are also implemented. [2]
Nondestructive testing (NDT) is any of a wide group of analysis techniques used in science and technology industry to evaluate the properties of a material, component or system without causing damage. The terms nondestructive examination (NDE), nondestructive inspection (NDI), and nondestructive evaluation (NDE) are also commonly used to describe this technology. Because NDT does not permanently alter the article being inspected, it is a highly valuable technique that can save both money and time in product evaluation, troubleshooting, and research. The six most frequently used NDT methods are eddy-current, magnetic-particle, liquid penetrant, radiographic, ultrasonic, and visual testing. NDT is commonly used in forensic engineering, mechanical engineering, petroleum engineering, electrical engineering, civil engineering, systems engineering, aeronautical engineering, medicine, and art. Innovations in the field of nondestructive testing have had a profound impact on medical imaging, including on echocardiography, medical ultrasonography, and digital radiography.
A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well isolated, well controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing. A cleanroom is designed to keep everything from dust to airborne organisms or vaporised particles away from it, and so from whatever material is being handled inside it.
A nephelometer or aerosol photometer is an instrument for measuring the concentration of suspended particulates in a liquid or gas colloid. A nephelometer measures suspended particulates by employing a light beam and a light detector set to one side of the source beam. Particle density is then a function of the light reflected into the detector from the particles. To some extent, how much light reflects for a given density of particles is dependent upon properties of the particles such as their shape, color, and reflectivity. Nephelometers are calibrated to a known particulate, then use environmental factors (k-factors) to compensate lighter or darker colored dusts accordingly. K-factor is determined by the user by running the nephelometer next to an air sampling pump and comparing results. There are a wide variety of research-grade nephelometers on the market as well as open source varieties.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place to ensure consistent checking. Inspections are usually non-destructive.
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. The measured entity is often called the analyte, the measurand, or the target of the assay. The analyte can be a drug, biochemical substance, chemical element or compound, or cell in an organism or organic sample. An assay usually aims to measure an analyte's intensive property and express it in the relevant measurement unit.
Predictive maintenance techniques are designed to help determine the condition of in-service equipment in order to estimate when maintenance should be performed. This approach claims more cost savings over routine or time-based preventive maintenance, because tasks are performed only when warranted. Thus, it is regarded as condition-based maintenance carried out as suggested by estimations of the degradation state of an item.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
A particle counter is used for monitoring and diagnosing particle contamination within specific clean media, including air, water and chemicals. Particle counters are used in a variety of applications in support of clean manufacturing practices, industries include: electronic components and assemblies, pharmaceutical drug products and medical devices, and industrial technologies such as oil and gas.
Pharmaceutical microbiology is an applied branch of microbiology. It involves the study of microorganisms associated with the manufacture of pharmaceuticals e.g. minimizing the number of microorganisms in a process environment, excluding microorganisms and microbial byproducts like exotoxin and endotoxin from water and other starting materials, and ensuring the finished pharmaceutical product is sterile. Other aspects of pharmaceutical microbiology include the research and development of anti-infective agents, the use of microorganisms to detect mutagenic and carcinogenic activity in prospective drugs, and the use of microorganisms in the manufacture of pharmaceutical products like insulin and human growth hormone.
Particle size is a notion introduced for comparing dimensions of solid particles, liquid particles (droplets), or gaseous particles (bubbles). The notion of particle size applies to particles in colloids, in ecology, in granular material, and to particles that form a granular material.
The Institute of Environmental Sciences and Technology (IEST) is a non-profit, technical society where professionals who impact controlled environments connect, gain knowledge, receive advice, and work together to create industry best practices. The organization uniquely serves environmental test engineers, qualification engineers, cleanroom professionals, those who work in product testing and evaluation, and others who work across a variety of industries, including: acoustics, aerospace, automotive, biotechnology/bioscience, climatics, cleanroom operations/design/equipment/certification, dynamics, filtration, food processing, HVAC design, medical devices, nanotechnology, pharmaceutical, semiconductors/microelectronics, and shock/vibration. Information on ISO 14644 and ISO 14698 standards can be found through this organization.
FED-STD-209 EAirborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones was a federal standard concerning classification of air cleanliness, intended for use in environments like cleanrooms. The standard based its classifications on the measurement of airborne particles.
ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1.
The ISO 14698 Standards features two International Standards on biocontamination control for cleanrooms. IEST, the Secretariat and Administrator of ISO Technical Committee 209, helped develop this series of ISO 14698 Standards.
Cleanability is a term used to describe a material's ability to have contaminants removed such as residue, stains, deposits, microorganisms, and dust. The term is applicable to materials used in the production of surfaces, tools, utensils, etc, that come into contact with media such as food, chemicals, or bio-hazardous materials that must be removed from the implements to prevent possible contamination of other media during later use. Highly cleanable materials will transfer little to no media from one batch to another if proper cleaning procedures are followed.
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes.
An inclusion is a solid particle in liquid aluminium alloy. It is usually non-metallic and can be of different nature depending on its source.
Cleanliness suitability describes the suitability of operating materials and ventilation and air conditioning components for use in cleanrooms where the air cleanliness and other parameters are controlled by way of technical regulations. Tests are carried out to determine this.
A fan filter unit (FFU) is a type of motorized air filtering equipment. It is used to supply purified air to cleanrooms, laboratories, medical facilities or microenvironments by removing harmful airborne particles from recirculating air. The units are installed within the system's ceiling or floor grid. Large cleanrooms require a proportionally large number of FFUs, which in some cases may range from several hundred to several thousand. Units often contain their own pre-filter, HEPA filter and internally controllable fan air distribution.
The characterization of nanoparticles is a branch of nanometrology that deals with the characterization, or measurement, of the physical and chemical properties of nanoparticles.,. Nanoparticles measure less than 100 nanometers in at least one of their external dimensions, and are often engineered for their unique properties. Nanoparticles are unlike conventional chemicals in that their chemical composition and concentration are not sufficient metrics for a complete description, because they vary in other physical properties such as size, shape, surface properties, crystallinity, and dispersion state.