Cleanliness suitability

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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. [1] [2]

Trends such as the miniaturization of structures as well as increased levels of reliability in technology, research and science require controlled “clean” manufacturing environments. The task of such environments is to minimize influences which could damage the products concerned. The cleanroom environments created by filtering the air were originally developed for the fields of microelectronics and microsystem technology but are now used in a wide range of other high technology sectors such as photovoltaics and the automotive industry.

Depending upon the industry and process concerned, different factors may have a damaging influence on a product, e.g.:

  1. Particles, in microelectronics such as the semiconductor industry and especially biotic particles in life science industries such as pharmaceutics, bio-engineering and medical technology (cleanroom suitability)
  2. Molecular contamination (outgassing), especially in microelectronics such as the semiconductor industry
  3. Electrostatic discharge phenomena (ESD), especially in microelectronics such as the semiconductor industry
  4. Resistance to cleaning and disinfection agents, especially in life science industries such as pharmaceutics
  5. Surface interaction, especially in life science industries such as pharmaceutics, bio-engineering and medical technology
  6. Cleanability, especially in life science industries such as pharmaceutics, bio-engineering and medical technology
  7. Microbicidity, especially in life science industries such as pharmaceutics, bio-engineering and medical technology

The following factors may be responsible for contamination:

Related Research Articles

Cleanroom Room which is used for industrial or research processes that does not tolerate dust

A cleanroom or clean room is an engineered space, which 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 product is being handled inside it.

SMIF (interface) Box carrying semiconductor wafers in its own internal atmosphere

SMIF is an isolation technology developed in the 1980s by a group known as the "micronauts" at Hewlett-Packard in Palo Alto. The system is used in semiconductor wafer fabrication and cleanroom environments. It is a SEMI standard.

Blow fill seal

Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed. It takes place in a sterile, enclosed area inside a machine, without human intervention, and thus can be used to aseptically manufacture sterile pharmaceutical or non-pharamceutical liquid/semiliquid unit-dosage forms. BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophtalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, parenterals, and several other liquid or semiliquid medications, with fill volumes ranging from 0.1...1000 cm³. Compared against traditional glass ampoules, BFS ampoules are inexpensive, lightweight, and shatterproof. Important BFS system suppliers are Weiler Engineering, Rommelag (Bottelpack), and Brevetti Angela.

Cleanroom suit Full-body garments worn to control contamination in cleanrooms.

A cleanroom suit, clean room suit, or bunny suit, is an overall garment worn in a cleanroom, an environment with a controlled level of contamination. One common type is an all-in-one coverall worn by semiconductor and nanotechnology line production workers, technicians, and process / equipment engineers. Similar garments are worn by people in similar roles creating sterile products for the medical device and biopharmaceutical industries.

Microfabrication

Microfabrication is the process of fabricating miniature structures of micrometre scales and smaller. Historically, the earliest microfabrication processes were used for integrated circuit fabrication, also known as "semiconductor manufacturing" or "semiconductor device fabrication". In the last two decades microelectromechanical systems (MEMS), microsystems, micromachines and their subfields, microfluidics/lab-on-a-chip, optical MEMS, RF MEMS, PowerMEMS, BioMEMS and their extension into nanoscale have re-used, adapted or extended microfabrication methods. Flat-panel displays and solar cells are also using similar techniques.

Semiconductor fabrication plant Factory where integrated circuits are manufactured

In the microelectronics industry, a semiconductor fabrication plant is a factory where devices such as integrated circuits are manufactured.

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.

Air shower (room)

Air showers are specialized enclosed antechambers which are incorporated as entryways of cleanrooms and other controlled environments to reduce particle contamination. Air showers utilize high-pressure, HEPA- or ULPA-filtered air to remove dust, fibrous lint and other contaminants from personnel or object surfaces. The forceful "cleansing" of surfaces prior to entering clean environments reduces the number of airborne particulates introduced.

Barrier isolator is a general term that includes two types of devices: isolators and restricted access barriers (RABS). Both are devices that provide a physical and aerodynamic barrier between the external clean room environment and a work process. The isolator design is the more dependable of the two barrier design choices, as it prevents contamination hazards by achieving a more comprehensive separation of the processing environment from the surrounding facility. Nonetheless, both Isolator and RABS designs are contemporary approaches developed over the last 35 years and a great advancement over designs of the 1950s-70s that were far more prone to microbial contamination problems.

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.

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.

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.

Contamination control Activities aiming to reduce contamination

Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas. Contamination control may refer to the atmosphere as well as to surfaces, to particulate matter as well as to microbes and to contamination prevention as well as to decontamination.

Reliability of semiconductor devices can be summarized as follows:

  1. Semiconductor devices are very sensitive to impurities and particles. Therefore, to manufacture these devices it is necessary to manage many processes while accurately controlling the level of impurities and particles. The finished product quality depends upon the many layered relationship of each interacting substance in the semiconductor, including metallization, chip material and package.
  2. The problems of micro-processes, and thin films and must be fully understood as they apply to metallization and wire bonding. It is also necessary to analyze surface phenomena from the aspect of thin films.
  3. Due to the rapid advances in technology, many new devices are developed using new materials and processes, and design calendar time is limited due to non-recurring engineering constraints, plus time to market concerns. Consequently, it is not possible to base new designs on the reliability of existing devices.
  4. To achieve economy of scale, semiconductor products are manufactured in high volume. Furthermore, repair of finished semiconductor products is impractical. Therefore, incorporation of reliability at the design stage and reduction of variation in the production stage have become essential.
  5. Reliability of semiconductor devices may depend on assembly, use, environmental, and cooling conditions. Stress factors affecting device reliability include gas, dust, contamination, voltage, current density, temperature, humidity, mechanical stress, vibration, shock, radiation, pressure, and intensity of magnetic and electrical fields.

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.

Ultrapure water (UPW), high-purity water or highly purified water (HPW) is water that has been purified to uncommonly stringent specifications. Ultrapure water is a term commonly used in manufacturing to emphasize the fact that the water is treated to the highest levels of purity for all contaminant types, including: organic and inorganic compounds; dissolved and particulate matter; volatile and non-volatile; reactive, and inert; hydrophilic and hydrophobic; and dissolved gases.

Fan filter unit

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.

Biomanufacturing is a type of manufacturing or biotechnology that utilizes biological systems to produce commercially important biomaterials and biomolecules for use in medicines, food and beverage processing, and industrial applications. Biomanufacturing products are recovered from natural sources, such as blood, or from cultures of microbes, animal cells, or plant cells grown in specialized equipment. The cells used during the production may have been naturally occurring or derived using genetic engineering techniques.

Carbon dioxide cleaning Family of methods for parts cleaning and sterilization

Carbon dioxide cleaning (CO2 cleaning) comprises a family of methods for parts cleaning and sterilization, using carbon dioxide in its various phases. Due to being non-destructive, non-abrasive, and residue-free, it is often preferred for use on delicate surfaces. CO2 cleaning has found application in the aerospace, automotive, electronics, medical, and other industries. Carbon dioxide snow cleaning has been used to remove particles and organic residues from metals, polymers, ceramics, glasses, and other materials, and from surfaces including hard drives and optical surfaces.

NIU College of Engineering and Engineering Technology was established in 1985 and offers ABET and ATMAE accredited programs in engineering and engineering technology. The college offers bachelor degree programs in biomedical engineering, electrical engineering, engineering technology, industrial and systems engineering, mechatronics engineering, and mechanical engineering. The college offers masters degrees in electrical engineering, engineering technology, industrial and systems engineering, and mechanical engineering. Ph.D. programs are offered in electrical engineering, industrial and systems engineering, and mechanical engineering.

References

  1. VDI 2083, Part 9.1: Cleanroom technology – Compatibility with required cleanliness and surface cleanliness
  2. VDI 2083, Part 17: Cleanroom technology – Cleanroom and cleanliness suitability of materials