Fill/Finish Operations

FILL/FINISH OPERATIONS TO ENSURE QUALITY AND TIMELY DELIVERY

Precisely orchestrated aseptic fill/finish operations are vital to both the quality and timely delivery of parenteral drugs at both the clinical and commercial stages. We offer tightly controlled fill/finish processes for liquid, lyophilized and powder-filled vials and prefilled syringes, all the way from development through packaging and storage, including the critical steps of technology transfer and lyophilization optimization. Analytical testing, automated and manual inspection, environmental monitoring and good manufacturing practices all combine to ensure compliance with regulatory requirements. For designated products, our specialized containment practices ensure a safe manufacturing environment, as do our cleaning methods to avoid cross-contamination.

FLEXIBLE FILLING OPTIONS TO MEET CLINICAL OR COMMERCIAL NEEDS

Our filling operations are optimized for high throughput, high speed, high quality, minimal loss and flexibility when required. We also maintain lower speed lines for clinical-scale manufacturing. Our world-class equipment includes rotary piston and peristaltic pumps and time-pressure filling mechanisms to meet product requirements. We strategically place production areas adjacent to aseptic formulation suites and utilize dedicated manufacturing suites and redundant filling lines as appropriate. When needed for high-value active pharmaceutical ingredients, in-process and final in-line nondestructive weight checking helps minimize loss.

COLD-CHAIN FILLING & STORAGE TO PRESERVE PRODUCT POTENCY

For temperature-sensitive products, we employ cold-chain filling and storage. Our production environments and warehouses are temperature-controlled at several ranges, including:

• -70 °C
• -25 °C to -15 °C
• +2 °C to +8 °C
• +15 °C to +25 °C

In our facilities, temperature is monitored 24/7, 365 days a year.

FLEXIBLE PACKAGING & INSPECTION OPTIONS

For both vials and syringes, we work with you to determine the right packaging and labeling for your product. Packaging can be automated or done manually, as appropriate. Options include bulk packaging, cartoning with weight checking and, for syringes, blister packaging. A package insert can be included if desired. We use both bar code scanning and laser printing. We also aggregate orders for all countries and incorporate packaging serialization, with serial numbers you provide or we generate, to enable worldwide shipment traceability.