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Fill & Finish
Fill & Finish

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

Facility

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 servicesAnnual 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

Clinical and Commercial Manufacturing

Clinical Vial Fill Line and Commercial Lyophilized Products Production Line

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

Commercial Syringe Filling Line

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

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