Cleanroom solutions and research

CLEANROOM PRODUCTS

syringe vaccine Syringe Forming Lines

Syringes are complex products that require an extremely precise forming process: Stevanato Group syringe manufacturing lines include several specifications, which are normally optional, such as servomotors for controlling the most critical manufacturing phases (cone forming, total length) and flow meters for automatically regulating the burners.

  • MiniCapt Remote Air Sampler
    Microbial Sampling: MiniCapt® Remote Air Sampler

    The MiniCapt® Remote Air Sampler features modern, easy to use data and sample configuration management by integration with a FacilityPro® system.

  • GettyImages-1252804945-vial-vaccine-bottle-medicine
    Wet Nanomilling And Vial Filling

    Nanomilling revolutionizes drug delivery by reducing particle size to enhance solubility, bioavailability, and therapeutic efficacy, addressing the challenges of poorly water-soluble APIs.

  • Valor vial bucket
    Primary Pharmaceutical Glass Packaging

    We’ve applied our expertise in glass science, optical physics, vapor deposition, precision forming, and extrusion to design and develop a 21st century glass container to protect 21st century drugs and vaccines. Corning® Valor® Glass vials enhance the storage and delivery of drugs, providing more reliable access to medicines essential to public health.

  • GettyImages-1290924802 transfection
    VirusGEN® Transfection Complex Stabilizer

    Scale AAV production with peace of mind. Extend transfection complex formation time by up to 3 hours, reduce complex volume by >50%, and maintain high titers and full capsids.

  • 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.

  • Ecolab - cleanroom
    Optimize Your Contamination Control Strategy

    An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

  • Powerfuge P12
    Stainless Steel Centrifuges for Regenerative Medicines

    Clean-in-Place / Sterilize-in-Place System

    The Powerfuge P12 System is a batch liquid/solid separation system for bacteria, yeast, proteins and sub-micron particles. It is designed to provide continuous-flow two-phase separation of solids and liquids and meets cGMP and CE requirements as well as chemical and pharmaceutical industry protocols.

    • Bowl capacity: 8L
    • Flow rates up to 500 L/hr for batches up to 500 L
    • Footprint ~ 78.7 cm wide x 172.7 cm deep x 203.2 cm high (31” x 68” x 80”)
    • Total weight ~ 1924 kg (4,240 lbs)
    • Fully scalable to smaller automated Pilot and P6 models
    • Fully scalable to larger automated P18 model
    • Drier solids and clear liquids
  • ASEPTiCell ScreenShot 8
    Aseptic And Syringe Filling Equipment For Contract Manufacturers (CDMOs)

    Having the right balance of capacity and capabilities in all market conditions is the struggle that Contract Manufacturer Organizations face daily. Add to it the cost and complexity of maintaining a suitable parenteral manufacturing facility, the risks can be high. With constantly evolving parenteral market needs, having flexibility while achieving high utilization is key to long term success. To support these challenges, AST’s line of aseptic and syringe filling and closing machines provide adaptive fill-finish capabilities to ensure that any contract manufacturing organization has the right capabilities for any vial, syringe filling or cartridge application.

  • 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.

  • 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.

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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

 

CLEANROOM EDITORIAL AND NEWS

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