CIGEAIR-Sterile Isolator
Product Introduce
The most widespread application of isolators is in the pharmaceutical industry, as drug research and production processes require an additional physical barrier to isolate operators from the sterile production environment and protect products from contamination.
Common processes such as dispensing, weighing, batching, crushing, sampling, etc. can be performed in a positive pressure sterile isolator.
Isolators are generally used in conjunction with the operation chamber and pass box, or can be used separately. The airflow design and flow direction of isolator are similar to those of biosafety cabinet, except that the isolator cabinet is fully enclosed under positive pressure, while the Class II biosafety cabinet is semi-enclosed by negative pressure, and the Class III biosafety cabinet is fully enclosed by negative pressure. These cabinets are designed according to their functions. The isolators can be large or small, and most of the functions and sizes are customized to the user's needs. In the use process, the operating samples and equipment are transferred to the operation chamber through the pass box, then the pass box door is closed, and the experimenters operate through gloves.
Product Introduce
The most widespread application of isolators is in the pharmaceutical industry, as drug research and production processes require an additional physical barrier to isolate operators from the sterile production environment and protect products from contamination.
Common processes such as dispensing, weighing, batching, crushing, sampling, etc. can be performed in a positive pressure sterile isolator.
Isolators are generally used in conjunction with the operation chamber and pass box, or can be used separately. The airflow design and flow direction of isolator are similar to those of biosafety cabinet, except that the isolator cabinet is fully enclosed under positive pressure, while the Class II biosafety cabinet is semi-enclosed by negative pressure, and the Class III biosafety cabinet is fully enclosed by negative pressure. These cabinets are designed according to their functions. The isolators can be large or small, and most of the functions and sizes are customized to the user's needs. In the use process, the operating samples and equipment are transferred to the operation chamber through the pass box, then the pass box door is closed, and the experimenters operate through gloves.
Negative Pressure Isolator
Product description
The negative pressure isolator can meet the isolation operation of highly toxic, highly active, and highly allergenic drugs, comply with the requirements of EH5 occupational health management system, and can be widely used in biopharmaceutical, chemical, and research institutes related laboratories.
It can provide an enclosed negative pressure environment for the operation of drug dispensing, weighing, dosing, sampling and other processes to protect the safety of personnel during the entire operation.
Cell Therapy Isolator
Cell Therapy Isolator
As cell therapy is gaining ground worldwide, more and more difficult diseases are looking to this advanced technology, including the COVID-19. At the same time, sterile isolators from traditional pharmaceuticals have penetrated into the cell therapy field, and isolators dedicated to the production of cell drugs have appeared, becoming the new favorite of cell therapy.
The so-called cell therapy isolator is a fully enclosed area for the production of cell therapy drugs, including reagent preparation, cell pretreatment operations, cell culture centrifugation, cell microscopy, and environmental monitoring.
Comparison with traditional mode
Economical
Economical: Meet Class D cleanroom installation conditions, with reduced maintenance running costs, no specific consumables and no highly trained professionals.
Stable
Stable: The cell production environment is easy to control and monitor, enjoying stable working area conditions, homogeneous and synchronized cell growth, rapid quality control and GMP certification of cell products.
Safe
Safe: Adopts intelligent and modular design, free from the troubles of traditional cleanrooms; the work area is always a Class A clean environment through positive pressure protection; the environmental conditions can be monitored and traced in real time.
Fast
Fast: Reduce sample processing time, delivery time and quality control time, and automatically implement H2O2 fumigation to simplify the sterilization process.
Sterile/Negative Pressure Filling Isolator
Product Description
The sterile/negative pressure filling isolator is mainly used for providing Class A sterile protection for the sterile filtration, filling, capping and other key sterile operating procedures of sterile, highly toxic and highly active preparations, and reducing the risk of environmental pollution in the sterile filling and capping production process. The sterile filling isolator is suitable for filling, capping and sterile solution filtration of sterile drugs, XDC-type conjugated drugs, oncolytic viruses and other products with high toxicity and high activity for trial and pilot R&D.
Product features
The sterile/toxic isolator system is mainly composed of isolator chamber, air filtration system, sterilization system and control system, which provides sterile Class A protection for the equipment inside the isolator and protects personnel from toxic drugs. For the production of sterile/highly toxic and highly active drugs, the isolator technology has the following features:
1. Flexible design: The sterile filling isolator can be flexibly designed according to the process, with matching filtering, dispensing, capping and other functional units;
2. Flexible production: The product can realize the common line production of penicillin bottle and pre-filled needle products;
3. Isolator segment design: The whole line or individual segments can be provided with independent leak testing and VHP sterilization;
4. Pressure gradient design: Each segment is connected by airtight valve, which can adjust the differential pressure independently and set appropriate differential pressure for each segment according to the process, which avoids cross contamination;
5. The product can be integrated with the online environmental monitoring and sampling system of particles and airborne microbes;
6. The sterile filling isolator equipped with RTP barrel/valve transfer device is optional according to supply needs;
7. The wireless glove leak detector can be configured to detect leakage for each glove before production, preventing damage to the internal environment of the isolator from glove breakage;
8. Wash-in-place (WIP) for chamber + clean-in-place (CIP) for air duct can be configured. The isolator bottom plate adopts tilt design, which can facilitate drain after cleaning;
9. Operational risk control confirmation: The Mock-UP wood mold and ergonomic testing confirm that the integrity of the isolator is not damaged, the airflow is not affected, the glove opening location is reasonable, and all interventions have been confirmed before the design of the isolator.
10. A professional validation service team, combined with a set of scientific and perfect validation management system documents proven by the project practice (including but not limited to RA, DQFAT, SAT, IQ, OQPQ, etc.), ensures the product quality and reliable validation results.
GMP pharmaceutical appliance washer & dryer
Cleaning validation
It validates the effectiveness of cleaning procedures (cleaning methods), to confirm that the equipment is cleaned in accordance with certain cleaning procedures, and the residues and microbial indicators achieve the standards specified in the cleaning requirements.
It validates the effectiveness of cleaning procedures (cleaning methods), to confirm that the equipment is cleaned in accordance with certain cleaning procedures, and the residues and microbial indicators achieve the standards specified in the cleaning requirements.
The product can fully replace manual cleaning, realizing recordable, verifiable, repeatable and traceable cleaning
Process: Pre-washing - Washing - Rinsing - Drying
Full process time ≤ 70min
Certificates
We always focus on customers, pay attention to their needs, provide high-quality products and excellent services to meet their expectations.
Company Advantage（Why choose us）
Integrated Manufacturer with Strong R&D
As a National High-Tech Enterprise, we control the entire process from R&D (2000㎡ center) to manufacturing (35000㎡ factory). 36% of our workforce are technical staff, driving innovation like our unique VHP saturation control technology.
Proven Industry Authority & Certifications
We are a recognized member of key industry associations (Chinese Contamination Control Society, etc.) and hold ISO9001, CE, UL, and other certifications, ensuring reliable quality and industry trust.
End-to-End Project Support
We provide a full service package from technical consultation and custom design to professional installation, commissioning, validation support, and responsive after-sales technical service.
Testimonials
The unit delivers stable VHP decontamination and greatly improves batch changeover efficiency. It effectively eliminates operator-borne contamination and ensures reliable sterility test results, helping us pass GMP audits smoothly.
We suffered from false positives in sterility tests for a long time. After adopting this isolator, contamination risk is greatly reduced, cutting retesting costs.
Excellent negative pressure containment prevents leakage of high-active powder and protects operator safety, with all leak test indicators fully compliant.
Used for weighing and dispensing highly potent APIs. Equipped with dual HEPA filtration and stable chamber tightness to keep occupational exposure under control.
FAQs
Contact Us
Ready to Secure Your Aseptic Transfer Process? Contact our sterilization experts today for a detailed consultation, a custom quote, or to request a comprehensive product datasheet. Let us design the perfect VHP solution for your critical environment.
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- Sterile Isolator.pdf
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- Negative Pressure Filling Isolator.pdf
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- Negative Pressure Isolator.pdf
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