What are the requirements for a clean room?

Author: Mr. Armando Hackett  |  Last update: Monday, October 6, 2025

A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot.

What are the basic clean room requirements?

ISO 1 Cleanroom Requirements:
  • Less than or equal to 10 particles (0.1 μm) per cubic meter of air.
  • Average airflow velocity of 0.305 – 0.508 meters/second (or 60 – 100 ft/min)
  • Air changes per hour: 360 – 600.
  • Fan/filter unit (FFU) coverage of 80 – 100%

What are the FDA requirements for a clean room?

The FDA describes a cleanroom as an isolated environment, strictly controlled with respect to: Airborne particles of viable and non-viable nature, Temperature, Humidity, Air pressure, Air flow, Air motion, and Lighting. There should be a monitoring system for your clean room.

What are the ISO 7 standards for clean rooms?

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.

What are the four basic components of a cleanroom?

Cleanroom and barrier isolator systems have four basic parts: the physical structure, the internal environment, the interaction technology, and the monitoring system. To create an aseptic environment, pharmacists must understand each of these components and be able to provide vendors with clear specifications.

Intro to Cleanroom Requirements for Pharmaceuticals

What makes up a clean room?

In addition to air filters, cleanrooms can also use ultraviolet light to disinfect the air. UV devices can be fitted into ceiling light fixtures and irradiate air, killing potentially infectious particulates, including 99.99 percent of airborne microbial and fungal contaminants.

What standard specify basic requirements for cleanroom operations?

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed.

Do and don'ts in clean room?

Don't engage in any horseplay. No leaning on surfaces or equipment. Allow unauthorized personnel into the room. Touch anything other than what you are working on, this means even scratching your face is prohibited.

What are the requirements for a Class 100 000 clean room?

An ISO 8 or Fed-Std 209E class 100,000 cleanroom must have 3,520,000 particles per cubic meter or less ≥0.5 µm sized particles, 832,000 particles per cubic meter or less ≥1 µm sized particles, and 29,300 particles per cubic meter or less ≥5 µm sized particles.

How many air changes per hour for a clean room?

Summary: Cleanroom air changes rates refers to how many times per hour the cleanroom air is passed thru the HEPA filtration . The more air changes per hour the cleaner the cleanroom. An ISO-8/class 100k cleanroom requires 20 air changes per hour. A cleaner ISO-7/class 10k cleanroom requires 60 air changes per hour.

What is a clean room not classified?

Unclassified cleanrooms (or clean not classified cleanrooms) are used in the pharmaceutical and specialist manufacturing industries that require a clean space to prevent contamination from dust or other external pollutants or exercise control over humidity and temperature.

What are the 5 cleaning standards?

Each level is defined by a range of tasks and their frequency. The cleaning levels are as follows: Level 1 Orderly Spotlessness, Level 2 Ordinary Tidiness, Level 3 Casual Inattention, Level 4 Moderate Dinginess, Level 5 Unkempt Neglect.

What PPE is required for a clean room?

The PPE worn in cleanrooms typically includes gloves, hoods, caps, helmets, coveralls, overboots, face masks, and goggles or safety glasses. The type of PPE required can vary significantly based on the ISO class of the cleanroom, the specific industry, and the nature of the work performed within the cleanroom.

Which rooms have to be cleaned first?

Bathrooms and kitchens are known as 'wet areas'. These often take the most time to clean. That's why they should be first in the order you clean your house. Once you've done step 1 and 3, dust everything and then get down to work in your bathrooms and kitchen.

What is a clean room law?

Clean room is a method of developing proprietary material in which a development team works in an isolated environment to ensure that the work is authentic and is not copied. The purpose is to provide evidence that similarities to others works is because of legitimate reasons and not copying.

How often must a clean room be certified?

Most people test annually. Some industries like pharmaceutical manufacturing do clean room testing and certification every 6 months. However, anytime you have reasonable cause, you should have your cleanroom tested. For example, you just completed an area expansion or there was a contamination event.

What are the ISO 8 standards for clean rooms?

Europe and the rest of the world uses the ISO cleanroom classification system for all industries except semiconductor. ISO-8 cleanrooms are required to have 20 air changes per hour of HEPA-filtered air and less than 29,300 particles/meter3 greater or equal to 5 microns.

What is the difference between clean room 100 and 1000?

Class 1,000: Particle count not to exceed a total of 1000 particles per cubic foot of a size 0.5 micron and larger or 10 particles per cubic foot of a size 5.0 micron or larger. Class 100: Particle count not to exceed a total of 100 particles per cubic foot of a size 0.5 micron and larger.

How do you qualify for a clean room?

Summary: Cleanroom certification is when a cleanroom is tested by 3rd party to ensure they meet cleanroom classification standards including particle counts and air changes per hour. Other parameters that are often tested include room pressure, temperature, humidity, viable particles, light and sound.

What is the clean room protocol?

Nothing is allowed inside the cleanroom complex which is not required in the cleanroom manufacturing process. This includes personal items such as jewelry or keys, cosmetics, tobacco or matches in any form, and food or drink in any form. Hair may not be combed in the cleanroom gowning area.

What materials are allowed in a cleanroom?

Cleanroom-Approved Materials

Instead, cleanroom-certified documentation is used. These materials are specially processed and packaged for cleanroom use. Even less obvious items such as chairs, workbenches, floors, adhesive tacky mats, pens, paper, and mouse pads must be cleanroom-approved.

What not to wear in a clean room?

No shorts, no sandals/flip-flops, no high heels. Your shirt must be at least a short sleeve shirt that is long enough to reach your pants (no bare midriffs) and it must not have a deep neckline. NO eating, smoking or gum chewing allowed inside the cleanroom.

What are the conditions for a clean room?

A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty.

What instrument is allowed to write inside a clean room?

We offer sterile pens and markers for use in aseptic cleanrooms to maintain the sterility of your application. Best practice is to introduce a single sterilized pen per work shift. All our sterile writing instruments come individually packaged to ensure sterility is maintained.

What are Class 3 clean room requirements?

ISO Class 3

Cleanrooms with this classification can have a maximum of 1,000 particles under size 0.1 µm present per cubic meter of air. ISO Class 3 cleanrooms allow up to eight particles 1 µm in size and do not allow any particles larger than 1 µm.

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