Aseptic Fill / Finish

Waisman offers validated aseptic fill/finish capabilities to meet client needs as either the culmination of an extended production campaign or as a stand-alone fill project. Our ultimate goal is to expedite your move to clinic with a packaged final product that meets regulatory requirements, specifically providing all necessary fill process documentation and final product testing data (outlined in the final product Quality Control Specifications, QCS). At Waisman, aseptic fill projects are a team effort and are conducted by an experienced staff that includes QC 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 four 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 Highlights

  • Semi-automated dispensing / crimping
  • Full environmental / personnel monitoring
  • Vial format 2000 unit capacity
  • Bag format available
  • Validation by annual Process Qualification