Telstar to promote breakthrough innovations at Achema 2022

Telstar will be promoting the latest innovative developments in both in line management devices and PAT for pharmaceutical freeze-drying systems and aseptic manufacturing processes, together with integrated process equipment and laboratory integrated management systems.

In the Laboratory field, Telstar will be promotingBiOptima IT,第一个生物安全柜保护与ZEROCOAT，一种新的涂层与抗菌屏障，已证明减少清洁和维护成本。BiOptima IT被设计为集成制药复合软件程序。此外，还将展出Bio II Advance Plus。它是一款小巧的微生物生物安全柜，适合操作生物风险等级为2级和3级的样品，用于实验室和医院的高风险微生物研究和高毒性应用，确保操作人员的最大程度保护。Boreas-86º超低温冰箱的设计，平均性能提高20%。配有VIP真空面板，保证最高隔热水平，保持温度-80ºC，环境温度高达+28ºC。

Finally, the freeze-dying technology designed for research and formulation applications will also be present at Achema (Frankfurt August 22-26, 2022), with TelstarLyoBeta 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.

GMP solutions

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 sterilized (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.

The newest PAT tool in lyophilization

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 optimize the primary drying steps in lyophilization 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 sterilizing that represent costs and additional risk for sterility and even cross contamination.

其他PAT工具也将得到推广:Lyonuc是Telstar开发的成核诱导方法，适用于任何类型的冷冻干燥机，减少了主要干燥周期的持续时间，并确保所有批次的瓶的均匀性和均质性，考虑到产品的形态和物理化学性质。Lyosensing是一种多功能的过程分析仪，用于监测冻干循环，检测和防止制药冻干机的真实和虚拟泄漏。Telstar Lyometrics是一款创新的软传感器温度监测系统，适用于GMP工业冷冻干燥机，具有自动加载/卸载系统，可在初级干燥过程中在线监测全球批次产品的温度，不受物理探针的限制和干扰。

Isolation and sterilization technologies

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 sterilization solutions, the company will also be promoting Sterimega Plus, a multi-purpose compact GMP autoclave range that is designed to minimize footprint while maximizing 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.

Green engineering services

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 optimize the development lifecycle, risk management, validation, and verification processes. The portfolio is completed with a Carbon footprint evaluation service, optimization engineering tools such as Fluid Dynamics or the design of Cold WFI technology to reduce energy consumption on fully compliant WFI production & distribution skids.

Telstar is a leading global brand of aseptic process solutions. The company, part of the azbil Group, specializes 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.

Telstar at Achema 2022 –Booth C49 – Hall 3.1