18 ANALYTICAL AND LABORATORY EQUIPMENT
Extra protection offered by containment technology
Michelle Frisch highlights the benefits of high containment gloveboxes for laboratories.
C
leanrooms have long been the preferred technology in
pharmaceutical laboratories for providing environmental control when conducting different operations where the product or compound needed protection. But with their increasing potency, the active ingredients and compounds that are developed nowadays require added protection for both the operators and the environment.
Cleanrooms are classified according to the number and size of particles permitted per volume of air. A typical cleanroom is 0.5 micron and this is directly related to the bacterial contamination levels.
Fig. 1. High containment isolator fully enclosed with lower and upper chambers for R&D dispensing and sampling operations.
Along with the classifications come the hypergeometric distribution sampling, utility consumptions and cleaning that has to be validated and repeatable. Cleanroom technology is trying to minimise particulates and maintain a set environmental condition, and other technologies achieve such requirements.
Fig. 2. GFD FilterBox, high containment filtration and drying systems for kilo-laboratories.
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Containment technologies such as the combination of barrier isolation, isolator and glovebox fulfil the above requirement even for laboratory scale. ISPE defines containment technology as a “leak-tight enclosure designed to protect operators from hazardous/potent processes or protect processes from people or detrimental external environments or both.”
Te advantages of such a closed type of enclosure are considerable in comparison to a cleanroom and this approach can offer a great number of benefits. A closed type of enclosure can achieve a set environmental condition that is repeatable and easy to control, such as relative humidity (RH) control with set points, as well as setting and maintaining oxygen levels.
Containment down to the nanogram range Achieving lower ISO class than cleanrooms is also possible, with a containment down to the nanogram range to a non- detectable level thanks to pre- filtered air or nitrogen, HEPA pre filtration and air pressure differential.
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