| Customization: | Available |
|---|---|
| Certification: | CE |
| Noise: | 60-70db |
Suppliers with verified business licenses
Audited Supplier Audited by an independent third-party inspection agency
| Cleanliness | Class 100 to Class 100000, ISO 5 to ISO 8, Class B to Class D |
| Project include | 1. Structure: Wall Panel, Ceiling Panel, Windows, Doors, Various Fittings, Flooring |
| 2.Electric: Lighting, Switch, Cables, Wires, Power Distribution Cabinet, etc | |
| 3.HVAC: AHU, Ducting, Piping, Chiller, dehumidifier, etc. | |
| 4.Auto-control: PLC Controller, Sensors for Humidity and Temperature, Control Panel | |
| 5. Process Piping System: Gas, Water Pipeline | |
| Temperature&Humidity | As clients request |
| Application | Pharmaceutical Industry |
| Qualification Documents | IQ, OQ, PQ,DQ |
| Our Service |
Professional Consultation, User-friendly English Sofaware, 24 hours technical support, |
An ISO 14644 Standard ISO 8 Controlled Environment Pharmaceutical Production Packaging Cleanroom is a
specific type of cleanroom that adheres to the international standards set forth by the ISO 14644 series for cleanrooms
and 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 classification
system, 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 classification
is suitable for less-sensitive operations, such as the packaging and labeling of pharmaceutical products, where the
risk of contamination is managed but not as critical as in the actual production or filling processes that occur in cleaner
ISO classifications like ISO 5 or ISO 7.
In a pharmaceutical production packaging cleanroom designated as ISO 8, rigorous controls are in place to minimize
the 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 strict
gowning procedures, limiting access, and regularly monitoring and testing the environment for particle counts and
microbiological contaminants. Despite being less stringent than some other cleanroom classifications, an ISO 8 cleanroom
still plays a vital role in preventing contamination that could compromise the efficacy or shelf life of pharmaceuticals.
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