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Potent Processing on Antiquated Equipment Image 1

Potent Processing on Antiquated Equipment

Challenge from the Client

Due to a business need and a lack of capacity in the company’s adjacent potent suites, our client needed to manufacture Band 3b potent materials in their existing areas on legacy equipment where these operations were not originally intended.

The client's facility operated based on a clean corridor premise. The clean corridors and processing rooms were supplied with the same grade of air, and the process rooms were negative to the corridor. This prevents particulate/contaminates from egressing into the clean corridor. The majority of processing rooms were not equipped with airlocks.

 

Classification

Occupational Exposure Levels (µg/m3)

 

 

 

 

 

Band Categories

Band 5

Band 4

Band 3b

Band 3a

Band 2

Band 1

Band Levels

< 0.1

0.1 to <1

1 to <10

10 to <100

100 to <1000

≥ 1000

Our Approach & Solution

Our team evaluated the industrial hygiene data near related processes, design, and processes associated with fluid bed processing (including granulation), compression, and coating to provide a gap assessment of the operations and provide a risk analysis with potential options to mitigate risk and enhance containment at designated locations and during specific operations.

Industrial Hygiene data had been collected near various locations associated with Fluid Bed, Compression and Coating operations in the manufacturing area to determine what operations/procedures result in higher exposures.  

IPS evaluated the high risk areas and developed a series of mitigation methods (engineering controls, and operating procedures) to prevent risk to the operators.

The Results

IPS designed a flexible glovebag isolator solution to retrofit around the existing granulator, as well as several single-use closed connections at various other make/break points throughout the manufacturing process. IPS utilized local ventilation to provide secondary containment in specific areas of higher risk.

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