Applications and Benefits of Tailin Containment Isolator for Handling High-Potency Materials

 

In modern pharmaceutical production, especially when dealing with highly active pharmaceutical ingredients (HPAPIs), operator safety and product integrity are paramount. To address these critical concerns, Tailin SciTech has developed advanced containment isolators that provide robust protection during high-risk operations such as weighing, dispensing, and sampling. These systems are engineered to meet the highest containment standards—reaching up to Occupational Exposure Band 5 (OEB5)—ensuring both personnel safety and environmental control.

What Is a Containment Isolator?

Definition and Core Functionality

A containment isolator is a sealed, controlled environment designed to isolate operators from hazardous substances while maintaining a contamination-free workspace. Unlike traditional cleanrooms or fume hoods, containment isolators offer superior protection through physical separation, negative pressure control, and integrated filtration systems (typically HEPA or ULPA filters).

Tailin’s containment isolators are specifically optimized for handling high-potency, cytotoxic, or allergenic compounds, commonly used in oncology drugs, hormone therapies, and advanced therapy medicinal products (ATMPs). The system ensures that no airborne particles escape into the surrounding environment, thereby minimizing cross-contamination risks and safeguarding worker health.

Key Applications in the Pharmaceutical Industry

1. Weighing and Dispensing of HPAPIs

One of the most critical—and risky—steps in drug manufacturing is the manual handling of potent powders. Even microgram-level exposures can pose serious health hazards. Tailin’s containment isolators provide a fully enclosed workspace where operators can perform precise weighing and dispensing using glove ports or robotic arms, all under continuous negative pressure and real-time air monitoring.

2. Sampling and Quality Control

During batch testing or quality assurance procedures, samples must be extracted without compromising containment. Tailin’s isolators integrate Rapid Transfer Ports (RTPs) and sterile transfer systems that allow safe passage of materials in and out of the isolator without breaking containment—a feature essential for maintaining both sterility and safety.

3. Support for ATMP and Biopharmaceutical Research

With over 1,300 units deployed globally, Tailin’s technology supports cutting-edge research in Advanced Therapy Medicinal Products (ATMPs), including gene and cell therapies. In these sensitive applications, containment isolators not only protect personnel but also preserve the biological integrity of the product by preventing microbial or particulate contamination.

Technical Advantages of Tailin Containment Isolators

Superior Containment Performance

Tailin’s isolators are validated to achieve containment levels suitable for OEB5 compounds, the most stringent classification for occupational exposure. This is accomplished through:

• Leak-tight construction with welded seams
• Dual HEPA filtration on exhaust air
• Continuous pressure differential monitoring
• Automated decontamination cycles using hydrogen peroxide vaporization

Integration with Decontamination Systems

Complementing its isolators, Tailin offers hydrogen peroxide vapor (VHP) decontamination technology, which enables rapid, residue-free sterilization of internal surfaces at room temperature. This ensures consistent microbiological control between batches and reduces downtime.

User-Centric Design

Ergonomic glove placements, intuitive control panels, and modular configurations allow seamless integration into existing workflows. Optional features include:

• Integrated balances and powder dispensers
• Real-time particle counters
• Data logging for regulatory compliance (e.g., FDA 21 CFR Part 11)

Regulatory Compliance and Industry Standards

Pharmaceutical manufacturers operate under strict regulatory frameworks, including guidelines from the FDA, EMA, and ISPE. Tailin’s containment isolators are designed to comply with:

• ISO 14644 (cleanroom classification)
• ISO 10993 (biocompatibility for medical devices)
• GMP Annex 1 requirements for aseptic processing

This compliance ensures that facilities using Tailin equipment can pass audits confidently and maintain uninterrupted production.

Tailin has always adhered to the vision of “Leading Innovation” and the mission of serving human health and benefiting the world. By leveraging cutting-edge technology and uncompromising quality, we have earned long-term trust from customers both domestically and internationally. Moving forward, we will continue to invest in research and development, expand our international market presence, and deliver more efficient and intelligent life science solutions. Our goal is to empower global industries, from pharmaceuticals to food safety, with robust technological support. We firmly believe that the power of science and collaboration will drive Tailin toward a new era of growth and innovation. We invite you to explore collaboration opportunities via our website, phone: +86‑571‑8658 9087, or email: marketing@tailingood.com. Follow Tailin on Facebook to stay updated on our latest advancements and share in our journey toward shaping the future of life sciences.

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