Case Study #4 – Biopharmaceuticals
Global Pharma Comparative Study with Sensitive Biopharmaceuticals
A study was conducted by the Client that compared syringe performance and drug stability of the following syringe systems:
- (NONE) SiO2 barrier coated syringes with no lubricant and a self-lubricated plunger
- (SILICONE) Glass syringes with silicone oil lubricant
The syringes were filled with the Clients proprietary biopharmaceutical formulations and stored at: (1) 40oC for 3months and (2) 25oC for 6 months.
No subvisible particles larger than 2 microns found in biopharmaceutical formulations packaged in SiO2, lubricant free syringes (NONE) measured by micro flow imaging (MFI).
Self Lubricated Plunger