B2 lubricity coating: A cleaner more efficient coating
Elastomeric components used for pharmaceutical primary packaging are naturally sticky. Applying lubricity coatings reduces the coefficient of friction improving break loose extrusion and insertion force, as well as overall machinability.
A clean silicone treatment
B2-Coating is a cross-linkable high molecular weight polydimethylsiloxane applied to the surface of rubber stoppers and syringe components and eliminates the need for conventional siliconization.
The benefits of B2-Coating
- B2-Coating can reduce visible and subvisible particulate matter.
- B2-Coating provides enhanced machinability; as a result, customers have experienced increased line speeds.
- There is negligible transfer of silicone oil particles into the solution, even after terminal sterilization.
- The reproducible amount of fixed silicone on the surface ensures the lubricity of treated stoppers.
- B2-Coating can be applied at various levels on the top and bottom surfaces of stoppers, providing the optimal degree of coating, especially for the drug contact side.
A patented B2-Coating application process ensures a controlled coating on each stopper; the coating can be applied in one of three levels.
Low potential for visible and subvisible particle release
Because of inherent B2-Coating properties and controlled manufacturing conditions for B2-Coating, the potential for release of subvisible particles is extremely low, as shown on Chart 1.
The standard B2-Coating product line is tested to ISO 8871:1990/Amend.I: 1995(E) standards for “Determination of subvisible Particles on Elastomeric Parts (Annex P only).” This method determines the release of particles having dimensions of 25 µm or smaller into liquid pharmaceutical preparations.
B2-Coated products produce lower extractables
B2-Coating is extremely low in extractable silicone oil species compared with conventional siliconized products. To demonstrate this key benefit, extractions in aqueous solutions were performed at pH 2, 7 and 10 under conditions of terminal sterilization. B2-44, the maximum coating level, was used in testing.
Using liquid-liquid extraction techniques developed by West, final solutions were Aqueous Extraction of Silicone Oil analyzed by atomic absorption spectroscopy (AA) to determine quantitatively the level of extractable silicone oil
The data illustrated on Chart 2 shows the significant reduction of extractable oil for B2-Coated closures compared with conventional siliconization at different pH levels.
For an even cleaner alternative, B2 can be combined with Westar® processing to deliver a ready-to-sterilize product to your facility.
Global market and regulatory acceptance
B2-Coated products are widely used by global pharmaceutical customers in all of the major market areas of Europe, Japan and the United States. B2-Coating is filed in a Drug Master File with the United States Food and Drug Administration and with Health Canada.
Contact your West representative to learn how you can put B2-Coating to work for you.
B2-Coating technology is licensed from Daikyo Seiko, Ltd.