Reducing Classified Space with Novel Science
As common as they are in industries ranging from biology to pharmaceuticals to semiconductors, glove boxes are unique among lab equipment in that they have not been “dumbed down.”
That, says Bob Applequist, product manager at Labconco (Kansas City, MO), is because of the nature of processes that go on inside, and the skills required to keep product and operator safe. “Glove boxes are hands-on devices. There’s no such thing as a glove box with pushbutton operation.” Users must be proficient not only in glove box operation and cleaning, but in the processes happening within the unit.
One application, in pharmaceuticals, is illustrative. “Nobody knows the toxicity or hazard for many potent, investigational drugs,” Applequist says. Yet lab workers are faced with the task of manipulating these materials through weighing, diluting, dispensing, mixing, etc. Here, glove boxes combine function (work space) with a high level of safety. For this application, the enclosures would incorporate HEPA (high-efficiency particulate arresting) or ULPA (ultra-low penetration air) filters and negative pressure.
Not routine science
Operating and cleaning glove boxes requires that customers know the physics and chemistry of their sample. “That is why glove box processes tend to be novel as opposed to rote science,” Applequist adds. Operators tend to be skilled not only in operating the glove box, but in what’s happening inside. “You can’t go to a cookbook and find a method for what you need to do. You or your lab manager are the ones who must develop the methodology.”
This makes purchase decisions somewhat more difficult than for other safety equipment. Managers must take a deep, hard look at their process: How much oxygen will it tolerate? Positive or negative pressure? How closely to document conditions?
“It’s the things you don’t know that will get you,” says Applequist. “There’s often no literature to guide you, so you must often sit down as a group to decide how much you know about your application.”
The 2012 meningitis outbreak traced to contaminated injectible drugs produced at a Massachusetts compounding lab has spurred regulators and state pharmacy boards to re-examine U.S. Pharmacopeia (USP) guidelines for microbial contamination at these facilities. The operative guidelines, USP , call for strict measures to prevent contamination of liquid, injectible drugs during manipulation. Central to adherence are glove boxes.
“As regulators were investigating this tragedy, we saw an uptick in sales,” says Mike Buckwalter, publications director at Terra Universal (Fullerton, CA). Other areas of growth, according to Buckwalter, are anaerobic (zerooxygen) and hypoxic (low-oxygen) environment glove boxes. Complying with USP guidelines for sterile preparation leads to one of two possible paths. One employs installing a biosafety cabinet or a filtered laminar flow bench inside a two-zone clean room. The problem is clean rooms are expensive to purchase and run, and gowning requirements open up too many avenues for lax technique.
“Glove boxes are a more popular, practical solution,” Buckwalter says. “They’re more restrictive in terms of work area, but they can duplicate clean room functionality and are much less expensive.” For example, a glove box can contain an antechamber that serves similarly to a gowning or entry chamber for a clean room. “Think of it as a mini clean room.”
For additional resources on Glove Boxes, including useful articles and a list of manufacturers, visit www.labmanager.com/glove-boxes