Telstar’s freeze drying innovations at Achema

The latest generation of aseptic freeze dryers with a magnetically driven automatic vial loading system under isolator including in-line vial management smart devices will be demonstrated.

At Achema in Frankfurt from 22 to 26 August, Telstar will be promoting the latest developments in in-line management devices and process analytical technology for pharmaceutical freeze-drying systems and aseptic manufacturing processes. It will also showcase 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 to illustrate some of the technologically advanced aseptic process integrated systems and services range developed by Telstar. Lyogistics Zero is the only automatic vial loading and 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 in-line vial management device with a small footprint, able to reject, reintroduce and retrieve vials during the loading and unloading for GMP freeze-dryers.

Newest PAT tool in lyophilisation

A new system capable of real time monitoring the advance of the sublimation front in GMP freeze-dryers will also be introduced at Achema. A single-use probe, containing five independent temperature sensors that are placed within the vial, including wireless communication, makes it an innovative system that is able to monitor the advance of the sublimation front accurately. This key to optimise the primary drying steps in lyophilisation processes. The new Sublime system offers five measuring points integrated in each probe, which accurately read in real time temperature information at various levels of the product when sublimation takes place. The sensor has been designed as a single use device. This saves the recovery procedure which in a sterile environment adds manual operations that increase costs and 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. It reduces the duration of the primary drying cycle and ensures uniformity and homogenisation of vials in batches, respecting the product’s morphology and physiochemical properties. Lyosensing is a versatile process analyser developed to monitor the freeze-drying cycle and 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.

Isolation and sterilisation technologies

Telstar will also be exhibiting a Safety Airlock System designed for transferring 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 be promoting Sterimega Plus. This multi-purpose compact GMP autoclave range is designed to minimise footprint while maximising maintenance access. The range is intended for steam sterilisation of solid products and porous and gravitational liquid loads in the pharmaceutical industry. Sterimega Plus can also be configured into a pass-through chamber for sterilisation and/or bio decontamination processes.

Green engineering services

The Telstar portfolio on display at Achema includes integrated turnkey engineering and 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.

Visitors can check out a smart HVAC control system for cleanrooms with monitoring and controlling capabilities that allow the system to reduce the number of air renovation cycles while maintaining, under control, the level of particles in the room according to GMP classification. This reduces energy consumption by more than 40% depending on the room operation and use.

Paperless engineering and C&Q service, using a BIM package for design and engineering plus DisQ (Digital Smart Qualification), is Telstar’s new software for commissioning and qualification with digital documents. This allows for the development lifecycle and risk management, validation and verification processes to be optimised. 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 and distribution skids.

Lab solutions

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 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 is designed with a condenser capacity of 6kg which is separate from the product chamber.