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YJ. Biotech Isolator

Taiwan
Introduction
Designed with user experience and production efficiency at its core, this system integrates all necessary elements of cell processing into a single Grade A compartment. YJ isolator includes an RTP quick-connect incubator, a hydrogen peroxide sterilizer, a VHP-resistant optical microscope, and a large-capacity centrifuge with a 316L medical-grade stainless steel chamber. The environment is maintained at ISO 5 cleanliness using H14 HEPA filters.

The digital environmental monitoring system provides real-time data and records, ensuring the entire cell production process is traceable and compliant with FDA 21 CFR Part 11. This is the first domestically produced pharmaceutical isolation equipment designed specifically for cell manufacturing that meets PIC/S GMP standards.
Features / strengths
New Cell Product Processing:
YJ isolator, which complies with Pharmaceutical regulations and is approved by TFDA, is used in the GTP cell processing unit and cell pharmaceutical industry.
This equipment can be placed in a lower-grade C or D background environment (ISO 8, Class 100,000 or higher).
Physical isolation of the chamber, an independent air circulation filtration system, and hydrogen peroxide vapor sterilization reduce the risk of contamination during cell processing, ensuring product safety.
Hospitals can more easily establish a Grade C or D background environment (ISO 8, Class 100,000 or higher) and use the isolator glove box for cell therapy processes.
Specification in detail
External dimensions
W2145 x D1240 x H2350 mm
Internal dimensions
W2120 x W790 x H960mm
In/Out air
CamFil H14 HEPA
Vertical flow air
H14 HEPA
Cleanliness class (ISO)
ISO 5
Airflow velocity
0.45m/s
Leak-rate test
+/- pressure criteria
Incubator
RTP quick-connect
Microscope
VHP-resistant optical microscope

Information
Introduction
Designed with user experience and production efficiency at its core, this system integrates all necessary elements of cell processing into a single Grade A compartment. YJ isolator includes an RTP quick-connect incubator, a hydrogen peroxide sterilizer, a VHP-resistant optical microscope, and a large-capacity centrifuge with a 316L medical-grade stainless steel chamber. The environment is maintained at ISO 5 cleanliness using H14 HEPA filters.

The digital environmental monitoring system provides real-time data and records, ensuring the entire cell production process is traceable and compliant with FDA 21 CFR Part 11. This is the first domestically produced pharmaceutical isolation equipment designed specifically for cell manufacturing that meets PIC/S GMP standards.
Features / strengths
New Cell Product Processing:
YJ isolator, which complies with Pharmaceutical regulations and is approved by TFDA, is used in the GTP cell processing unit and cell pharmaceutical industry.
This equipment can be placed in a lower-grade C or D background environment (ISO 8, Class 100,000 or higher).
Physical isolation of the chamber, an independent air circulation filtration system, and hydrogen peroxide vapor sterilization reduce the risk of contamination during cell processing, ensuring product safety.
Hospitals can more easily establish a Grade C or D background environment (ISO 8, Class 100,000 or higher) and use the isolator glove box for cell therapy processes.
Specification in detail
External dimensions
W2145 x D1240 x H2350 mm
Internal dimensions
W2120 x W790 x H960mm
In/Out air
CamFil H14 HEPA
Vertical flow air
H14 HEPA
Cleanliness class (ISO)
ISO 5
Airflow velocity
0.45m/s
Leak-rate test
+/- pressure criteria
Incubator
RTP quick-connect
Microscope
VHP-resistant optical microscope

YJ. Biotech Isolator

Taiwan
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