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
Aseptic Fill Specifics
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
- 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