Isolators for Stem-Cell/Cell Culture/Live Viruses, Specialized Isolators

Specialized Isolators for Critical Applications

Specialized isolator systems are essential for handling sensitive, high-risk, or contamination-sensitive processes across multiple industries, especially where high containment levels are required. The Shree Bhagwati Group provides custom solutions tailored for various critical processes involving hazardous, biologically active, or radioactive substances.

Overview of the different specialized isolators designed for specific applications:

Key Features of Specialized Isolators

1. Automatic Leak Test:
   • ISO 10648-2 (5.2) Pressure Change Technique: All isolators come with an automatic leak testing system that performs an independent leak test for each chamber, ensuring the isolator’s integrity.
2. High Containment Standards:
   • Ensures total containment and operator safety through engineered containment systems, particularly in critical applications like cell culture, radiopharma, and vaccine production.

Types of Specialized Isolators

1. Isolators for Stem-Cell/Cell Culture/Live Viruses

• cGMP Class A/ISO 5 Environment: These isolators provide a sterile, contamination-free environment for cell culture operations, ideal for stem-cell work, gene therapy, and viral vector production.
• Bio-Decontamination: Equipped with integrated bio-decontamination systems (e.g., H2O2 vapor), these isolators ensure a 6-log bacterial reduction to maintain sterility during processes like transduction and activation of non-infectious viruses.
• Full Equipment Integration: Includes incubators, digital microscopes, centrifuges, and refrigerators for a seamless, fully integrated system.
• Exhaust Air Filtering: The exhaust air is treated with hot air to eliminate any viruses missed by the filters, ensuring additional safety.

2. Isolators for Nuclear/Radiation/Radiopharma Applications

• Lead Shielding: The work area is lined with lead shielding on all sides (back, sides, bottom, and front) to protect operators from radiation exposure.
• USP 797 Compliance: These isolators comply with USP 797 standards without the need for extensive cleanroom ventilation upgrades, thus offering significant cost savings.
• Enclosed and Regulated Environment: Filtration systems for supply and exhaust air provide complete environmental control, ensuring safe handling of radiopharmaceuticals.
• Negative Pressure Chamber: The isolator operates under negative pressure to prevent any leakage of radioactive substances into the surrounding environment.

3. Walk-In Isolator

• Ease of Access and Optimized Efficiency: Walk-in isolators allow for easy access and optimize operational efficiency, making them suitable for large-scale operations that require frequent operator entry.
• Leak Test Compliance: Certified for Class 3 Leak Test as per ISO 10648-2, ensuring the system’s containment and integrity.
• Double Protection Airlock: The airlock system features a bubble-type pressure gradient to prevent external contamination, with a gowning area for operator protection.
• Decontamination Shower: The walk-in isolator is equipped with a mist shower for operator decontamination before exiting, ensuring complete decontamination and reducing dust contamination.

4. Flexible Isolators

• Versatility: Flexible isolators provide a portable and easy-to-use containment solution for applications like contained filter changes, inspection, dispensing, vessel charging, drying, and sampling.
• High Containment: Designed for handling active pharmaceutical ingredients (APIs) and other hazardous compounds, these isolators maintain GMP compliance throughout the manufacturing process.
• Operator Access: The flexible nature of the isolators allows for easy operator access while maintaining a high level of containment.

5. VHP Pass Box

• Vaporized Hydrogen Peroxide (VHP) Decontamination: Used for bio-decontamination of materials that cannot be sterilized by heat or steam, like sterile Petri dishes, validation materials, or API containers.
• Log 6 Efficacy: The VHP pass box ensures log 6 efficacy in sterilization, making it highly effective in removing bacterial, viral, and fungal contamination.
• Continuous Monitoring: The process is monitored continuously to ensure flawless performance, providing a sterile transfer pathway for items entering sterile areas.

6. Sterility Test Isolator

• cGMP Class A/ISO 5 Modular System: Specifically designed for sterility testing in compliance with GMP standards.
• Aseptic Environment: Ensures the highest air quality with HEPA H14 filtration, unidirectional airflow, and integrated VHP bio-decontamination for fast and effective sterility cycles.
• Multiple Applications: Besides sterility testing, this isolator can also be used for aseptic dispensing, sampling, and product transfer.

7. Isolators for Poultry Vaccine Manufacturing Process

• Critical for Disease Control: Used in the production of poultry vaccines, which are crucial in preventing diseases such as avian influenza and Newcastle disease.
• Cost and Production Efficiency: Designed to optimize cost-effectiveness and improve the quality of vaccines through a highly controlled, aseptic environment.
• Regulatory Compliance: Compliant with international regulatory standards to ensure that vaccine manufacturing processes maintain the highest level of safety and efficacy.

Applications of Specialized Isolators:

• Cell Culture and Gene Therapy: For safe handling of live viruses and sensitive biological materials.
• Radiopharmaceuticals: To maintain a controlled environment while working with radioactive compounds.
• Aseptic Testing and Sterility Testing: Ensuring the highest standards of cleanliness and accuracy for pharmaceutical testing.
• Poultry Vaccine Manufacturing: To produce safe and effective vaccines, preventing contagious diseases in poultry.

Benefits of Specialized Isolators:

• Contamination Prevention: Ensures that the process material is isolated from environmental contaminants, safeguarding both the operator and the product.
• Cost-Effective: Walk-in isolators and flexible isolators reduce the need for extensive cleanroom environments, offering cost savings while maintaining high levels of containment.
• Operator Safety: Through the integration of personal protective equipment (e.g., air-fed suits, gloves, breathing accessories) and bio-decontamination systems, operators are protected from harmful substances during the process.
• Enhanced Process Efficiency: Automatic decontamination, integrated monitoring, and a modular design allow for seamless integration with existing production systems, boosting operational efficiency.
• GMP Compliance: All isolators comply with FDA, ISO, and cGMP standards, ensuring regulatory adherence and high product quality.

Conclusion

Shree Bhagwati Group’s Specialized Isolators are meticulously engineered for critical applications that require high levels of containment and operator safety. Whether you are working with live viruses, radiopharmaceuticals, stem cells, or vaccine production, these isolators ensure a sterile, safe, and efficient environment that meets the stringent standards of modern pharmaceutical and biotechnological industries.