Applying the DPTE® transfer system to the Flow Sciences Glovebox Workstation


Glovebox Workstation with RTP

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure. Rather, the product is intermittently contained between Point A (enclosure) and Point B (another enclosure or otherwise contained atmosphere). In this scenario, Flow Sciences designed an enclosure featuring a Getinge La Calhene DPTE® Alpha Rapid Transfer Port (RTP).

 

Background information regarding the client’s process and equipment was provided, which affected the decision-making process leading up to the engineering design of the enclosure. This includes a discussion on engineering decisions and development of design, level of containment, verification testing, and an explanation of how the Getinge La Calhene Alpha RTP combines with a transport capsule to yield leak-free containment during transport.

 

A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. Internal policy stipulated that the operator’s 8-hour respiratory exposure concentration, expressed as an 8-hour Time Weighted Average (TWA), be less than 500 nanograms per cubic meter (<500 ng/m3) in the breathing zone. Consultative discussions revealed to Flow Sciences that the client was using a Mettler analytical balance for weighing operations. Additionally, it was ascertained that the client was utilizing polyethylene DPTE® Beta Capsules (DPTE® PE Container) in other parts of the facility. The Beta containers were being used for safe transfer of cytotoxic product from one contained work area to a distant other.

 

When the basis of the design was submitted to the Flow Sciences design team, it was decided that the enclosure could be designed to include a Getinge La Calhene Alpha port to coincide with the Beta containers that the client already owned.  As a result, the enclosure incorporated a 24” x 14” Inlet HEPA and 24” x 14” Dual-HEPA Top – Mount fan / filter housing used in conjunction to create lateral, laminar flow across the work surface.  After air is captured by the inlet HEPA filter, the negative pressure top-mounted fan causes the air to slowly move laterally across the workspace. As a result, the statistical interferences of cross-contamination and product loss are attenuated.

 

When implemented into its practical environment, the enclosure seamlessly integrated into the client’s process flow.  After product was weighed, it was containerized for transport.  Even while containerized, an inherent exposure hazard still existed in the event of a catastrophic spill event during transport. Containment during product transport is yielded synergistically by the combination of the Alpha and Beta Rapid Transfer Ports, thereby serving as an engineering control for this hazard.  The client possessed DPTE® PE [Beta] Containers.  Now, as a result of the incorporation of an Alpha port on the side of the enclosure, operators were able to safely insert weighed product into the Beta Container by performing the following steps in chronological order:









In Flow Sciences’ in-house laboratory, the enclosure was tested in accordance with ISO 14644-1 – ISO Class 5 for particles ≥0.3µm/m3. The average result was 2,276 particles with a diameter greater than or equal to 0.3 micrometers per cubic meter air (2,276 particles with diameter ≥0.3 µm per cubic meter air). Additionally, the enclosure provided personnel protection through its negative-pressure containment design and four (4) 10” oval glove ports on the front of the unit. Specifically, “personnel protection” entails employee protection from exposure via the respiratory and dermal routes of exposure. Similar enclosure models in the Flow Sciences Glovebox Workstation (GBWS) series were evaluated internally using surrogate powder testing. During this test, lactose powder was manipulated into the interior of the enclosure while three operators performed operations similar to that of its real-world application. Air samples were taken in the breathing zone of the operator and in several locations throughout the Flow Sciences laboratory. Upon interpretation of the exposure data, Flow Sciences validated that the GBWS series contained down to a respiratory exposure concentration of 30 nanograms per cubic meter (30 ng/m3), expressed as an 8-hour Time Weighted Average (TWA). Compared to the Occupational Exposure Limit (OEL) stipulated by the customer (<500 ng/m3), the validated containment level is sixteen-times (16x) lower; or 6% of the stipulated OEL.

 

The GBWS is capable of containing today’s most toxic powder substances and the operations that involve them. Ray Ryan, Founder and President of FSI states “Flow Sciences is a solution based company. Sometimes we have the solution on our shelves, but most of the time we have to develop a solution to fulfill a particular industry need”.  This case study serves as a prime example of a project where Flow Sciences used a recently developed containment device and augmented it to fit the specific needs of the client. In this case, Flow Sciences fulfilled a need for temporary mobile containment of HPAPI product through the incorporation of the Getinge La Calhene Rapid Transfer Port system.


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  • What is being done inside of the enclosure? What type of material (powder, liquid, gas, nuisance odor) is being worked with? How does the material enter and exit the enclosure system? etc...
  • What type of filtration is required? Single HEPA, Dual HEPA, Carbon, House Exhaust, etc... What is the required OEL (Occupational Exposure Limit) for the process, or any other details about containment goals? What is the quantity of powder or liquid, task duration, composition of powder, etc...?
  • What equipment is being worked with? What is the equipment model, size, scope, function, and any other information that will affect the design of the enclosure, including movement, heat output, etc...? *State the specific equipment make and model if available*
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    • Are there any additional notes or information that should be considered? Are there any special design requirements?