HEPA vacuum cleaner
Particle counter
Chart recorder for temperature and humidity records
UV disinfection lamps
De-ionizer systems
Automatic shoe cleaners
DI spray guns
Nitrogen spray guns
Stainless steel tables
Stainless steel bench
Common industries that have cleanrooms are:
American Cleanrooms is a full-service manufacturer of modular cleanrooms, hybrid cleanrooms, softwall cleanrooms, medical device cleanrooms, pharmaceutical cleanrooms, turnkey complete cleanrooms, mask manufacturing cleanrooms, laser cleanrooms, static dissipative cleanrooms, e-liquid cleanrooms, USP797/800 cleanrooms, & CBD extraction cleanrooms.
Example 1600 S.F. modular cleanroom by American Cleanroom Systems start to finish 9 to 14 weeks. This includes 1-2 weeks for modular cleanroom shop drawings, 4-6 weeks for modular cleanroom manufacturing, and 4-6 weeks for modular cleanroom installation and testing. By comparison, standard construction is 20 to 34 weeks not including building permits which typically add another 12 weeks. This includes 6-8 weeks for approved standard construction plans, 4-6 weeks purchasing material and 10-20 weeks standard construction and testing. Modular cleanroom can result in 50% time saved.
A: GMP stands for Good Manufacturing Practice. The FDA in USA and EU in Europe define acceptable manufacturing standards for pharmaceutical, nutraceutical, sterile and food products. Sometimes people also say CGMP which stands for Current Good Manufacturing Practice.
A: European Grade A cleanroom is comparable to an ISO-5 or class 100 cleanroom. They are used for terminally sterilized products that are high risk for contamination. They are also used for aseptic preparation and filling of sterile ointments, creams, suspensions and emulsions. Sinks and drains are forbidden.
A: A European Grade B cleanroom is comparable to ISO-5 at rest and ISO-7 operational cleanroom. Grade B spaces for terminally sterilized products are typically background environment for Grade A operations. For aseptic products Grade B is background space for grade A zones operations when needed for transfers and other less critical tasks. Sinks and drains are forbidden. Particle monitoring systems with alarm required.
A: A European Grade C cleanroom is comparable to ISO-7 at rest and ISO-8 operational cleanroom. For terminally sterilized products they are used for less critical operations. Preparation of solutions to be filtered.
A: A European Grade D cleanroom is comparable to ISO-8 at rest. May be used for Aseptic handling of components after washing. Often used for assembly.
A: Cleanrooms are grade on particle count, air changes per hour, and allowed or required equipment.
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