Behaviour rules in a cleanroom - Blog - Colandis

Jul. 22, 2024

Behaviour rules in a cleanroom - Blog - Colandis

So that the cleanroom can maintain its air cleanliness class according to ISO, it is necessary to check all factors in the cleanroom for their cleanroom suitability and to optimise them, if necessary. Besides machines, assemblies and some processes in the cleanroom, it is above all the personnel who work there, that contribute significantly to the purity of the room. In this blog post, we give an insight into the most important rules of behaviour, which must be observed when working under clean conditions for employees.

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Staff in a cleanroom

The employees in a cleanroom are considered to be one of the biggest sources of contamination. Especially the particles found on the human body, such as dust, skin particles, hair or even bacterial particles can severely impair the cleanliness class of the room. Through a high intensity of movement of employees, these individual particles quickly reach the clean environment, so that the particle emission can be increased by intensive movements many times.

In addition to a cleanroom-compatible dress code the behaviour of the staff itself in such an environment is of great importance in maintaining the air cleanliness class of the cleanroom. Only through appropriate training, a transparent and open communication, the staff can be enabled to behave adequately in the cleanroom.

How should employees behave?

The rules of proper behaviour in a clean environment should be adhered strictly by every employee, visitor and even management, so as not to unnecessarily contaminate the cleanroom. The behaviour rules can be divided into different categories:

Personal traffic: One of the most important rules is that only trained staff should work in the cleanroom. Only the required minimum of staff should be present at the clean workplace. When not busy or just monitoring, staff should stay as far as possible from the critical area.

Personal: Bringing personal items into the clean environment such as jewellery, food or handbags should be forbidden. Also the use of make-up is not permitted.

Food and beverage: Bringing food and beverage to the clean workplace is prohibited. They can lead to a high degree of particle emission. A water dispenser in the personnel lock is very accommodating for staff.

Movement: An intensive movement can lead to a stronger particle emission. That's why the staff should move carefully in a clean environment. Hectic or fast movements should be avoided.

Diseases: Never cough or sneeze in the direction of the critical work area. It should be avoided under any circumstances. If any employee is unfit for working in a cleanroom temporary or permanently - after an appointment with a doctor - the employee should be transferred into another equivalent workplace in the company.

Material: No further storage should be provided in the clean area, apart from materials and objects required for the production.

Miscellaneous: Only use the permitted cleanroom wipes and special cleaning materials for cleaning the area. For taking notes or sketches only ballpoints or fiber-tip pens should be used (no pencils). If paper is brought into the cleanroom, it should be suitable for use in cleanroom.

If these and other important rules of conduct are observed by the trained personnel during work in the cleanroom and consistently adhered to, strong particle contamination by humans in the cleanroom can be reduced.

In addition to adhering to certain rules of conduct in the cleanroom, the dress code and intensive knowledge of the processes when entering and leaving the clean environment can also contribute significantly to ensure the air quality of the room. If you would like to learn more about &#;behaviour in the clean environment&#;, then download our free whitepaper!

Clean Room Classifications & ISO Standards

Our team can design, manufacture and install your certified cleanroom in as little as 4 weeks , on-site with minimum disruption.

A Turnkey Complete Cleanroom is when the modular cleanroom company provides beginning to end service, doing all aspects of the cleanroom project. This includes:

A Mask Manufacturing Cleanroom is a cleanroom that is used for manufacturing of K95 and surgical masks during the Covid-19 crisis.

A Static Dissipative Cleanroom is designed to prevent static from building up within the cleanroom which can damage sensitive electronic components. Features include:

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FAQs About Cleanroom Classifications

Q: What Is a Cleanroom?

A: A cleanroom (or clean room) is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. The FDA mandates the use of cleanrooms to create GMP manufacturing factories.

Q: What Are Cleanrooms Used For?

A: Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. Cleanrooms use HEPA filters to remove particles from the air. It is common to see pharmaceutical cleanrooms, medical device cleanrooms, semiconductor cleanrooms, electronic cleanrooms, aerospace cleanrooms, food cleanrooms, USP797 compounding pharmacy cleanrooms and biotech cleanrooms. Cleanrooms are also used by the government such as national labs, defense industries, and R&D labs at universities.

Q: How Clean Is a Cleanroom?

A: Very clean. A class 100 cleanroom has 100 particles per cubic foot. By comparison your typical office space has between 500,000 and 1 million particles per cubic foot. Cleanrooms come in different classes from class 100 to 100,000.

Q: When Is a Cleanroom Required?

A: Medical device and pharmaceutical manufacturing requires sterile environments to produce their products. Cleanrooms provide this sterile super clean manufacturing space which reduces the chance of contamination getting in your medicine. Semiconductor manufacturers produce devices with ultra small super dense features. Examples are computer chips for your cell or PC. If contamination were to get on the chip during manufacturing, they would not work.

Q: What Does ISO Stand For?

A: ISO is the International Standards Organization. It has created the ISO -1 Cleanroom Standards that describe the allowed number of particles, the allowed size of particles and HEPA filtered air flow changes per hour meet ISO-4, ISO-5, ISO-6, ISO-7, and ISO-8 standard. It relies on measurements per cubic meter. It corresponds to the USA based Fed Standard 209E which relies on measurements per cubic foot. Fed Standard 209E corresponding classes are 10, 100, , 10k and 100k.

Q: What is Clean Room in Pharma?

A: In pharma a clean room is a controlled environment using HEPA filtration to minimize particulate contamination. Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharma cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

Q: What is a Data Cleanroom?

A: A data cleanroom is a secure isolation virtual platform that typically stores anonymized marketing data from multiple sources. It is used to protect privacy and share data from multiple sources. It is very different from physical cleanrooms used for manufacturing.

Q: How Do Cleanrooms Work?

A: Cleanrooms rely on HEPA or ULPA filtration to remove particles from the air and create an ultra clean environment. With sufficient air changes per hour and laminar air flow it is possible to reduce particulate count from greater then 500k/ft3in typical office space to as low as 100/ft3(class 100 cleanroom). Airlocks are used to prevent contamination from entering the cleanroom. Workers inside cleanrooms typically wear cleanroom garments such as booties and bunny suits to prevent them from bringing contamination into the room. Eating and drinking are never allowed in cleanrooms.

Q: Who Needs a Cleanroom?

A: Industries such as pharmaceutical, medical device and USP797 compounding pharmacies are required by the government to manufacture in sterile environment and must use cleanrooms. Other industries such as semiconductor, electronics, aerospace and optics find the ultra-clean environments in cleanrooms are the only way to cost effectively manufacture their products. Other industries that use cleanrooms include food, beverage, e-liquid, CBD and vitamins.

Q: What is a Pharmaceutical Cleanroom?

A: Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharmaceutical cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

Q: What is a Class 1 Cleanroom?

A: A class 1 cleanroom refers to ISO standard allowing less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 1 cleanroom typically has from 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the cleanest classification.

Q: What is a Class 2 Cleanroom?

A: A class 2 cleanroom refers to ISO standard allowing less than 11 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 2 cleanroom typically has 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 2nd most clean classification.

Q: How Many Types of Cleanrooms Are There?

A: The most common type cleanrooms are modular cleanrooms, stick-built cleanrooms (or standard), and softwall cleanrooms. Modular cleanrooms utilize prefabricated modular wall systems which allow for faster installation, easy modification(s) and reasonable cost. Stick built or standard cleanrooms rely on conventional steel stud(s) drywall construction. It can be slightly cheaper. Softwall cleanrooms use clear vinyl curtains suspended from metal frames. Small softwall cleanrooms are often mounted on casters so they can be easily moved around.

Q: What is a Class 4 Cleanroom?

A: A class 4 cleanroom refers to ISO standard allowing less than particles greater than 0.3 microns and less than 2 particles greater than 5.0 microns per cubic meter. A class 5 cleanroom requires from 500-600 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 4th most clean classification.

Q: How Do You Prepare For Cleanroom / Installations?

A: If you need an ISO-7 cleanroom you should prepare your facility for the modular cleanroom installation. Check that area is free and clear up to height of cleanroom. Frequently existing electrical conduit, lighting, sprinklers, and HVAC ducting need to be relocated. When installing new cleanroom flooring make sure the existing concrete is in good shape. Have any cracks and depressions filled to level the floor.

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