Use a sporicidal disinfectant, EPA-registered disinfectant, or sterile 70% isopropyl alcohol (IPA) to wipe down any products entering the clean room. Personnel must wear gloves during this process and disinfectant agents must be allowed to dwell for sufficient contact time before moving products into the compounding area. These practices reduce bioburden and microbial contamination on supplies used for compounding.
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The entire compounding environment, which includes the clean rooms and ante-rooms or the SCA, must be cleaned and disinfected daily on days when compounding occurs. This includes floors, pass-through chambers, and frequently touched work surfaces outside the hood. Additionally, ceilings, walls, shelving, and bins must be cleaned monthly. Sporicidal disinfectants must be applied at least monthly throughout the hoods and rooms. Sterile disinfectant and sporicidal agents are required for cleaning within the hoods. Pay attention to cleaning and disinfecting supplies, such as wipers, pads, and mop heads which must be low-lint, and disposable if possible.
If cleaning tools are reusable, they must be dedicated for use within specific areas, not removed from classified areas or the SCA, and constructed from cleanable materials (avoiding porous materials like wood).
Ensure that your facility has a modern clean room environment. Install HEPA filters in the ceiling; evaluate the condition of walls and repair any dents or dings; replace floors with seamless vinyl flooring, ensuring the juncture between the floor and the walk is caulked and sealed. All surfaces must be maintained in good condition and resistant to damage from frequent cleaning applications.
Consider designing access doors to operate in a hands-free manner. This ensures a seamless and efficient transition between these spaces while minimizing the need for manual contact with the doors. When possible, pass-through chambers should be interlocking to prevent both sides from being opened at the same time.
All classified areas, including the hood, must be recertified every 6 months. This report includes validation of the air quality and airflow within the compounding area and is a key indicator that your cleanroom is in good working order. In the event something is out of specification, determine a corrective action plan and ensure follow-up occurs and is documented.
Make staff training and competency and compliance documentation more seamless by investing in an easy-to-use web-based pharmacy compliance system that helps staff achieve and maintain USP 797 compliance.
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:
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
For more information, please visit class 8 cleanroom standards.