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Vials (Liquid + Lyo)

Vials (Liquid + Lyo)

Bioworkshops have two aseptic manufacturing lines for vials that meet US and EU GMP standards including Annex 1 requirements that will enter into force from August 2023. 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.

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 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

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

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