Our isolated vial drug product filling line by BOSCH, is adaptable for GMP aseptic fill & finish for 2mL, 6mL, 10mL, 20mL, 25mL, 30mL ISO standard vials, with a maximum capacity of 100,000 vials per batch. The cleanroom grade of this filling line is Grade A, with isolator in a grade C background environment. All materials in direct contact with the products use a single-use system, preventing cross contamination and ensuring product safety.
• Grade A aseptic processing area within a Grade C background
• Accommodates 2 mL/ 6 mL/ 10 mL/ 20 mL/ 25 mL / 30 mL ISO standard vials
• Fills up to 200 vials per minute and 100,000 vials per batch
• Completed 70 batches with a 100% success rate
• Completed multiple tox and GMP batches for mAb, bispecific Ab, and siRNA
• All materials in direct contact with products use a single-use system
• Experienced in fill & finish of high-viscosity, high concentration formulated products
• Fill volumes rang from 0.4 mL/vial to 35 mL/vial, meeting the typical 0.5 mL ~ 1.5 mL filling requirement for RNA drugs, with an accuracy of <5%
• Achieved higher DP yield with lower than industry standard filling line loss (< 100 mL, typically 400 - 500 mL), offering significant cost saving for clients
You can copy the link and paste it into the browser to watch the whole process of filling production video.
https://www.youtube.com/watch?v=QJvxtjTs8UE