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Fill and finish

Contamination is a killer, and aseptic and sterile handling is essential for the integrity of all pharmaceutical products and devices. And it is just as complex, as it is vital – both in terms of technology and compliance with regulatory requirements.

Fill finish processing is critical in biotech product manufacturing where the product value, and hence the risk, is high. Because of its criticality, fill finish has historically been an area with a focus on “proven solutions” and less innovation, but driven by the current shift in the pharmaceutical industry, this is changing.

A growing trend towards small batch sizes is pushing manufacturers to increase the level of flexibility of aseptic production. Processes need to accommodate multiple products – products which are high in value, very sensitive, highly potent and produced in smaller batch sizes. This brings about a need for facilities that can provide more flexibility, decrease investment costs and increase productivity for smaller batch sizes (format change, cleaning, sterilisation, maintenance, qualification etc.).

In addition, preventing particle and microbiological contamination remains as important as ever. Next generation biotech products will require state-of-the-art barrier technology for their aseptic fill and finish operation, since regulatory authorities to a growing extent demand physical separation of the product from the operator.

Furthermore, due to their high value and/or high product sensitivity, new products typically pose major demands towards the primary packaging material driven by quality, the objective to minimise the number of rejects during production and extra challenges linked to the increased use of devices.

Providing full-range support in fill-finish

NNE helps customers design and implement future-proof solutions for fill-finish facilities. We apply our unmatched process technology knowledge from conceptual design over commissioning and qualification to operational support within the entire fill-finish area to supply a full range of services to our customers.

  • Selection and customisation of primary packaging materials
  • Front-end studies and conceptual designs of new fill finish facilities and facility changes with seamless cGMP compliance based on latest regulations
  • Complete engineering of fill finish facilities
  • Technical facility due diligence
  • Selection of suppliers and technology
  • Qualification and validation of fill-finish facilities
  • On-going site support after project completion to ensure a  smooth production start-up