Classical Pharmaceuticals
Small Molecule Manufacturing Expertise

Gaining Efficiencies During Final Fill

The Final Fill process is a critical aspect of drug manufacturing to assure safe therapeutic drug products are provided to patients. Our expertise can help you examine ways to address risks of this critical step in the manufacturing process.


1. Meeting Stringent Requirements of a Final Filling Process with Proper Assembly Design


Meeting Stringent Requirements of a Final Filling Process with Proper Assembly Design

The implementation of single-use technologies in the final filling process is steadily increasing. Single-use technologies need to meet the stringent requirements for this final process step – fluid path sterility, integrity, operational safety and fit for purpose of the single-use assembly.

Solution

Mobius® Fill Solutions can effectively meet these requirements with proper assembly design for integration in a filling machine. Evaluation of risks and regulatory compliance need to be considered designing the sterile filtration process. It is essential to evaluate supporting documentation to enable appropriate validation. Learn more about design considerations of assemblies for final filtration and filling.

2. Increase Productivity and Manage Risk


Single-use fill-finish assemblies can improve filling line productivity - providing flexibility to manufacture a variety of drug products and fill volumes while mitigating contamination risks.

Drug manufacturers face pressure to efficiently and effectively advance pipeline assets while minimizing risks associated with product loss, product contamination, sterility and patient safety.

Solution

Single-use fill-finish assemblies can improve filling line productivity - providing flexibility to manufacture a variety of drug products and fill volumes while mitigating contamination risks.

However, single-use fill finish assemblies require rigorous process validation to ensure compliance with regulatory guidelines. Steps which can be taken to ensure this validation are:

  • A systemic and thorough evaluation of the assembly manufacturing and filling process
  • An accurate interpretation of regulatory requirements
  • A step-wise approach to identify and mitigate risks associated with process components

Learn more about how to increase manufacturing flexibility while mitigating risk using single-use assemblies.




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