Telstar exhibited the latest developments in aseptic technology for pharmaceutical production in GMP at the PharmaTechnica exhibition, which took place in the framework of Pharma Congress event (Düsseldorf 2022, 31 May - 1 June).
The company deployed a portfolio of solutions in the field of process equipment & integrated solutions in isolation technology systems, sterilisation and freeze-drying applications covering the complete phases of a pharmaceutical manufacturing process.
Telstar will be promoting an 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 Zero is an automatic vial loading & unloading system for pharmaceutical freeze-dryers integrating a steam-sterilisable slider with no concealed parts which is moved by a contact-free magnetic drive mechanism. This system enables the transfer device, or ‘slider’, to remain inside the chamber to undergo cleaning and sterilisation in place along with the internals of the freeze dryer. Suitable for use in production processes involving hazardous products, Lyogistics Zero has been designed to be integrated within aseptic isolators requiring high level protection for the operator (OEL5), the product (ISO5) and the environment.
Lyomega SV, designed to optimise the usable technical area in facilities with limited space, will also be promoted at the exhibition. It is a new single-vessel GMP production freeze-dryer optimised to maintain conventional workspace while making the footprint up to 20% smaller than a lyophiliser with standard external condenser configuration. The integration of the chamber and condenser allows a reduced and optimised size –from 4m2 to 30m2 (40m2 - pit mounted) - whose chamber contains a high-capacity workspace of product shelves area. The latest version of the compact GMP clinical and production-scale freeze dryer also accommodates a condenser of high capacity, up to 570kg, integrated under the product chamber. Fitted with a versatile thermal system that guarantees higher performance and operational efficiency saving water consumption. Lyomega SV belongs to the Telstar’s customised range of GMP production freeze-dryers designed to operate under aseptic conditions.
The company will be showing the sterility test isolators integrated with Telstar’s innovative ionHP+ bio-decontamination system proven to dramatically decrease cycle times, increase time available for process and reduce running costs. This range of isolators is designed to avoid the risk of false results and to protect the product from both the process and externally generated factors that would compromise its quality. In addition, the Telstar range of Isolator systems includes aseptic and containment Isolator systems for the pharmaceutical, biotech, healthcare, cell therapy and veterinary markets from stand – alone Isolators to more complex integrated filling line Isolator systems.
Telstar provides complete systems, integrating barrier systems with either Telstar process equipment or third-party devices with the ability to provide complete turnkey solutions. Client’s requirements and initial designs are challenged extensively with full size ergonomic models prior to the manufacturing process.
In the field of sterilisation solutions, the company will also be promoting EtO sterilisation chambers. Specialised in design and construction of industrial scale Ethylene Oxide sterilisation plants, the company designs sterilisation chambers up to 170m3 volume or more than 32 pallets.
The company has also solid experience in development of solutions using depyrogenation, steam autoclaves and counter pressure autoclaves. In addition, Telstar will be disclosing a new automated product handling systems for automatic loading and unloading processes integrated in high-capacity pharmaceutical sterilisation systems. The new robotised solution has been incorporated in the SteriDelta autoclave designed for parenteral products.