Waisman Biomanufacturing

Clinical Production

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 campaign. WB offers an in-house validated process to accelerate timelines and reduce cost for pilot-scale CGMP aseptic fills.

  • Fully automated Aseptic Technologies Crystal SL1 vial dispensing and capping system housed in a barrier isolator to ensure the highest level of aseptic processing
  • Vial lot size ranges between hundreds of units up to 2,000 vials appropriate for clinical trials
  • In-house validation with requalification by annual media fill simulations and container closure integrity testing
  • Final product aseptically dispensed with or without terminal sterile filtration
Contact to Discuss the Proposal Process

Aseptic Fill Specifics


Automated ASeptic Fill Line in a Barrier Isolator

Packaging Formats

  • Choice of vials currently validated include ISO 2R, ISO 6R, and ISO 10R Type I borosilicate glass vials and 2 mL AT-Closed (cyclic olefin copolymer) vials
  • Other vial sizes/configurations can be added with custom media fills
  • Choice of color for tamper evident seals
  • Cryocyte® freezer bags in aluminum cassettes available for large format cell packaging (custom, manual fill process)
  • Vials, stoppers, seals and ancillary materials are sterilized using a pure steam source, or for certain components, gamma irradiation

Quality Control Monitoring/Inspection

Drug Product Inspection
  • Environmental monitoring, particulates and viable counts
  • Personnel exit monitoring, viable counts
  • Full visual inspection for defects in vials performed after fill
  • Filter integrity testing post-fill
  • Safety testing of products can include:
    • USP <71> sterility
    • USP <788> particulates
    • USP <85> endotoxin
    • Container Closure Integrity testing

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
  • Aseptic Technologies Crystal SL1 robotic fill line for aseptic dispensing into vials using single-use product contact components
  • Extract Technologies barrier isolator exceeding ISO Class 5 containing the fill line
  • Pneumatic vial crimper

GMP Aseptic Fill / Finish Highlights

  • Fully automated dispensing / capping
  • Full environmental / personnel monitoring
  • Vial format 2000 unit capacity
  • Bag format available
  • Validation and requalification by annual media fill simulations and container closure integrity testing

Clinical Production