Audited Supplier
| Cover: | SS304 | Control: | PLC |
|---|---|---|---|
| Supply: | AC220V 50Hz | Noisy: | ≤65dV(A) |
| Power Suppy: | 3KW,220v | External Dimension: | 2050*750*2200mm |
| High Light: | compounding isolator,cleanroom isolator | ||
Experience a high-efficiency clean environment with our advanced sterility test isolator - your ultimate solution for precise and reliable sterility testing in controlled environments.
PVC Sterility Test Isolator Documentation - PDF Format
Our state-of-the-art aseptic isolation system is meticulously engineered and crafted to align with the stringent requirements of Good Manufacturing Practice (GMP), ensuring the highest standards for medical and healthcare products.
Introducing a superior barrier system designed for elevated environmental control and protection. This cutting-edge system is engineered to prevent any product contamination while safeguarding the operator, effectively shielding against toxic substances. It delivers exceptional environmental control technology solutions tailored for sterility testing, aseptic processing, and protection in the production of highly sensitizing and toxic drugs. The PDA strongly advocates for these isolation system definitions to be universally adopted within the healthcare sector globally:
Our isolation system boasts a sealed or microbial filtration system (HEPA) that delivers purified air and features a self-cleaning mechanism. In confinement, rely solely on the pristine interior surface or utilize the rapid transfer channel for seamless material transfer. During operation, material transitions are exclusively conducted through a bespoke, designed, and verified aperture to eradicate contamination risks. It serves as an ideal solution for isolating active mixtures during aseptic processes and is versatile for sterilization and isolation applications.
2. Parameter
| Supplier: | AC380±38V 50HZ±1HZ |
| Power: | 2500W |
| Internal lighting: | ≥500Lux |
| Noisy: | ≤65dB(A) |
| High efficiency filter: | H14 grade filtration efficiency 99.995% |
| Sterilization rate: | The ability to kill a thermophilic adipose spore is 106 |
| Airflow model: | Vertical unidirectional flow |
| Wind speed: | 0.36~0.54m/s |
| Pressure control range: | -80~80Pa |
| Pressure resolution: | 0.1Pa |
| Temperature resolution: | 0.1ºC |
| Touch screen size: | 10" / 12" touch screen or industrial tablet |
| In-cabin purification level: | Dynamic A level |
| Model | size of machine | Size of operation | Air lock chamber size | description |
| YT-L1500 | 1500*1100*2300 | 1500*700*800 | NO | Single-sided hard cabin laminar flow isolator 3 gloves |
| YT-L1500A | 2100*1100*2300 | 1500*700*800 | 500*600*500 | Single-sided hard cabin laminar flow isolator 3 gloves |
| YT-L1800 | 1800*1100*2300 | 1800*700*800 | NO | Single-sided hard cabin laminar flow isolator 4 gloves |
| YT-L1800A | 2400*1100*2300 | 1800*700*800 | 500*600*500 | Single-sided hard cabin laminar flow isolator 4 gloves |
| YT-DL1800A | 2450*1100*2300 | 1800*1000*800 | 500*600*500 | Double-sided hard cabin laminar flow isolator 4+4 gloves |
- Designed with a robust hard hatch structure, comprising entirely enclosed stainless steel and tempered glass for optimal durability and protection.
- The cabin is expertly welded from 316L stainless steel, ensuring all internal angles are arc-shaped, facilitating effortless cleaning and sterilization procedures.
- Designed with a robust hard hatch structure, comprising entirely enclosed stainless steel and tempered glass for optimal durability and protection.
- The cabin is expertly welded from 316L stainless steel, ensuring all internal angles are arc-shaped, facilitating effortless cleaning and sterilization procedures.
- With a completely unidirectional airflow mode, it provides a superior aseptic operating area, ensuring unmatched cleanliness.
- Employing a vertical unidirectional airflow system, it expedites the removal of biofouling during ventilation, maintaining pristine conditions.
- The material door features an inflation seal with pneumatic locking and an interlocking function for optimal security during operation.
- Integrated or standalone hydrogen peroxide sterilization capabilities drastically reduce bioactive substance contamination by up to 10^6, ensuring a pristine environment.
- The YT-601B/YT-608B integrated aseptic detection system minimizes the use of operating space, enhancing efficiency.
- Equipped with Siemens PLC control, the system integrates signal acquisition, real-time data display, high and low voltage alarms, and data storage with printing functions for comprehensive monitoring.
- Boasting an hourly leakage rate of ≤0.5%, it assures product quality reliability and operator safety, adhering to ISO14644-7.2004 and GB/T25915.7-2010 standards.
cleanroom isolator,
positive pressure isolator,
compounding isolator
