How Norden ensures pharma filling line compliance and efficiency
Manufacturing pharma filling lines is one of Norden’s core business areas, and our well-proven technology and methodology make sure that your new pharma filling line complies with all applicable regulations as well as your internal requirements. And, equally importantly, we make sure you get off to a great start with your new filling line and can produce safely and efficiently.
The process starts with your user requirement specification, URS. But there are different ways to meet a requirement, hence it is important to have a close co-operation to understand which solution that works best for you. We need to understand your current procedure, room classification, cleaning and sterilization requirements and so on. So, a series of meetings are normally required until the final scope of supply, layout of the equipment etc can be agreed.
Then we will have follow-up meetings like Design Verification and Design Qualification to really make sure that the machine we are designing and manufacturing for you meets all your expectations and requirements.
A trusted partner for pharma filling projects
When it’s time to implement your new Norden filling line, we cooperate closely with you throughout the start-up phase, and we help train your operators on how to use the new equipment properly. We will of course provide validation of the equipment based on your requirements. We can assist your validation expert with documentation, or we can perform the full validation. It is up to you.
The flow of products and packaging material through the filling line is tightly controlled at all time by different types of code reading and vision systems. With an audit trail or full CFR21 part 11 compliance on the machine it also keeps track of who is operating the machine, who is changing which parameter and when the change was made. By having this recorded you know exactly which products that was impacted by any change in your process, when they were produced etc.
If required, we can also connect our machine with your systems for production planning, active directory, time synchronization for full integration to ensure highest possible safety and quality.
All of this ensures pharma filling line compliance and efficiency throughout the lifecycle, allowing you to reliably fill and sell your products.