BioStem excels at validated aseptic fill/finish processes to meet client needs as either the last step of an extended production campaign or as a stand-alone fill project. BioStem provides you with a packaged final product that meets regulatory requirements, specifically providing all necessary fill process documentation and final product testing data. At BioStem, aseptic fill projects are conducted by an experienced staff that includes quality control oversight of environmental monitoring, personnel monitoring, and final product labeling and inspection.
Aseptic Fill Specifics
Vial lot size ranges between hundreds of units up to 2,000 vials
Bag lot size varies depending on specific client requirements
Semi-automated vial dispensing and capping system
Final product aseptically dispensed with or without terminal sterile filtration
Final product sterilization in vials (steam sterilization or gamma irradiation) is available
Unique custom fills are available and require technology transfer and process qualification
Packaging Formats
Choice of vials available include Type I borosilicate glass vials and plastic vials (PETG, PP)
Cryocyte® freezer bags in aluminum cassettes available for large format cell packaging
Choice of standard 13 mm and 20 mm FO/FOTO (Flip Off / Flip Off Tear Off) tamper evident seals
Vials, stoppers, seals and ancillary materials are sterilized using a pure steam source, or for certain components, gamma irradiation
Quality Control Monitoring/Inspection
Environmental monitoring, particulates and viable counts
Personnel exit monitoring, viable counts
Full visual inspection for defects in vials performed before and after fill
Seal integrity testing post-fill
Aseptic Fill Suite
The Aseptic Filling Suite consists of two adjacent rooms with specific roles in the aseptic fill process: entry gowning, exit gowning, dispensing/crimping of product into vials, and inspection/labeling of filled vials. Additionally there is a Quarantine/Storage area for temporary storage of unreleased finished products pending QC test results and QA release.
Special Features
ISO Class 7 rooms (< 352,000 particles/m3, 0.5 micron particles)
Separate AHU providing single-pass air with terminal HEPA filters
ISO Class 5 biological safety cabinet (certified biannually)
Equipment for semi-automatic dispensing of bulk liquid (peristaltic dispensing pump) into vials using single-use product contact components
Pneumatic vial capper
GMP Aseptic Fill / Finish Highlight
Semi-automated dispensing / crimping
Full environmental / personnel monitoring
Vial format 2000 unit capacity
Bag format available
Validation by annual Process Qualification
Are you interested in working with us?
If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.
