Documentation, service program and validation are available upon client’s request. The following documentation and supporting services are available for all Clean Air environments and isolators.

• Operating manuals and design drawings.
• User requirements specifications and Project Management.
• Standard Operating Procedures (SOP).
• Validation documentation.
• Validation execution including Installation Qualification (IQ), Design Qualification (DQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Loading analysis for sterility testing.
• Service Program: regular visit (6 months or 1 year) to ensure the proper operation of the unit, replace the parts required and train the personnel.
• Certification.
• Ergonomic Design and mock-up study.

Mock-up (made of wood, acrylic, etc.) of the chosen isolator / RABS unit, can be provided upon client’s request. Such a mock-up will ensure that the ports and accesses will be positioned in a way to permit all needed manipulations.