Michelle Frisch highlights the benefits of high containment gloveboxes for laboratories
Cleanrooms 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. 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.
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.”
The 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.
Containment technology also offers easy cleaning with a small area and no floor to wash, which is simple to validate as operations are repeatable. Isolator systems allow the use of solvents for cleaning and can be sterilised to reduce any bacterial contamination. Reduced cross-contamination is also achieved via the elimination of operators within the same environment as the materials.
A closed set-up also makes it more effective and ergonomic to contain the operation instead of wrapping the operators up with full suits and head covers, whilst handling products and instrumentations easily through the glove ports. And improved operator safety is enabled by removing the operator from the same environment as the operation (such as filling) occurs.
Another advantage is that containment technology represents a fully automated system to control all utilities and environmental conditions. As well as this, it offers lower capital expenditure with a greatly reduced footprint – and in many cases containment technology is less expensive than a cleanroom to purchase and install. Overall, such systems offer a lower operating cost with less maintenance but also reduced or even eliminated gowning and de-gowning time.
Isolators also reduce energy costs
One final advantage is that of 35% to 50% lower energy costs as isolators generate less utility consumption thanks to a small space to contain and small air flow capabilities.
Overall the benefits of containment technology provide a much superior sterility assurance and cost savings. With the trend of higher potency and purity of pharmaceutical and biopharmaceutical compounds, containment technology is becoming the norm. Since operators need to limit their exposure to these products, handling operations must be carried out inside the isolator. Using glovebox technology eliminates any possible operator contamination of the compound or process as the operator never has direct contact with the product. This is one of the main advantages of such systems as human interaction is the most difficult parameter to control.
Containment technology has vastly changed over the past five years and these systems can accommodate integrated equipment, providing set environments, operator and product protection for a very competitive investment.
For more information at www.scientistlive.com/eurolab
Michelle Frisch is senior manager, Global Technical Systems at Powder Systems Limited (PSL).