Freeze Dries Small-Batch Biopharmaceuticals

The MINIMAX Small-Scale Freeze Dryer from IMA Life is a GMP-compliant solution designed to tackle the challenges of handling small production batches in the pharmaceutical and biotech industries. Built on the successful LYOMAX industrial freeze dryer concept, it offers unparalleled precision in moisture removal for sensitive biopharmaceuticals, such as vaccines, monoclonal antibodies, and gene therapy products.

This versatile lyophilizer features a compact and modular design, ideal for pilot-scale and small-scale production. It operates using process analytical technologies (PAT) for optimal monitoring and control, ensuring consistent drying outcomes and high product quality. With shelf areas ranging from 1.0 to 3.9 m² and an ice condenser capacity from 29 to 78 kg, the MINIMAX efficiently scales processes up to full commercial production.

Integration options include automation with vial-loading systems, PLC control, and compatibility with isolation technology for high-potent product handling. The unit is pre-arranged for more complex applications, such as processing non-aqueous solvents. Made with IMA Life’s proprietary FUSION™-FUSION PLUS™ technology, its shelves enhance heat transfer and offer robust resistance.

The Freeze Dryer supports extensive data collection, aiding in quick drug commercialization and allowing seamless adaptation to GMP standards. A built-in CIP-SIP system ensures effective cleaning and maintenance, minimizing downtime. Furthermore, options for monitoring tools like Veriseq™, a Quantum mass spectrometer, and WiSe wireless sensors enable precise control over every batch process, maximizing uptime and operational efficiency.

The post Small-scale freeze dryer for pharmaceutical applications appeared first on Making.com.

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 Superheated water shower sterilizers for parenteral solutions appeared first on Making.com.

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 Sterilization chambers for medical device sterilization appeared first on Making.com.

Fills Lyophilized Pharmaceuticals with Precision

The Sterile Lyophilised Filling Line from Telstar is designed specifically for pharmaceutical and biotech manufacturers, ensuring sterile and precise filling of lyophilized pharmaceuticals such as monoclonal antibodies and injectable drugs. This engineered-to-order system features a multi-chamber design that facilitates seamless integration into existing production lines, addressing stringent regulatory requirements with GMP compliance. The line’s high-accuracy weighing and filling capabilities ensure consistent dosing, minimizing product wastage and contamination risks. With automated PLC controls, it allows for remote monitoring and integration with upstream and downstream processes. Constructed from high-grade stainless steel, it offers excellent corrosion resistance and is equipped with a CIP system for efficient cleaning, reducing downtime and ensuring continuity in production. Customizable elements, such as chamber sizes and throughput rates, ensure that the system can be tailored to your specific production needs, accommodating various pharmaceutical powders, lyophilized vaccines, and controlled-release formulations.

The post Sterile lyophilised filling solution appeared first on Making.com.

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.

The post Two lyophiliser unloading isolators for hygroscopic products appeared first on Making.com.

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 Aseptic barrier isolators for pharmaceutical applications appeared first on Making.com.

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.

The post Containment isolators for pharmaceutical and biotech applications appeared first on Making.com.

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 Restricted access barriers systems for aseptic processing appeared first on Making.com.