Gmp freeze dryer for small batch production
Optimize small-scale biopharmaceutical production with precise freeze-drying technology designed for clinical trials, ensuring product sterility and integrity while handling both toxic and non-toxic formulations.
Facilitates Precise Freeze Drying for Sterile Products
The Lyotris from Telstar is a compact GMP freeze dryer crafted for small batch production in the pharmaceutical and biotechnology sectors. Its standout feature is the integration of CIP/SIP systems, ensuring sterile product handling for vaccines, monoclonal antibodies, and high-potency APIs. With a loading surface of up to 1 square meter, it accommodates approximately 1600 type 10R vials or 30 liters of bulk product. The Lyotris excels in energy efficiency with optimized cooling systems and offers conformity with global certifications such as PED, ASME, and CE. It seamlessly integrates with isolators and RABS, and supports induced nucleation for precise freeze drying. Maintenance is simplified through Telstar Insights, their smart maintenance platform, while options for configuring to handle toxins and various solvents enhance its versatility.
Benefits
- Ensures product sterility, meeting GMP compliance for safe pharmaceutical production.
- Minimizes batch processing time with efficient loading and unloading systems.
- Enhances product quality through precise control of freeze drying conditions.
- Offers flexibility with customization for handling a variety of solvents and toxins.
- Simplifies maintenance, reducing downtime with integrated smart maintenance platform.
- Applications
- Clinical trials,Sterile products,Solvents,Biopharmaceuticals,Toxins
- End products
- Alcohols,Vaccines,Lyophilized drugs,Hormonal treatments,Monoclonal antibodies,Antibiotics,Ethers,High-potency active pharmaceutical ingredients (hpapis),Protein therapeutics,Oncological formulations
- Steps before
- Formulation,Filling,Capping,Sealing
- Steps after
- Quality Control,Packing,Labeling,Storage
- Input ingredients
- sterile products,toxins,solvents,bulk product,vials
- Output ingredients
- freeze-dried sterile products,freeze-dried toxins,freeze-dried solvents,freeze-dried bulk product,freeze-dried vials
- Market info
- Telstar is known for specializing in the design, engineering, and manufacturing of advanced vacuum and aerospace solutions, gaining a strong reputation for their innovative and customized equipment in pharmaceutical, medical, and scientific research sectors.
- Loading Surface
- 1 square meter
- Vial Capacity
- 1600 type 10R vials
- Bulk Product Capacity
- 30 litres
- Design for Sterile Products
- GMP,ASME BPE
- Compliance
- CFR21-11,GAMP5
- Sublimation Monitoring
- Single-use wireless sensors
- Silicone Oil Leak Detection
- Lyosensing
- Induced Nucleation
- Lyonuc
- CIP/SIP Integrated
- Yes
- Certification
- PED,ASME,GB,CE,UL
- Integration Options
- Isolators and RABs
- Critical Components Inclusion
- Vacuum pumps,cooling systems,etc.
- Working Mechanism
- Freeze drying / Lyophilization
- Integrated Steps
- CIP/SIP integrated
- Batch vs. Continuous
- Batch Production
- Automation Level
- Smart Maintenance Platform
- Versatility
- Customizable Design Options
- Safety
- Compliance with GMP,ASME BPE
- CIP Principles
- CIP/SIP Capable
- Sublimation Monitoring
- Single-use Wireless Sensors
- Data Integrity
- CFR21-11,GAMP5 Compliance
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Sterile Product Production
- GMP,ASME BPE
- Compact footprint
- Compact Design
- Shelf surface area
- Up to 1 square meter
- Loading capacity
- 1600 type 10R vials or 30 litres of bulk product
- Ergonomics
- Maintained for compact size
- Production of Sterile Products
- Yes/No