Discussing E&L Study Design Between ISO and USP (AAPS PharmSci 360)

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Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.


Speaking with Pharmaceutical Technology® at AAPS PharmSci 360, Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, summarizes some of the points in her presentation at the conference, mainly about the differences and similarities between extractables and leachables (E&L) study design between ISO and USP standards.

For instance, she points out that for E&L studies being conducted on medical devices, then the standards from ISO 10993-18 for the chemical characterization of medical devices, whereas E&L studies being done on pharmaceuticals will typically follow USP <1663>/<1664> guidance for pharmaceutical packaging, such as the finished packaging/container closure system, and USP <665>/<1665> for the pharmaceutical manufacturing component.

The major difference between the two, she emphasizes, is that there are different extractables that may be tested. For instance, for a medical device, ”you might need to do an exhaust extraction for implants, while, for the pharmaceutical, you don't really need to do that,” Lu states. In addition, a different type of solvent may be used on a medical device, such as some harsher solvents (e.g., hexane, isopropanol, etc.).

However, in terms of analytical testing between ISO and USP, Lu says that they are similar, such as gas chromatography with mass spectrometry (GC–MS).“There is GC–MS for volatiles; there is direct injection GC–MS for semi volatiles, LC–MS [liquid chromatography with mass spectrometry] for the nonvolatiles, and the ICP–MS [inductively coupled plasma mass spectrometry] for elemental impurities,” she says.

Lu was featured as a speaker at AAPS PharmSci 360, where she gave a talk, “Regulatory Expectations in Extractables and Leachables Testing of Combination Products.” In her talk, she discussed chemical characterization, per ISO 10993-18, which has become important in biocompatibility testing for medical devices. One of the key points in her talk was on the differences and similarities of E&L study designs between medical devices (based on ISO standards) and drug product ( based on USP standards). She also discussed the need for understanding the recent regulatory expectations on E&L testing of medical devices and combination products.

AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.

View Lu’s video interviews on E&L considerations during formulation and the distinction between E&L testing for combination products vs. conventional drug products.