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.