Bioworkshops currently has a Fill Finish manufacturing area of approximately 2000 square meters and our quality systems for aseptic filling have passed EU QP audit. The first aseptic filling line has been operational since August 2020. Our Fill Finish team have more than 10 years of experience focused on sterile filling of liquids, lyophilized products, pre-filled syringes, and cartridges.
Delivered 50+ batches successfully
Annual filling capacity of 15 million vials and prefilled syringes/cartridges (PFS)
Multiple production lines for aseptic filling of PFS, vials, and freeze-dried products from clinical phase up to large batches for commercial sale.
Fill and Finish expertise for a broad range of biologics
Fill Finish manufacturing workshops include Grade D, Grade C and Grade B areas. All quality systems have been audited to comply with EU GMP
Clinical & Commercial Fill and Finish services, Annual filling capacity of 15 million vials and prefilled syringes
Online weight-check standard on all lines
Grade A aseptic processing area in Grade B background with oRABS
All product-contact surfaces use disposable components to prevent cross-contamination
Robotic arm in aseptic processing area (APA) to minimise risk of contamination
Peristatic filling, fully disposable wetted parts Min System hold-up liquid ≤70mL
Eight heads for commercial line
Filling volume range: 0.2 mL – 50 mL
Aseptic filling
- Grade A oRABS
- Auto-washer and tunnel
- Auto-filling, closing and capping
Batch volume up to 500L, Batch size up to 100,000 vials
Vial size: (2R, 6R, 8R, 10R, 15R, 20R and 50R)
Filling speed: 200 vials per minute, depending on vial size
Filling volume range: 0.2 mL – 5 mL
Maximum lot size: 100,000 syringes
Line speed up to 12,000 units/h
Robotic arm in aseptic processing area (APA) to minimise risk of contamination
No. 5, Dongwang Road, Suzhou Industrial Park, China
energize@bioworkshops.com
(+86) 512 6799 9700
