Sterility Test Glovebox Isolators
Isolation Systems, Inc designs and manufactures custom, GMP aseptic containment, RABS, and isolators.
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Fully welded 10 ga. 316L or 304 stainless steel construction with #4 finish on both exterior and interior surfaces. All welds are ground smooth and polished to matching finish.
Hinged service and equipment introduction lift up front sash with gas cylinder assist.
All interior corner transitions are coved radius.
Pass thru Ante chamber Hinged service and equipment introduction door.
Support frame is 12 ga 3” sq. 316 or 304 stainless steel tube with a brushed #4 finish with leg levelers.
⅜” thick clear laminated safety glass view panel. Potted to structure for enhanced seal integrity.
10”-12” dia. round or oval 316 SS glove ports with compression seal rings.
One piece Hypalon rubber gloves and sleeves.
HEPA or ULPA filtration. Gel seal to chamber.
PLC Controlled VFD Blower speed control.
VHP circulation fan within chamber.
Integrated automatically actuated VHP introduction and extraction circuit.
Sliding tray and internal storage system.
Lighting is LED type
Low pressure audible visual alarm.
Digihelic Differential Pressure Gauge to monitor HEPA & Chamber pressure differential.
PLC control all functions of isolator and gassing cycle.
Power and light switches.
Connections for VHP level monitoring.
Tri-clamp and cap penetrations into main chamber for service connections.
Steritest Equinox Isofit pump.
Hydrophobic HEPA & ULPA filtration.
Security sensor for VHP High & Low Levels.
Integrated VHP circuit.
In Lab VHP security monitoring system.
Sterisart NF Sartorius.
VHP cycle development & PQ.
Humidity and temperature sensor.
Paperless data recorder.
Rapid decontamination chamber.
Air flow sensor.
Hydraulic Height adjustment.
Automated or Manual control valves.
On board Glove Integrity Tester.
Complies with AGS-G001 guidelines for glove box standards.
All stainless steel materials used in the construction of this equipment conforms to AISI and SAE standards.
All filters are PSL challenged at factory to insure media integrity. Certificates of conformance are available upon request.
System performance meets or exceeds standards as specified in Fed. Std. 209E for Class 100 /ISO-5 conditions and IES-RP-CC-002.
USP 795, 797 & 800 ,compliant
All electrical wiring is in conformance with NEMA standards.
All sealants and gaskets used in the construction of this equipment are FDA approved.
Complete test procedures and protocols available upon request.
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