Cleanroom solutions and research

CLEANROOM PRODUCTS

Facility Design Pharmaceutical Cleanroom Design Services

Your next cleanroom is more akin to a piece of equipment than a room. Operational efficiencies, compliant flow of materials and personnel, and lifecycle considerations should dictate the selection of your cleanroom partner. AES designers have been engineering functional cleanroom facilities for over three decades, guaranteeing the performance of each and every facility. Our in-house designers work as a team with our cleanroom construction personnel to engineer a cost-effective project while maximizing performance, value, and constructability. The greatest value is realized when AES is integrated into the design team at the start of the project. Early project integration with the AES experts helps the infrastructure team decide what support and cleanroom solutions the clean space requires. Early participation by AES saves design costs, expedites schedule, and eliminates a duplication of services.

  • 7010
    Remote Active Air Sampler For Reliable Microbial Monitoring

    Provides confident and reliable aseptic microbial monitoring in pharmaceutical manufacturing Grade A and B environments with external vacuum systems.

  • API Mfg
    API Manufacturing And Material Handling Equipment

    Active pharmaceutical ingredient (API) manufacturing requires powder handling in a GMP and contained manner. Similar to chemical manufacturing, operations like charging powders into a chemical reactor, emptying a centrifuge or charging and discharging a dryer are standard processes.

  • 3P Innovation - CellPro
    Robotic Aseptic Filling System: Cell Pro

    Part of our Evolve range, the robotic fill-finish Cell Pro is a fully autonomous system, offering hands-free flexible processing of RTU containers, up to 3,000 per hour.

  • L3 310 C.jpg
    Lasair® III Aerosol Mobile Particle Counter

    The Lasair® III Aerosol Mobile Particle Counter minimizes operator errors with intuitive recipe configuration and meets ISO 14644-1/2:2015, ISO 21501-4, EU-GMP.

  • Cleanroom Enviro Contamination Monitoring
    Pharmaceutical Cleanroom Environmental Contamination Monitoring

    Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.

  • Germfree - lightweight panels
    Lightweight Cleanroom Panels: GFRMC

    GFRMC panels are primarily used in the production of 40-foot mobile labs and mini labs. Due to their weight and the efficacy of the Dry Build installation process, GFRMC panels are also used to construct cleanrooms in challenging or remote locations.

  • BioCapt Microbial Impactor
    BioCapt®: Microbial Impactor

    Microbial impactors for continuous viable monitoring, minimize false positives, and are Annex 1 compliant.

  • FTS Feature
    Fluid Transfer Sets

    Bring your biopharma processes together seamlessly. Charter Medical’s extensive range of standard and custom fluid transfer sets are optimized for bioprocessing and sterile transfer of media, biologics, and drug substances from one container to another.

  • ViralVectors
    Cleanrooms And Equipment For Viral Vector Drug Manufacturing

    Viral vector manufacturing: key to successful gene therapy

    Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

  • mRNA
    Cleanrooms And Equipment For mRNA Drug Manufacturing

    Revolutionizing Global mRNA Production: Germfree's Innovative Cleanrooms Drive Manufacturing Success

    Cleanroom requirements for mRNA manufacturing encompass stringent particle control, temperature and humidity management, solvent management and robust contamination prevention strategies. Germfree’s advanced cleanroom solutions address these challenges, ensuring seamless equipment integration, process adaptability, and compliance with regulatory standards. Their tailored mobile and modular facilities support the emerging trend for localized vaccine production, empowering biopharmaceutical companies to harness the transformative potential of mRNA technology in a rapidly advancing field, and ultimately contributing to global immunization efforts.

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CLEANROOM OVERVIEW

Cleanrooms can be very large. Entire manufacturing facilities can be contained within a cleanroom with factory floors covering thousands of square meters. They are used extensively in semiconductor manufacturing, biotechnology, the life sciences and other fields that are very sensitive to environmental contamination.

The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly recirculated through high-efficiency particulate air (HEPA) and/or ultra-low penetration air (ULPA) filters to remove internally generated contaminants.

Staff enter and leave through airlocks (sometimes including an air shower stage), and wear protective clothing such as hoods, face masks, gloves, boots and coveralls.

Equipment inside the cleanroom is designed to generate minimal air contamination. Only special mops and buckets are used. Cleanroom furniture is designed to produce a minimum of particles and to be easy to clean.

Common materials such as paper, pencils, and fabrics made from natural fibers are often excluded, and alternatives used. Cleanrooms are not sterile (i.e., free of uncontrolled microbes);[3] only airborne particles are controlled. Particle levels are usually tested using a particle counter and microorganisms detected and counted through environmental monitoring methods.[4][5]

Some cleanrooms are kept at a positive pressure so that if there are any leaks, air leaks out of the chamber instead of unfiltered air coming in.

Some cleanroom HVAC systems control the humidity to low levels, such that extra equipment ("ionizers") is necessary to prevent electrostatic discharge (ESD) problems.

Low-level cleanrooms may only require special shoes, with completely smooth soles that do not track in dust or dirt. However, for safety reasons, shoe soles must not create slipping hazards. Access to a cleanroom is usually restricted to those wearing a cleanroom suit.[6]

In cleanrooms in which the standards of air contamination are less rigorous, the entrance to the cleanroom may not have an air shower. There is an anteroom (known as a "gray room"), in which clean-room clothing must be put on, from which a person can walk directly into the room (as seen in the photograph on the right).

Some manufacturing facilities do not use fully classified cleanrooms, but use some cleanroom practices to maintain their contamination requirements.[7][8]

Air flow principles

Air flow pattern for "Turbulent Cleanroom"
Air flow pattern for "Laminar Flow Cleanroom"

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream towards filters located on walls near the cleanroom floor or through raised perforated floor panels to be recirculated. Laminar air flow systems are typically employed across 80 percent of a cleanroom ceiling to maintain constant air processing. Stainless steel or other non-shed materials are used to construct laminar air flow filters and hoods to prevent excess particles entering the air. Turbulent, or non-unidirectional, air flow uses both laminar air flow hoods and non-specific velocity filters to keep air in a cleanroom in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the cleanroom environment.[9]

Cleanroom classifications

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FED-STD-209E, and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe, for example, "class 2000".

A discrete-particle-counting, light-scattering instrument is used to determine the concentration of airborne particles, equal to and larger than the specified sizes, at designated sampling locations.

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic metre of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per cubic metre.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, zero particle concentration does not exist. The table locations without entries are non-applicable combinations of particle sizes and cleanliness classes, and should not be read as zero.

Because 1 m3 is approximately 35 ft3, the two standards are mostly equivalent when measuring 0.5 µm particles, although the testing standards differ. Ordinary room air is approximately class 1,000,000 or ISO 9.[10]

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

US FED STD 209E was officially cancelled by the General Services Administration of the US Department of Commerce November 29, 2001,[11][12] but is still widely used.

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

BS 5295 cleanroom standards

  maximum particles/m3
Class ≥0.5 µm ≥1 µm ≥5 µm ≥10 µm ≥25 µm
Class 1 3,000   0 0 0
Class 2 300,000   2,000 30  
Class 3   1,000,000 20,000 4,000 300
Class 4     200,000 40,000 4,000

BS 5295 Class 1 also requires that the greatest particle present in any sample does not exceed 5 μm.[13]

GMP EU classification

Class maximum particles/m3[14]
At Rest At Rest In Operation In Operation
0.5 µm 5 µm 0.5 µm 5 µm
Class A 3,520 20 3,520 20
Class B 3,520 29 352,000 2,900
Class C 352,000 2,900 3,520,000 29,000
Class D 3,520,000 29,000 n/a n/a

 

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