Evolving Standards in Cleanroom Classification

Clean rooms have become integral to advancements in modern science and technology, finding widespread application across diverse industries since their inception in the 1960s. These controlled environments, meticulously designed and maintained, serve crucial roles in sectors like medicine, electronics, aerospace, and precision instruments.

Definition of Cleanrooms:

Cleanrooms are precisely controlled environments aimed at minimizing particulate contamination, managing environmental factors such as temperature, humidity, and air quality, and preventing the intrusion of contaminants or microorganisms. Their significance spans various industries, including pharmaceuticals, electronics, biotechnology, and aerospace, where even minute particles or impurities can disrupt processes, compromise product quality, or skew research outcomes.

A Brief Historical Overview of cleanrooms:

The genesis of cleanrooms traces back to the 1940s when semiconductor technology highlighted the detrimental effects of dust and microorganisms on electronic component manufacturing. The initial clean rooms emerged to address these challenges. Subsequent decades witnessed significant advancements and refinements in clean room concepts, particularly in the 1960s and 1970s. The 21st century witnessed their expanded usage in burgeoning fields. To cater to diverse cleanliness requirements across industries, continuous optimization and innovation in clean room technology have propelled the industry’s rapid evolution.

American Standard:

The foundation of cleanroom classification originated in the United States. In 1963, the inception of the first federal standard, FS-209, delineated clean room standards for the military sector. The familiar 100-level, 10,000-level, and 100,000-level standards stem from this milestone. Transitioning from the FS-209E standard in 2001, the United States adopted the ISO standard, signifying an evolution toward globally recognized standards.

By restructuring and refining the language, the information regarding cleanroom standards becomes clearer and more concise, ensuring the reader comprehends the importance and evolution of these controlled environments.

ISO standards, devised by the International Organization for Standardization (ISO), extend across various industries beyond pharmaceuticals. These standards encompass nine levels, spanning from Class 1 to Class 9.

Cleanliness levels of airborne suspended particles in clean rooms and controlled areas are assessed. 

(1) All concentrations listed in this table are cumulative calculations. For instance, in ISO grade 5, the threshold for 0.3μm particles is 10,200 particles. This threshold encompasses all particles equal to or larger than this size.

(2) These concentration measurements necessitate substantial sampling volumes. ISO specifications lack explicit quantity requirements, only suggesting the utilization of the sequential sampling method in Appendix D. Contrasting with the Level A testing requisites outlined in the Chinese GMP Appendix, Level A mandates a minimum sampling volume of 1 cubic meter.

(3) Concentration thresholds for exceptionally high particle densities do not fall within the range specified in this table.

(4) There are limitations in sampling and statistically assessing low-concentration particles, along with inadequacies in their classification.

In Class C and Class D environments, the limit for particles smaller than 0.5 μm does not apply. Simultaneously, in ultra-clean environments with stringent cleanliness standards, the constraint on suspended particles might primarily pertain to smaller particles. This is because detecting larger particles becomes impractical in environments with exceptionally high cleanliness requirements.

EU GMP/GMP standard

1.Grading standards

Known as the ABCD system, originate from the GMP (Good Manufacturing Practice) guidelines established by the World Health Organization (WHO) and stand as a widely adopted quality management standard within the pharmaceutical industry worldwide, including in the European Union and China.

The EU GMP/GMP framework categorizes air cleanliness levels in clean rooms and controlled environments based on suspended particle concentration indicators, focusing on particles within the size range of 0.1 μm to 5.0 μm. These are divided into conventional particles (0.1μm ~ 5.0μm), ultrafine particles (<0.1μm), and macro particles (>5.0μm).

Clean rooms are stratified into four levels, denoted as ABCD, with the associated purification levels depicted in the accompanying illustration:

In this depiction, the lower the assigned level of the clean area, the higher the purification standard it embodies.

Air cleanliness pertains to the size and quantity of particles, including microorganisms, present in a unit volume of air, serving as the benchmark for discerning the cleanliness level within a specific space.

“Static” denotes the condition subsequent to the installation and full functionality of the clean air conditioning system, with personnel having evacuated the site, allowing for self-purification over 20 minutes.

“Dynamic” signifies the operational phase of the clean room, where equipment runs normally, and designated personnel execute tasks according to stipulated protocols.

2.Definition of Class A, B ,C, D areas

Class A clean areas represent the highest level, designated for high-risk operations like filling areas, placement of rubber stopper buckets, and sterile assembly operations. These areas typically utilize laminar flow operating tables (hoods) to maintain environmental conditions, requiring a consistent air supply with a specific wind speed range of 0.36-0.54 m/s. The functionality of the laminar flow system must be verifiable, with data supporting its status. In enclosed settings like isolated operator or glove boxes, lower air speeds or unidirectional flow might suffice.

Class B clean areas serve as background zones for high-risk operations associated with Class A areas, such as aseptic preparation and filling, often utilized in pharmaceutical sterile manufacturing processes.

Class C clean areas constitute lower-priority zones in sterile drug production, primarily used for assembling hydraulic or pneumatic equipment, occasionally employed in the food and beverage industry.

Class D clean areas represent low-priority zones in sterile drug production.

Precautions:

Sampling Volume and Airborne Particle Standards:

For Class A clean areas, confirm the level by sampling a minimum of 1 cubic meter per point. Airborne particles in Class A areas should adhere to ISO 4.8, with particles ≥5.0μm serving as the limit.

In Class B static clean areas, the airborne particle level is ISO 5, encompassing particle sizes detailed in the table.

Class C clean areas (static and dynamic) adhere to ISO 7 and ISO 8 respectively. Class D static areas should maintain an airborne particle level of ISO 8. Test methodologies can refer to ISO14644-1.

Sampling Procedures:

To confirm levels, use portable particle counters with shorter sampling tubes to prevent settling of ≥5.0 μm particles. Isokinetic sampling heads are recommended in unidirectional flow systems.

Exceptions During Operations:

During filling or dispensing, suspended particles ≥5.0 μm at the filling point might deviate from standards due to product particles or droplets.

Dynamic Testing and Standards:

Dynamic testing during routine operations or simulated filling processes using culture mediums helps validate achieved cleanliness levels. The latter requires testing under the “worst condition.”

Different clean room levels serve distinct purposes, and selection should align with specific requirements. Environmental control in clean rooms involves multifaceted considerations. Proper understanding and utilization of clean rooms are critical to preventing cross-contamination, ensuring environment quality and stability, and consequently, product safety and quality.

Cleanroom suit Requirements:

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Different clean areas necessitate specific clean clothing. The quality of attire significantly impacts the cleanroom environment. Choosing qualified clean clothing is imperative. Gaible, with 15 years of expertise in the cleanroom industry, specializes in manufacturing and supplying protective wear equipment for clean areas. With a comprehensive product range and valid qualifications, tailored clean clothing solutions are available to meet diverse user needs.here equipment runs normally, and designated personnel execute tasks according to stipulated protocols.

Gaible reusable cleanroom PPE:

Gaible focuses on producing reusable cleanroom PPE aligns with sustainability efforts, provides customers with cost-effective solutions, maintains consistent protection, and ensures compliance with stringent cleanliness standards in controlled environments.

The fabric of most of Gaible PPE are made of polyester and conductive fiber, which resists to moist-heat temperature sterilization and repeatedly washing.

Gaible 3-in-1 cleanroom coverall(L-3111X)

Gaible Upgraded 3-in-1 Cleanroom Coverall(hooded) – gaible.com

The 3-in-1 cleanroom coverall is crafted from an exceptional blend of polyester filament and conductive fiber, and meticulously stitched using a specialized technique, this coverall is a masterclass in cleanroom apparel. Designed with an attached hood, a front zipper for easy access, and elasticated cuffs adorned with finger rings, it ensures unparalleled protection. Features such as flat pant hems, hidden buttons, and an

adjustable hood only enhance its appeal. It’s optimized for pairing with sterilizable boots or shoe covers, and can be complemented with protective goggles, masks, gloves, and clothes bags for full protection.

Our 3-in-1 cleanroom coverall boasts two innovative designs that set it apart. The pull-ring design at the cuffs ensures they remain securely in place, reducing the risk of contamination. Moreover, strategically placed hidden buttons connect the sleeves, back, and hat, preventing them from touching the ground and facilitating easy folding.

Available in six vibrant colors – white, blue, pink, green, yellow, and navy blue – and sizes ranging from XS to 6XL, it caters to heights from 153cm to 202cm. Not only is this coverall reusable, but it also promises cleanliness, comfort, barrier properties, moisture heat sterilization resistance, durability, and anti-static attributes. Soft against the skin and supremely comfortable, it’s the go-to attire for pharmaceutical clean areas graded A/B workshops.

Cleanroom sterilizable boots(X-002B)

Sterilizable Boots for Cleanroom Environments – gaible.com

Gaible sterilizable boots are designed with precision and a keen understanding of cleanroom requirements, these boots are a marriage of form and function. The soles, crafted from imported, eco-friendly TPV material, ensure a durable yet environmentally conscious footprint. The boot uppers, made from low-dust canvas, reduce both dust generation and absorption – a paramount feature in cleanroom environments. Employing an integrated injection molding process, these boots boast an adhesive-free, benzenefree construction, ensuring they are both waterproof and resistant to weak acids and alkalis.

But beyond the technical specifications, comfort isn’t compromised. The boots are breathable, wear-resistant, and can withstand the rigors of 121℃ moist-heat sterilization. With intrinsic anti-static properties, exceptional cleanliness, durability,

and resilience, they stand as a testament to Gaible’s commitment to quality.

Upgraded 2-in-1 Cleanroom Coverall

Upgraded 2-in-1 Cleanroom Coverall – gaible.com

Exceptional Durability in Sterilization: Designed to endure, our coveralls can withstand approximately 100 sterilizations at 121°C without compromising integrity. Most alternatives falter after just 20-30 cycles, becoming rigid, misshapen, or even damaged.

Superior Anti-Static Properties: Our fabric is masterfully woven with conductive fibers, strategically embedded within both warp and weft. With a meticulous 0.45CM grid pattern using 2/3 twill, it achieves an impressive point-to-point resistance of 1.8×10^8Ω. This ensures rapid dissipation of static electricity, safeguarding both product quality and the wearer from potential hazards.

Sustainability and Precision Craftsmanship: Constructed using premium polyester filament fiber, our coveralls are dust-free by design. Enhanced with corrosion-resistant Japanese YKK buttons, they’re crafted to last. All integral components, from zippers to threads, are robust enough to endure high-temperature sterilization. Our rigorous pre-production quality checks and state-of-the-art sewing techniques ensure a product that’s both visually appealing and functional.

GMP-Compliant Dressing Protocols: Setting industry standards, Gaible has introduced China’s premier training video for Sterile Dressing, aligning with EU CGMP gowning specifications, ensuring users adhere to best practices in dressing and folding.

Integrated RFID Technology: Stay ahead with our RFID-embedded coveralls. These chips facilitate recording of personnel details, role permissions, and the complete lifecycle of the garment. Paired with advanced access control systems, they revolutionize personnel management within sterile environments.

ommodate various users.

the heights ranging from 153 cm to 202 cm

Sterilizable Closed Shoes for Cleanroom Compliance(X-006B)                                

Sterilizable Closed Shoes for Cleanroom Compliance – gaible.com

The closed-toe cleanroom shoes is versatile and indispensable in industries that prioritize sterility, such as pharmaceuticals, food services, and electronics manufacturing.

Material and Design:

Sole Composition: Crafted from imported TPV material recognized for its environmental friendliness and durability.

Upper Construction: Made with clean canvas that offers a blend of comfort and sterility, suitable for rigorous cleanroom standards.

Properties: The shoes are inherently anti-static and capable of being sterilized, aligning with the critical needs of controlled environments.

Style: Featuring a closed-toe design that ensures full coverage and protection.

Gaible cleanroom bags(D-001)

Closure Type Cleanroom Clothes Bag – gaible.com

Delving deeper into the product line, Gaible offers an array of specialized cleanroom bags, segmented into closure-type bags, dual-compartment clean bags, the expansive three-in-one clean bags, and dedicated shoe bags. Each comes in an array of colors to cater to varying preferences: classic white, regal blue, soft pink, vibrant green, sunny yellow, and deep sea blue.

The closure-type bag, crafted for clean undergarments, exudes simplicity. Woven from premium polyester fibers intertwined with conductive strands, its design boasts a single layer with a drawstring closure.

For those seeking an ideal storage for boots or closed-toed shoes, the cleanroom shoe bag offers a perfect solution. Constructed from a blend of polyester filament and conductive fiber, this slender, single-layered bag features a side zipper for easy access.