ILLIES China partners with major healthcare multinational to further enhance CRDMO platform capabilities
Abstract
ILLIES China successfully delivered the latest automatic aseptic filling line operates in a full isolation system.
Cycle Development at site was handled by local team for the first time, incl. isolator debugging, complete process from installation, commissioning, cycle development, throughout to PQ.
The state-of-the-art technology empowers our customer to further improve their CRDMO platform capability.
Project Background
The company is a leading provider of global outsourcing solutions, and has established long-term strategic cooperation relationships with most multinational pharmaceutical giants. The company invests continuously to ensure first-class technologies and state-of-the-art research.
The most advanced aseptic filling line from Groninger and isolator from Franz Ziel ensures great flexibility and stability. Therefore, our task was to support the customer to achieve relevant technical requirements, enabling them to further enhance the CRDMO capabilities with higher yields and shortened new product timelines to market.
Technical Highlights
I. Groninger filling line
For a CRDMO company, it is vital to be able to offer a high degree of flexibility and meet the diverse needs of its customers. The solution we offer features a fully automatic aseptic filling line in a fully isolator. The filling technology comes from Groninger, supports vials in a full range of sizes for solutions and lyophilized powder while allowing rapid switches between modes for maximum filling flexibility and efficiency. It can be applied for a wide range of packing materials (from 2R to 100H), and can realize rapid changeover between different product sizes and specifications, supporting our customers in providing flexible and comprehensive solutions.
Customer Benefits:
One of the leading companies in filling technology: ensure higher product safety and higher process quality and reliability combined with filling accuracy
Flexible filling range for all size of the vials: from 2R to 100H vial size, enable customer to cover a very broader service scope
Pressure control of the sterile tunnel regulates to the appropriate value automatically: achieve more efficient and reliable sterilization
Higher availability: quick change of format parts: ensure that the system is available to the greater extent - the OEE is maximized
Smaller number of format parts: one sorting bowl is applicable to stopper of all specifications, conduce to lower investment, save time and effort in production
100% In-Process-Control (IPC)：lower rejection rate, less waste, prevents losses in the production process led to huge yield and cost saving
II. FZ isolator
As the shell of the aseptic processes, isolator is the barrier between operator and product, enabling product protection and enhancing product safety.
We equip our customers with industry-leading fully enclosed isolation systems from Franz Ziel, the entire process is wholly automated in the isolator to ensure high product quality with minimal human interventions.
Customer Benefits:
The overpressure Isolator with LAF recirculation is a Barrier System against environmental contamination, which protects aseptic filling processes including their loading and unloading processes.
Fast and reliable microbiological surface decontamination prior to this process is achieved using vaporized hydrogen peroxide (vH2O2).
Flexible combination with filling line, freeze dryer incl. automatic loading and unloading system.
BDS system: the vapour module is an autonomous module with integrated controller. In the vapour module, the H2O2 required is vaporized and transferred to the isolator in an air flow, which leads to:
High accuracy - during the vaporizing process, the H2O2 quantity used is metered - more accurate control of H2O2, which contributes to saving consumable costs.
Equipped with catalyst unit: reduce the aeration time after VHP cycle to less than 45 minutes, which increases the production time.
Pressure difference is stable and self-regulated: prevent mis-operation, isolator technology helps to save cost and operators' effort, ensuring the quality for sterile room.
Customer Experience
ILLIES is not only committed to delivering products or service, but also providing a customer-centered overall experience.
Overcoming difficulties to deliver on time
The project was on a tight schedule and our local team fully kept pace with the customer and stayed on schedule. Our service team at the customer site followed strict restrictions to ensure the project delivered on time.
Thinking like a customer
ILLIES China team took ownership of the entire project, acting as a single point of contact for the delivery of complex projects. By streamlining project management, we have taken the lead in the continuous operation of the entire production line, giving our customers an optimal experience
Providing full process support