Landry Engineering Xience V Mixing System. Used for mixing the Drug Eluding coating for Coronary Stents.
This was a custom built unit by Landry Engineering out of Fair Oaks in 2005. Minimal Trial runs were done and the unit was put in storage. It may be able to be repurposed for other applications.
Guidant Xience V Mixing unit custom made in 2005 by Landry Engineering Development. Unit powers on and comes with everything in the pictures. Please inquire for more information.
Per Landry engineers: This is a formulation mixing system designed to make a formulation and a placebo (no active ingredient in it). The mixture consists of two solvents and two solids. Solvents were acetone and cyclohexanone. Solids were pelletized pvdf (2nd cousin to teflon) and powdered api (active pharmaceutical ingredient). End product is drug eluding paint/coating. Once mixture is dissolved, it can be sprayed on something and the solvents evaporate, while the api is embedded throughout the plastic or item being coated. It was designed for drug eluding stints.
According to Landry, a formulation with 2 solvents, a plastic, and an api is not uncommon in the biopharma business. This machine is designed specifically for particular ratios of these solvents (includes 3 different batch sizes: 5, 10, and 15L reservoirs) – on left facing machine are stainless steel spools of different height (4 and 6″ diameter for the two solvents). Can achieve accuracy of 0.5% by weight for the solvents; this needs to be reset per batch to maintain accuracy.
Another feature is the capability to mix the formulation in a low oxygen environment. Solids needed to be added after mixing tank was filled with solvents for good mixing, but system was sealed and purged of oxygen prior to solvent coming in and it does not require opening up the unit to add solids. The special solid carriers are in the mix tank and not dropped until they are actuated by an external key to keep actuation without breaching the seal (vacuum). The carriers also make sure that as the liquid is filling the tank, they do not trap any bubbles, and as liquid is being drained, it drains completely and does not retain any puddles.
Once batch is mixed, then it is transferred to the batch vessel and because the two solvents had willingness to evaporate (differing by 100 times), the process had to limit exposure to air space to minimize evaporation (i.e. controlled evaporation is part of the design). Batch vessel is pressurized and is a special type of chemical packaging to keep chemicals clean (similar to a teflon bag in a steel can). To avoid evaporation, that bag is cycle purged (vacuum to remove air and introduce nitrogen to reduce oxygen levels), then bag is collapsed so it holds nearly nothing. Formulation is pressure injected into this to avoid evaporation. Now the formulation batch is in the batch vessel, above that is the filling drawer, which is a bag in a plastic bottle container (~1L), driven with pressure to use bottle in drawer then it is taken to a sprayer to coat the stints.