Lyophilizer Tray Transfer & Mill/Charge Isolator
Isolation Systems, Inc designs and manufactures custom, GMP aseptic containment, RABS, and isolators.
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Available in Single or Dual Chamber with Antechamber
Fully welded 10 ga. 316 or 304 stainless steel construction with #4 finish on both exterior and interior surfaces. All welds are ground smooth and polished to matching finish.
All interior corner transitions are coved for ease of cleaning.
Hinged service and equipment introduction lift up front sash with gas cylinder assist.
Support frame is 14 ga 2” sq. 304 stainless steel tube with a brushed #4 finish with sanitary leg levelers.
Ergonomic hydraulic lift system.
⅜” thick clear laminated safety glass view panel. Potted to structure for enhanced seal integrity.
Dual Hydrophobic ULPA Filtration.
10” dia. round Stainless Steel glove ports with compression seal rings.
One piece Hypalon coated rubber gloves and sleeves.
Lighting is vapor-tight LED type Illuminated power and light switches.
Tri-clamp and cap penetrations into main chamber for service connections A/R.
FDA approved D-Bulb silicone gasket.
PLC & HMI Integration with FMS/BMS connection.
Automated gas control system.
Butterfly Valve flow control.
Flow Meters and Regulation A/R.
Humidity & Temperature monitors A/R.
Alarm Systems A/R.
Optional Negative or Positive Pressure Configurations.
Optional Automated purge cycle.
Optional Oxygen sensor with Alarm.
Optional Material transfer trolley.
Additional options as required
Cl-1 Div-1, Cl-1 Div-2, Cl-2 Div 1
Optional 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
Containment band level 4.
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.
All Isolation Systems, Inc. isolators are designed, engineered and manufactured to the highest standards, fully utilizing state of the art design and manufacturing processes. Complete as built drawings are submitted to our customers for their approval prior to manufacturing to assure total compliance with their requirements and specifications. Upon completion each isolator is fully tested for seal integrity and performance. A complete installation, operation and maintenance manual is provided including all test and certification reports, electrical and control schematics, certified final drawings, replacement parts lists, and component specification sheets, sufficient to compile your IQ’S, OQ’S and SOP’S. Isolator testing and validation protocols and procedures are available for your review upon request.
Thank you for considering Isolation Systems, Inc. for your containment equipment needs.
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