Controlled and Safe Processing for Active Pharmaceutical Ingredient Manufacturing
During peptide manufacturing, the handling and dissolution of crude materials may create occupational-exposure risks, particularly when powders, highly potent substances, or process solvents are involved.
The Tailin Containment Isolator for Crude Peptide Dissolution provides an enclosed workspace specifically designed for crude peptide dissolution during API processing. It combines high-level exposure control, continuous liquid dispensing, and fully explosion-proof protection within one integrated platform.
OEB5 Containment Design
The isolator meets OEB5 design requirements with an Occupational Exposure Limit below 0.1 µg/m³.
Its enclosed operating environment helps contain peptide powders and highly potent materials within the working chamber, supporting:
- Reduced direct operator contact with process materials;
- Controlled powder dispersion within the production area;
- Lower cross-contamination risk;
- Safer weighing, feeding, and dissolution operations.
Integrated 8Y one-piece gloves enable operators to perform procedures inside the chamber without directly contacting the contained materials.
Integrated Liquid-Dispensing Container
A key feature of the system is its integrated liquid-dispensing container, which supports continuous weighing and feeding operations.
This configuration facilitates the controlled addition of liquid during dissolution, reduces material-transfer steps, and helps maintain process continuity. Performing these activities within one enclosed system also reduces the need to open the isolator and minimizes potential material release.
Fully Explosion-Proof Design
Crude peptide dissolution may involve solvents or operating conditions with potential ignition risks. The isolator therefore incorporates a fully explosion-proof design meeting EX d II BT4 requirements.
Its main explosion-proof components include:
- LED lighting;
- Blower;
- Electrical socket;
- Computer.
This design improves operational safety in solvent-handling processes. The final equipment configuration should be selected according to a detailed process-risk assessment and the conditions at the installation site.
HEPA Air-Control System
The isolator is equipped with:
- An H13 cartridge HEPA filter;
- An H14 PUSH–PUSH HEPA filter.
This filtration arrangement supports particle control during processing and helps manage exhaust air before it is discharged from the system.
The PUSH–PUSH configuration facilitates filter replacement in applications requiring rigorous containment, helping reduce potential contact with hazardous material retained by the filter.
Closed Material Transfer
An integrated continuous liner system supports the enclosed transfer of materials and waste into or out of the isolator.
This solution helps:
- Maintain containment during material transfer;
- Minimize the release of peptide powders;
- Reduce operator exposure;
- Support safer material and waste collection.
Secure Construction and Clear Visibility
All isolator doors are fitted with inflatable seals to maintain enclosure integrity. Observation windows are manufactured from 15 mm thick tempered glass, allowing operators to monitor processes clearly while preserving the containment performance of the working chamber.
An exhaust outlet is installed on top of the isolator and connected to outdoor exhaust piping, supporting controlled air discharge in accordance with the facility design.
Applications
The system is specifically designed for:
- Crude peptide dissolution during API processing;
- Weighing and feeding peptide materials;
- Handling highly potent powder materials;
- Operations requiring continuous liquid addition under containment;
- Solvent-based processes requiring explosion-proof equipment;
- Applications requiring OEB5-level exposure control.
Technical Specifications
| Parameter | Specification |
|---|---|
| Containment level | Designed to meet OEB5 requirements |
| Occupational Exposure Limit | OEL < 0.1 µg/m³ |
| Explosion-proof design | Fully explosion-proof, meeting EX d II BT4 |
| Fresh-air supply volume | ≥ 100 m³/h |
| Clean compressed air | 0.6 MPa ≤ P ≤ 0.8 MPa |
| Power supply and consumption | 380 V, 1.5 kW |
| Overall dimensions | 3,600 × 1,350 × 3,200 mm (L × W × H) |
| Operation chamber dimensions | 1,800 × 750 × 800 mm (L × W × H) |
| Net weight | 500 kg |
| Doors | Fitted with inflatable seals |
| Observation windows | 15 mm thick tempered glass |
| Exhaust system | Exhaust outlet on top of the isolator, connected to outdoor piping |
An Integrated Platform for Safe Peptide Dissolution
The Tailin Containment Isolator combines OEB5 containment, continuous liquid dispensing, HEPA filtration, closed material transfer, and fully explosion-proof protection in one integrated system.
It is an effective solution for API manufacturing facilities seeking to protect personnel, control material dispersion, and improve safety during crude peptide dissolution.
