Fills and Seals Liquid Products Hygienically

The FS211 Clean-Fill by OMVE is a bench-top hygienic filling and closing solution crafted in stainless steel, facilitating sterile operations essential for diverse industries. It leverages an automated aseptic control system with a foot pedal-operated integrated filler and CIP/SIP processes. Tailored for applications in dairy, beverages, and nutraceuticals, it seamlessly handles products like almond milk, sparkling water, and soups, ensuring contamination-proof packaging in PET, HDPE, glass, and cans. With a user-friendly TFT touchscreen, you can easily set and monitor critical control points like sterilization temperature and filling accuracy. Additionally, its HEPA 14 filter enhances operational cleanliness while its modular design allows easy integration into existing lines. Engineered for reliability, it supports a smooth transition from pilot-scale to full-scale production, complying with industry standards and enabling efficient cleaning cycles to maintain optimum sterility.

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Controls and Isolates Hazardous Material Processing

The containment and isolation systems from Hosokawa Micron Ltd. are designed for sectors where safety and environmental protection are paramount. Known for their robust design and integration capabilities, these systems control and isolate hazardous materials during processing, ensuring optimal safety and compliance. They feature gloveboxes and downflow booths that support industries such as pharmaceuticals, chemicals, and nuclear fuel processing, making them essential for handling APIs, catalysts, and battery materials.

With precise filling and weighing systems, these solutions accommodate continuous, pilot, and manual operations, integrating seamlessly with existing production lines. Their automation capabilities allow for efficient process control and remote monitoring, enhancing operational efficiency and safeguarding personnel. Constructed from corrosion-resistant materials, these systems maintain integrity in challenging environments and are compliant with GMP standards for pharmaceuticals.

Additionally, the systems support efficient cleaning through CIP/SIP technologies, streamlining maintenance and reducing downtime. Hosokawa Micron provides comprehensive engineering support and customization options, ensuring tailored solutions for complex processing challenges.

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Filters and Shields Radiochemistry Processes

The FHR1 50 LAF Shielded Radiochemistry Laminar Flow Fume Hood by Comecer is engineered for safe handling of medium activity radiochemicals in nuclear medicine and radiopharmaceutical labs. This equipment features a laminar air flow system with HEPA and charcoal filtration to ensure containment and purity of manipulation processes involving radiolabeled gases and liquids, such as Fludeoxyglucose (FDG) and Iodine-131.

Designed with AISI 316L stainless steel and incorporating 50 mm of lead shielding throughout key surfaces, the fume hood offers robust protection against radioactive exposure. Its lead glass window facilitates safe visual supervision of operations.

Integration of a bag-in bag-out system allows for secure and straightforward filter changes, while on-board gauges provide real-time monitoring of air quality and filter status, aligning with ECC-GMP directive flow speed requirements. Ideal for laboratory scale operations, the FHR1 50 LAF ensures compliance with strict cleaning and contamination control standards, supporting research, production, and safety in radiopharmaceutical environments.

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Ensures Sterile Conditions and Effective Containment

The FHB-10 Laminar Flow Hood with Lead Glass from Comecer is engineered to meet the stringent demands of sterile environments in industries like pharmaceuticals, biotechnology, and nuclear medicine. This laminar flow hood features a HEPA filtration system and meticulously regulated air flow to maintain a contaminant-free workspace, essential for processes such as CAR T-cell therapy production and chemotherapy compounding. Designed for both manual and continuous operations, it efficiently handles both liquid and gas applications, ensuring reliable containment. Its robust construction includes an epoxy-coated steel structure and removable AISI 304 stainless steel worktops, offering excellent corrosion resistance. Coupled with shielded lead glass, it provides additional protection while maintaining visibility. The FHB-10 is compliant with EN 12469 safety standards, ensuring it meets industry requirements. Additionally, its design allows for easy cleaning and maintenance, essential for ensuring operational efficiency and product safety. Customization options are available to cater to unique production needs, supported by Comecer’s engineering expertise.

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Unloads and Isolates Lyophilised Products

The Two Lyophiliser Unloading Isolators from Telstar offer specialized solutions for handling and unloading hygroscopic products post-freeze drying. These isolators are designed to provide low moisture control using dry N2 with precise dew point regulation. Ideal for pharmaceutical manufacturers and biotech companies, the equipment ensures safe manipulation of lyophilized vaccines, drugs, sterile injectables, and aseptic vials. With a structure comprising a left-hand chamber, middle pass chamber, and right-hand chamber, each with multiple glove ports, it facilitates seamless operation and prevents contamination. Fully compliant with GMP standards, these isolators support integration into existing aseptic and multi-chamber operations, offering engineering support for custom configurations.

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Ensures Sterile Environment for Drug Production

The Aseptic Barrier Isolators from Telstar are designed to meet the stringent demands of pharmaceutical and biotech production. These isolators are crucial for maintaining sterility in processes involving vaccines, oncology drugs, and protein-based biologics. The system incorporates advanced filtration and environmental monitoring to ensure compliance with ISO and GMP guidelines. Constructed from 316 stainless steel and toughened safety glass, these isolators offer robust protection against contamination while facilitating aseptic transferring and bio-decontamination. Capable of integrating with OEM and third-party equipment, the isolators support seamless production line automation and high-speed operations. With validated Log 6 bio-decontamination and options for customizing airflow systems, Telstar provides tailored solutions that enhance product and operator safety, reduce downtime, and ensure regulatory compliance.

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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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Separates Operators from Critical Aseptic Environments

Telstar’s Restricted Access Barrier Systems (RABs) are designed to optimize aseptic processing by creating a high level of separation between operators and critical environments in pharmaceutical production. These systems are essential for manufacturing sterile injectable drugs, vaccines, and various biologics, offering a unique combination of physical barriers and dynamic airflow. RABs can be tailored to integrate with third-party equipment, ensuring compliance with GMP and current regulatory standards. They feature unidirectional laminar flow (active RABs) to maintain an ISO 5 positive pressure environment, crucial for protecting sensitive processes. With aseptic transfer capabilities for powders and liquids, and advanced environmental monitoring systems, these units are ideal for cleanrooms requiring enhanced sterility without the need for fully leak-tight isolators. Telstar supports customization and offers technical assistance, ensuring the RABs meet specific operational needs while facilitating ease of cleaning and maintenance through integrated systems.

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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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