Class 10000 Cleanrooms | Custom ISO 7 Cleanroom Manufacturer (2024)

Home>Cleanroom Classifications>ISO 7 Cleanrooms

Class 10000 Cleanrooms | Custom ISO 7 Cleanroom Manufacturer (1)

Class 10,000 Cleanrooms

An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot.

Cleanrooms By United produces fully functional ISO 7 cleanrooms that meet all required specifications and requirements. We provide the layout, square footage, and features that your project specifications require. The custom, flexible, modular construction of our ISO 7 clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs evolve.

Contact us for more informationregarding our ISO 7 clean room options or call us at800-959-0878and we will gladly answer any questions that you may have. Cleanrooms By United is your trusted source for premium grade, high-efficiency ISO 7 clean rooms.

ISO 7 Cleanroom Requirements

Cleanroom classificationsrange from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. ISO class 7 clean rooms were previously defined under US Federal Standard 209E but are now defined under ISO 14644-1, however, both are still regularly used as reference points.

  • US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air.
  • ISO 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.

ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 7 Cleanrooms

(FED STD 209E Equivalent: Class 10,000)

≥0.1 µm≥0.2 µm≥0.3 µm≥0.5µm≥1µm≥5 µm
1,020,000352,00083,2002,930

US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 10,000 Cleanrooms

(ISO 14644-1 Equivalent ISO 7)

≥0.1 µm≥0.2 µm≥0.3 µm≥0.5µm≥5 µm
350,00075,00030,00010,00070

ISO 7 Cleanroom Protective Requirements

Class 10,000 cleanrooms require workers to wear fewer protective garments than cleanrooms with a lower classification but still require the use of cleanroom clothing such as face masks, hair and beard covers, and lab coats or other frocks to cover street clothing. In some ISO7 cleanrooms, coveralls and gloves may also be required. Cleanroom clothing is made from nonwoven fabrics to prevent contamination from shedding material fibers. Gloves are sterile and made from latex, nitrile or other synthetic materials.

Depending on industry and application requirements, other precautionary measures may be taken to control particle count in an ISO 7 cleanroom environment. Sticky mats are often placed outside of cleanroom entrances to remove dirt and other contaminants from shoes. Pass-thru cabinets fitted with filtration systems may also be used to safely transfer products while limiting the number of people entering and exiting the room.

Cleanroom requirements vary widely based on industry standards and the type of processes being performed. Always consult with a cleanroom professional for assistance in selecting the cleanroom design components, requirements,and cleanroom classification that are best suited for your application. Common ISO 7 clean room requirements include:

  • Product pass throughs
  • HEPA fan filters
  • Heat welded vinyl or epoxy floors
  • Gowning atrium
  • Air locks
  • Air conditioners
  • Entrance and exit sticky mats
  • Sealed lighting
  • Bunny suit, booties, and hood requirements
  • Stainless steel bench and hands free sink

How to Determine the Correct Cleanroom Classification Based on Your Needs?

A typical cleanroom is designed to keep outside contaminants and particles at a minimum based on the ISO clean room standards. Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, the two things that can introduce particles and contamination into your cleanroom are people and processes.

Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. The lower the ISO class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class.

As an example, Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot. The chart below provides an explanation of the differences between our clean room classes.

ISO 7 Cleanroom Applications

ISO 7 clean rooms provide air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot and a minimum of 60 air changes per hour. Industries that utilize ISO 7 cleanrooms include:

  • Medical device manufacturing
  • Electronics manufacturing
  • Pharmaceutical compounding
  • Laboratories
  • Aerospace product development
  • Cosmetics production

Contact Cleanrooms By United for ISO 7 Cleanrooms Today

Learn how we solved a fast and minimal disruption set up of anISO 7 cleanroom within a manufacturing facility.

Cleanrooms By United is your trusted source for premium grade, high-efficiency ISO 7 cleanrooms.

Contact Cleanrooms By Unitedfor more information regarding our ISO 7 cleanroom options, request a quote

or call us at800-959-0878to discuss your specific cleanroom requirements.

Class 10000 Cleanrooms | Custom ISO 7 Cleanroom Manufacturer (2024)

FAQs

What are the Class 10000 cleanroom requirements? ›

For example a class 10,000 cleanroom is allowed 70 particles/ft3 greater than 5 microns, 10,000 particles/ft3 greater than 0.3 microns and minimum 60 air changes per hour. ISO cleanroom classifications are also by particle count and HEPA filtered air changes per hour.

What are the limits for ISO 7 cleanroom? ›

ISO 7 Cleanroom Standards & Quality Requirements

An ISO 7 or Fed-Std 209E class 10,000 cleanroom must have 352,000 particles per cubic meter or less ≥0.5 µm sized particles, 83,200 particles per cubic meter or less ≥1 µm sized particles, and 2,930 particles per cubic meter or less ≥5 µm sized particles.

How much does a Class 10000 clean room cost? ›

10,000/7 $105/sq. ft.

What is ISO Class 7 classification? ›

An ISO 7 cleanroom will go through 30-60 air changes per hour. An ISO 7 cleanroom can use numerous construction materials, hard wall, monobloc, PVC, Glass etc the main feature of these materials being that they are smooth and resilient to the most common detergents and so easy to clean.

What are the requirements for ISO 7 certification? ›

For a cleanroom to achieve ISO 7 certification, also known as Class 10,000, there must not be over 325,000 air particles (each . 5 microns in size) per cubic meter. In comparison, an ordinary room contains at least 35,200,000 particles per cubic meter, making an ISO 7 cleanroom more than 100 times cleaner.

How to clean ISO 7 cleanroom? ›

High ISO class cleanrooms (ISO level 5-7) often require disinfectants to be sterilized before use, further protecting the cleanroom from any contaminants. Never use scrubs or rags that could shed or corrode surfaces. Instead, only use woven polyester that is specified for cleanroom use.

What are the uses of ISO 7 cleanroom? ›

ISO 7 Cleanrooms are utilized in biotechnology, pharmaceutical, nanotechnology, compounding, and various cleantech manufacturing applications such as ion lithium battery, solar, medical device, film/packaging, nutraceuticals, and certain packages foods.

Which ISO cleanroom class is the cleanest? ›

ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it's classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room. The most common ISO clean room classes are ISO 7 and ISO 8.

What is the ISO equivalent of Class 10000 clean room? ›

This is the second dirtiest cleanroom environment and the penultimate level of cleanliness, according to federal 209E standards. Class 10,000 (ISO 7) production conditions can be achieved in cleanrooms with non-unidirectional airflow.

What is a Class 10000 cleanroom environment? ›

An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot.

How much is a Class 10000 clean room per square foot? ›

The Global Construction Newsletter Q1 2023
CLASSIFICATIONCost per Square Foot Range for small applications less than 500 SFCost per Square Foot Range for larger applications over 2,500 SF
ISO 6 - Class 1,000$400 - $550$300 - $450
ISO 7 - Class 10.000$350 - $500$250 - $400
ISO 8 - Class 100,000$300 - $450$200 - $350
6 more rows

What is the cleanest cleanroom? ›

Situated in Stuttgart, Germany, the Fraunhofer Institute's ultra-clean room takes cleanliness to an extraordinary level. The air quality surpasses the ISO 1 standard, containing less than one particle per cubic meter.

Is ISO 7 or 8 better? ›

Cleanrooms are also divided into classes based on the number of particles that are in the air. As a general rule, each class has ten times fewer particles than the class above it. While a Class 8 cleanroom can have 100,000 particles per square foot of air, Class 7 cleanrooms can only have 10,000.

What is the difference between ISO 7 and 8? ›

The main differences between the cleanroom classes is the average number of air changes per hour. The more often this happens, the 'cleaner' the cleanroom gets. As mentioned above in a class 7 cleanroom, the air changes 30-60 per hour. For a class 8 this is 10-25 times per hour.

What is the highest class clean room? ›

The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9.

What are the OSHA guidelines for cleanroom? ›

Always conduct chemical processes under fume hoods or in designated wet benches, if possible. Practice good housekeeping with chemicals: clearly label containers, minimize quantities, and clean up materials after use. Ensure that chemicals are stored in rated chemical cabinets and are separated by hazard class.

What are the basic cleanroom design requirements? ›

Here are some essential cleanroom design requirements and best practices: 1. Design Considerations: The design of a cleanroom should consider the level of cleanliness required, the type of equipment and processes being used, the number of personnel, and the materials used in construction.

What is a Class 100000 clean room environment? ›

Class 100,000 Cleanroom Operating Conditions

Contamination levels in ISO 8 cleanrooms have a maximum particle count of 100,000 particles per cubic foot of air, and require 20 air changes per hour of HEPA-filtered air to meet requirements.

Top Articles
Latest Posts
Article information

Author: Jerrold Considine

Last Updated:

Views: 6611

Rating: 4.8 / 5 (58 voted)

Reviews: 81% of readers found this page helpful

Author information

Name: Jerrold Considine

Birthday: 1993-11-03

Address: Suite 447 3463 Marybelle Circles, New Marlin, AL 20765

Phone: +5816749283868

Job: Sales Executive

Hobby: Air sports, Sand art, Electronics, LARPing, Baseball, Book restoration, Puzzles

Introduction: My name is Jerrold Considine, I am a combative, cheerful, encouraging, happy, enthusiastic, funny, kind person who loves writing and wants to share my knowledge and understanding with you.