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Sterile Vial Filling

We will support you from clinical phase through commercial production. With flexible lot sizes ranging from less than 500 units up to 100,000 units per batch — capacity expanding further with our newest line coming online in 2027 — we scale with your program as it grows. By utilizing best-in-class isolator technology and flexible fillers, we deliver the highest degree of sterility assurance possible at every stage.

Vial filling capabilities

Sterile Vial Filling Detail

  • Container Sizes: 2 mL – 100 mL
  • Capacity: up to 100,000 vials/batch with expanded capacity coming online in 2027
  • Components: nested or bulk glass
  • Peristaltic or Rotary Piston
  • Fully isolated filling environments

Manual Filling Line

Low Loss Filling

Our Low Loss Fill Process reduces drug product loss to less than 30 mL. This process is isolator-based, highly precise, and is an excellent solution for low volume fills of less than 1.2 liters.

Manual Filling

We offer isolator-based, manual aseptic vial filling. This solution is excellent for pre-clinical or Phase I drug product lots of less than 2,000 units per batch.

Semi-Automated Filling Line

Semi-Automated Aseptic Vial Filling

Our semi-automated isolator-based filling line can process vials from 2mL to 100mL up to lots of 35,000 units.

Semi-Automated Line: Processing Modes

Automated Filling Line

Automated Aseptic Vial Filling

To support growing demand for sterile injectable manufacturing, we are expanding our vial filling capabilities with a new fully automated IMA Life isolator-based filling line for Ready-To-Use (RTU) vials. Designed for high-throughput aseptic manufacturing, the system combines advanced robotics, integrated non-destructive weight verification, and modern lyophilization technology to efficiently manufacture batches up to 100,000 units.

This investment complements our existing flexible vial filling capabilities, enabling us to support programs from early clinical development through commercial supply while maintaining the sterility assurance and quality standards expected for injectable drug products.

Image courtesy of IMA Life.

Image courtesy of IMA Life.

Sterile Manufacturing Inquiry

Would you like to find out more about our sterile fill finish services? Fill the form below so we know what area you’re interested in and we’ll be very happy to help.

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Sterile Manufacturing Services
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Trusted by many

“The people at Sharp are collaborative, responsive and always willing to accommodate our needs, and this is something to be admired. If they say they can do something, they will deliver no matter what – ultimately, their success is our success, and vice versa.

Sr Quality Supplier Manager, Top 10 Pharmaceutical Company

“Sharp’s responsiveness and flexibility are truly gold standard. Their dedication to the core values of quality and service allows for a true partnership and success in getting our product to patients in need.

External Manufacturing, Top Mid-size Pharma Company

“Sharp is an exceptional partner in the packaging CMO space. They have a dedicated launch team which is unique and a huge benefit vs. having the project lead that handles commercial business also manage the launches. Launches can be very time consuming and they can focus on these activities vs. having to also manage the commercial side.

Top 10 Pharmaceutical Company

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