Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

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Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.


Speaking with BioPharm International® at AAPS PharmSci 360, Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, gave her views on what key extractables and leachables (E&L) issues pharma manufacturers should keep in mind, from a regulatory standpoint, when formulating a pharmaceutical that requires a medical device for drug delivery.

She points out that, for any drug product that uses a device as a drug delivery system, a pharma manufacturer will need to consider extractable/leachable testing for both aspects. “You need to conduct your extractables and leachables study for your container closure system for the drug product, but, on the other hand, you need to work out your extractables and leachables for your drug delivery device,” she says.

That that end, a pharma manufacturer may need to consider the regulations in place for that device and then design its E&L study that is applicable to that portion. “You need to consider both aspects in that case,” Lu recommends.

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 study design between ISO and USP and the distinction between E&L testing for combination products vs. conventional drug products.