The latest generation of aseptic freeze dryer with a magnetically driven automatic vial loading system under isolator including inline vial management smart devices will be shown in action
At Achema (Frankfurt August 22-26, 2022), Telstar will be promoting the latest innovative developments in both in line management devices and process analytical technology for pharmaceutical freeze-drying systems and aseptic manufacturing processes, together with integrated process equipment and laboratory integrated management systems.
A prototype featuring a freeze dryer with Lyogistics Zero, Smart Format and Smart R3 under an aseptic isolator will be shown in operation at Achema, to illustrate some of technologically advanced aseptic process integrated systems & services range developed by Telstar displayed at the event. Lyogistics Zero is the only automatic vial loading & unloading system for freeze-drying processes which can be cleaned (CIP) and sterilised (SIP) in place, inside the freeze-dryer chamber. Lyogistics Smart Format is a new system using a single mobile platform configured to automatically fit a wide range of vial sizes without the need to disrupt the isolated enclosure. There is no need for manual operations inside the aseptic area when changing formats and no line clearance operations are required.
Lyogistics Smart R3 is an innovative automated inline vial management device with a small footprint, able to reject, reintroduce and retrieve vials during the loading / unloading for GMP freeze-dryers.
A new system capable of monitoring the advance of the sublimation front in real time in GMP freeze-dryers will also be introduced at Achema. A single-use probe, containing 5 independent temperature sensors which are placed within the vial, including wireless communication, makes it an innovative system able to monitor the advance of the sublimation front accurately, key to optimise the primary drying steps in lyophilisation processes. The new Sublime system offers five measuring points integrated in each probe, being able to read accurately information of temperature at various levels of the product in real time when the sublimation takes place. The sensor has been designed as a single use device. After being placed in the vial it comes into direct contact with the product and at the end of the freeze-drying process it is disposed. This saves the recovery procedure which in a sterile environment adds manual operations for cleaning and sterilising that represent costs and additional risk for sterility and even cross contamination.
Additional PAT tools will also be promoted: Lyonuc is the nucleation induction method developed by Telstar, suitable for any type of freeze-dryer that reduces the duration of the primary drying cycle and ensures the uniformity and homogenisation of the vials in all the batches, respecting the product’s morphology and physiochemical properties. Lyosensing is a versatile process analyser developed to monitor the freeze-drying cycle & detect and prevent real and virtual leakages in pharma freeze-dryers. Telstar Lyometrics is an innovative soft-sensor temperature monitoring system in GMP industrial freeze-dryers with automatic loading/unloading systems designed to provide on-line monitoring of the global batch product temperature during primary drying, without the limitations and interferences imposed by physical probes.
In aseptic barrier isolation technology, the company will also be exhibiting a Safety Airlock System (SAS) designed for the transfer of materials into aseptic areas with an integrated ionHP+ bio-decontamination system. Proven to reduce cycle times, no preconditioning phase is required as the process is performed at room temperature and humidity. In the field of sterilisation solutions, the company will also be promoting Sterimega Plus, a multi-purpose compact GMP autoclave range that is designed to minimise footprint while maximising maintenance access and intended for steam sterilisation of solid products and porous and gravitational liquid loads in the pharmaceutical industry which can be configured also as a pass-through chamber for sterilisation and/or bio decontamination processes.
The Telstar portfolio on display at Achema also includes integrated turnkey engineering & construction services for process facilities. The company will be promoting the latest next-generation engineering services for pharmaceutical production, designed to offer greater performance with less environmental impact from the initial design.
A smart HVAC control system for clean rooms will be promoted, whose monitoring and controlling capabilities allow the system to reduce the number of air renovation cycles while maintaining, under control, the level of particles in the room in accordance with GMP classification. This creates a saving of over 40% in energy consumption depending on the room operation and use. Paperless engineering & C&Q service, using a BIM package for design and engineering plus DisQ (Digital Smart Qualification), the new Telstar’s software for commissioning and qualification with digital documents instead of the traditional paper allows to optimise the development lifecycle, risk management, validation, and verification processes. The portfolio is completed with a Carbon footprint evaluation service, optimisation engineering tools such as Fluid Dynamics or the design of Cold WFI technology to reduce energy consumption on fully compliant WFI production & distribution skids.
In the Laboratory field, Telstar will also be promoting BiOptima IT, the first biological safety cabinet protected with ZEROCOAT, a new coating with an antimicrobial barrier proven to reduce cleaning and maintenance costs. BiOptima IT has been designed to integrate pharmacy compounding software programs.
Bio II Advance Plus will be also on display. It is a compact microbiological biosafety cabinet, suitable for the manipulation of samples with biological risk level 2 and 3, designed for use in high-risk microbiological research and high toxicity applications in laboratories and hospitals, to ensure the maximum level of operator protection. Boreas, meanwhile, is a -86º ultra-low-temperature freezer designed to increase average performance by 20%. Equipped with VIP vacuum panels, the freezer guarantees the highest level of thermal insulation and maintains a temperature of -80ºC with ambient temperatures up to +28ºC. Finally, the freeze-dying technology designed for research and formulation applications will be present at Achema with Telstar LyoBeta Mini. It is a compact (W94cm x H76cm x D63cm) pilot-scale freeze dryer specifically intended for small scale formulation, research, and development work. It has been designed with a condenser capacity of 6kg which is separate from the product chamber.
Telstar is a leading global brand of aseptic process solutions. The company, part of the azbil Group, specialises in the development of highly complex projects, from integrated process equipment to design, engineering and construction of complete turnkey pharmaceutical and biotech production facilities, critical installations, clean rooms, and R&D laboratories.