ISO 8 Clean Room Manufacturer

Sunnyda ISO 8 Clean Room

Sunnyda ISO 8 cleanroom wall panels and ceiling panels can be customized anti-static and ordinary. This depends on the product you produce to determine what type of materials you need.

If you need fire-resistant walls and roof panels, we have different levels of fire-resistant purification panels, their materials can be selected from rock wool, glass magnesium, silica rock, etc. Their fire protection time is 1 hour, 2 hours and 3 hours, and our best material can reach up to 4 hours of fire protection.

ISO 8 Cleanrooms / Class 100,000 Cleanrooms FAQ’s
Table of Contents

Introduction
Q1: What Is ISO 8 Clean Rooms?
Q2: What Are The Applications Of ISO 8 Cleanrooms?
Q3: What Are The Advantages Of ISO 8 Clean Rooms?
Q4: What Are The Protective Requirements Of ISO 8 Cleanroom?
Q5: What Is The Difference Between ISO 8 Cleanroom and Other ISO Cleanroom Classes?
Q6: What Are The Types Of ISO 8 Cleanrooms?
Q7: Does Manufacturer Provide ISO 8 Cleanroom Design?
Q8: What Are the Common Design Considerations For ISO 8 Cleanroom?
Q9: What Are The Specifications Of ISO 8 Cleanroom?
Q10: Does Manufacturer Offer Recirculating And Non-Recirculating Modular ISO 8 Cleanroom?
Q11: Does Manufacturer Provide ISO 8 Clean Room Customization?
Q12: Are ISO 8 Cleanrooms Durable?
Q13: What Are The Standards Of ISO 8 Clean Room?
Q14: What Covers The Warranty Of ISO 8 Cleanroom And For How Long?
Q15: How Much Do ISO 8 Cleanrooms Cost?
Q16: Do You Ship ISO 8 Cleanrooms Internationally?
Q17: How Long Does It Take To Deliver ISO 8 Cleanrooms?
Q18: Why China Is The World’s Factory For ISO 8 Cleanrooms?
Q19: Why Choose Our ISO 8 Cleanrooms?
Q20: Contact Us for any Cleanroom Solutions Your Industry Requires?

Introduction

ISO 8 Cleanroom has become essential for various manufacturing industries and scientific research labs that require an extremely clean environment to protect their products and process from harmful particles and micro-organisms. This document is designed to provide a complete idea about ISO 8 Cleanrooms applications, benefits, design, modular cleanrooms types, specifications, customization options; air filter systems, standards and more.

For more information about ISO 8 cleanrooms, please contact us.

Q1:  What Is ISO 8 Clean Rooms?

Generally speaking a “clean room” is a contained space that protects the environment from contamination and controls the number of particles in the interior of a workspace. ISO 8 clean rooms have a maximum particle count of 100,000 particles ≥0.5 micrometre (um) per cubic foot of interior air. ISO 8 Cleanroom should fulfill the requirement of 10-25 air changes per hour minimum and airflow rates of 4-8 CFM per square foot; while High-efficiency particulate air filters (HEPA) is used to control the number of particles per volume of air.

ISO 8 Cleanrooms are extensively used in industries where small particles are critical and can affect the manufacturing, medical or research process. ISO 8 Cleanrooms can be designed and manufactured to meet all applications requirements; they are available in modular hard wall and soft-wall systems. They come in different sizes, materials, features, finishes, equipment, pass-thru, air showers, and more options can be added to respond to the functional and aesthetic needs.

Q2:  What Are The Applications Of ISO 8 Cleanrooms?

ISO 8 or Class 100,000 Cleanrooms are widely used across a variety of industries application which requires a specific particle concentration limits within a given space including:

Pharmaceuticals and Medical

ISO 8 Cleanrooms are used for medical and pharmaceutical manufacturing to provide a sterile production environment free of particles. Robust clean benches and pass-thru chambers can be designed as per requirements.

Application areas for ISO 8 Clean Room

Manufacturing and Processing

Contamination control is a priority for the manufacturing process of many industries such as Aerospace, Automotive, Computer, Sterile drug; Semiconductor; Electronics and microelectronics, Lithium-ion battery, Solar, Military, Energy, Optics, Food Processing; Cosmetics manufacturing; Bottling lines, Surgical kit assembly, Nutraceuticals, Food packaging and any other sensitive products. They are used to guarantee a high-quality product free from defects, and avoid products failure or money loss.

Biotechnology

ISO 8 Cleanrooms can be designed and engineered mainly to protect the biotechnology manufacturing environment from contamination. They have become a necessity for the success of the whole production process as particles and micro-organisms can harm the products and can cause a potential failure.

Laboratories and Science Research

ISO 8 Clean cleanrooms help researchers to maintain the highest standard level of cleanliness required to process scientific research, experiments and lab analysis. The whole cleanroom system and enclosed areas are designed to offer extremely low levels of pollutants such as aerosol particles, airborne microbes, and dust, in addition to controlling the level of particulate contamination; humidity, temperature, pressure, etc.

Q3: What Are The Advantages Of ISO 8 Clean Rooms?

ISO 8 clean rooms are designed and engineered to offer many distinct advantages to many industries as follow:

Maximum Protection

ISO 8 cleanrooms are designed especially to ensure high levels of microbiological protection for different manufacturing environments; they are fitted with the highest performance HEPA filters, which can keep workspace tightly controlled from contamination hazards caused by substances such as particles or bacteria.

Cost-effective

Using ISO 8 cleanrooms can greatly reduce design, engineering, construction time, and minimizes costs as well. ISO 8 Cleanrooms are efficiently designed to offers long-term benefits and keep the energy cost of heating, cooling and ventilation minimized. In addition to that durable materials, and easy-to-clean walling, ceiling and flooring systems are used to provide a maintenance-free ISO 8 Cleanroom and therefore lower the running costs.

Install ISO 8 Clean Room with detailed drawing and instructions

Fast And Simple Installation

High-performing and easy to install free-standing ISO 8 cleanrooms can be delivered in hard wall, rigid wall and soft wall systems, all components are pre-cut, and finished off-site for a rapid installation. This speeds the installation process and enables a fast project delivery.

Flexible

Unlike traditional brick and mortar cleanroom structures which require a contractor to be hired, more time, money and workers, modular cleanrooms are prefabricated off-site in a manufacturing controlled environment, this makes them very flexible and adaptable as the whole structure can be easily assembled, disassembled and relocated at any time.

Q4: What Are The Protective Requirements Of ISO 8 Cleanroom?

In order to meet the protective requirements of ISO 8 cleanrooms, all the components should be designed and manufactured in accordance with the International Standards Organization (ISO) guidelines; while the following are the basic protective requirements:

Air Quality

The air quality of ISO 8 cleanroom is determined by the number and size of particles permitted per volume of air, whereas, the air change rate is engineered to scrub particles from the room as per the application requirements. ISO 8 Cleanroom has an air change (ACH) rate of 10 to 25 times per hour. Also the more is bigger the ISO 8 cleanroom, the more airflow will be needed, as the size of ISO 8 cleanroom, length, width, and height has a big influence in ensuring the amount of airflow required, while the height of the ceiling is normally minimized to reduce the total surface area and lower the cost.

electrostatic spray HEPA Filter Box

HEPA Filters

ISO 8 cleanroom should be fitted with HEPA (high-efficiency particulate air) filters which meets the European standard and filtration efficiency in removing 99.95% of particles from the air that passes through, or 99.97% of air particles (0.3 μm) as per the ASME and U.S. DOE.  In addition to that HEPA filters system should be able to capture virus sized (0.02-0.3 μm), submicron liquid aerosol of (0.02-0.5 μm), bacteria of (0.2-2.0 μm), pollen, dirt, dust, moisture, and other contaminants from entering the workspace.

Air Flow Filters Systems

Airflow filter is an air movement system used to keep the ISO 8 cleanroom free from particulates by circulating vapor, moisture, and contaminants out of the room. HEPA (high-efficiency particulate air) filters and ultra-low particulate air (ULPA) filters are the most commonly used, while laminar flow and turbulent flow are the main standard airflow patterns used to remove 99.9 % of all microparticles in an ISO 8 Clean room air.

People Access And Process

People are massive generators of contaminants, for this reason, airborne contamination level is determined according to the number of people and their activities, clothing and behavior inside the ISO 8 cleanroom. To eliminate human-generated contamination from the cleanroom environment staff clothing should be conformant to ISO 14644-1  clothing standards. In addition to that, HVAC system should be designed according to the number of personnel working in the ISO 8 cleanroom area, while a comfortable environment of 19°C and 21°C (66.5°F to 70°F) should be maintained to eliminate heat generated by people.

Furthermore, material, equipment and process used within the cleanroom constitute also a source of particle contamination, transfer hatches and pass-through chambers and other solutions can be used to reduce contamination in such cases.

Other Requirements

Air pressure, humidity or temperature control.

Static control needs.

Sanitation requirements.

Number and type of windows and doorways.

Lighting and electrical needs.

powder coated air shower

Q5: What Is The Difference Between ISO 8 Cleanroom and Other ISO Cleanroom Classes?

Cleanrooms are classified according to the cleanliness level of the air inside the room which is determined by the size and quantity of particles per volume of air. Cleanrooms Classification ranges from ISO 1 to ISO 9, with ISO 1 being the “cleanest” class and ISO 9 being the “dirtiest” but offer a certain level of cleanliness more than a regular room. The most commonly used classes are ISO 7 and ISO 8. ISO 8 Cleanrooms have a maximum particle count of 100,000 particles (≥0.5 um) per cubic foot of interior air and provide a minimum of 20 air exchanges per hour with airflow rates of 4-8 CFM per square foot.

Air cleanliness for all classes is achieved mainly by passing the air through HEPA filters, and determined by the number of air changes per hour. Below is a comparison between ISO 8 cleanroom and other classifications.

ISO 8 cleanroom = Class 100,000; air changes per hour 10-25.

ISO 7 cleanroom = Class 10,000; air changes per hour 30-60.

ISO 6  cleanroom = Class 1,000; air changes per hour 90-180.

ISO 5 cleanroom = Class 100; air changes per hour 240-360.

All Cleanrooms classes 100,000; 10,000; 1,000; 100; 10; 1 are equivalent to FED-STD-209E standards, ISO 14644-1  and ISO 14698 .

Prefab modular ISO 8 Clean Room

Q6: What Are The Types Of ISO 8 Cleanrooms?

Modular cleanrooms offer more flexibility and versatility in designing a fully functional ISO 8 cleanroom for all applications. When compared to traditional construction methods, modular cleanrooms are cost-effective, durable and provide the exact cleanliness level and control required. Moreover, the off-site planning, design and manufacturing, offer more cost-saving benefits while it reduces significantly the on-site construction time as all modular panels come pre-wired and all other elements come ready to install.

Furthermore, modular panels used in ISO 8 cleanroom allow more flexibility, the whole room can be easily reconfigured, expanded, or relocated. In addition to that, functional and aesthetic requirements and unique applications specification can be achieved.

There are two main types of modular ISO 8 cleanrooms that can serve any project needs as follow:

Hard-wall ISO 8 Cleanroom

Hard Wall Modular Cleanroom can be designed and manufactured to suit different industries’ requirements in terms of specifications, level of air cleanliness, sterile environment, temperature, humidity and pressure. All ISO 8 cleanroom sizes can be produced including large-scale projects. This type of hard-walled system offers better performance than other types because it allows increased volumes of air pressure inside the room, this minimizes effectively dirty air from accessing the space.

Hard walled modular clean rooms are made of durable materials and feature a fully enclosed area engineered to reduce the level of dirty air from entering the room as required.

Soft-wall ISO 8 Cleanroom

Soft-wall ISO 8 cleanrooms are a great choice for many manufacturing applications; they can be virtually designed and prefabricated to respond to the cleanliness level needed and meet all sizes, layouts and configurations. This type of cleanrooms is made of soft-sided suspended structure and because of its lightweight soft-walled cleanroom can be installed virtually anywhere. Compared to hard wall modular cleanrooms, soft walled cleanrooms are more economic and can be installed as freestanding structures or hung from the ceiling, they are easy to move, disassemble, expand, relocate, or even stored.

RigidWall ISO 8 Cleanrooms

This type of ISO 8 cleanrooms are designed and manufactured to achieve extreme environmental control and ensure extra contamination protection for aerospace and other industries’ applications. Rigid wall cleanrooms are made from a robust wall system while the structure is formed using high-strength 6063-T6 aluminum extrusions, and all aluminum panels and other components are protected from corrosion using powder coat baked enamel.

Q7: Does Manufacturer Provide ISO 8 Cleanroom Design?

ISO 8 cleanroom can be designed to fit the exact need of all industries requirements in terms of cleanliness level, material specifications, size, layout, configuration, materials, finishing, and more. The latest technology design software such as 3D BIM (Building information modeling) and VCD (Virtual design and construction) are implemented to visualize ISO 8 cleanroom project. Also, all aspects of the process, equipment and staff are considered in the design. Architectural drawings and diversified design options can be offered to meet your functional and aesthetic requirements and suit your budget and project timeline as well.

Q8: What Are the Common Design Considerations For ISO 8 Cleanroom?

Several factors should be considered when designing an efficient and effective ISO 8 Cleanroom, these factors include the size which needs to be sufficient to accommodate the whole production process and the layout which should allow the most flexible flow of material, equipment and personnel.

Designs for Prefab ISO 8 Clean Room

Q9: What Are The Specifications Of ISO 8 Cleanroom?

ISO 8 Cleanrooms can be designed and manufactured to meet different applications specifications as below:

Typically measured micron sizes: 5.0µ and 0.5µ.

Cleanroom Classification: Class 8.

Federal Standard 209E equivalent: 100,000.

EU GMP Grade: D.

Air changes/hour (ACH): 5-48 per hour.

Maximum allowable concentrations (particles/m3): 3,520,000 or less ≥0.5µm sized particles; 832,000 or less ≥1µm sized particles; 29,300 or less ≥5.0µm sized particles.

Structure Frame: High-strength 6063-T6 Extruded Aluminum.

Filtration: HEPA and ULPA cleanroom filters are available in different sizes and options including standard model 421-SPX motorized HEPA fan filter units (FFU’s) with 99.99% efficiency. All FFU delivers high volumes of HEPA (or ULPA) filtered air at the low sound.

Sizes: ISO 8 cleanrooms standards sizes are available with up to 30′ clear span.

Finish:       White powder-baked enamel or as per customer specifications.

Q10: Does Manufacturer Offer Recirculating And Non-Recirculating Modular ISO 8 Cleanroom?

Yes, absolutely. Manufacturer offer ISO 8 cleanrooms with recirculating and non-recirculating cleanrooms:

Recirculating ISO 8 Cleanrooms

Recirculating ISO 8 Cleanrooms

This system is used to recirculates the air within the cleanroom and does not allow the air to escape once the room is conditioned. Air return chambers built within the walls are built to prevent air from mixing with the outside air, this offers better control of humidity and temperature while it ensures less contamination through the continuous recycling of previously cleaned air. High-performance HEPA filters are used to recalculate the air and are placed in the ceiling of the clean room.

Non-Recirculating ISO 8 Cleanrooms

This type of airflow design is also called a “single-pass cleanroom” or “once-through”, the non-recirculating cleanroom system draws in air through a mounted HEPA filter units placed within a ceiling grid system. The filtered air enters into the cleanroom, and then it exits via either a small gap planned below the walls or from near-floor mounted grilles without recirculation. Non-circulating clean rooms are ideal when air temperature and humidity are less critical to the operational process; they are more economic than recirculating clean rooms.

Q11: Does Manufacturer Provide ISO 8 Clean Room Customization?

Yes, absolutely. ISO 8 Cleanroom can be fully customized to suit any application requirements in terms of design, layout, airflow pattern, HVAC and filtration systems specifications. A wide range of materials, features and accessories can be provided as follow:

Walls Panels

A wide range of lightweight and noncombustible Rigidwall, Softwall, Anti-static wall material and ordinary wall panels can be offered as follow:

Aluminum Rigid Wall Panels

Modular Stainless Steel Panels

Acrylic Panels

Polycarbonate Panels

Static Dissipative PVC Panels

Antistatic Acrylic or Polycarbonate

Flexible Vinyl Sheeting

Sandwich Panel or Double-glazed Wall or Combined option.

Insulated wall options

A wide selection of insulation solutions for ISO 8 cleanroom can be offered as per application requirements including EPS color steel sandwich panels and Polyurethane (PU) Thermal insulation.

Ceiling System for ISO 8 Clean Room

Ceiling Systems

A complete line of sophisticated ceiling systems can be provided to serve the ISO 8 Cleanroom specifications including:

Aluminum Grid System

Steel Grid System

Clip-in Cassette System

Self-supported ceiling system

Suspended ceiling grid

A variety of ceiling system accessories such as air vent openings, railings for walkable cleanroom ceiling systems and tightly closing inspection flaps can be also provided.

Flooring Systems

The most cost-effective, resistant and non-slip flooring systems can be offered in different thicknesses and aesthetic features as follow:

Static-dissipative Flooring (Rubber or Vinyl Sheets)

PVC Anti-static Floor Paint

Conductive Flooring

Aluminum Raised Floors

Hollow Floors

Lighting options

ISO 8 cleanrooms come standard with efficient, long-lasting LED light flat panels; LED light panels to come in several options and sizes, cleanroom flow-thru lights are also available.

Other customization options

Air shower, Pass-thru airlocks, pass-through box, cleanroom benches, mobile cabinets and more options can be designed to achieve a higher level of cleanliness and prevent effectively contamination from entering the workspace.

Various models of motorized HEPA and ULPA fan filter units (FFU’s) can be provided to meet ISO 8 cleanroom operational needs.

Industry-specific equipment and accessories.

High-quality fire-rated doors and windows are available.

Security cameras, network and access control devices (optional).

Prefab ISO 8 Clean Room with glass panels

Q12: Are ISO 8 Cleanrooms Durable?

ISO 8 Cleanrooms are robust and durable spaces designed to handle operations for life long. High-quality materials are used to offer an extremely durable cleanroom and protect the whole space from any type of contamination. All components are carefully selected to provide the lowest outgassing results. Materials such as stainless steel, anodized aluminum, non-particle shedding, ESD-safe materials are used for quality purposes. Heavy-duty and maintenance-free HVAC systems (Heating, ventilation, and air conditioning) are provided. All materials are fire and impact-resistant and can withstand regular cleaning and sanitizing.

Q13: What Are The Standards Of ISO 8 Clean Room?

ISO 8 Cleanrooms should be designed and prefabricated in compliance with international standards and shall respond to the industry requirements in terms of contamination protection, control of parameters, safe operating practices and regular cleaning procedures.

ASTM Standards

ISO 8 Cleanrooms should be designed and manufactured in accordance with the ASTM technical standards in terms of materials specifications, design, processes, safety regulations, etc. In addition to that, ISO 8 Clean room should be maintained according to ASTM E2042 / E2042M – 09(2016) standards which determine the practice and methods for cleaning and maintaining controlled areas.

International Standards Organization

ISO 14644-1

ISO 14644-1 standard determine the requirements of the ISO 8 Cleanroom in terms of contamination levels, filtration, environmental control, allowed air particulates in number and size, air change rates and airflow speed, design and construction, protection of products, processes, employees, test methods, surface cleanliness by particle concentration and by chemical concentration.

ISO 14644-2

ISO 14644-2 describes the standards for monitoring and testing ISO 8 cleanrooms, a periodic testing plan is necessary to ensure the complete cleanroom system can achieve the required particle count.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice is specifically applied to ISO 8 Cleanrooms used for the manufacturing of medical devices, pharmaceutical products, drugs and food. GMP are applied essentially to ensure the end product is free from contamination, for that, ISO 8 cleanroom production process, materials, equipment, staff training, hygiene practices and facility requirements should be compliant with GMP guidelines.

USP Standards

ISO 8 Cleanrooms used in the manufacturing and packaging of pharmaceutical products should be designed and engineered as per the standards of USP 795, USP 797, or USP 800 to guarantee the best quality and safe use of pharmaceutical compounds.

Q14: What Covers The Warranty Of ISO 8 Cleanroom And For How Long?

ISO 8 Cleanroom structural performance is covered by a 25 years warranty, while other materials and components are guaranteed for a period of 5 years against any manufacturing defects.

Q15: How Much Do ISO 8 Cleanrooms Cost?

The cost of modular ISO 8 cleanroom typically costs anywhere from $100 to $250 per square meter. The cost may vary depending on the cleanroom size, specification, controls features and customization options required.

Q16: Do You Ship ISO 8 Cleanrooms Internationally?

We deliver ISO 8 Cleanrooms worldwide to all countries; our clients benefit from the most economic rates and reliable shipping services. We can provide qualified installers or turnkey services for international projects.

Loading and delivery

Q17: How Long Does It Take To Deliver ISO 8 Cleanrooms?

ISO 8 cleanroom can be designed and manufactured in 5-15 Days; delivery time is largely dependent to project size, specifications and customization options.

Q18: Why China Is The World’s Factory For ISO 8 Cleanrooms?

China’s resilient supply chain has enabled ISO 8 Cleanrooms manufacturers to design, manufacture and deliver worldwide durable and cost-effective cleanrooms. China ISO 8 Cleanrooms respond to all manufacturing industries and scientific research applications that require particle and bacteria-free environments. The latest technology software and machinery are used to design fully functional and high-performance modular cleanrooms.

ISO 8 Clean Room with equipments

Q19: Why Choose Our ISO 8 Cleanrooms?

Sunnyda is your one-stop solution provider for cleanrooms technology and controlled environment manufacturing for any industry application. With over 20 years of experience, we design, engineer, manufacture, and deliver the most innovative and cost-effective ISO 8 cleanrooms that offer the highest level of contamination protection, and efficiency of airflow.

All ISO 8 Cleanroom components are manufactured in-house in our manufacturing facilities, while, our experienced designers can meet and even exceed your design requirements in terms of size, layout, configuration, cleanroom systems performance, features and finishes. We produce all types of modular cleanrooms including Hard Wall, Soft Wall, and Rigid Wall systems.  ISO 8 cleanroom can be fully customized to respond to your unique application.

Our ISO 8 cleanrooms high performance and compliance to international standards is guaranteed as all of our manufacturing systems and practices are certified by the following international standardization organizations:

Q20: Contact Us for any Cleanroom Solutions Your Industry Requires?

For more information about our ISO 8 Cleanrooms Contact Now.