Ensures Dust-Tight Powder Transfer and Containment

The Uni-Cap and Uni-Cap+ from Hanningfield are silicone dust caps designed for effective dust-tight powder transfer and containment, integral to maintaining cleanliness and efficiency in production lines across the pharmaceutical, food and beverage, nuclear, chemical, cannabis, and nutraceutical industries. These systems use a flexible silicone rubber seal, allowing for the controlled charging and discharging of powders, reducing contamination and ensuring safety. Applications include sealing contacts for powdered pharmaceutical drugs, nutritional supplements, protein powders, and more. The Uni-Cap models offer compatibility with various stainless steel mounting rings, while the Uni-Cap+ ensures visibility with its transparent design. Both models meet stringent hygienic standards, are compliant with FDA regulations, and are available with customization options to meet specific operational needs. Easily retrofitted to existing equipment, these caps support both manual and batch operations, providing robust solutions for powder containment challenges.

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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 and Safe Aseptic Processing

The ISOPRIME Isolators from Getinge provide a robust solution for pharmaceutical, biotech, and healthcare facilities requiring stringent sterility and contamination control. Designed with modular rigid-wall systems, the ISOPRIME excels in a range of aseptic and sterile processing applications, including compounding, aseptic filling, and sterility testing. Engineered for continuous operation, these isolators incorporate a validated Siemens PLC for reliable process control and traceability while supporting large-scale production efficiency through versatile airflow options—unidirectional or turbulent.

Suited for a diverse array of end-products like monoclonal antibodies, saline IV bags, and personalized cancer vaccines, ISOPRIME ensures compliance with FDA 21 CFR Part 11. It delivers comprehensive bio-decontamination capabilities through an integrated H2O2 generator, facilitating in-situ cleanliness and safety.

Optimized for ease of access and maintenance, the design features upward-opening doors and convenient electrical cabinet entry points, reducing downtime. Integration with Getinge’s DPTE® transfer system guarantees secure material transfer without breaking containment, while glove leak testing technology ensures operational integrity.

Constructed for resilience, ISOPRIME offers various customization options, including specific ventilation and access configurations, tailored to meet unique production line needs. It supports both liquid and solid product types, making it adaptable across laboratories and processing departments dedicated to cutting-edge medical solutions.

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Ensures Sterile and Contained Transfers

The DPTE®-XS Alpha Port by Getinge offers a robust solution for secure, sterile transfer in challenging environments. Designed to maintain aseptic conditions, this innovative system connects cleanroom or isolator walls to Beta devices like containers or bags, ensuring a leak-tight and contamination-free transfer. With industry applications spanning pharmaceutical production, biotech operations, and chemical sectors, it’s essential for processes like liquid and component transfer, environmental monitoring, and waste disposal. Its integration into existing systems is seamless, minimizing downtime and operational interruption.

A validated DPTE® system features reliable Alpha/Beta connections, supported by FDA-compliant silicone or PVC lip seals, ensuring each transfer is performed with the utmost safety and efficiency. The manual 60° rotation mechanism guarantees a leak-tight seal and secure connections, while its maintenance-free design and sterile, ready-to-use components reduce downtime and maximize production uptime. Designed to comply with stringent international regulations, the DPTE®-XS Port is a trusted choice for any sterile or containment process requiring rigorous quality assurance and reliable expert support.

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Transfers and Contains Sterile and Hazardous Materials

The DPTE® Beta Containers from Getinge are engineered for critical sterile and hazardous material transfers in pharmaceutical and biotech industries. These containers utilize a locking mechanism that ensures seamless bi-directional flow while maintaining containment, critical in aseptic environments. Designed for applications like vaccine and monoclonal antibody production, they support a range of processes, including sterilization and biodecontamination. Compatible with DPTE® Alpha Rapid Transfer Ports, they prevent microbial contamination during material transfers. Offering material options like stainless steel for steam sterilization and polyethylene for gamma or H2O2 sterilization, the containers meet stringent industry standards while ensuring operational efficiency. Options for modular configurations and custom engineering support ensure adaptability to diverse production needs. With autoclavable and configurable options, DPTE® Beta Containers deliver a reliable solution for maintaining sterile conditions in complex production lines.

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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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Processes Cytotoxic and Hygroscopic Pharmaceuticals Safely

The Freeze Dryer & Aseptic Isolator Filling Line from Telstar is engineered to meet stringent pharmaceutical and biotech production needs. This integrated system performs critical tasks such as filling, lyophilization, capping, and crimping of cancer treatment vials and cytotoxic injectables while ensuring aseptic conditions. It employs a sterile multi-chamber configuration with VHP biodecontamination and advanced monitoring systems to maintain operator safety and product integrity. Designed for high potency and hygroscopic products, this equipment handles both batch and continuous operations with precision. It features cold shelf loading and low-temperature air handling units for effective lyophilization, ensuring the stability of delicate compounds. The inclusion of RFID glove testers and advanced isolation units supports seamless integration into existing lines, while compliant with GMP standards. The use of stainless steel construction enhances durability and corrosion resistance, reducing maintenance burdens and ensuring longevity.

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Processes and Lyophilizes Aseptic Vial Fillings

The Sterile Lyophilised Vial Filling Line from Telstar offers cutting-edge solutions for pharmaceutical and biotech companies needing precision in aseptic processing. This line integrates seamless vial filling with advanced lyophilization, ideal for high-potent drugs like monoclonal antibodies and mRNA vaccines. Featuring an automatic row-by-row single-side push-in/pull-out system, it ensures efficient loading and unloading. The system incorporates SCADA for comprehensive process control and real-time monitoring, optimizing production efficiency. Designed with a mushroom-type chamber-condenser isolation valve, it excels in solvent handling and vacuum processing, minimizing contamination risks. The equipment meets stringent GMP standards, ensuring compliance for pharmaceutical applications. With integrated CIP and SIP systems, it offers enhanced cleaning and sterilization efficiency, reducing downtime and ensuring product safety. Customization options cater to specific production needs, supported by expert engineering support from Telstar.

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Fills, Freeze Dries, and Isolates Vials

The Vial Filling Line from Telstar integrates a freeze dryer with an aseptic isolator, addressing the stringent sterility needs for biopharmaceutical and vaccine manufacturing. Designed for high potency drug production, this system automates vial filling, freeze drying, and bio-decontamination processes under Grade A unidirectional airflow. It features an automatic loading and unloading system, reducing manual handling and contamination risk. With integrated temperature and humidity control, and RFID glove testing, it ensures precise environmental conditions for handling sensitive products like trastuzumab and live attenuated vaccines. Compliant with GMP standards, the line supports remote monitoring and offers reliable isolation with return BIBO HEPA filters. Installation supports seamless integration into existing production lines, providing operational efficiency and scalability.

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