Firstline: Datwyler's most advanced manufacturing concept

Introduction:

This paper discusses the Quality by Design(QBD) approach the FirstLine^TM   facilities to manufacture components that require the highest quality levels for sensitive drug applications so as to achieve patient safety.

The consept of FirstLine^TM Was commercially launched in 2009; although the seeds were sowed long before that. The concept stemmed from a powerful thought that the Active Pharmaceutical Ingredients (API), and drug formulations were being manufactured within clean room environments, but the packaging materials were not. Once these drugs are packaged, it is the packaging that defines the cleanliness and efficacy of these drugs. Ultimately, the manufacturing of packaging components should be considered an extension of the drug manufacturing environment and held to similar standards.

FirstLine^TM :   Datwyler's most advanced manufacturing concept

At the time of ideation of FirstLine ^TM, Datwyler collaborated with pharmaceutical and biotech clients to understand the needs of the market. There was clearly an unmet need to deliver the highest quality elastomeric components. Through alliances with pharma clients and surveys, we were able to distill the information into three macro trends: (1) development of complex and sensitive drugs and challenges to package and deliver these drugs in an efficacious manner, (2) more stringent expectations of the regulatory authorities, and (3) globalization and supply chain optimization to meet the requirements of the pharmaceutical companies. Let us elaborate on these three macro trends and how the FirstLine ^TM,manufacturing concept delivers on them.

Whitepaper Conclusion

In order to meet the needs of the pharmaceutical and biotech markets, Datwyler has poineered the FirstLine^TM manufacturing concept, making the goal of zero defects in parenteral packaging manufacturing a possibility. With processes in place to reduce contamination, meet stricter authority requirements, and supply products around the ZRUld, Datwyler's FirstLine^TM is the most advanced manufacturing standard to meet the parenteral packaging needs for pharmaceutical and biotech companies.