Isolator Validation

Flexible film and rigid isolators are becoming the preferred method for the manufacturing of sterile pharmaceuticals. They provide a physical barrier to protect both the product and the operator. Unless containment is required isolators are kept at positive pressure to ensure only filtered air enters the chamber and maintains a high air quality.

Experience
QA TECH  staff are experienced in the validation of Isolators. We understand the requirement of the relevant standards and guidelines for all isolator types.


QA TECH staff are experienced in the validation of Isolators. We understand the requirement of the relevant standards and guidelines for all isolator types.

We are experienced in the validation of many manufactures of safety cabinets.
We are able to assist in the qualification of all types of isolators. We can provide operational resources and assistance with the generation of User Requirement Specifications (URS), Fatctory acceptance test (FAT), site acceptance test (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

QA TECH staff are experienced in carriying out Isolators OEL test