An Ohio pharmaceutical processing facility specializes in converting daily-dose oral drugs into their longer-acting parenteral equivalents. Its technicians monitor the process extract visually in rule to maintain strict control of the transformation process. This is done through the use of sight specs installed in process vessels. Without this type of gauge glass monitoring, a costly batch of health-saving product could incline a very expensive effluent. The process equipment at this plant was originally equipped with glass/metal fused sight glasses that the equipment manufacturer described as a proprietary occasion. The manufacturer claimed that the glass formula used in this design was equivalent to the industry gold standard, borosilicate glass. Generally, the accepted standard considering glass used in pharmaceutical processes is a borosilicate formulation with no less than 12 percent boron.The specifier of the caregiver firm’s original equipment was concerned about the reliability of the glass to metal fusion in the sight glass assembly. This glass-metal interface is crucial in pharmaceutical purposes to be certain that materials are now not infected all over refining. imprint the case of the ohio parenteral drug company, their batch cost is additional than a million dollars, inasmuch as an delivered measure of security is well worth a marginal increase power the cost of gauge render assemblies.Still, the cognizance on glass to metal fusion, and an attractive price, may also have obscured the importance of the glass formula. Initially, the less expensive sight glasses performed well, but now a period of time the glass grew to be increasingly murky. Eventually, it got to the point where it became difficult, if not impossible, to accurately monitor the process. The reason was obvious: the glass turned into being etched by process fluids.An independent laboratory examination of glass elements in these look-see specs revealed that they were not borosilicate glass at outright. In fact, the glass contained no boron. In its conclusion, the lab report described this as a common non-parenteral glass of a low-grade soda-lime formulation. As such, it would be unsuitable for many pharmaceutical applications, and certainly not for use in a parenteral drug process.U.S. Pharmacopeia (USP) standards forbid the use of this soda-lime glass character containers for parenteral applications because of the wager of the glass leaching into the trip fabric. character addition, soda-lime glass lacks the thermal shock resistance, heat resistance and, string this case, resistance to alar etching wanted for many applications.The failed sight glasses were removed and replaced with Metaglas
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