This partnership was initiated when Rottendorf Pharma, a leading pharmaceutical contract development and manufacturing organisation (CDMO) identified a growing need for small batch blister packaging of pharmaceutical products in compliance with the 21 Code of Federal Regulation (CFR) Part 11 standards.
The successful joint efforts resulted in an innovative system that enables pharmaceutical manufacturers to produce small quantities of blister packs, in full 21 CFR Part 11 and GMP-compliance, without having to halt full scale production lines to switch to small batch runs. The EZ Blister+ offers the functionality of a large-scale production system with digital reporting, full audit trail generation, and seamless switching between different batch production runs.
A collaborative approach
During the development process, Sepha’s technical specialists worked hand in hand with Rottendorf Pharma’s experts, including Dr. Judith Uhlenbrock, Senior Project Manager for Formulation Development, and Tina Sonsalla, an expert in formulation development. The collaboration fostered open communication, allowing Rottendorf Pharma to provide valuable input throughout the product development process.
“The new machine needed not only to be used for small-run production of drugs for development purposes, but also for clinical trial packaging,” says Dr. Uhlenbrock. This meant that all GMP requirements needed to be fulfilled. “Compliance was the major challenge we had to overcome, because most of the smaller machines on the market are used purely for development purposes.”
GMP & 21 CFR Part 11 compliance
The critical achievements of the collaboration are the integration of 21 CFR Part 11-compliant features into the machine and meeting GMP compliance. “The machine has a database which stores every step of the packaging process and transfers it to our secure server,” says Tina Sonsalla. Furthermore it ensures secure user access, user identification, and the ability to store audit trail data, meeting the stringent electronic record maintenance guidelines outlined in 21 CFR Part 11.
The successful collaboration between Sepha and Rottendorf Pharma has propelled small batch blister packaging to new heights, allowing Rottendorf Pharma to offer faster, more flexible, and cost-effective production solutions. “Previously, we couldn’t create blister packaging in our development department. When small batches were required, we had no choice but to put them on the fully automatic blister line,” says Dr. Uhlenbrock. Not only was this costly and inefficient, but it also slowed down the potential to bring other products to market. Furthermore, the EZ Blister+ has opened doors for Rottendorf Pharma to expand its client base and foster stronger collaborations with existing customers.
At the heart of this development was what the Rottendorf team describe as a great collaboration. Dr. Uhlenbrock concludes: “I would definitely recommend Sepha as a supplier, not only because of their development of the machine, but because of their customer support. Having regular contact with the Sepha team has been absolutely crucial to the success of the project. As a result of the partnership, we have a new machine that precisely meets our specification, allows us to take on a greater breadth of project work with no need to halt other production runs, and continues to operate in full 21 CFR Part 11-compliance.”