Used VirTis 35L Ultra Clean Room Lyophilizer

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Our Lyophilizer Testing Process

1. Freeze dryer is visually inspected on arrival and then a performance test is initiated to see how well the unit is operating.

2. The interior and exterior of the unit are cleaned using a dry ice blasting method to remove buildup and contaminants.

3. The freeze dryer technician checks the ambient pressures of the high and low side compressors (if applicable). A functional test of the refrigeration circuit is performed to verify that the unit is cooling in accordance with the manufacturer's specifications.

4. Air-cooled units use a condenser and fans to remove heat from the system. The condenser is inspected and cleaned to ensure proper airflow. Water-cooled units use facility water or a standalone chiller to dissipate heat from the refrigeration circuit. The water circuit is inspected for leaks and verified to be functioning correctly.

5. For rotary vane vacuum pumps, the oil is flushed and refilled. Scroll vacuum pumps, which are oil-free, are inspected and calibrated accordingly.

6. For benchtop and floor model freeze dryers equipped with tree and drum manifolds, the valves are cleaned, inspected, and regreased to ensure proper sealing and functionality.

7. The unit’s temperature sensors are calibrated to ensure accurate readings and proper performance (on non-Lyo software units).

8. Door seals and other critical components are inspected and replaced as needed.

9. Refrigeration lines are reinsulated, and all vacuum hoses are inspected or replaced to ensure proper system integrity.

10. If the unit includes software, the technician runs functionality tests, including checking the minimum and maximum achievable temperatures.

11. The freeze dryer technician verifies that the stoppering mechanism (if present) and isolation valves are functioning correctly.

Note: Isolation valves are designed to prevent air leaks within the system and must be tested for proper sealing during operation, heating, and defrost cycles.

12. The unit is repainted and redecaled where necessary to ensure a professional appearance.

VirTis 35L Ultra Upgrades and Accessories

- PC with Lyos 2.0 Control Software Installed
- Vacuum Pump
- Corrosive-resistant Glass Door
- Power Cable
- 90-Day to 1-Year Warranty

Our Freeze Dryer Technician Checklist

After our freeze dryer technician finishes the initial testing process, this Freeze Dryer Technician Checklist is filled out to record the important information gathered throughout the repair process. This checklist will be available publicly after the unit has undergone tech completion and is ready for the customers. 

VirTis 35L Ultra Clean Room Freeze Dryer Applications

• Vaccine Development Labs - Labs working on vaccine production, especially those requiring aseptic freeze-drying to preserve the potency of live or inactivated viruses.
• Gene and Cell Therapy Labs - Labs focused on gene therapies (e.g., plasmids, mRNA) and cell therapy (e.g., stem cells) use freeze dryers to preserve the viability and stability of biological materials.
• Diagnostic and Assay Labs - Laboratories producing diagnostic kits, reagents, and assays, especially for long-term storage and stability, use freeze dryers to maintain their integrity over time.
• Research and Biotech Labs - Labs involved in biological research, including the preservation of biological samples, cell lines, and microbial cultures, use freeze dryers for sample storage and transportation.
• Blood Bank and Plasma Labs - Labs that process and store blood plasma, serum, and other biological materials often use freeze dryers to maintain the stability of these sensitive components.
• Nutraceutical and Exosome Therapy Labs - Labs producing nutraceuticals (e.g., probiotics) or exosome-based therapies use freeze dryers to stabilize these products for longer shelf life.

Benefits of Clean Room Freeze Dryers

• Steam-in-place (SIP) Feature - Ensures sterility without manual cleaning.
• Clean-in-place (CIP) Feature - Minimizes contamination risk.
• Smooth interior design prevents particle accumulation.
• Low particle emissions maintains ISO class rating.
• Isolator and barrier systems enhance sterility assurance.
• SCADA-based control systems enable audit trails and batch records.

SP Scientific VirTis 35L Lyophilizer Specifications

Utility Requirements: