Cleaning Room Assessment
Eurofins Sac Ky Hai Dang provides in-depth consulting services and design services on request related to cleanroom quality assessment according to ISO14644-1 standards
What is a cleanroom?
Cleanroom is a place where the amount of dust and microorganisms in the air is limited to the lowest level to avoid contamination of components, equipment, and products during the manufacturing and production process.
Cleanroom: room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.
For a range of uses, cleanrooms are made to regulate the atmosphere and airborne particulates. Due to the capacity of microorganisms to proliferate under favorable conditions and to cause serious injury when contaminated products or preparations are ingested or injected, monitoring of live particles in cleanrooms for pharmaceutical manufacture and compounding requires specific care.
Standards and methods for cleanroom monitoring
Cleanrooms and controlled environments, with minimal contamination of air and surfaces, and levels appropriate for performing pollution-sensitive operations during operation. Contamination control has an important role in protecting product or process integrity for industries such as aerospace, microelectronics, pharmaceuticals, medical devices/instruments, health care, and food.
A clean room is a room in which the concentration of airborne particles is controlled and classified, and designed, constructed, and operated in a manner that controls the introduction, generation, and retention of particles inside the room.
Standards related to clean rooms Eurofins Sac Ky Hai Dang can provide:
- US Federal Standard STD STD 209E
- International standards: ISO 14644-1 and GMP Standards (GMP EU, GMP WHO, cGMP).
Factors when controlling cleanroom quality
- Temperature
- Humidity
- Pressure
- Particulate dust
- Microbiology
Eurofins Sac Ky Hai Dang environmental services
Eurofins Sac Ky Hai Dang uses a very large selection of methods, under internationally approved quality systems and the relevant accreditation and approvals. Our highly trained employees have built fair experience, and knowledge over the years to deliver these testing, samplings, and quality evaluation thoroughly.
Eurofins Sac Ky Hai Dang provides in-depth consulting services and design services on request related to cleanroom quality assessment according to ISO14644-1 standards
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- Hotline: (+84) 28 7107 7879 - Press 1 (see Sales Department)
- Email: VN01_Environment@eurofinsasia.com