The OncoGenerix facility is purposefully designed to be multi product and can handle the a range of product types, including:
- Solution/Suspension Products
- Lyophilized Products
- Cytotoxic/Potent Products
- Nano Products
- Cold Chain Products (2C to 8C)
To allow this flexibility while achieving enhanced sterility assurance, bioburden and endotoxin control, effective cleaning and contamination control the facility incorporates the following key features:
Enhanced Sterility Assurance:
- All manufacturing steps are undertaken within isolator systems.
- All transfers into the isolator system are undertaken using closed transfer systems.
- Integrated environmental monitoring systems (viable & non viable) in the isolator system
- Automation to minimize personnel intervention with the process
Bioburden & Endotoxin Control:
- Single use pre-sterilized equipment
- Pre-sterilized equipment and utensils
- Stringent personnel gowning requirements
- Hi level of clean room finishes to ensure effective cleaning and sanitization.
The facility is provided with the following fully segregated unit operations with single pass air systems (other than the final packaging area):
- Formulation equipment GMP cleaning/prep
- Formulation equipment decontamination
- Filling equipment GMP cleaning/prep
- Filling (solution & lyophilized product)
- Filling equipment decontamination
- Vial inspection & packaging
- Vial inspection & packaging equipment decontamination
- All unit operations are laid out to ensure unidirectional flows
- Gowning to GMP areas with secondary gowning to GMP areas with product exposed –
- High quality seamless surface finishes in all GMP areas to allow effective cleaning
- Single use systems for all product contact parts:
- API & buffer formulation vessels
- Product fluid path/filter assembly
- Filling needles/filling tubing/filling surge vessel
The facility & technology work together to enable the following containment strategy:
- Primary level containment: primary level of containment is provided by maintaining the product within the product pathway (i.e., the formulation vessel & fluid path) with the filling needles designed to minimize aerosoling of product.
- Secondary level containment: secondary level containment is provided by the isolator system in the event of a vial breakage or product spill within the isolator system
- Tertiary level containment: tertiary level containment is provided by the room space in the event the product is released from the isolator.