Equipment Performance and Conformance Standards.

All Isolation Systems Inc. Products Meet or Exceed The Following Standards.
 

  1. All Applicable ISO Standards and Guidelines
  2. Federal Standard 209E    
  3. IEST-RP-CC-002.2
  4. IEST-RP-CC-006.3
  5. IEST-RP-CC-006-84T
  6. NSF/ANSI
  7. ASHRAE applications Hand Book Sec-16
  8. MIL Std-1425A
  9. AGS-G001
  10. AF Tech Order-T.O.00-25-203
  11. Current CGMP Standards
  12. AABC National Standards
  13. Nano Containment Isolation per development guidelines
  14. SEMPACS Developing Guide Lines
  15. OEL Conformance Testing for Levels–1,2,3,4,5 as required 
  16. USP-797
  17. EC Guide for Manufacture of Sterile Medicinal Products ANNEX-1
  18. NIOSH
  19. OSHA

 

SYSTEM/AREA CLASSIFICATION CONFIGURATOR

AREA CLASSIFICATIONS

Operator Exposure



Note: All Operator Exposure Level Testing (OEL) is performed by A Board Certified Industrial Hygienist or Scientist.                     
 
All Steel And Stainless Steel Materials used in the construction of our products and equipment conforms to: (1) AISI  (2) SAE
 
All electrical wiring is in conformance with the NEC & NEMA standards.
 
All sealants and gaskets used in the construction of our equipment made from FDA Listed Ingredients per Title 21 part 177.2600, Rubber articles intended for repeated use and NSF standard No. 51
                                  
  


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