Prevention of cross-contamination with highly potent active pharmaceutical ingredients (HPAPI) is a crucial part of a safe manufacturing process. Similarly, it is essential for APIs or finished drug products manufacturing companies to ensure the safety of workers and the environment they work in, especially when manufacturing with compounds that require high containment. Inadequate containment can put employees and the environment at increased risk.
To keep employee exposures within acceptable limits and to protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high-containment compounds must carefully select their containment equipment. We have outlined the points to consider when choosing the right containment system.
The properties of basic materials being processed play a key role in choosing the containment system. Occupational Exposure Level (OEL), as well as the physical and chemical properties of the materials, must be considered carefully.
PROCESS FLOW & REVIEW
Document the process flow in detail and conduct a containment review for each step involved in the process including the quantity of material being handled:
- Material IN
- Material OUT
Material transfer from one process step to another process step in a contained manner must be appropriate to OEL level. Decontamination of the entire process (process equipment and containment system)
MATERIAL OF CONSTRUCTION
For Rigid Systems, MOC is SS316 L. The gasket and manipulative device material must be FDA compliant and compatible with molecules being processed. Standard electrical execution is NFLP (non-flame proof). However, FLP execution is recommended for solvents and depending on the characteristics of molecules being handled.
For Flexible Systems, MOC is PU based. Risk assessments determine which manipulative devices and gaskets are utilised. The entire system is intended for single use.
Process equipment integrated with the containment system must also be compatible. A detailed engineering study is performed to ensure airtight integration with the containment system. An ergonomic study is conducted to evaluate the feasibility of each manipulation as well as an evaluation of the decontamination and cleaning process. There must be a seamless integration of mechanical, electrical and control systems of process equipment and the containment system.
An ergonomics study is conducted with a replica of the Containment System. Extensive tests are performed to ensure everything is in line with the actual operations. Once this is completed a final 3D drawing is prepared, and the manufacturing process begins.
Process equipment is validated as per standard protocol. However, for containment systems a combined validation of process equipment and containment system is also conducted including:
- Leak testing of the entire system. (This is a crucial test.)
- Air cleanliness level which includes HEPA integrity testing, velocity profile and particle count
- Sound levels
- Light intensity
- Process equipment interlocking with the containment system
Once the system is commissioned, OEL validation is conducted using surrogate materials to validate the entire system design. This is a one time exercise performed by certified hygiene professionals in close coordination with the end user and results are independently certified for OEL exposure.
Fabtech’s Containment systems can be used for tablet and capsule manufacturing, injectables, APIs and customised solutions. Use the form below to request more information about our Containment Systems.