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Aseptic Test Isolator (STI)
Sterility Test Isolators (STI) Product Introduction: Sterility Test Isolators (STI) are excellent sterile isolation barriers that provide good environ
Product details

Aseptic test isolator(STI

Introduction to Sterile Test Isolator STI Product
Sterility Test Isolators (STIs) are excellent sterile isolation barriers that provide good environmental control to minimize false positive interference during the aseptic testing process. Esco's latest series of sterile test isolators (STI), combined with advanced material transfer technology and biological decontamination methods, can effectively reduce contamination of bioactive substances by up to 6 times. The standard configuration products provided can meet the needs of different batches and process flows. Through the configuration selection system determined by the end user, the operating status of the isolator can be changed to circulating airflow or unidirectional airflow, positive pressure operation or negative pressure operation mode, making the system multifunctional to meet the operational needs of toxic or non-toxic sterile materials. The system has a filter safety replacement function for handling toxic materials.

Basic principle of sterile test isolator STI
·Completely unidirectional airflow mode provides excellent sterile operating area
·The safety laminated glass is opened through a pneumatic rod system, which facilitates material loading
·The airflow mode is either recyclable airflow or unidirectional airflow. The unidirectional airflow mode can quickly eliminate biological pollutants during ventilation, and choosing the circulating airflow mode can reduce the air intake and exhaust requirements in the room during normal operation, system adjustment, and disinfection and sterilization
·Safe replaceable U15 level air supply and exhaust high-efficiency filter system, suitable for handling toxic or non-toxic sterile materials
Characteristics of sterile test isolator STI product
·Single piece 316L stainless steel welded as a whole, with a large circular arc angle transition in the inner cavity;
·Stress testing is conducted in accordance with ISO 14644-7 standard;
·Inflatable anti bacterial contamination design, meeting the cleanliness level of 6 required by the US Pharmacopeia USP, with active and passive sealing performance meeting the food safety level approved by the US FDA;
·The glove safety replacement system ensures that contamination is safely replaced under controlled conditions;
·Integrated or standalone hydrogen peroxide (HPV) disinfection and sterilization can effectively reduce the contamination of bioactive substances by up to 6 times;
·The system integrates automatic pressure attenuation detection function;
·Smooth and easy to clean inner and outer surfaces;
·The U15 level high-efficiency filters for air supply and exhaust can be safely replaced, and the embedded rubber seal design provides the best operability and sealing performance;
·Integrated sterile testing system;
·The lighting system is designed outside the isolator chamber, easy to maintain, low heat output, and fully covered inside the chamber;
·The system is equipped with a hydraulic support that can be electrically adjusted to a height of 280mm, providing comfortable height for operators;
·Can integrate optional accessories such as data loggers, biological and non biological particle monitoring devices.
airflow pattern



technical specifications - Aseptic test isolator(STI

model

STI-2G_

STI-3G_

STI-4G_

Standard specification operating room

1.2 m

1.6 m

2.0 m

Operating room size(Wide)xdeepxHigh)

1.2 x 0.75 x 0.85 m

1.6 x 0.75 x0.85m

2.0 x 0.75 x 0.85 m

Dimensions

(Wide)xdeepxHigh)

Including bottom adjustable height bracket (minimum)

1.2 x 1.1 x 2.2 m

1.6 x 1.1 x 2.2 m

2.0 x 1.1 x 2.2 m

Including bottom adjustable height bracket (highest)

1.2 x 0.75 x 2.68 m

1.6 x 0.75 x2.68m

2.0 x 0.75 x 2.68 m

Glove hole height (minimum)

1080

1080

1080

Glove hole height (maximum)

1360

1360

1360

Cleanliness of the cavity

All chambers have achieved cleanlinessISOstandard Class 5Level of Cleanliness(AGrade)

High efficiency air filter type intake

ULPAUltra efficient air filter,U15Type, integral protective net, embedded rubber seal

High efficiency air filter retention efficiency intake

99.9998%

99.9998%

99.9998%

High efficiency air filter type exhaust

HEPAEfficient air filter,H14Type, embedded rubber seal

High efficiency air filter retention efficiency exhaust

99.997%

99.997%

99.997%

illuminance

≥600 Lux

≥600 Lux

≥600 Lux

noise

≤68 dBA

≤68 dBA

≤68 dBA

Isolator material

Working chamber

316L

316L

316L

Maintain the cavity

316L

316L

316L

support frame

316L

316L

316L

Polishing degree of isolator

External cabinet

≤0.4 Ra

≤0.4 Ra

≤0.4 Ra

Inside the cabinet

≤0.6 Ra

≤0.6 Ra

≤0.6 Ra

Maintain the exterior of the cavity

0.6 Ra

0.6 Ra

0.6 Ra

support frame

1.0 Ra

1.0 Ra

1.0 Ra







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