Pharmaceutical production finishing isolator: capable of processing IV bags, vials, syringes, bottles, or dry powder. TELING filling and finishing isolators are deployed in pharmaceutical laboratories, R&D departments, and manufacturing facilities.
The aseptic production isolation system is a high-end sterile protection solution specifically designed for the pharmaceutical industry, providing professional environmental assurance for laboratories and manufacturing facilities that require strict aseptic conditions for drug production. The system combines physical barriers with advanced airflow control technology to create a continuously stable GMP Grade A clean environment, effectively preventing exogenous contamination.
The pharmaceutical production finishing isolator can process various pharmaceutical containers including IV bags, vials, syringes, bottles, or dry powder, meeting the production needs of different drug formulations. TELING filling and finishing isolators can be deployed in pharmaceutical laboratories, R&D departments, and manufacturing facilities, providing comprehensive solutions for aseptic drug production.
The system adopts a modular design concept, allowing flexible configuration according to different production spaces and process requirements, supporting continuous production line integration. The integrated intelligent control system features real-time environmental monitoring, data recording, and audit trail functions, complying with domestic and international pharmaceutical production quality management regulations.
Through HEPA/ULPA efficient filtration systems and laminar airflow design, provides a continuously stable GMP Grade A clean environment, effectively preventing microbial contamination.
Capable of processing various pharmaceutical containers including IV bags, vials, syringes, bottles, or dry powder, adapting to production needs of different drug formulations.
Can be deployed in various environments including pharmaceutical laboratories, R&D departments, and manufacturing facilities, meeting full-process requirements from R&D to production.
Achieves complete human-machine isolation through physical barriers and glove operation systems, reducing risk of human contamination while protecting operator safety.
Integrated advanced PLC control system enables real-time monitoring of production parameters, data recording, and alarm management, complying with regulatory requirements.
Supports quick switching between different product specifications, reducing equipment cleaning validation and production changeover time, improving equipment utilization.
The aseptic production isolation system is widely used in the following pharmaceutical and production processes:
In pharmaceutical laboratories, the aseptic production isolation system provides a professional Grade A clean environment for drug sterility testing, method validation, and stability studies. The system supports sterility testing methods specified in international pharmacopoeias such as membrane filtration and direct inoculation, ensuring the accuracy and professionalism of test results.
During the drug development phase, the aseptic production isolation system provides an aseptic operation platform for formulation development, process optimization, and small-batch trial production. The system's flexible configurability supports various R&D scenarios, accelerating the new drug development process.
In commercial production environments, the aseptic production isolation system ensures aseptic conditions for large-scale drug filling and dispensing processes, meeting GMP production requirements. The system's high reliability and stability provide assurance for continuous production.
| Cleanliness Level | ISO Grade 5 (GMP Grade A), optional ISO Grade 4 |
|---|---|
| Airflow Pattern | Vertical laminar flow, wind speed 0.45±0.1m/s |
| Filter Configuration | H14 grade HEPA filters, optional ULPA filters |
| Processing Container Types | IV bags, vials, syringes, bottles, dry powder containers |
| Sterilization Method | VHP vaporized hydrogen peroxide sterilization, optional dry fog hydrogen peroxide |
| Control Method | Touchscreen control panel, optional remote monitoring system |
| Power Requirements | 380V±10%, 50Hz, three-phase five-wire system |
| External Dimensions | Customizable according to customer requirements (standard width: 1500-3000mm) |
Provides standardized Grade A clean environment for drug sterility testing and microbial detection, ensuring the accuracy and professionalism of test results.
Supports small-batch trial production, formulation and process research in new drug development, providing an aseptic operation platform for innovative drug R&D.
Applied in commercial drug production lines, ensuring aseptic assurance in large-scale production environments, improving production efficiency.
The aseptic production isolation system complies with domestic and international pharmaceutical production quality management regulations and related technical standards:
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