Finding a solution to provide personnel protection when working with Highly Potent Active Pharmaceutical Ingredients (HPAPI) is very tricky. In a business sector where regulations and policies are prevalent, exposure control options are limiting; both physically and financially. Laboratory operations require unwavering precision and physical/financial limitations cannot be avoided in many cases. The information below describes a situation where a containment solution was designed for a benchtop vacuum oven process.
Flow Sciences’ sales process begins by ascertaining information regarding the client’s process and equipment they wish to contain and enclose. From there, proactive and reactive engineering design measures are made in accordance with customer stipulations. The overall purpose of this article is to educate the reader on Flow Sciences’ Discovery process and how it resulted in a containment solution.
The Memmert VO 200 Vacuum Oven Enclosure was designed to enclose a pharmaceutical vacuum oven drying process for use of the Memmert VO 200 Vacuum Oven. The client stipulated a maximum respiratory concentration of 1 microgram powder per cubic meter air (<1 ug/m3). Flow Sciences collaborated with a distributor to create a Single HEPA-filtrated enclosure with a cutout on the interior left side. Flow Sciences included the cutout on the left side so the oven is able to be connected.
With this design, the operator is able to open the oven door without worrying about hitting anything. This facet of design allows the operator copious space to manipulate product before and after processing. The added ergonomics yield industry-leading utility of space. The additional space increases operator comfort which can improve work quality.
Let’s address another worry: high temperature. Opening the oven will not negatively impact the integrity of the enclosure’s structure. The phenolic base is more than capable of withstanding the temperature of the outflowing air when the oven door opened. Phenolic doesn’t even begin to thermally decompose until it reaches a temperature of 220 degrees (Fahrenheit) itself. When considering the cooling effect of the fan drawing the heat upwards and the time it takes for phenolic to thermally equalize, there is no room for apprehension in this respect. Additionally, the enclosure features a removable draft shield, which offers the operator protection from dermal exposure with butyl or CSM gloves and the option to complete the operation with open face containment.
Before the design was finalized, a nonfunctional mockup of the unit was constructed and evaluated by the client at their facility. FSI added the oven “mating” feature to the enclosure design after the client stated that were interested enclosing the sample preparation portion of the operation as well as insertion/removal of product into and from the oven.
Factory Acceptance Testing (FAT) was performed on the enclosure shortly before shipment to the client. FAT testing included ASHRAE 110 testing protocols with the draft shield on and face the enclosure face.