Tempris GmbH

Season's Greetings and Best Wishes for the New Year! As 2024 comes to a close, we look back with pride and gratitude on a year filled with exciting projects and excellent collaboration with our customers and partners. We’ve accomplished a lot together and are excited about what lies ahead. We wish you and your families a joyful holiday season and a fantastic start to 2025, a year full of new opportunities and projects. Please note that Tempris GmbH will be closed from December 23, 2024, to January 6, 2025. We’ll be back to support you starting January 7, 2025. For urgent matters, please contact us at service@tempris.com – we’ll respond within 24 hours on business days. Thank you for your trust, and here’s to a successful 2025! Your Tempris Team

Lyophilization Cycle Scale-Up and Transfer require reproducing the initial product temperature profile onto the target freeze-dryer. By application of the Tempris GmbH system, the product temperature differences arising during the transfer can be quantified and compensated by process adaptation, and the characterization of equipment effects can be improved. During the scale-up of a #freezedried product, many processing parameters that affect the product quality can change. This is not only due to differences in the equipment setup and performance but also includes environmental factors. The same systematic differences can also occur when transferring a FD product to a different production #freezedryer. To obtain a comparable product and achieve consistency in the product quality attributes, the reproduction of the product temperature profile in the target freeze dryer is of paramount importance. Some important factors that can lead to changes in the freezing and drying properties of a product during scale-up and transfer are: > Thermal radiation effects transfer additional heat to the product and lead to elevated product temperatures in exposed vials. The extent of radiation depends on the characteristics of the equipment surfaces, such as chamber door and walls. Typically, radiation effects are higher in small-scale units, which leads to shorter drying time and stronger gradients within the batch. > Shelf temperature heating and cooling rates are often limited in manufacturing equipment compared to modern laboratory scale units, and larger gradients in shelf surface temperature can arise during fast ramping. In addition, potential worst-case positions (hot and cold spots) need to be determined and considered for each #lyophilizer. > The refrigeration performance of the condenser system in the production freeze-dryer is often a limiting factor in the transfer and scale-up of #lyophilization processes. The commonly higher condenser surface temperature compared to small-scale equipment leads to longer process times and can limit the mass transfer rate due to loss of pressure control. > The traditionally applied product temperature sensors in laboratory #freezedrying (thin wire thermocouples) and manufacturing (PT-100) are poorly comparable. The operation principles of these sensors are completely different, as thermocouples provide a point measurement at the bottom of the product. In contrast, the larger PT-100 sensors record average temperatures over the cake. The resulting product temperature profiles are poorly comparable and cannot be used to investigate scale differences or process adaptation systematically.

Meet Spinco Biotech at CPHI & PMEC India 2024!  We’re excited to announce that our valued partner, Spinco Biotech, will be attending CPHI & PMEC India from November 26–28, 2024, at the India Expo Centre. You can find us at Booth C41 in Hall 11!  Here’s what awaits you at the booth:   - Tempris – Wireless real-time temperature sensors providing precise data directly from your vials.   - Insights into how Tempris can optimize your freeze-drying processes, accelerate regulatory approval, and help bring products to market faster.   - Innovative solutions for all primary packaging types – from vials to bulk bags.  Our experts will be on-site to show you how to enhance process efficiency and monitor critical process parameters in real time.  Don’t miss the chance to see our cutting-edge technology in action! We look forward to insightful conversations and collaborating on the future of pharmaceutical innovation.  Join us at Booth C41, Hall 11. Let’s shape the future of freeze-drying together!  #Tempris #SpincoBiotech #CPHIIndia #PMECIndia #FreezeDrying #PharmaInnovation

Sensors designed for automation! Tempris sensors have transformed the measurement of product temperature during lyophilization, making them ideally suited for automatic loading systems in compliance with GMP Annex 1. This innovation eliminates the need for human intervention, thereby reducing errors and contamination risks. With the launch of our 3rd generation sensors in January 2024, the process has become even more streamlined. Each sensor is equipped with a data matrix code that simplifies identification and placement. This feature not only allows for easy scanning of sensor IDs but also aids in visual identification and automatic placement. This advancement ensures consistent and compliant recording and documentation of all sensors, marking a significant improvement in traceability and electronic readability. Furthermore, the integration of Process Analytical Technology (PAT) is noticeably simplified, paving the way for fully automated processes. Learn more about automated loading with Tempris sensors: https://lnkd.in/d6m253RH #PharmaInnovation #TemprisSensors #GMPCompliance #Automation #PATTechnology #ManufacturingAdvancements #lyophilization #TemperatureMonitoring

Accelerate Your Time to Market with Precise and Reliable Data from Tempris! The latest SpincoTech CuttingEdge Magazine article highlights how Tempris accelerates the development and approval of freeze-dried pharmaceuticals. Our technology provides all necessary regulatory data, reduces development and approval timelines by up to 8 months, and strengthens process control to ensure quality and consistency. Learn more about how Tempris supports pharmaceutical companies in working more efficiently and precisely. 👉 Read the full article here: https://lnkd.in/dFJ7BWmd #Pharmaceuticals #FreezeDrying #ProcessOptimization #Lyophilization #RegulatoryCompliance #TimeToMarket #PharmaTech #Tempris #PharmaInnovation #QualityControl

Development and optimization of a #lyophilization cycle is a labor-intensive and re-iterative process. Several limiting factors need to be considered; in addition, the different process steps have individual requirements that need to be taken into account. Real-time monitoring of product temperatures with the Tempris GmbH system in all #freezedryer scales offers versatile possibilities for optimization of all steps of the freeze-drying process. A lyophilization cycle is limited by the critical quality attributes of the product and the performance limitations of the equipment. For the design of an optimized process, both aspects need to be considered. In addition, the critical points to consider change within the various processing steps of a #freezedrying cycle. Formulation selection is typically based not only on the stabilizing effect but also on the critical formulation temperature during freeze-drying.

#Hiring – Wir suchen eine:n neue:n Backoffice Manager and Executive Assistant (m/w/d) in Holzkirchen, Bavaria. Bewerben Sie sich noch heute oder teilen Sie diese Stellenanzeige mit Ihrem Netzwerk.

#Hiring – Wir suchen eine:n neue:n Backoffice Manager and Executive Assistant (m/w/d) in Holzkirchen, Bavaria. Bewerben Sie sich noch heute oder teilen Sie diese Stellenanzeige mit Ihrem Netzwerk.

PN Update: Tempris makes debut at A3P Congress Biarritz with freeze-drying innovations #Tempris #TemperatureMonitoring #Lyophilization

Accelerate Your Freeze-Drying Process. Get It Right the First Time! What if you could optimize your freeze-drying process from the very first run? With a method that is not only precise but also efficient and fully scalable. With Tempris' innovative solution for laboratory freeze-dryers, you're equipped with cutting-edge measurement technology and software. Our wireless sensors, Digital Twin, and LyoCLC software provide real-time data to precisely determine the endpoint of primary drying – helping you accelerate process development, ensure product quality, and speed up approvals. Discover how you can enhance your lab's efficiency: https://lnkd.in/dN5Mi3aY #PharmaceuticalInnovation #FreezeDrying #TemprisTechnology #ProcessOptimization #Lyophilization #PAT #BiotechSolutions #LaboratoryExcellence #PharmaTech #DataDrivenDecisions #PrimaryDrying