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GMP Workshop Specialized Freeze Dryer

GMP freeze-drying equipment complies with the requirements of the production process. The inner surfaces of equipment that come into direct contact with drugs are smooth, even, and free of dead angles, ensuring effective control of product quality.
The equipment itself does not generate pollution in the production environment or contaminate materials. It can prevent cross-contamination without affecting product quality and is easy to clean and maintain.
Optional features include CIP online cleaning and VHP sterilization functions.
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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


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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.


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Beijing Songyuan Huaxing Technology Development Co., Ltd. was founded in 2000, with its headquarters located in Beijing, China.

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