Integrated solutions for sterilisation, freeze-drying and cold storage

Growth in vaccines production, including the SARS-COV-2 vaccine, is fuelling the increased need for sterilisation facilities to manufacture single use medical devices such as plastic syringes. To meet the demand, Telstar has expanded its engineering and manufacturing capacity in process systems, which integrate sterilisation, containment and lyophilisation technologies.

To face the next mediumterm phase in the rollout of global COVID-19 vaccination programmes, Telstar has strengthened the development of its freeze-drying systems for the manufacturing of vaccines under lyophilised form to guarantee their complete and safe distribution.

The company’s end-to-end engineering and GMP services are highly specialised. Its integrated solutions cover all phases of vaccine manufacturing, from the development of process equipment and integrated solutions in isolation technology systems to sterilisation and freezedrying applications.

Its solid, multidisciplinary team consists of experts in GMP pharma production processes, cleanroom installations and critical utilities, working alongside customers to provide a comprehensive service throughout the project life cycle.

Experienced in turnkey integrated projects for complete pharma manufacturing and process critical installations, Telstar has led numerous complex and unique projects designed to guarantee aseptic and efficient production processes in pharmaceutical and life sciences environments.

NEW AND IMPROVED UPRIGHT FREEZERS

Telstar has reinforced the production of Boreas, its -80°C ultra-lowtemperature freezer, to meet vaccine manufacturers’ immediate and increased needs for robust cold chain infrastructure. The company will also double its production of the latest generation of ultra-low-temperature freezers, which comply with the stringent storage requirements set out to protect the integrity of vaccines – not only in the healthcare sector but also in logistics and transport processes.

Boreas has been designed to increase the average performance by 20%. An innovative mechanical design enhances its robustness, efficiency and ergonomics as well as ensures the integrity of the cold preservation process. Equipped with vacuum panels, the freezer guarantees the highest level of thermal insulation and maintains a temperature of -80°C with ambient temperatures up to 28°C.

Unlike standard freezers designed with panels of polyurethane foam, the storage capacity of Boreas is increased by up to 30% due to its thinner inner VIP insulation. It is also ecological as the freezer has been developed with Telstar’s in-house cold storage technology and uses high-purity natural refrigerant CFC-free gases, which contribute to environmental protection.

TELSTAR LYOBETA – A SMALL-SCALE SOLUTION

Specifically designed for labscale formulation, research and development work, the latest LyoBeta innovation developed by Telstar sees the integration of a mobile app which tracks temperature and pressure parameters in real-time, enabling any freeze-drying process parameter or alarm to be monitored remotely.

This small-scale solution offers flexibility and performance within the compact footprint often required by laboratories. Its advanced process control features include a PLC-based control system, enhanced control and programming capabilities and management software. These features are said to make LyoBeta the most complete, efficient and convenient pilot unit on the market.

INTEGRATED LAB AND ANALYTICAL SOLUTIONS

In the context of pharma 4.0 transformation, Telstar has played an active role in the development of smart solutions for the field of process analytical technology. These innovations also span integrated process equipment and laboratory integrated management systems.

In the field of freeze-drying, 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.

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 batches, respecting the product’s morphology and physiochemical properties.

Lyogistics Smart R3 is the new automated in-line vial management device equipped to reject, reintroduce and retrieve vials during the loading and unloading processes into pharmaceutical freeze-dryers.

Telstar Lyosensing is a versatile process analyser developed to monitor the freezedrying cycle and detect and prevent real and virtual leakages in pharma freeze-dryers. Telstar Lyometrics is an innovative softsensor temperature monitoring system in GMP industrial freeze-dryers with automatic loading/unloading processes. The system is designed to provide on-line monitoring of the global batch product temperature during primary drying, without the limitations and interferences imposed by physical probes.

Lyomega SV is a new single- vessel GMP production freeze-dryer, optimised to maintain conventional workspace with a footprint that is up to 20% smaller than a lyophiliser with a standard external condenser configuration. •

Telstar has played an active role in the development of smart solutions for the field of process analytical technology

Telstar – www.telstar.com