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Fill/Finish Operations

Ensuring Quality and
Timely Delivery

Precisely coordinated aseptic fill/finish operations are vital to both the quality and timely delivery of parenteral drugs at both the clinical and commercial stages. Following formulation development, lyophilization cycle development and optimization and technology transfer, we offer tightly controlled fill/finish processes for liquid and lyophilized vials and prefilled syringes, as well as packaging and labeling.

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 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 and 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 and 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 barcodes for 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.

Explore Our Delivery Options For More Specific Information

  • Liquid Vials

    Offering flexible filling options for clinical or commercial production of liquid vials.

  • Lyophilized Vials

    Leveraging our deep lyophilization expertise and drawing on our Lyophilization Center of Excellence.

  • Prefilled Syringes

    Offering a comprehensive range of prefilled syringe manufacturing capabilities.

Contact Us

Learn more about our fill/finish operations.

Related Resources

Scale-Up and Tech Transfer

When lyophilized products move from lab- to full-scale production, considering the differences in equipment design and capability aids in process scale-up and transfer.

Simtra Capabilities Overview

Simtra brings reliable performance, trusted expertise and future-focused capabilities to help its clients achieve their commercialization objectives.

Simtra BioPharma Solutions’ Capabilities Overview

Simtra is a premier contract development and manufacturing organization with a singular focus on sterile injectables.