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Lyophilization​ Services

Some pharmaceutical products are simply too sensitive and require lyophilization to maintain appropriate shelf-life and efficacy for their intended patient. Sharp Sterile has a clean-in-place, steam-in-place lyo.

Our services:

We also have experience with lyophilizing products within a syringe which can reduce costly waste from hold-up volumes. All filling operations and transfer to the lyo are performed in permanently connected isolators.

Lyophilization Details:​

  • Container Sizes: Client Directed
  • Capacity: Client Directed – up to 31,500 10 mL vials
  • Operations: Manual, Semi-Automated, or Automated – all
  • Components: Client Specified
  • Fully isolated filling environments
  • Lyo development and optimization services

Semi-Automated Filling Line

Semi-Automated Vial Filling & Lyophilization

Our semi-automated isolator-based fill and lyophilize up to 3,500 10R vials. This line is ideal for clinical-scale lyo projects.

Processing Modes

Automated Filling Line

Automated Vial Filling & Lyophilization

Our automated filling line can lyophilize up to 31,500 10R vials, and the line will be fitted with a second lyophilizer to double capacity by 2025. This line features fully robotic and automated filling in isolators to offer the greatest sterility assurance achievable.

Processing Modes

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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