GMP Manufacturing Facility, cGMP Formulation Development
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NLI has been part of the UBC facilities since its establishment. As a result of significant growth in the last decade and also to help us better service our clients, NLI decided to add a cGMP manufacturing facility. In June 2006, NLI purchased the facility at 8855 Northbrook Court in Burnaby. The building was renovated to accommodate a GMP Manufacturing & Filling area, & Scale-up area, Analytical laboratories, Technical support services and offices.
GMP Manufacturing and Filling Area |
The GMP Manufacturing facility was designed for the production of parenteral drug product and includes separate areas for the following functions:
The GMP manufacturing suite is equipped with a state-of-the-art equipment like an air-ballasted autoclave, depyrogenation oven, horizontal laminar flow hood and cytotoxic glove box. The entire GMP manufacturing facility is under positive pressure relative to the adjoining areas. The environmental conditions within the GMP manufacturing facility, including temperature, humidity, air pressure, and air quality, are monitored by a dedicated system & at regular intervals, to maintain cleanroom conditions. Access to the GMP manufacturing facility is controlled & restricted to authorized personnel. The route for final products is separated from incoming goods and final product is stored in a designated area while awaiting shipment.The facility is also equipped with a cold storage, back-up generator, purified water distribution loop, WFI reservoirs, Glycol heating system, HVAC, Clean compressed air & bottled gases.
- Personnel gowning & entry
- Materials & equipment airlock
- ISO 7 compounding & preparation room
- ISO 6 filling suite
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