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High Efficiency Cleanroom for Cosmetics Workshop Operating Room Pharmacy Industry1
Air Clean Equipment, Other Air Clean Equipments, Cleanroom Class 10000, ISO 7/8/9 Cleanroom
Suzhou Pharma Machinery Co., Ltd.
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Product Description CleanlinessClass 100 to Class 100000, ISO 5 to ISO 8, Class B to Class DProject include1. Structure: Wall Panel, Ceiling Panel, Windows, Doors, Various Fittings, Flooring2.Electric: Lighting, Switch, Cables, Wires, Power Distribution Cabinet, etc3.HVAC: AHU, Ducting, Piping, Chiller, dehumidifier, etc.4.Auto-control: PLC Controller, Sensors for Humidity and Temperature, Control Panel5. Process Piping System: Gas, Water PipelineTemperature&HumidityAs clients requestApplicationPharmaceutical IndustryQualification DocumentsIQ, OQ, PQ,DQOur ServiceProfessional Consultation, User-friendly English Sofaware, 24 hours technical support,Foreign installation and commissioningAn ISO 14644 Standard ISO 8 Controlled Environment Pharmaceutical Production Packaging Cleanroom is aspecific type of cleanroom that adheres to the international standards set forth by the ISO 14644 series for cleanroomsand associated controlled environments.In this context, an ISO 8 cleanroom means that it meets the criteria for the eighth level of the ISO 14644-1 classificationsystem, which specifies the maximum concentration of airborne particles allowed in the cleanroom environment.In an ISO 8 cleanroom, the air must contain fewer than 352,000 particles (≥0.5 μm) per cubic meter. This classificationis suitable for less-sensitive operations, such as the packaging and labeling of pharmaceutical products, where therisk of contamination is managed but not as critical as in the actual production or filling processes that occur in cleanerISO classifications like ISO 5 or ISO 7. In a pharmaceutical production packaging cleanroom designated as ISO 8, rigorous controls are in place to minimizethe introduction and spread of contaminants, ensuring the integrity and safety of the packaged pharmaceutical products.This includes controlling air flow, using High-Efficiency Particulate Air (HEPA) filtration systems, maintaining strictgowning procedures, limiting access, and regularly monitoring and testing the environment for particle counts andmicrobiological contaminants. Despite being less stringent than some other cleanroom classifications, an ISO 8 cleanroomstill plays a vital role in preventing contamination that could compromise the efficacy or shelf life of pharmaceuticals.
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