Aseptic powder filling is another Bioserv core competency. Our skilled and highly trained technicians are capable of managing unique powder filling procedures, fill tolerances, and special handling requirements during an aseptic powder filling project. Our validated Class 10,000 (Class 7 or Class A) formulation and compounding rooms and Class 100 (Class 5 or Class A) filling hoods and suite ensure that our customer’s products maintain sterility throughout the manufacturing process. In addition, Bioserv conducts all powder filling operations by hand or using precision powder dispensing equipment following validated aseptic powder filling procedures.
Pre-Clinical, Phase I and II Clinical Trial production of complex aseptic liquid formulations
- Process Development
- Final Formulation
- Manual Product Filling using Powder Gun Systems or by hand.
- Documentation Development
Three (3) Fill Suites
- One Class 100 (Class 5 or Class A) Aseptic Suite
- Two Class 10,000 (Class 7 or Class C) Clean Rooms
- Small Molecules
- Cytotoxics (up to Safebridge Level 2)
- Contact Bioserv
- Phone: (858) 450-3123