Facilitates Sterility Testing and Bio-Decontamination

The ISOTEST Sterility Testing Isolator from Getinge is engineered for precise sterility testing and bio-decontamination in pharmaceutical and biotechnological operations. This two-person isolator optimizes workflows, enabling continuous operations with dual-operator access. Designed to support diverse applications such as aseptic processing, cell culture, and gene therapy, it facilitates the production of sterile vials, pre-filled syringes, and more.

The isolator integrates a single Siemens PLC control system for process monitoring and offers SCADA integration, enhancing control and traceability. It boasts a high throughput of up to 40 tests per 8-hour shift with rapid bio-decontamination cycles using hydrogen peroxide vapor (HPV). The DPTE-BetaBag® system ensures safe waste handling without compromising isolator integrity. Its design meets industry standards for sterile environments, making it ideal for healthcare facilities, pharmaceutical manufacturers, and research labs.

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Maintains Sterility and Controls Contamination

The ISOFLEX Modular Aseptic GMP Isolator from Getinge is engineered to provide a robust solution for aseptic processing and contamination control in biopharmaceutical and pharmaceutical manufacturing. This isolator stands out with its modular design, allowing customization to fit specific process needs, including sterility testing, bio-decontamination, and repacking. Utilizing engineered turbulent flow or unidirectional airflow, it ensures precise environmental control, meeting Grade A/ISO 4.8 standards necessary for handling sterile APIs or personalized medicines.

The ISOFLEX efficiently supports high-throughput operations, integrating seamlessly into existing production lines with its PLC-based control system from Siemens or Allen Bradley. This system offers user-friendly interfaces for intuitive process monitoring and parameter adjustments. Energy efficiency is enhanced by focusing control within the isolator environment, reducing consumption compared to traditional cleanrooms.

Tailored for various applications, it finds use in producing monoclonal antibodies, insulin analogs, TPN admixtures, and more. The isolator is fully compliant with FDA 21 CFR Part 11 and GMP Annex 11, ensuring adherence to stringent regulatory standards. Optional features like bio-decontamination hatches and adaptable PLC systems underscore its capability to evolve with technological and process requirements, backed by engineering support for unique configurations.

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Ensures Sterility in Pharmaceutical Testing

The Pura 2+ Sterility Test Isolators from Telstar are engineered for pharmaceutical and biotechnology sectors, offering a double-chamber system for continuous sterility testing. The isolators maintain Class ISO 5 (Grade A) air cleanliness, vital for injectable vials and lyophilized pharmaceuticals. These units facilitate controlled sterility testing through a positive-pressure environment and integrated HP+® bio-decontamination, ensuring process integrity. Designed for flexible operations, they allow additional materials to be bio-decontaminated in a transfer chamber while ongoing tests continue in the main chamber. The Pura 2+ prioritizes contamination-free environments with H2O2 monitoring and rigorous glove testing. Fully compliant with GMP standards, it is an ideal choice for manufacturers seeking reliable sterility assurance in batch and continuous production settings.

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Facilitates Aseptic Sterility Testing

The Telstar Pura from Telstar is a precision-engineered sterility test isolator designed to create a reliable aseptic environment. What sets the Pura apart is its robust bio-decontamination system using ionHP+ H2O2, ensuring rapid Log 6 bioburden reduction. This isolator is ideal for pharmaceuticals and biopharmaceuticals, particularly in sterility testing of products like sterile injectables and vaccines. It features PLC control with local HMI and SCADA packages for seamless operation, integrating easily with OEM and third-party equipment. Constructed from durable 316 stainless steel and toughened safety glass, the Pura meets strict ISO and GMP guidelines, making it suitable for Grade D cleanrooms and above. The system supports direct inoculation and filter membrane tests while providing reliable environmental monitoring. Assembly and manufacture are conducted in the UK, ensuring compliance and a high standard of quality. Configuration options allow personalization to meet specific production needs, helping you maintain stringent aseptic standards with ease.

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Ensures Safe Containment and Sterility

Telstar’s Containment Isolators are engineered to deliver unparalleled safety and sterility for pharmaceutical and biotech operations. Designed to protect operators and ensure product integrity, these isolators are ideal for handling hazardous materials and sterile injectable drugs. They integrate seamlessly with existing systems and support both stand-alone and continuous operations. Telstar offers customizable designs, including single and multi-chamber options, tailored to client needs. The isolators boast positive and negative pressure capabilities and are constructed from standardized mechanical and electrical components for reliability. With rigorous OEL containment validation to less than 200 picograms/m³ (OEB 8), they comply with GMP and ISO standards, ensuring suitability for cleanrooms of grade D and above. Built in the UK, these isolators feature energy-efficient solutions and ergonomic designs, and they include worldwide maintenance services to support long-term use.

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Provides Containment and Filters Air for Safety

The Telstar Downflow Booths are designed to meet stringent containment and air filtration requirements across diverse industries such as pharmaceuticals, chemicals, and robotics. Featuring ISO 5 air quality and negative pressure, these booths ensure triple protection for products, operators, and the environment. They are ideal for handling active pharmaceutical ingredients, chemical solvents, and optical components, offering modular customization to fit specific production needs.

Equipped with an efficient air handling system, Telstar Downflow Booths provide continuous contamination control, making them suitable for operations involving hazardous materials. Available in both standard and custom-built modular series, they can be integrated with additional equipment like scales and lifters, enhancing overall production line efficiency.

These booths are fully compliant with ISO 14644-1 and cGMP guidelines, ensuring stringent manufacturing standards are upheld. Designed with user-friendly features such as a complete 3D model and low maintenance requirements, they incorporate green technology options to optimize energy consumption. With ATEX explosion-proof versions, they cater to industries requiring robust safety measures against gas and dust hazards.

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