Pharmaceutical Production Freeze Dryer

Product Advantage

• Lyophilizer Chamber: Mirror-polished 316L stainless steel with large rounded corners for easy CIP (Cleaning-in-Place) and SIP (Sterilization-in-Place with Fo value monitoring). High pressure resistance and sealing grade.
  

• Shelve System: Silicone oil circulation for temperature control, temperature uniformity ±1°C, enabling rapid heating and cooling. Supports automatic hydraulic stoppering (capping of vials under vacuum to prevent contamination).

• CIP/SIP Unit: Fully automatic cleaning and steam sterilization, orbital welding of pipelines, helium mass spectrometry leak detection.

• Control System: PLC + SCADA, full-process data acquisition, audit trail, electronic signature, in compliance with 21 CFR Part 11.

• Comply with CGMP, FDA, EMA, ISO 14644 cleanliness standards.

  Materials meet USP Class VI.

  Complete validation documentation package (DQ, IQ, OQ, PQ).

  Real-time monitoring and recording of key parameters such as vacuum, temperature, pressure, Fo value.

  Integration with Class A laminar flow/isolator for sterile production.

Maintenance & Risk Control

• Regular replacement of vacuum pump oil/filters, calibration of temperature/vacuum sensors.

• Periodic CIP/SIP validation and equipment leak detection.

• Prevention of batch scrappage caused by vacuum failure, cold trap overload, and uneven shelf temperature.

• Spare parts management and emergency shutdown plan.

Product Uses

• Biological products: vaccines, monoclonal antibodies, recombinant proteins, plasma products.

• Chemical APIs/injection powders: antibiotics, hormones, polypeptides.

• Traditional Chinese medicine freeze-dried powders, cell therapy products, diagnostic reagents.

Selection & Common Specifications

• Lyophilization Area: From 0.5 m² to 50 m², corresponding to a production capacity of tens of thousands to hundreds of thousands of vials per batch.

• Configuration Grades:

• Standard type: basic functions.

• CIP type: suitable for non-sterile APIs.

• CIP+SIP type: mandatory for sterile injection production lines.

• Additional Functions: Automatic loading & unloading, N₂/inert gas backfilling.

Product Video

FAQ

• Q: What are CIP and SIP for a pharmaceutical freeze dryer?

  A: CIP (Cleaning-in-Place) is an automatic cleaning system that cleans the chamber, shelves, pipes and condenser without disassembly. SIP (Sterilization-in-Place) uses saturated steam to sterilize the whole product contact system under controlled temperature and pressure to meet GMP sterile production requirements.
  
  
• Q: Why are CIP and SIP essential for pharmaceutical lyophilizers?

  A: CIP and SIP ensure no cross-contamination between batches, meet strict GMP, FDA and EMA standards, reduce manual operation risks, and guarantee the safety and consistency of injectable drugs, biologics and sterile products.
  
  
• Q: Can your pharmaceutical freeze dryer perform CIP and SIP fully automatically?

  A: Yes. Our machine is equipped with a fully automatic CIP/SIP control program. Parameters such as cleaning flow rate, temperature, sterilization time, Fo value and pressure are automatically controlled, recorded and traceable.
  
  
• Q: What parts of the freeze dryer are included in CIP and SIP?

  A: CIP and SIP cover all product-contact parts: drying chamber, shelves, condenser, valves, pipelines and seals. Non-contact parts can also be designed for cleaning or sterilization upon request.
  
  
• Q: Do you provide validation documents for CIP and SIP?

  A: Yes. We provide complete validation documents including DQ, IQ, OQ, PQ, CIP/SIP qualification reports, pressure test reports, helium leak test reports and Fo value validation data to support customer factory audit and certification.