Hangzhou Winteam Scientific Instruments Co., Ltd.
THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION
|Place of Origin:||CHINA|
|Minimum Order Quantity:||1 set|
|Packaging Details:||wooden case|
|Delivery Time:||30work days|
|Supply Ability:||10set one month|
|Cover:||SS304 SS316 Pvc||Noise:||≤6060db(A)|
|Reduction:||Log 6||Class:||Laminar Flow A Turbulent Flow A|
positive pressure isolator,
class A ss316 sterility test isolator with 4 gloves for laboratory compounding aseptic containment isolator
Aseptic isolator is the first fully enclosed isolation device. It has a unidirectional flow inside and maintains a slight positive pressure externally. It can reach the ISO5 standard. The staff only rely on the glove hole to operate, so that the internal cleanliness of the device is not subject to the outside. influences. In order to confirm that the sterile isolator is working properly, its performance needs to be verified and studied to ensure the accuracy of the sterility test results.
The inside of the sterile isolator can be repeatedly sterilized by a vaporized hydrogen peroxide sterilizer. The inner wall can be treated with a sterilizing agent to remove all bioburdens. After the sterilization is completed, the sterile isolator passes through a high efficiency air filter (HEPA). Or higher air filters deliver clean air to the interior to maintain an internal sterile environment.
The use of the sterile isolator essentially avoids direct contact between the operator and the experimental items. Instead of wearing a special cleansing suit, the operator does not need to wear the operating gloves or the half-length suit on the sterile isolator to inboard the items and instruments. Take action. Glove-sleeve assemblies or half-length suits are an integral part of a sterile isolator compartment that is made of a soft material and is compatible with the sterilant used.
Therefore, the aseptic sterilizer can perform sterility test to avoid contamination of the experimental articles and auxiliary equipment, and improve the accuracy of the sterility test results.
1. Confirmation of cabin tightness
Whether the sealing performance of the aseptic isolator meets the requirements is determined by the pressure maintaining capability of the sterile isolator in a fully static closed state.
Where: Q/V: hour volume leak rate; Ps: initial absolute pressure Pt: end absolute pressure; t: mean pressure drop, min.
Judging criteria: 1 hour leak rate Q/V ≤ 0.5%. If the cabin is tested three times, the leakage rate is less than 0.5%, indicating that the sterile isolator has good sealing performance and can prevent the entry of external microorganisms.
|size of operation||1200*650*850||1500*650*850||1800*650*850|
|Air lock chamber size||750*650*850|
|Power supply||AC220V 50Hz|
|Operation port||single side 2+1||single side 3+1||single side 4+1|
|Operating port size||240mm diameter|
|Airflow mode||engineering turbulence|
|High efficiency filter||99.98% H13|
|Operating port protection wind speed||0.5m / s (refer to ISO 14644-7)|
|Hour leak rate||≤0.5% (refer to ISO 14644-7)|
2, the system's efficient integrity detection
By detecting the amount of high-efficiency filter leakage from the sterile isolator, the high-efficiency filter and its defects during installation are found to take remedial action. The detection method uses the PAO method to evaluate the high-efficiency filter leakage rate by testing the aerosol concentration ratio upstream and downstream of the high-efficiency filter.
Judging criteria: the detection point transmittance is higher than 0.01%, which is the leak point, and the entire filter plane transmittance is less than 0.01%.
Contact Person: wong