For years Dow 365 has been widely used to siliconize glass syringe barrels and rubber stoppers, but now Dow Corning is revising their syringe lubricant formulation. There is a surfactant change and the removal of parabens with the arrival of Dow Corning 366.
Background on the Dow 365 Lubricant Change
Dow Corning® 365, 35% Dimethicone NF Emulsion contains the non-ionic surfactant polyethylene glycol tert-octylphenyl ether, often known by the trade name Triton X-100. Triton X-100 has been added to the REACh (Registration, Evaluation, Authorisation and Restriction of Chemicals) Authorization List administered by the EChA (European Chemical Agency). Dow Corning does not intend to file with EChA for authorization. Effective 04 July 2019, no new applications for such material in the European Union or European Economic Area (EU/EEA) shall occur without EChA authorization. EChA has communicated a sunset date of 04 January 2021 for the surfactant.
In anticipation of such limitations, Dow Corning developed a new material, Dow Corning® 366 35% Dimethicone NF Emulsion, which is similar to Dow Corning 365, 35% Dimethicone NF Emulsion, however with the polyethylene glycol tert-octylphenyl ether replaced by a different surfactant which is not currently a listed substance under REACh. An additional difference is that the Dow Corning 366 35% Dimethicone NF Emulsion formulation does not contain parabens.
Will your injection system need revalidating?
To assist our customers in minimizing risk, ZebraSCI offers material change verification programs. A typical program to assess the impact of the change on pre-filled syringe (PFS) may include break loose & extrusion force confirmation, injection time confirmation, an analysis of sub-visible particle formation and an assessment of inherent integrity. Monitoring functional performance on stability at real time and elevated conditions is also a useful aid. Programs are also available for similar parenteral applications such as cartridges and vials.
ZebraSci’s experienced engineers have been researching silicone’s impact on drug quality & device performance for over a decade. Some of our more specialized analytical services include:
Contact ZebraSci today to learn more about what you can do to prepare for the change.