Potent Compound Isolators
ISI
Isolation Systems, Inc designs and manufactures custom, GMP aseptic containment, RABS, and isolators.
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Standard Features:
Fully welded 10 ga. 304 or 316L 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.
Pass-thru chamber for material introduction.
Hinged service and equipment introduction door A/R.
Support frame is 14 ga 3” sq. 304 stainless steel tube with a brushed #4 finish with leg levelers.
⅜” thick clear Tempered safety glass view panel. Potted to structure for enhanced seal integrity.
10” or 12” dia. Round or Oval stainless steel glove ports with compression seal rings.
One piece Hypalon rubber gloves and sleeves.
Blowers are non sparking low profile backward curved impellers.
Hydrophobic HEPA ULPA Filtration.
“BIBO” Bag in / Bag out HEPA change.
PLC controlled VFD for blower speed modulation.
PLC control w/ A/B HMI, custom programed.
LED Lighting (IP 69 dust tight / vapor tight).
Low pressure audible visual alarm filter load.
Magnehelic / Photohelic /Digihelic gauge to monitor filter & chamber pressurization.
Negative pressure configuration.
Power and light switches.
Tri-clamp and cap penetrations into main chamber for service connections A/R.
FDA approved D-Bulb silicone gasket.
Custom configurations and optional features are available upon customer request & requirement.
Optional Explosion Proof CL-1 Div-1.
Optional on board Glove integrity Tester.
Standard Conformance:
Complies with AGS-G001 guidelines for glove box standards.
All Stainless steel materials used in the construction of this equipment conform to AISI and SAE standards.
All filters are PSL challenged at factory to insure media integrity.
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 OEL-5 NANO Containment Certification Available.
SB Level-4 Nano-Containment Certification available
All electrical wiring is in conformance with NEMA standards.
All sealants & gaskets are FDA approved.
Complete test procedures and protocols available upon request.
UL listed upon request.
Note:
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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