Sterilizes Heat and Moisture Sensitive Products

The GEE Ethylene Oxide (EO) Sterilizers from Getinge are tailored for healthcare facilities and manufacturers requiring precise sterilization of heat and moisture-sensitive products. This system utilizes a low-temperature EO process capable of sterilizing packed and palletized goods efficiently, preserving packaging integrity and product properties.

Equipped with a PLC automation system (Allen Bradley or Siemens), these sterilizers are designed for seamless integration into your production line with centralized SCADA support for comprehensive monitoring. The flexible data storage and monitoring capabilities cater to specific processing requirements, ensuring compliance with industry standards.

Primarily serving the pharmaceutical, medical device, and healthcare equipment industries, these sterilizers are instrumental in processing surgical sutures, catheters, implantable devices, and electronics like circuit boards. The equipment runs automated and high-speed batch operations suitable for solid and gas product types.

These sterilizers are built with safety in mind, featuring compliance with ATEX regulations and employing redundant safety measures. The chamber design includes a dual gasket for airtight sealing, even in varying pressure conditions, supported by external vaporization of liquid EO.

GEE sterilizers boast components for effective load handling without operator entry into the EO chamber, while also allowing customization to your facility layout and workflow. The system’s robust vacuum pumps facilitate rapid EO removal, and the chamber recirculation system ensures optimal gas and temperature distribution for reliable sterilization results, supporting a safe and efficient sterilization process across various applications.

The post Etilén-oxidos sterilizálás hőérzékeny orvosi termékekhez appeared first on Holimex Hungary.

Sterilizes and Dries Parenteral Liquid Products

The SteriDelta A from Telstar is a steam and air mixture sterilizer specifically engineered for processing large batches of parenteral solutions and diverse pharmaceutical products. It utilizes a modular and compact design facilitating seamless integration into existing production lines with minimal downtime. By incorporating an air recirculation system, the SteriDelta A ensures uniform steam and air distribution, effectively sterilizing and drying complex packaging formats such as pre-filled syringes and vials. This autoclave handles a range of liquid products including sterile saline solutions, injectable antibiotics, and monoclonal antibody therapies, maintaining compliance with stringent GMP and European regulatory standards. The system features automatic batch processing, enhanced by a user-friendly PLC-driven interface for robust control and monitoring. It is constructed with corrosion-resistant materials, offering durability and extended operational life, and is equipped with a CIP system to ensure efficient, contamination-free cleaning between cycles. Telstar provides engineering support for customizing solutions to meet specific production requirements, ensuring each unit is tailored for optimal performance in pharmaceutical and biotech manufacturing environments.

The post Gőz és levegő keverék sterilizátor parenterális oldatokhoz appeared first on Holimex Hungary.

Sterilizes and Conditions Liquid Pharmaceuticals

The SteriDelta W from Telstar is a superheated water shower sterilizer designed specifically for the sterilization of parenteral drugs and liquid pharmaceuticals in pharmaceutical and biopharmaceutical industries. This equipment leverages a high-flow recirculation system with a sanitary pump and heat exchanger to effectively sterilize, heat, and cool batches, ensuring containers emerge moist yet sterile. Ideal for processing liquid pharmaceuticals, the SteriDelta W showcases a compact and modular design, allowing seamless integration into existing production lines and ensuring compliance with European standards such as PED and CE marking. The design supports automatic operations and offers efficient sterilization cycles suitable for high-speed processing environments. Furthermore, its user-friendly features, including easy validation and maintenance, make it a versatile choice for demanding production conditions.

The post Túlhevített vízzuhanyos sterilizátorok parenterális oldatokhoz appeared first on Holimex Hungary.

Sterilizes Medical Devices Using Ethylene Oxide

The SteriEtox from Telstar is a sophisticated ethylene oxide sterilization system designed for the medical devices sector. It uniquely addresses the sterilization challenges of thermo-sensitive products such as syringes, catheters, and pacemakers by maintaining their integrity through precise ethanine oxide exposure. The system features an integrated process that includes preconditioning, aeration, and seamless loading and unloading operations, ensuring continuous and automated processing. With a focus on safety and efficiency, the SteriEtox is designed to comply with stringent regulatory requirements while offering flexibility through customizable cycles tailored to specific device configurations. This system supports parametric release, enhancing throughput in high-demand environments. Its construction boasts options for stainless steel components, ensuring corrosion resistance and durability, while Telstar’s engineering support provides tailored solutions to meet unique production needs.

The post Etilén-oxid sterilizátorok orvosi eszközökhöz appeared first on Holimex Hungary.

Performs Sterilization of Diverse Pharmaceutical Products

The SteriMega Plus from Telstar is a saturated steam sterilizer designed to handle a wide range of materials, including solid, porous, and liquid products, critical in pharmaceutical and biotech manufacturing. Its high-performance steam sterilization process conforms with GMP standards and European certifications like EN 285 and PED, ensuring regulatory compliance. With customizable options, this equipment offers versatility to address specific production needs, making it suitable for sterilizing ampoules, syringes, culture media, and more.

Incorporating advanced automation, the SteriMega Plus seamlessly integrates into existing production lines, offering PLC control for efficient operation. Its robust design supports batch, pilot, and continuous operations. Material options like stainless steel enhance durability and corrosion resistance. Equipped with a CIP (Clean-In-Place) system, it simplifies maintenance and ensures minimal downtime, solidifying its role as a reliable asset in ensuring sterility and product safety in critical production environments.

The post Telített gőzsterilizátor gyógyszeripari gyártáshoz appeared first on Holimex Hungary.

Sterilizes Medical Devices and Hygroscopic Products

Ethylene oxide sterilization chambers from Telstar provide crucial sterilization solutions for the pharmaceutical and medical device industries. These turnkey chambers use ethylene oxide gas and vaporization for a thorough sterilization process, ensuring the safety of medical devices, intravenous solutions, and lyophilized vaccines. Featuring an automatic loading and unloading system, these chambers integrate seamlessly into production lines. Equipped with a SCADA system, they offer precise control over preconditioning, sterilization, and aeration phases. Their robust design supports compliance with strict GMP standards, and they include options for customizing chamber size and configurations to meet specific operational needs. The system’s connection to air purification systems ensures operator safety and environmental compliance, making it an essential component in maintaining sterile production environments.

The post Sterilizáló kamrák orvosi eszközök sterilizálásához appeared first on Holimex Hungary.

Sterilizes and Depyrogenates Glassware and Products

The PyroMega Dry Heat Sterilization and Depyrogenation Oven from Telstar is your solution for precision thermal processing in sterile production environments. Specially designed for industries such as pharmaceuticals, biotech, and medical devices, this oven effectively sterilizes and depyrogenates materials like glassware, surgical instruments, and sterile saline solutions. Employing dry heat technology, it eliminates pyrogens on glass surfaces, vital for contamination-free products such as ampoules, syringes, and laboratory pipettes.

This equipment supports both batch and continuous operations, making it versatile for varying production scales. Integration with existing systems is seamless, thanks to its advanced PLC control that offers remote monitoring capabilities, ensuring seamless compatibility with your production line.

The oven operates with high energy efficiency, significantly reducing power consumption through optimized heating design. Built with durable materials, it withstands high temperatures necessary for depyrogenation, while meeting stringent GMP and FDA standards for quality assurance. Routine cleaning is simplified with its straightforward design, minimizing downtime and ensuring consistent performance.

Additionally, Telstar provides customization options, engineering support, and a comprehensive range of accessories such as custom-made trays and carts to tailor solutions to your exact needs. Align with Telstar for a sophisticated and reliable approach to sterilization and depyrogenation processes.

The post Száraz hővel történő sterilizálás és depyrogenizáló kemence üvegárukhoz appeared first on Holimex Hungary.

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.

The post Aszeptikus feldolgozásra szolgáló, korlátozott hozzáférésű sorompórendszerek appeared first on Holimex Hungary.

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.

The post Sterilitásvizsgálati izolátor gyógyszeripari folyamatokhoz appeared first on Holimex Hungary.

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.

The post Aszeptikus gátszigetelők gyógyszeripari alkalmazásokhoz appeared first on Holimex Hungary.