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Product Advantage
Multiple optional configurations are available:
Program setting
Authorization management
Curve temperature control
Automatic air intake
Backfill filtration
Remote control
Endpoint determination
Vacuum fine-tuning
Eutectic point testing
Pressure rise experiment
Chamber trap isolation valve
Capacitive vacuum gauge
External bottle attachment
Data recording and storage
Technical Parameters
Freeze-drying area: 0.2㎡ ~ 2.25㎡;
Feeding capacity: 2kg ~ 22.5kg;
Cold trap temperature: ≤-75℃;
Vacuum degree: ≤1Pa;
Shelf temperature range: -55~+70℃;
Heating and cooling rate: 1℃/min.
Validation documents include:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Operating Manual (OM)
Maintenance Manual (MM)
Installation Manual (IM)
Process and Instrumentation Diagram (P&ID), among others.
Optional accessories include:
Eutectic point testing
Chamber trap isolation valve
Data recorder
Paper recorder/online printing
PC or mobile app remote control
Imported brand vacuum pump
Anti-reflux oil solenoid valve
Oil mist filter, and more.
Product Uses
The application of freeze dryers in cleanrooms is extensive and particularly suitable for industries and applications that require a highly clean and sterile environment. Here are some key application scenarios of freeze dryers in cleanrooms:
1. Pharmaceutical Industry: In pharmaceutical processes, drugs, vaccines, biologics, and other products often undergo freeze-drying to maintain their long-term stability and activity. Using a freeze dryer in a cleanroom ensures the product's cleanliness and sterility, meeting the strict requirements of pharmaceutical production.
2. Biotechnology and Life Sciences Research: Laboratories and research institutions in the fields of biotechnology and life sciences often need to freeze-dry biological samples, enzymes, antibodies, and more for long-term storage and analysis. A freeze dryer in a cleanroom environment ensures the purity and reliability of samples.
3. Food Industry: In the food industry, certain products like coffee, fruits, vegetables, and more require freeze-drying to extend their shelf life. Using a freeze dryer in a cleanroom reduces the risk of external contamination and microbial contamination.
4. Medical Device Manufacturing: When manufacturing medical devices and components, ensuring product cleanliness and sterility is crucial. A freeze dryer can be used to remove moisture from devices, ensuring product quality and safety.
5. Chemical Industry: In some chemical reactions and synthesis processes, freeze-drying is necessary to maintain the stability and activity of compounds. Using a freeze dryer in a cleanroom environment reduces the impact of external contamination.
Product Operate Guide
The touchscreen can be flexibly placed either on the cleanroom side of the front of the enclosure or at the rear of the enclosure. If necessary, a second touchscreen can be optionally added to enable simultaneous control from both the front and rear of the enclosure. Additionally, remote computer control can be selected as an option, allowing real-time monitoring of equipment operation even from an office setting.
FAQ
1: How should the freeze dryer in the GMP facility be maintained and cleaned to ensure product quality and compliance with GMP standards?
To ensure compliance with GMP standards, the freeze dryer in the GMP facility should undergo regular maintenance and cleaning. This includes cleaning the inside and outside surfaces of the equipment, replacing seals and filters, cleaning vacuum pumps and condensers, among other tasks. Maintenance records should be meticulously documented for auditing and validation purposes. Additionally, equipment performance should be periodically validated to ensure compliance with GMP standards, including Operational Qualification (OQ) and Performance Qualification (PQ).
2: How does the freeze dryer used in the GMP facility ensure that it does not contaminate the production environment?
The freeze dryer used in a GMP facility should have sealing capabilities to ensure that samples inside the equipment do not leak or contaminate the production environment. The internal surfaces of the equipment should be smooth, polished, and free of dead spaces to minimize opportunities for microbial attachment. Furthermore, the freeze dryer should prevent cross-contamination to ensure that products from different batches do not contaminate each other.
3: Does the freeze dryer used in the GMP facility support Clean-in-Place (CIP) online cleaning functionality?
Some freeze dryers used in GMP facilities support Clean-in-Place (CIP) online cleaning functionality. This feature simplifies the cleaning process, reduces equipment downtime, and ensures that the equipment remains clean during production. CIP systems can automatically clean internal pipes and components, ensuring compliance with the hygiene requirements of GMP standards.
Product Advantage
Multiple optional configurations are available:
Program setting
Authorization management
Curve temperature control
Automatic air intake
Backfill filtration
Remote control
Endpoint determination
Vacuum fine-tuning
Eutectic point testing
Pressure rise experiment
Chamber trap isolation valve
Capacitive vacuum gauge
External bottle attachment
Data recording and storage
Technical Parameters
Freeze-drying area: 0.2㎡ ~ 2.25㎡;
Feeding capacity: 2kg ~ 22.5kg;
Cold trap temperature: ≤-75℃;
Vacuum degree: ≤1Pa;
Shelf temperature range: -55~+70℃;
Heating and cooling rate: 1℃/min.
Validation documents include:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Operating Manual (OM)
Maintenance Manual (MM)
Installation Manual (IM)
Process and Instrumentation Diagram (P&ID), among others.
Optional accessories include:
Eutectic point testing
Chamber trap isolation valve
Data recorder
Paper recorder/online printing
PC or mobile app remote control
Imported brand vacuum pump
Anti-reflux oil solenoid valve
Oil mist filter, and more.
Product Uses
The application of freeze dryers in cleanrooms is extensive and particularly suitable for industries and applications that require a highly clean and sterile environment. Here are some key application scenarios of freeze dryers in cleanrooms:
1. Pharmaceutical Industry: In pharmaceutical processes, drugs, vaccines, biologics, and other products often undergo freeze-drying to maintain their long-term stability and activity. Using a freeze dryer in a cleanroom ensures the product's cleanliness and sterility, meeting the strict requirements of pharmaceutical production.
2. Biotechnology and Life Sciences Research: Laboratories and research institutions in the fields of biotechnology and life sciences often need to freeze-dry biological samples, enzymes, antibodies, and more for long-term storage and analysis. A freeze dryer in a cleanroom environment ensures the purity and reliability of samples.
3. Food Industry: In the food industry, certain products like coffee, fruits, vegetables, and more require freeze-drying to extend their shelf life. Using a freeze dryer in a cleanroom reduces the risk of external contamination and microbial contamination.
4. Medical Device Manufacturing: When manufacturing medical devices and components, ensuring product cleanliness and sterility is crucial. A freeze dryer can be used to remove moisture from devices, ensuring product quality and safety.
5. Chemical Industry: In some chemical reactions and synthesis processes, freeze-drying is necessary to maintain the stability and activity of compounds. Using a freeze dryer in a cleanroom environment reduces the impact of external contamination.
Product Operate Guide
The touchscreen can be flexibly placed either on the cleanroom side of the front of the enclosure or at the rear of the enclosure. If necessary, a second touchscreen can be optionally added to enable simultaneous control from both the front and rear of the enclosure. Additionally, remote computer control can be selected as an option, allowing real-time monitoring of equipment operation even from an office setting.
FAQ
1: How should the freeze dryer in the GMP facility be maintained and cleaned to ensure product quality and compliance with GMP standards?
To ensure compliance with GMP standards, the freeze dryer in the GMP facility should undergo regular maintenance and cleaning. This includes cleaning the inside and outside surfaces of the equipment, replacing seals and filters, cleaning vacuum pumps and condensers, among other tasks. Maintenance records should be meticulously documented for auditing and validation purposes. Additionally, equipment performance should be periodically validated to ensure compliance with GMP standards, including Operational Qualification (OQ) and Performance Qualification (PQ).
2: How does the freeze dryer used in the GMP facility ensure that it does not contaminate the production environment?
The freeze dryer used in a GMP facility should have sealing capabilities to ensure that samples inside the equipment do not leak or contaminate the production environment. The internal surfaces of the equipment should be smooth, polished, and free of dead spaces to minimize opportunities for microbial attachment. Furthermore, the freeze dryer should prevent cross-contamination to ensure that products from different batches do not contaminate each other.
3: Does the freeze dryer used in the GMP facility support Clean-in-Place (CIP) online cleaning functionality?
Some freeze dryers used in GMP facilities support Clean-in-Place (CIP) online cleaning functionality. This feature simplifies the cleaning process, reduces equipment downtime, and ensures that the equipment remains clean during production. CIP systems can automatically clean internal pipes and components, ensuring compliance with the hygiene requirements of GMP standards.
