How to divide the cleanliness level of laminar flow vehicles?
2024-12-19
How to divide the cleanliness level of laminar flow vehicles?
The classification of cleanliness of laminar flow running vehicles is usually based on relevant standards and specifications, and the common classification methods and grades are as follows:Standard ISO 14644-1
ISO 14644-1 is a standard developed by the International Organization for Standardization to classify the level of clean workshops according to the number of particles in the air, and the clean level of laminar flow running vehicles can also refer to this standard:
ISO Level 1: The maximum allowable amount of particulate matter below 0.1μm per cubic meter of air is 1000. This grade is suitable for environments that require very high cleanliness, such as the manufacture of certain high-precision semiconductors or the production of ultra-high purity chemicals, but is generally less used for laminar flow vehicles.
ISO Level 5: The maximum allowable number of particles below 0.5μm per cubic meter of air is 3520, which is usually used in production environments requiring higher cleanliness, such as aseptic operation areas in the pharmaceutical industry and production lines of some advanced electronic products, and some laminar flow vehicles can reach this cleanliness level, which can provide a good local clean environment for drug production and biological experiments.
Domestic common clean grade standards
In the domestic pharmaceutical industry, the following classification methods are often used:
Level 100: The number of dust particles and microorganisms with a diameter greater than 0.5 microns in each cubic meter of air shall not exceed 100. In some scenes such as sterile drug production and high-purity biologics preparation with extremely strict environmental requirements, laminar flow vehicles are required to reach a 100-level cleanliness level to ensure that drugs are not contaminated during transport.
Thousand-level: The number of dust particles and microorganisms with a diameter greater than 0.5 microns in each cubic meter of air shall not exceed 1000. It is suitable for drug production, medical device manufacturing, and other links with high cleanliness requirements, and some laminar flow running vehicles can reach this level to meet the transport and temporary storage needs in the corresponding production process.
Class 10,000: The number of dust particles and microorganisms with a diameter greater than 0.5 microns in each cubic meter of air shall not exceed 10,000. In the production process of some common drugs or the production process of drugs with slightly lower cleanliness requirements, the laminar flow running car can meet the requirements by reaching the 10,000 level of cleanliness.
Class 100,000: The number of dust particles and microorganisms with a diameter greater than 0.5 microns in each cubic meter of air shall not exceed 100,000. In some areas where the cleanliness of the drug production environment is relatively low, the laminar flow running vehicle carries out clean control at this level, which can ensure that the drug is not polluted by the external environment to a certain extent.
Enterprise custom standards
Some enterprises will, according to the special requirements of their product production process, develop more stringent or slightly different internal cleanliness level standards to regulate the use of laminar flow running vehicles. For example, some high-end biopharmaceutical companies may require laminar flow vehicles to operate with no more than 100 dust particles greater than or equal to 0.3μm per cubic meter of air in the working area to better meet the production needs of their specific drugs.

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