The basic containment goals to be reached center around affording the operator the optimum protection based on the containment band for the product being processed, maintaining good cGMP conditions, eliminating cross contamination, and reducing cleanup requirements.
Historically, stainless and glass isolators and cross flow booths were the systems of choice for active pharmaceutical powder containment. Containment by isolation solutions involves total process isolation; and, thereby, effectively shields the operator and the remaining process train from powder transfer operations. Although these solutions are acceptable for new construction, they often are challenging to implement in a retrofit situation due to space and process flow considerations.
To provide a viable retrofit solution and eliminate many of the worker ergonomic constraints, flexible film containment solutions have emerged. These tough, film-based products offer engineers many options for adapting to in place equipment while maintaining high levels of powder containment. They serve as engineering controls that permit effective product transfer without the use of Personal Protective Equipment (PPE). They also address the needs for larger volume API transfer without sacrificing containment.
Flexible containment solutions are viable down to containment levels of 1 µg/m3 on an 8-hour time weighted average basis. Other benefits include:
- Low capital expense
- Easily retrofit in confined spaces
- Short lead times
Many pharmaceutical companies around the globe are now employing flexible containment solutions not only at their plants but at those of critical suppliers providing API’s to their manufacturing operation. By shipping API’s in these flexible systems, the material can be loaded readily into the process vessel without costly or time-consuming, on-site transfer operations.
As demands for higher levels of powder containment emerge, another solution available to the process engineer is the use of hybrid approaches – the integration of flexible and stainless designs. Several major pharmaceutical companies have recently installed hybrid solutions involving the use of flexible film systems. Examples of these include:
- Attachment to alpha/beta ports as a make/break mechanism within the isolator
- Use with canisters inside the isolator to allow powder containment within the isolator itself
- Attachment to canisters mounted on the exterior of the isolator for contained transfer of products out of the isolator
This approach provides the benefit of achieving even lower nanogram levels of containment while eliminating many of the cleaning issues associated with normal isolator operation. In addition, higher process yields by containing the powder within the liner are achieved.
As containment challenges arise, the process engineer now has more choices than ever to address them.
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