Equipment Performance and Conformance Standards.
All Isolation Systems Inc. Products Meet or Exceed The Following Standards.
- All Applicable ISO Standards and Guidelines
- Federal Standard 209E
- ASHRAE applications Hand Book Sec-16
- MIL Std-1425A
- AF Tech Order-T.O.00-25-203
- Current CGMP Standards
- AABC National Standards
- Nano Containment Isolation per development guidelines
- SEMPACS Developing Guide Lines
- OEL Conformance Testing for Levels–1,2,3,4,5 as required
- EC Guide for Manufacture of Sterile Medicinal Products ANNEX-1
SYSTEM/AREA CLASSIFICATION CONFIGURATOR
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