Potent Compound Pharmaceutical Containment Isolator
Isolation Systems Glove Box Barrier Isolation Systems provide the highest levels of isolation and containment ensuring operator or product protection meeting current Operator Exposure Containment B and Levels 4 & 5.
All isolators operate at FS209E Class 100/10 (ISO Level 5/4) through the utilization of double HEPA filtration 99.99% eff at .3 microns or Class 10 (ISO Level 4 ) utilizing ULPA filtration 99.9995% eff @ .12 microns at increased air volume displacement. All filter seals to housings are Knife Edge to Gel Seal to prevent air bypass. Air flow patterns within these enclosures are engineered specifically to customer requirements. Isolation Systems Inc. has successfully designed and engineered Barrier Isolation Glove Boxes for, Potent Compound Containment, Sterility Testing, Aseptic Filling, Fine Powder Containment and Transfer, Class III Bio level 4 and Radiological containment requirements. All Glove Box Isolators can be configured for Both Positive or Negative pressure operation as well as Closed Loop Re-circulating or Laminar Flow performance standards. NEMA 7 & 9 Explosion Proof Class-1 Div-1 construction is also available.
All Isolation Systems Inc. Barrier Isolation equipment is put through rigorous in house testing prior to certification and validation to assure seal integrity and performance criteria. Testing methods specific to containment criteria include, Pressure Decay @ Positive 3"wg, Gas Leak Detection utilizing Ammonia, Helium, or Sulfur Hexafloride and Ultra Sound Leak detection.
Air Volume and Flow performance is tested via Hot Wire Anemometer readings taken at intake and discharge sides of filters. Internal chamber cleanliness levels are validated utilizing Met One particle size analyzer to .3 microns per IES-22 and FS209E. Further OEL testing can be provided by Board Certified Industrial Hygienist per NSF standards and requirements.