Aseptic production isolation
Aseptic production isolation
Aseptic Production Isolation System
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.
Product Overview
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.
Core Features
Aseptic Assurance
Through HEPA/ULPA efficient filtration systems and laminar airflow design, provides a continuously stable GMP Grade A clean environment, effectively preventing microbial contamination.
Multi-functional Processing
Capable of processing various pharmaceutical containers including IV bags, vials, syringes, bottles, or dry powder, adapting to production needs of different drug formulations.
Flexible Deployment
Can be deployed in various environments including pharmaceutical laboratories, R&D departments, and manufacturing facilities, meeting full-process requirements from R&D to production.
Human-Machine Isolation
Achieves complete human-machine isolation through physical barriers and glove operation systems, reducing risk of human contamination while protecting operator safety.
Intelligent Control
Integrated advanced PLC control system enables real-time monitoring of production parameters, data recording, and alarm management, complying with regulatory requirements.
Rapid Changeover
Supports quick switching between different product specifications, reducing equipment cleaning validation and production changeover time, improving equipment utilization.
Application Fields
The aseptic production isolation system is widely used in the following pharmaceutical and production processes:
- Liquid injection (small volume injectable) filling and sealing
- Aseptic filling and lyophilization process of freeze-dried powder injections
- Pre-filled syringe filling and assembly
- Large volume infusion (IV bag) filling production lines
- Filling and weighing of sterile active pharmaceutical ingredients
- Aseptic preparation of cell therapy products
- Aseptic operations of genetic engineering products
- Aseptic filling and packaging of biological preparations
Pharmaceutical Laboratory Applications
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.
R&D Department Applications
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.
Manufacturing Facility Applications
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.
Technical Specifications
| 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) |
Deployment Solutions
Pharmaceutical Laboratories
Provides standardized Grade A clean environment for drug sterility testing and microbial detection, ensuring the accuracy and professionalism of test results.
R&D Departments
Supports small-batch trial production, formulation and process research in new drug development, providing an aseptic operation platform for innovative drug R&D.
Manufacturing Facilities
Applied in commercial drug production lines, ensuring aseptic assurance in large-scale production environments, improving production efficiency.
Compliance and Certifications
The aseptic production isolation system complies with domestic and international pharmaceutical production quality management regulations and related technical standards:
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