Support Areas

gowning room

Gowning Rooms

The facility is divided into 3 different suites with 3 separate Grade D Gowning Rooms.  Gowning Room A leads to Processing Rooms 1, 2 and 3.  Gowning Room B leads to Processing Rooms 4 and 5 and Gowning Room C to Processing Room 6.  Staff are qualified for sterile gowning prior to being authorized to work in the cleanrooms.  

Intermediate Entry Rooms

These Grade C rooms are designed as material storage rooms within the GMP area. Staff enter these rooms from the Gowning Room. The room contains refrigerators, freezers and ultra-low freezers designated for each processing room allowing storage of consumable items previously inspected and released for use by the Quality Assurance department.

Airlocks

Each Processing Room is entered through an "airlock in" and exited through an "airlock out" to maintain a unidirectional flow of personnel, materials and waste.  The airlocks are classified as Grade B.

Intermediate Exit Rooms

These room is entered through the airlocks located between the processing room and the exit room. Staff enter the degowning room from this room.

The Intermediate Exit Room supporting cleanrooms 1 - 5 contains liquid nitrogen dewars and a controlled rate freezer.

Waste Processing Room

Waste is passed from the Intermediate Exit Rooms to the Waste Processing Room through a cart pass-through. The Waste Processing Room is equipped with an autoclave that is used to decontaminate all waste generated in the facility.

Supply Room

A large central supply room equipped with refrigerators and freezers as well as a separate quarantine area is used to store supplies and materials for the facility.  Refrigerators and freezers are monitored and alarmed 24/7 via a Facility Monitoring System.

File Room

GMP records are stored in fireproof cabinets in a secure and dedicated file room.

Material Preparatory Room

This room is used to sterilize materials and apparatus and is equipped with the following equipment: GMP autoclave, plasma sterilization unit, glassware washer, depyrogenation oven.