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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 use of freeze dryers in cleanrooms is very common and especially applicable to industries and applications that require a very clean and sterile environment. Below is a list of key applications of freeze dryers in cleanrooms:
1. Pharmaceutical Industry：This is where pharmaceutical processes ensure that drugs, vaccines, biologics, and other products are freeze-dried to keep them long-term stable and active. A freeze dryer in a cleanroom guarantees the cleanliness and sterility of the product, meeting high standards for pharmaceutical production.
2. Research in Biotechnology and Life Sciences: For laboratories and research bodies dealing in biotechnology and life sciences, biological samples, enzymes, antibodies, and various other materials are required to be preserved for storage and analysis. The freeze dryer, when used in a cleanroom environment, guarantees sample purity and reliability.
3. Food Industry: In the food industry, products such as coffee and fruits and vegetables can be extended in their shelf life by freeze-drying. Installation of the freeze dryer in a cleanroom facility reduces risk due to external contamination and microbial contamination.
4. Medical Device Manufacturing: Cleanliness and sterility of the product are major factors in the manufacture of medical devices and components. Freeze drying can be used to remove moisture content from the product after processing, thereby ensuring quality and safety of the product.
5. Chemical Industry: Freeze-drying may be applied to certain chemical reactions and synthesis, wherein the resultant compounds must retain stability and activity. Cleanroom operation of a freeze dryer reduces the compound effect 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 use of freeze dryers in cleanrooms is very common and especially applicable to industries and applications that require a very clean and sterile environment. Below is a list of key applications of freeze dryers in cleanrooms:
1. Pharmaceutical Industry：This is where pharmaceutical processes ensure that drugs, vaccines, biologics, and other products are freeze-dried to keep them long-term stable and active. A freeze dryer in a cleanroom guarantees the cleanliness and sterility of the product, meeting high standards for pharmaceutical production.
2. Research in Biotechnology and Life Sciences: For laboratories and research bodies dealing in biotechnology and life sciences, biological samples, enzymes, antibodies, and various other materials are required to be preserved for storage and analysis. The freeze dryer, when used in a cleanroom environment, guarantees sample purity and reliability.
3. Food Industry: In the food industry, products such as coffee and fruits and vegetables can be extended in their shelf life by freeze-drying. Installation of the freeze dryer in a cleanroom facility reduces risk due to external contamination and microbial contamination.
4. Medical Device Manufacturing: Cleanliness and sterility of the product are major factors in the manufacture of medical devices and components. Freeze drying can be used to remove moisture content from the product after processing, thereby ensuring quality and safety of the product.
5. Chemical Industry: Freeze-drying may be applied to certain chemical reactions and synthesis, wherein the resultant compounds must retain stability and activity. Cleanroom operation of a freeze dryer reduces the compound effect 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.
