Outgassing

Barbara Kanegsberg and Ed Kanegsberg, June 2005


IN OUTGASSING, ONE OR MORE VAPOR PHASE CONTAMINANTS
that have been trapped in a product or component are released. At first glance, this might seem like a non-problem. After all, if a contaminant is adsorbed into the materials of construction and then released, the product becomes cleaner as outgassing progresses. In that sense, one might think of outgassing as the obverse of airborne molecular contamination (AMC) [1]. However, outgassing itself has the potential for contamination.


Depending on the environment and on the use of the product, outgassing may result in catastrophic product failure. For one thing, the released vapor is not always removed from the vicinity of the component or product. If the component is in a sealed environment, the outgassing chemical may react with other materials of construction, resulting in materials compatibility problems or corrosion. As a general rule, outgassing and reactivity are enhanced as the temperature increases. Decreased pressure also enhances the removal of vapors. Outgassing problems have been observed in sealed navigation systems where solvent residue reacts with a flotation fluid or with metal parts. Outgassing can produce clouding of optics. Avoiding outgassing is essential in deep-space exploration, where the systems must perform reliably over long periods of time and where possibilities for rework are at best problematic. Obviously, one must also minimize outgassing from medical devices.


Whether or not the product is sealed, release of solvents from implantable medical devices is inherently undesirable. During our recent Medtec workshop, we provided an example where a proposed solvent was considered preferable to the currently-used solvent because, under similar conditions, less of the proposed solvent was found to outgas using gas chromatography. An attendee correctly commented that the lower level of solvent was not per se necessarily sufficient to demonstrate acceptability, given the variable differences in toxicity among solvents. This is an important point. Further, one cannot necessarily extrapolate potential impact of outgassing solvents based on toxicity characteristics. Even vapors of mild or relatively safe solvents can exhibit undesirable effects.

While a contaminant has very occasionally been shown to have beneficial effects, it is probably prudent to assume that solvents should be removed to as low a level as possible. It would also probably be prudent to supplement analytical testing with at least in vitro studies, particularly for very critical biomedical applications. By the way, relatively non-volatile (i.e. high boiling point) solvents and water are included in this discussion.


Minimizing outgassing of process solvents involves process control. One aspect is careful selection of the cleaning agent or process agent so that minimal solvent is retained. In addition, removal of the solvent can be expedited by drying, by a process referred to as a bake-out. Often a forced air or vacuum oven is used. Vacuum drying is an important aspect of contamination control, particularly for components with blind holes, complex geometries, or porous surfaces. The drying process itself has to be controlled. The time must be adequate to remove the solvent, with the understanding that absolute solvent removal is impossible. The temperature must be adequately high to coax the solvent away from the part, but not so high as to produce substrate damage. When trying to remove high boiling point solvents or water, more time and higher temperatures are frequently needed. The drying chamber itself must not significantly add to contamination. Contaminants from the drying chamber include particles and vacuum pump oil.

One additional approach might be to clean using the new chemistry, but not make it the last step in the process. After cleaning, the chemistry could be displaced with successive rinse steps using chemistries where there is known historical performance data.


Cleaning solvents are one obvious source of outgassing, but there are others. Incompletely or inappropriately cured adhesives may continue to react. In this case, the outgassing material itself may do damage and in addition, the materials of construction continue to be altered. Further, the complexity of most adhesives makes it difficult to assess potential toxicity issues. The solution is to assure that complete curing has occurred prior to assembling the product or medical device.

Reactive chemicals, reactive processes, and adsorbed chemicals are part of many complex products. Outgassing can be controlled by awareness of the potential problem, careful process design and control, and judicious analytical testing.


Reference:
1 B. Kanegsberg, M Chawla, “Airborne Molecular Contamination (AMC) Parts 1 to 5,” A2C2 Magazine, (January – April, 2001).


Barbara Kanegsberg and Ed Kanegsberg are independent consultants in critical cleaning, precision cleaning, surface preparation, and contamination control. They are the editors of “Handbook for Critical Cleaning,” CRC Press. Contact them at BFK Solutions LLC., 310-459-3614; info@bfksolutions.com; www.bfksolutions.com.

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