Isolator

Background
The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products (NYLMP) in the Office of Regulatory Science (ORS), Office of Medical Products and Specialty Lab Operations (OMPSLO), located at 158-15 Liberty Avenue, Jamaica, NY, 11433, is experiencing significant growth in the demand for sterility testing.

To maintain high standards of quality and meet accreditation requirements, there is a recognized need to enhance NYLMP’s infrastructure by incorporating isolators. This acquisition aims to alleviate current resource strains and enhance analytical capabilities in sterility analysis.

Work Details
The contract requires the provision of one isolator designed to support sterility analysis processes within NYLMP. The isolator must meet the following specifications:
- Modular rigid-wall with fast bio-decontamination solutions
- Full traceability compliant with FDA 21 CFR Part 11
- Upwards opening door with optional transfer hatch and main chamber
- Validated process control providing connectivity and traceability
- Safe access to the chamber and hatch
- (1) 4 glove Isoflex-UDAF 110V/UL Siemens PLC/Win 10 panel PC HMI in English
- Integrated H2O2 generator
- Bio decontamination hatch on LH side with internal basket and 2 shelves
- Openable glass window with inflatable gasket
- Sleeve extenders for biodecontamination with finger separators
- Hanging bars with hooks
- Removable drain on clamp for liquid filtrate
- Modular shelving with 4x4 baskets
- DPTE-XS 190 on base for waste, with false container
- Fully integrated glove leak tester with wifi plug, charging station, self-test features
- Millipore Symbio US pump with foot pedal, supply and integration
- MAS100-ISO NT active air sampler supply and integration
- Integrated low concentration H2O2 sensor for operator safety; high concentration H2O2 sensor for hatch/workstation; additional low concentration sensor for hatch/workstation; 316L on RH side wall for future DPTE=XS 190; H2O2 catalytic converter; documentation package in English; preparation/packing in wooden box for sea freight including disconnection of the hatch; GAMPS documentation package in English; capable of producing vaporized hydrogen peroxide for decontaminating work surfaces by a minimum of a 6 log reduction of spores. Comprehensive user manuals and training for at least four personnel using the isolators are also required.

Place of Performance
158-15 Liberty Avenue, Jamaica, NY, 11433