Thermo Scientific™ GLP Compliance Services for Biological Safety Cabinets

Supplier:  Thermo Scientific™ IOQPCKE89003610

Catalog No. 13-262-242

Description

IQ 

• Unpacking, Assembly and Installation Verifies that the equipment, manuals, supplies and any other accessories arrived undamaged as specified in the sales order. Verifies equipment is assembled and installed and any initial diagnostics tests have been performed. Any abnormal event(s) observed during assembly and installation have been documented.
• Utility, Facility and Environment Verifies that the installation site satisfactorily meets manufacturer-specified environmental requirements.

OQ

• System Component Information Detailed configuration information for each system component have been recorded.
• OQ Limits: Record a list of manufacturer recommended limits for ensuring that the system is operating as expected.
• Equipment Operational Tests and Results: Test important equipment functions to verify that the equipment operates as intended by the manufacturer and required by the user. This is a group of selected important equipment parameters for testing according to the intended use of the equipment.

- Key Tests: Filter leakage, Air Velocity, Electrical Safety, Air-Flow Smoke Pattern, KI-DISCUS.

Specifications

• For Use With (Equipment): Thermo Scientific Biological Safety Cabinets and Clean Benches including Thermo Scientific: MaxiSafe 2020, HeraSafe, SAFE 2020, 1500-series A2, 1300-series A2
• Product Type: GLP Documentation and Services for Biological Safety Cabinets
• Includes: Includes travel to major metropolitan areas. Does not include Installation. Instrument must be installed powered up and set temperature point for 24 hours before on-site service.

• Description: Validation (IQ/OQ) includes a standardized protocol procedure, IQ: Verify Installation and environmental conditions, OQ: Verify operation to design specification, Filter leakage, Air Velocity, Electrical Safety, Air-Flow Smoke Pattern, KI-DISCUS testing.
• Location: Contact your local sales representative for a list of standard and extended coverage areas.