ISO 9 Clean Room Manufacturer in China - Sunnyda

ISO 9 Cleanrooms / Class 1,000,000 Cleanrooms FAQ&#;s Table of Contents

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Introduction

Q1: What Is ISO 9 Clean Rooms?
Q2: What Are The Applications Of ISO 9 Cleanrooms?
Q3: What Are The Benefits Of ISO 9 Clean Rooms?
Q4: What Are The Types Of ISO 9 Cleanrooms?
Q5: What Factors To Consider When Selecting ISO 9 Clean Rooms?
Q6: What Are The Design Parameters Of ISO 9 Clean Room?
Q7: Does Manufacturer Offer ISO 9 Clean room With Single Pass Clean rooms?
Q8: Does Manufacturer Manufacture ISO 9 Cleanroom With Recirculating Cleanrooms?
Q9: What Are The Main Areas Of ISO 9 Cleanroom?
Q10: What Are The Sizes Of ISO 9 Cleanrooms?
Q11: What Are The Features Of ISO 9 Clean Room?
Q12: Does Manufacturer Customize ISO 9 Clean Room?
Q13: What Are The Standards Of ISO 9 Clean Room?
Q14: How ISO 9 Cleanrooms Are Installed?
Q15: What Covers The Warranty Of ISO 9 Cleanroom And For How Long?
Q16: How Much Do ISO 9 Cleanrooms Cost?
Q17: Where Do You Deliver ISO 9 Cleanrooms?
Q18: How Long Does It Take To Deliver ISO 9 Cleanrooms Order?
Q19: Why Choose Our ISO 9 Cleanrooms?
Q20: Request A Free Quote Now?

 

Introduction

Here you can find the frequently asked questions about ISO 9 Cleanrooms, and the answers to them. Here you will find primary information about ISO 9 Cleanroom applications, benefits, critical factors to be considered prior to purchasing, level of environment control and protection, standards, design parameters, modular systems, features provided, customizations options, warranty, and more.

For more information about ISO Cleanrooms, please contact us.

ISO 9 Clean Room for Lab use

Q1: What Is ISO 9 Clean Room?

ISO 9 Cleanroom is a highly-controlled space in which the airborne particles are faltered out; its main function is to minimize the introduction, generation and retention of particles inside the room from pollutants such as aerosol particles, dust, airborne microbes and chemical vapors. ISO class 9 clean rooms can actively control challenging factors such as temperature, humidity, airflow, filtration and pressure. ISO 9 cleanrooms are designed and manufactured to offer a high cleanliness level, energy efficient and maintenance free space.

ISO 9 Cleanroom/class 1,000,000 cleanroom is classified 9 in ISO standards air cleanliness, it ensure 35,000,000 particles in each cubic meter, Particle size > 0.5 μm and larger. They are used to filter and remove particles and dust from the Air that enters from the outside while the inside air is continuously recirculated by high-efficiency particulate air (HEPA) filters.

Automatic sliding door in cleanroom

Q2: What Are The Applications Of ISO 9 Clean Rooms?

ISO 9 clean rooms are extensively used as a part of specialized industrial production or scientific research to ensure the environment, materials and people are controlled from contamination throughout the whole manufacturing process, assembling, inspecting, and packaging. They are also essential for micro-level goods industries where particles can adversely affect the manufacturing process and product efficacy and safety. ISO 9 Clean rooms are widely used in the following industries:

Medical device manufacturing

ISO 9 Clean rooms are used in the medical device manufacturing industry to ensure the medical space remain controlled from contamination. A wide range of medical device clean room options can be provided in different ISO class specifications, sizes, modular clean room system, configuration and features, while ISO 9 Clean rooms can be custom-designed to suit any medical application specifications.

Pharmaceutical compounding

Pharmaceutical and biotechnology industry require ISO 9 clean rooms or other ISO clean rooms classes to maintain a sanitary environment and offer a proper hygiene factors. ISO clean rooms are a must to prevent any kind of contamination that can affect the levels of cleanliness and sanitation throughout the production stages and ensure providing the highest quality medicines. Various classes of ISO Cleanrooms can be designed and manufactured in modular system based on application level of cleanliness and specifications.

Laboratories

ISO 9 Cleanrooms are ideal for laboratories medical and pharmaceutical research, analysis, experiments and testing. Modular cleanroom solutions ranging from ISO Level 9 to ISO Level 4 can be designed and manufactured to meet the cleanliness standards of any laboratory application, research group, or similar organization.

Electronics manufacturing

The cleanliness of electronic manufacturing space is very critical to the product sterility and success, ISO 9 cleanrooms can provide the highest standards controlled ISO systems and protect sensitive advanced electronics assembly from particulate contamination and damage.

Aerospace product development

In order to produce effective components for the aerospace industry, ISO 9 clean rooms are essential to protect sensitive equipment from particulate contamination and eliminate all type of defects or failure. Excellent aerospace clean rooms solutions are available to provide a controlled environment and serve the aerospace unique needs.

Automotive Cleanroom

ISO 9 clean rooms are in high demand for the automotive industry, they are essential for processing and delivering effective assembled parts. The clean rooms play an important role in ensuring a controlled environment which eliminates failure of sensitive components and defects caused by the wrong paint finish.

Cosmetics production

Top-quality cosmetic industries require ISO 9 cleanrooms to protect their manufacturing facilities from contaminants, micro-organisms, particles, air impurities, chemical vapors or other irritants. Cosmetics, perfumes, bottling production, filling assembly and packaging should be made in an ISO Clean room environment, since cosmetics and perfumes are applied directly to our skin, hair and body. ISO 9 cleanroom is necessary to provide safe cosmetic and perfumery products and protect users from skin irritation and allergic reactions.

ISO 9 Clean Room for Research Use

Other Applications

ISO 9 Clean room is used generally used in all applications where contamination could be detrimental including:

Life sciences

Biotechnology

Nanotechnology

Research centers

Health science

Semiconductor manufacturing

Optics

Plastics/Injection Mold

LCD, OLED and microLED displays

Solar/Alternative Energy

Government Departments

Military applications

Biological safety cabinet in cleanroom

Q3: What Are The Benefits Of ISO 9 Clean Rooms?

Using ISO 9 clean rooms offers many benefits including:

Cleanliness

The cleanliness of cleanroom is determined by its classification level and the quantity of particles per cubic meter (m³). ISO 9 cleanroom is normal room air, having 35,200,000 or fewer particles measuring 0.5 microns or 8,320,000 particles measuring 1 micron, and 293,000 particles measuring 5 microns. The desired air purity is generally achieved through High Efficiency Particulate Air (HEPA) filters which fulfill international standards and remove 99.95% as per the European Standard or 99.97% (ASME) of particles (less and greater than 0.3 μm) that passes through the HEPA filters. This system can capture also pollen, dirt, dust, moisture, bacteria (0.2-2.0 μm), virus (0.02-0.3 μm), and trap submicron liquid aerosol (0.02-0.5 μm).

Versatility

ISO 9 Cleanroom can be virtually designed to meet all applications, operations and functionality requirements in terms of level of cleanliness, particles control; parameters of temperature, humidity and pressure. ISO 9 cleanroom can be designed to suit all sizes, layouts, features, specifications, and project complexity, while all units and components are made in conformance with the international sterility standards and regulations.

Cost-effective

ISO 9 cleanrooms are constructed offsite using modular building methods in which the whole planning, design, manufacturing and all of the components are prefabricated under a controlled production conditions and transported to the site location for a simple and fast assembly process. Modular cleanrooms constitute an economical alternative to permanent construction, this is due to the quick manufacturing and installation process which reduce significantly construction time and allows investors to realize important saving on construction cost.

Flexible

Modular ISO 9 cleanrooms systems offers superior flexibility and adaptability, the layout of the unit can be easily relocated, reconfigured, moved, and re-erected, modified or expanded. The outdoor emission control, outdoor air intake and other features can be adjusted as per application requirements, while the indoor quality environment can be configured for air temperatures, humidity, supply air distribution speed, positive and negative pressure environments.

Modular ISO 9 Clean Room

Q4: What Are The Types Of ISO 9 Cleanrooms?

ISO 9 Clean rooms are designed and prefabricated to meet all manufacturing, scientific and research applications requirements in terms of particulate contamination control, environmental parameters, standards, specifications, configurations, entrance, sizes and features and finishes. The following ISO 9 clean rooms types of can be provided:

Modular ISO 9 Clean room

Because of their high performance, cost-effectiveness and rapid prefabrication time, modular clean rooms offers more flexibility in design, they can be designed to respond to all sizes, layout and configurations. In addition to that the highest strength modular steel frame, hard and soft walls, ceiling, floor systems, hybrid combination, finishes and various features can be offered.

Modular clean rooms are easy to install and maintain, all components can be simply assembled, dismantled, modified or even relocated in a minimal time and expenses.

Portable ISO 9 Clean room

This type of clean room is available in standard designs and can be custom-engineered with soft wall or hard wall as per the application demand. Portable clean rooms can be installed in a single day as all units/components are delivered ready for a quick erection. Portable clean rooms comes with HEPA filtration of up to 99.97% efficiency on particles, lighting, a variety of curtain wall panels can be offered, 4&#; strip door, transfer hatches, caster, and more.

 

Q5: What Factors To Consider When Selecting ISO 9 Clean Rooms?

To select the right ISO 9 clean room, it&#;s very important to determine the project&#;s requirements in terms of functionality and aesthetics, however, while several factors should be considered, the most critical factors are as follow:

Prudential ISO 9 clean room

Air-change per hour (ACH)

ISO 9 Clean room should be selected according to the air-change rate (ACR), this variable measure mainly the level of cleanliness in a clean room, air change per hour ranges from 10 to more than 600 times per hour. Industries such as biotech, pharmaceutical, and healthcare applications may require higher ACR standards which should be considered.

Energy Efficiency of a Supply Air Handler Unit

This metric determine the total airflow rate per unit of total electricity input (kW) for all recirculation air fans (m3 /kWh, or cfm/kW).

Average Clean room Air Velocity,

The average clean room air velocity is calculated by dividing the total circulation airflow rate by primary clean room floor area (m/s, or fpm).

• Industry Standards

• Particulates

• Temperature

• Humidity

• Airflow

• Filtration

• Pressure

• Microorganism

• Government Regulations

• Maintenance and Cleaning

• Restriction of Access

Portable ISO 9 clean room

Q6: What Are The Design Parameters Of ISO 9 Clean Room?

ISO 9 Clean rooms are cleverly designed to offer an ultra clean area and more control on the indoor and outdoor environment. Airflow is designed using High Efficiency Particulate Air (HEPA) filter which can trap particles of 0.3 μm or larger; or Ultra Low Particulate Air (ULPA) filter which can effectively remove 99.999% of airborne particles of 0.1 μm, ultrafine particles, bacteria, dust, pollen and mold.

ISO 9 Cleanrooms are designed to respond to the requirements of ISO standards system, high quality materials and equipment are used to ensure air flow performance and protection from particles. Furthermore, the whole production process and number of people are considered carefully on the design planning stage.

Design versatility

ISO 9 clean rooms are designed to respond to various applications requirements in terms of size, layout, finishes. In addition to that, durable materials are used to withstand microbial growth, cleaning solutions, sanitizing and chemicals used.

ISO 9 clean room can be built using negative or positive pressure capabilities, HEPA filters, soft wall, hard wall, doors, ceilings, partitions, floors, and other options can be provided as per required specifications.

Airflow design

To ensure an effective contamination control and efficient airflow, several factors are analyzed including application process, cleanliness class, airflow rate, airflow distribution, particle size, particle transport rate, HVAC system, energy efficiency and more. ISO 9 clean room airflow systems can be designed to matches exact application or classification requirements.

Pass-Thru Chambers

Pass-through chambers play a vital role in detecting any sign of contamination that can be caused by equipment, people, or other pollutant introducers. Positioning a pass through at the entrance of the ISO 9 clean room can maintain a low particulate level within a transfer box enclosure. Using pass-thru chambers can reduce foot traffic and lower operating costs, while it helps to maximizes cleanliness, quality control and safety within the ISO 9 clean room. Fully-sealed air showers with 99.97% filters can be designed and engineered in a variety of sizes and features.

Bunny suit ISO 9 clean room

Q7: Does Manufacturer Offer ISO 9 Clean room With Single Pass Clean rooms?

Yes, absolutely. this type of air flow system is provided, and used mainly for small applications of up to 1,000 square feet and environments which do not require humidity and temperature control. In &#;single pass&#; design, cleanroom ambient air is filtered and then transferred out into the surrounding space. ISO 9 single pass cleanrooms are available in softwall and hardwall modular.

 

Q8: Does Manufacturer Manufacture ISO 9 Cleanroom With Recirculating Cleanrooms?

Yes, this recirculating cleanroom system can be offered as per application requirements. It&#;s specifically designed and engineered to maintain the required level of temperature, humidity, and pressure controls. Recirculating airflow systems filters air through a dedicated low wall returns and ceiling plenum. HEPA filtration modules can be placed inside a recirculating cleanroom to achieve unidirectional airflow.

ISO 9 clean room layout

Q9: What Are The Main Areas Of ISO 9 Cleanroom?

ISO 9 Cleanroom comprises ancillary areas, surrounding cleanrooms, interior clean zones and outdoor environment. ISO 9 Cleanroom can be designed to meet any cleanroom layout, configuration, equipment or accessories requirements.

 

Q10: What Are The Sizes Of ISO 9 Cleanrooms?

ISO 9 Cleanrooms can be designed to suit all sizes requirements, size is normally determined according to the production process needed, number of staff, materials, equipments and many other factors that should be discussed prior to design.

Finished Clean Room Windows

Q11: What Are The Features Of ISO 9 Clean Room?

ISO 9 cleanroom comes with the highest quality features that ensure a controlled environment free from any contamination. The following features can be provided:

HEPA Filters

Fan Filter Units

The company is the world’s best iso class 9 clean room supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.

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Gowning, Ante Rooms and Air Showers

Unidirectional Airflow

Air Conditioners

Temperature Control

Desiccator Cabinets

Horizontal Flow Wall Modules

Pass thru chambers

Access Control

Inter Lock Door Systems

Ceiling System

Insulated wall options

Heat welded vinyl or epoxy flooring

Entrance and exit sticky mats

Laminar flow cabinets and Laminar Flow Canopy

Hands free sinks and Stainless steel bench

Various custom features can be provided.

ISO 9 Clean room design

Q12: Does Manufacturer Customize ISO 9 Clean Room?

Yes, absolutely. We custom built in house ISO 1 to ISO 9 cleanrooms, we offer a wide range of functional and aesthetics customization options including:

Walls Panels

A complete line of anti-static and ordinary wall panels can be provide depending on the needed wall systems including:

Biotech non-shedding systems and gasketed grid systems.

Load-bearing wall panels &#;built-in&#; air return ducts.

Non load-bearing wall panels for internal partitions and external sheet metal ductwork.

Finishes can made using fiberglass reinforced plastic (FRP), vinyl, high pressure laminates, and an array of colors are available to choose from.

Prefabricated Clean Room Panel

Insulated walls

We offer a wide selection of insulation solutions for ISO 9 cleanroom including EPS color steel sandwich panels, Polyurethane (PU) Thermal insulation and many more.

Ceiling Systems

Purpose-built ceiling systems are selected depending to the purpose of ISO 9 Cleanroom. Cleanroom ceiling panels, Ceiling tiles with vinyl facing and sealed edges, Gasket grid, and other ceiling materials are also available.

Flooring Systems

The most cost effective, resistant and non-slip flooring systems in different thickness and aesthetic features can be offered as per ISO 9 cleanroom industry requirement including:

PVC Anti-static floor paint with a thickness from 1.5 mm to 3mm, can be applied after a layer of water-soluble floor adhesives.

Heat sealed vinyl flooring system.

Resinous floor system.

Epoxy floor paint.

Wear-resistant floor paint.

Doors& Entryways

A wide array of doors and entryways can be tailored to suit different ISO 9 cleanroom access needs in terms of size, design, materials and safety. Single or double entry doors, manual sliding doors, automatic rollup doors can be provided. Safety viewing windows can be incorporated in the door design.

Static Pass Box in Cleanroom

Windows

Various windows can be designed to meet ISO 9 cleanroom requirements including tempered safety glass windows; double pane windows, polycarbonate windows, UV tinted, and other types are also available.

Fire-resistant Walls and Roof

ISO 9 cleanroom is made from fire proof materials and all components are fire tested, materials with 4 hours fire resistance can be offered. Different levels of fire-resistant panels depending can be provided as per cleanroom fire safety requirements.

Accessories

Various types of security cameras, network and access control devices are available.

ISO 9 Cleanroom garments such as face masks, shoes, boots, aprons, beard covers, bouffant caps, frocks/lab coats, gowns, glove, finger cots, hairnets, hoods, sleeves and shoe covers.

Additional Customizable Features

HVAC systems

Fire protection systems

Lighting and Electrical Options

Q13: What Are The Standards Of ISO 9 Clean Room?

ISO 9 Cleanrooms are designed and manufactured to meet the strictest regulations and standards as follow:

ISO -1 cleanliness standard

ISO 9 Cleanrooms should be designed and engineered in compliance with the ISO -1 cleanliness standards which specify the classification of air cleanliness in terms of concentration of airborne particles, quantity and size of particles per volume of air. This standard sets also the criteria for designing an effective cleanroom space.

797 regulatory standards

ISO 9 clenarooms used in Pharmaceutical Compounding and Sterile Preparations compounding sterile drug preparations and production, shall be produced in accordance with the USP 797 standards.

EU GMP Standards

ISO 9 Cleanrooms shall be designed and manufactured in compliance with the European Union Good Manufacturing Practice (GMP) guidelines and standards.

FDA CGMP Standards

ISO 9 Cleanrooms shall be designed and engineered in accordance with the FDA Good Manufacturing Practices in terms of facilities, and controls used in manufacturing, processing, and packing of a drug product.

Double Shower Air Shower

Q14: How ISO 9 Cleanrooms Are Installed?

ISO 9 Cleanroom are easy to install as all components are delivered ready for a quick erection, complete wall panels are prefabricated and pre-wired, deck systems and all other elements are simple to install. A detailed installation drawing and guide are provided, while manufacturer can offer installation support needed.

 

Q15: What Covers The Warranty Of ISO 9 Cleanroom And For How Long?

All ISO 9 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.

 

Q16: How Much Do ISO 9 Cleanrooms Cost?

The cost of an ISO 9 clean room typically costs anywhere from $100 to $150 per square Meter. The cost varies depending on the type, specifications and control parameters required.

 

Q17: Where Do You Deliver ISO 9 Cleanrooms?

We ship worldwide. We can provide qualified&#;installers or turnkey service for international projects.

Packing and loading for the ISO 9 clean room

Q18: How Long Does It Take To Deliver ISO 9 Cleanrooms Order?

ISO 9 cleanrooms delivery takes normally from 10 to 15 Days; while customised cleanrooms may take longer depending to the size and level of customization required.

 

Q19: Why Choose Our ISO 9 Cleanrooms?

In our 50,000 square meter manufacturing facility located in one of the most strategic locations in Shanghai &#; China, we design and manufacture the highest quality and the most cost effective ISO cleanroom class 1 to class 9. Throughout our 20+ year of experience, we successfully delivered + world class clean rooms to different parts of the World. We utilize the latest clean room design technology to ensure maximum protection from contamination. We serve all manufacturing, Semiconductor, Biotech, Nanotech, Cleantech, Pharmaceutical, laboratories, Research, and other industries with the most robust and innovative ISO clean rooms.

Whether you&#;re looking for Modular or Portable ISO cleanrooms, we can meet all of your requirements in terms of application, ISO classification, design, functionality, aesthetics, HEPA filter systems. Many features are provided inclduing temperature, humidity and pressure control, monitoring systems, softwall and hardwall cleanrooms, containment modules, equipments, furnishing, accessories and many more.

As pioneer in the field, we can provide our clients with the highest quality ISO 9 cleanrooms on time and on budget. All of our manufacturing system and products are recognized by the following international organizations:

ISO : Quality Management Systems.

ISO : Environmental Management System.

CE marked

Bureau Veritas Certification.

We work with our client from the initial design to delivery and installation, consultancy services can be also provided prior to order confirmation.

 

Q20: Request A Free Quote Now?

For more information on our ISO 9 Cleanrooms, get in touch with our team today contact us now.

What is a Clean Room Environment?

A cleanroom is any controlled area where contaminants and airborne particles are highly controlled and kept within strict limits. They are used in different industries, including aerospace, healthcare, life sciences, electronics, biotech, optics, military, and other branches where substantial amounts of particles could affect manufacturing.

The High-Efficiency Particulate Air (HEPA) filter is the key component of any cleanroom. Its role is to trap all the particles larger than 0.3 microns, which represent one of the most penetrating particle sizes. According to scientists, 0.3 micron-particles tend to evade air filters more than any larger or smaller particles.

The air inside a cleanroom goes through the HEPA filter, capable of trapping even 99.97% of 0.3-micron particles. Modern HEPA filters have interlaced glass fibers twisted and turned in multiple directions to form a fibrous maze. When particles enter this web, they leave it in some of the following ways:

• Direct impaction: Dust, mold, pollen, and other types of large contaminants tend to travel in a straight path.
• Sieving direction: Sieving happens when the particle is too large to fit between the fiber spaces.
• Interception: Direct interception occurs when the particles are not large enough to have inertia or small enough to diffuse within the flow.
• Diffusion: Diffusion works on the tiniest particles. Since the air cannot hold small particles in place, they tend to diffuse within the flow stream.

While HEPA filter purifies the air quite efficiently, some cases may require Ultra Low Particulate Air (ULPA) filters. These provide next-level cleanliness in situations where it is needed

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