The XLTC800 isolator provides advanced protection for pharmacies, hospitals, and laboratories involved in hazardous drug (HD) handling and sterile compounding. Engineered for precise airflow control and contamination containment, the XLTC800 ensures both operator safety and product sterility in accordance with USP <797> and USP <800> standards.

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Unmatched Contamination Control for Hazardous Drugs

Handling hazardous drugs requires rigorous engineering controls. The XLTC800 isolator incorporates a high-performance HVAC system that maintains critical positive and negative pressure zones to prevent particulates from contaminating the compounding environment.

Key design features include:

• Unidirectional airflow from top to bottom to maintain laminar conditions.

• Controlled airflow between chambers to reduce cross-contamination risks.

• High-efficiency particulate air (HEPA) filtration for ISO5 compliant environments.

Through these features, the XLTC800 dramatically reduces exposure risks from spills, airborne particulates, and surface contamination compared to traditional pharmacy cleanroom setups with open BSCs and negative pressure.

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Three-Chamber Design for Maximum Safety

The XLTC800 consists of three specialized chambers, each serving a distinct function in the sterile compounding workflow:

1. Containment Vented Enclosure (CVE)

The CVE is the most negative-pressure chamber. It is used for:

• Unpacking hazardous drugs safely

• Staging and temporary storage of materials

• Bag-out preparation to minimize operator exposure

By maintaining negative pressure, the CVE ensures that hazardous drug vapors and particulates cannot escape to the surrounding workspace.

2. Containment Secondary Engineering Control (C-SEC)

The C-SEC is an ISO5-compliant chamber designed for:

• Surface wipe-down of incoming materials

• Preparation of materials before transfer into the primary compounding area

The C-SEC acts as a buffer zone, reducing contamination risks during the transition from unpacking to direct compounding.

3. Containment Primary Engineering Control (C-PEC)

The C-PEC is the positively pressurized ISO5 chamber where direct sterile compounding occurs. It provides:

• Maximum protection for compounded products

• Minimal risk of contamination from airborne particulates

• Optimized workflow for hazardous drug preparation

By integrating pressurization and controlled airflow, the XLTC800 allows operators to work confidently in compliance with USP <797> and <800> guidelines.

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Optimized Airflow and Pressurization

The XLTC800’s airflow management system is designed to maintain strict separation between chambers while ensuring smooth material transfer. Benefits include:

• Reduced cross-contamination between containment zones

• Consistent ISO5 conditions throughout the C-SEC and C-PEC

• Enhanced sterile product protection without compromising operator safety

A smoke demonstration test shows precise unidirectional airflow from top to bottom, confirming the isolator’s ability to maintain sterile conditions and prevent hazardous drug exposure.

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Comparison with Traditional Cleanroom Setups

Compared to standard cleanroom layouts with open BSCs and negative pressure:

This comparison highlights the safety and efficiency advantages of the XLTC800 for sterile compounding of hazardous drugs.

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Key Benefits of the XLTC800

1. Enhanced Particulate and Contamination Control
   The isolator’s multi-chamber airflow system minimizes particulates, reducing the risk of contamination for both operators and compounded products.

2. Optimized Airflow Between Chambers
   Controlled pressure differentials ensure safe material transfer, with negative pressure in the CVE and positive pressure in the C-PEC.

3. Safe Handling of Hazardous Drugs
   Operators can handle cytotoxic and hazardous drugs in ISO5 conditions with minimal exposure risk.

4. Improved Sterile Product Protection
   ISO5 laminar airflow and HEPA filtration maintain sterility standards for compounded preparations.

5. Compliance with USP <797> and <800>
   The isolator is fully compatible with regulatory requirements, supporting safer, compliant sterile compounding workflows.

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Ideal Applications

The XLTC800 is suitable for:

• Pharmacies compounding chemotherapy or hazardous medications

• Hospitals managing high-risk sterile preparations

• Laboratories conducting sterile research with hazardous compounds

Its design ensures safe handling of hazardous drugs, reduces exposure risk, and provides regulatory-compliant sterile compounding environments.

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Operator Safety and Ergonomics

The XLTC800 prioritizes user safety and comfort:

• Glove ports and arm access reduce direct contact with hazardous drugs

• Clear chamber visibility supports precise manipulations

• Ergonomic layout minimizes strain during extended compounding sessions

• Continuous airflow monitoring provides real-time verification of ISO5 conditions

By combining safety and efficiency, the XLTC800 enables operators to focus on accuracy and compliance without compromising health.

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Installation and Maintenance

The XLTC800 is designed for ease of integration into existing sterile compounding workflows:

• Plug-and-play HVAC connections for rapid setup

• HEPA filter replacement without exposure to hazardous residues

• Remote airflow and pressure monitoring for compliance reporting

• Durable materials and surfaces for routine cleaning and disinfecting

Maintenance procedures are optimized to minimize downtime while preserving safety standards.

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Why Choose the XLTC800 Isolator

Selecting the XLTC800 provides:

• Proven contamination control superior to traditional BSCs

• Regulatory compliance with USP <797> and <800>

• Reduced occupational exposure for pharmacists and lab technicians

• Enhanced workflow efficiency with multi-chamber design

It represents a next-generation solution for pharmacies and laboratories that require both hazardous drug containment and sterile compounding excellence.