Within this framework of Standard Operating Procedures (SOPs) and Unit Operation Procedures (UOPs) the protection cascade exists of the following four levels:
Level 1: Sealed Processing
Wherever possible, all processes are contained within sealed process envelopes such as reactor systems, and filtration and drying systems. When this is not possible, we consistently apply supplementary contain-ment to ensure the presence of a first level of containment.
Level 2: Containment
Our second level of protection is achieved with our state-of-the-art containment equipment. This equipment enables us to handle highly potent raw materials, intermediates and APIs in liquid or powder form with a specialized dispensing, charging, liquid/solid separation and drying system. All containment systems (glove boxes, rapid transfer ports, endless liner systems) are subject to periodic containment testing.
Level 3: Room and Associated Environment
The infrastructure for our third level of containment applies to the containment facility itself and employs a "building within a building" practice. All operations equipment, supplies and even the building's infrastructure are dedicated to containment activities.
Air locks fully segregate our containment facility from the rest of the building. All utilities such as vacuum, ventilation, and waste disposal systems, are separate from our general systems, and our heating, ventilation and air-conditioning system (HVAC) delivers high-efficiency filtration into and out of the building. Access to the containment facility is restricted to the trained personnel who exclusively work on these projects by a swipe-card entry system. We also have in place a clearly defined, auditable waste management plan and rigorous emergency procedures and plans.
Level 4: Personal Protective Equipment and Occupational Health Monitoring
In case additional safety equipment is needed Personal Protective Equipment (PPE) serves as our final backup at the end of the protection cascade. All employees working in the plant are subject to a health monitoring program.