Aseptic Fill and Finish
Goodwin Biotechnology has been providing aseptic fill and finish services for 30 years both as a stand alone and integrated project. Our clients range from large, multinational companies to medium, small, and virtual biotechs.
Full Aseptic Fill and Finish Capabilities
Goodwin Biotechnology augments aseptic manufacturing by maintaining an ISO5 filling suite that provides customized, economical, and compliant liquid filling of your products under cGMP conditions to support human clinical trials on a global basis (US, Europe, Asia). Our aseptic filling process operations are fully validated for batch fills up to 1500 vials or 400 cartridges and volumes of 0.5mL to 10.0mL per vial. We can also accommodate larger fill volumes to meet your needs.
- A semi-automated process utilizing a programmable pump and manual fill nozzle, providing improved yields for small lot sizes.
- Vial stoppering and crimping are performed immediately after filling by a second operator.
- Fill checks performed at predetermined intervals. This semi-automated process has consistently met all standards for acceptable fill volumes.
- All fill operations continuously observed and environmentally monitored by Quality personnel.
- Sealing and fill checks performed outside the fill room are monitored by Quality.
Aseptic Fill and Finish Manufacturing Equipment
(Multi-Format AST system for Filling and Crimping GENiSYS® C with Vial Sealing Module [VSM-10])
Goodwin’s AST system (GENiSYS® C with Vial Sealing Module (VSM-10)) is a multi-format aseptic fully automated filling machine, capable of filling, stoppering & crimping ready-to-use (RTU) vials, syringes, and cartridges when equipped with the appropriate tooling. The intended purpose of this equipment is the cGMP (cGMP 21 CFR parts 210 and 211) liquid filling and closing. The AST GENiSYS® C multi-format aseptic filling machine has the following primary functions:
- Vials/Syringe: With one (1) needle filling, 480 units per hour can be achieved for a 1mL water fill into a 2R vial at 2% IPC followed by a serum stopper close assuming 20 seconds for nest handling.
- Accuracy: The standard deviation for peristaltic dosing of water will be:
± 1.0% from 0.5mL – 3.0mL fill volumes
± 0.5% from 3.0mL – 50 mL fill volumes
The new automated AST filling system has Electronic batch reporting (EBR) capabilities.
The Goodwin Approach
In addition to cGMP contract development and manufacturing of biologics, Goodwin specializes and has been performing sterile drug aseptic fill and finish applications since its inception in 1992. This critical activity can be as a stand-alone service for our client or as a fully integrated service together with the process development and cGMP manufacturing of our client’s biologics products. Goodwin’s aseptic fill and finish applications meet the needs for most biologics molecules including:
- Semi-automated and hand fills up to 1,500 vials per shift for early- to mid-stage clinical studies
- Fully automatic AST fill and finish system with expanded capacity (up to 5,000 vials) for late stage and commercial applications.
- Goodwin has unique experience with small scale, customized and specialized fills such as light-sensitive products, controlled (DEA regulated) vaccines conjugates, exosomes and fragile ADC conjugates.
The automated AST fill and finish system meets most worldwide regulatory agencies requirements including the FDA, Canadian and EU regulatory authorities.