Pharma CMO has awarded Telstar the design and build contract for an aseptic filling process plant in Switzerland
Baccinex, a full-service pharmaceutical contract manufacturing organisation (CMO) that specialises in the fill and finish of sterile lyophilised or liquid dosage forms, has entrusted Telstar with the design and construction of a cleanroom installation to accommodate an aseptic and lyophilised filling process line. The project expands Baccinex’s existing manufacturing plant in the Switzerland region of Jura near France.
The new building, which will be completed in 2019, includes approximately 1000 m2 devoted to the production of sterile pharmaceutical batches for clinical trials. The turnkey project, equipped with a fully automatic aseptic filling line, comprises a vial washing machine connected to a depyrogenation and sterilisation tunnel, and a vial filling machine — operating under laminar flow — that’s equipped with a restricted access barrier system (oRABS).
Vials are transferred to two freeze-dryers with automatic loading systems via a conveyor belt; a subsequent capping machine completes the packaging process. There is also an option for both non-lyophilised products and products requiring terminal sterilisation to be manufactured, providing improved versatility.
The aseptic area integrates a number of auxiliary manufacturing processes, including raw material dispensing, compounding, washing and preparation for the sterilisation process. The state-of-the-art plant design derives from specific requirements to implement oRABS isolation technology and minimise the risk of product contamination.
The scope of the project involves conceptual, basic and detailed engineering, the construction of a new manufacturing area and the provision of pharmaceutical production equipment — almost entirely designed and manufactured by Telstar. It also covers cleanroom architecture, an HVAC system fitted with integrated decontamination technology, critical utilities (highly purified water, water-for-injection [WFI], pure steam and nitrogen gas), non-critical utilities (compressed air, softened water, chilled and hot water, industrial steam), electricity and the entire automation system, which controls the HVAC process, decontamination and particle monitoring system, among others. The new plant will also be fitted with two liquid nitrogen freeze-dryers with automatic vial loading and unloading systems — operating under laminar flow oRABS — and two autoclaves used for material sterilisation and, when required, terminal product sterilisation.
Ten items of containment equipment have been purchased, including weighing booths, pass-through boxes with an integrated biological disinfection system, and laminar air flow cabinets.
Telstar will also perform and manage the validation process, including risk analysis, design qualification (DQ), commissioning, installation qualification (IQ), operation qualification (OP) and performance qualification (PQ), as well as providing support services for quality assurance.
The company, a specialist in the development of aseptic manufacturing facilities, undertook both the design and complete execution of the project, from concept to final validation, as well as supplying equipment that has been designed and manufactured using in-house technology.
Having completed the engineering, design and equipment definition phases in May 2017, the project was awarded in July 2017 and is expected to be completed during the first quarter of 2019.
Taking GMP compliance and the latest industry trends into account, the design of the new plant benefits from integrated energy efficiency systems that both generate power and save money. And, prompted by the newly revised European Pharmacopoeia monograph 169 on WFI, which, since 1 April 2017, allows water to be obtained by non-distillation methods, Telstar has implemented a WFI generation system that uses reverse osmosis and ultrafiltration in the new plant. The facility can also product WFI by distillation when and if required.