NNE has deep insight into aseptic and sterile fill and finish pharma processes. We can help you design and implement future-proof solutions for fill-finish operations, providing services within facility design, process engineering and automation and IT. Our know-how and expertise combines:
- First-hand experience operating in fill-finish environments
- Extensive knowledge of regulatory developments
- Practical experience integrating different filling technologies
- Awareness of the industry’s most recent developments
We can advise you to find the right technology that best matches your needs. We can also help you balance your investment costs, operational costs, regulatory requirements and risks. 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, including:
- Selection and customization 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
- Ongoing site support after project completion to ensure a smooth production start-up
NNE masters all aspects of fill-finish (blistering, wallets, bottles, sachets) and our track record for projects related to sterile and aseptic filling is impeccable: We have executed countless projects involving blistering (plastic and aluminums), vial filling, blow fill seal, cartridges filling, bottle filling, inhaler devices, cartooning, boxing, wrapping and palleting. Our expertise is extensive and we manage projects in sterile, aseptic, containment and even nuclear environments. NNE has strong relationships with all suppliers of fill-finish equipment and cooperate closely with these suppliers to ensure that your project is a success.
Are you the traditional or the flexible type?
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. However, traditional aseptic processing is a dedicated process that is specific to the container format. Introducing a new format on a traditional filling line is difficult. Flexible aseptic processing leverages the commonalities between various container fill-finish processes and allows you to fill multiple container formats and sizes on a single modular platform.
Supporting technologies such as isolator technology and RABS (restricted access barrier system) can be applied for both traditional and flexible aseptic production.
There are advantages and disadvantages of both traditional aseptic processing and flexible aseptic processing. Choosing between traditional and flexible filling is a matter of priorities. Teaming up with NNE will get you a technical partner, who will ensure that you make the right choices based on your specific situation.