Large scale containment

BL2-Large Scale
• = BL1-Large Scale +:
• Anything >10 L must be in a closed system; smaller
cultures (seeding etc…) can be handled outside a closed
system provided all BL2 physical containment
requirements are met
• Rotating seals of a closed system designed to prevent
leakage of viable organisms (e.g. double mechanichal
seal with steam circulation)
• Sensing devices to monitor integrity of containment
during operations
• Closed system integrity testing: prior to usage and after
replacement or modification of containment features;
Procedures for testing appropriate to the equipment
design (e.g. supplier’s specs);