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2024 ISPE Singapore Affiliate Conference & Exhibition
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ASEPTIC MANUFACTURING & ANNEX 1: Next Generation of Aseptic Filling - Highest Flexibility Meets Regulations of Annex 1

Open Tracks

Open Tracks

2:00 pm

30 August 2024

Onsite Only @ Suntec Singapore - Room 1

Open Tracks - Aseptic Manufacturing & Annex 1

Talk Description

Next generation of aseptic filling - highest flexibility meets latest regulations of Annex 1
Pre-sterilized packaging has been an integral part of pharmaceutical production for some time now. RTU syringes have become widely accepted in the market – mostly due to their huge benefits: With the focus being on the core process, i.e. on filling pharmaceutical products, upstream processes, such as washing and sterilizing, have been outsourced.

In recent years, RTU vials and cartridges have been following this trend. The prevention of glass-to-glass contact and the flexibility of processing various packaging materials on one machine also play a key role. But RTU containers
present some challenges as well: Sterile transfer into the cleanroom, inspection processes such as 100% IPC or the crimping process, for example.

In summary, flexible multi-product fill and finish lines offer pharmaceutical manufacturers the ability to adapt to changing market demands, improve production efficiency, reduce costs and maintain high-quality standards while ensuring regulatory compliance. These systems are a valuable asset for pharmaceutical companies seeking to remain 
competitive and flexible in an evolving and demanding industry. In the pharmaceutical industry nothing stays the same for very long. There are always new processes, challenges, and developments to contend with. It’s important that you quickly adapt your approach to meet changing times

– Therefore, flexibility is key.

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