Enflex PH Series: design innovations to better suit pharmaceutical environments
The pharmaceutical industry operates under rigorous standards to ensure product safety, quality, and compliance. With increasingly demanding requirements for cleanliness and cross-contamination prevention, packaging machinery must evolve to meet these needs. The new Enflex PH Series stands as a cutting-edge solution, incorporating design improvements tailored to the stringent environments of pharmaceutical production.
These innovations mark a significant evolution from the F Series drawing on its proven reliability and expertise. The PH Series is specifically designed to tackle contamination risks, minimize dust accumulation, enhance seal integrity, and ensure superior pouch finishing quality, all while improving cleanability.
Superior materials for improved hygienic standards
One of the defining improvements of the Enflex PH Series is the use of high-grade materials for components that come into direct contact with the packaging film. All rollers in direct contact with the film are now constructed from AISI-316L stainless steel, a material known for its superior resistance to corrosion and excellent hygienic properties. Where stainless steel cannot be used, FDA-certified silicone ensures that every point of contact adheres to stringent safety and regulatory standards.
The sealing jaws have also been upgraded to AISI-304 stainless steel, enhancing both durability and hygiene. This commitment to premium materials significantly reduces the risk of contamination while ensuring the machinery meets pharmaceutical-grade cleanliness requirements.
Avoiding cross-contamination through intelligent design
The Enflex PH Series introduces key modifications to its operational layout to further minimize contamination risks. For example, the film opener device has been repositioned away from directly sitting on top of the film. This redesign eliminates a significant contamination point, as the device no longer poses a risk of introducing unwanted particles onto the film surface.
Additionally, the height adjustment mechanism for the fourth weld has been moved outside the main operational area. These changes not only streamline the machine’s workflow but also contribute to maintaining a clean production environment by reducing areas of potential contact or obstruction.
Enhanced cleaning capabilities
A critical consideration in pharmaceutical production is the ability to thoroughly clean machinery to prevent product residue buildup. The Enflex PH Series addresses this need with a redesigned tray and cover system. This new design eliminates unnecessary edges and crevices where dirt or dust could accumulate, ensuring faster and more effective cleaning.
To further improve cleanability and hygiene, electrical and pneumatic inlet connections have been placed outside the machine guarding. By moving these connections out of the operational area, the machine reduces contamination risks and eliminates spaces where dust or product remnants might gather. This design not only simplifies cleaning procedures but also enhances the overall hygiene of the production process.
Improved product reject system for operational efficiency
Another major innovation in the PH Series is the introduction of a reject ramp with a 45º slope and a length of 500 mm. This design facilitates the efficient removal of rejected products from the production line. The ramp includes a sight-glass, providing clear visibility into the internal area to monitor rejected items. This feature allows for precise observation, ensuring quality control processes are robust and efficient.
The improved reject system reflects Enflex's focus on operational efficiency while maintaining the highest hygienic standards. By optimizing product handling, the PH Series reduces downtime and enhances productivity without compromising cleanliness.
State-of-the-art guarding and auger filler design
The Enflex PH Series also incorporates a new guarding system that prioritizes both hygiene and machine accessibility. Notably, the auger filler motor is now located outside the “clean/operational” area. This adjustment prevents motor components from interfering with hygienic zones, addressing a key challenge in pharmaceutical production environments.
The guarding structure itself has been redesigned using an AISI-304 stainless steel tubular frame, while the doors are made of PETG. This combination ensures durability, compliance with hygiene standards, and improved maintenance access.
Advanced user interface for streamlined operations
To enhance usability and compliance, the PH Series is equipped with the Coesia Digital OptiMate HMI featuring a 15.6-inch touchscreen. This modern interface simplifies machine operation, offering an intuitive and responsive user experience. Additionally, for pharmaceutical manufacturers requiring data integrity and traceability, the HMI can be upgraded to comply with 21 CFR Part 11. This optional module ensures the machine aligns with the electronic recordkeeping regulations critical for pharmaceutical production.
For added flexibility, the PH Series supports turn-key projects, operating seamlessly as a stand-alone machine or as part of an integrated production line. It can be paired with the Enflex Cartoner PK Series or even systems from sister companies like MGS Cartoner, offering a complete, tailored solution for diverse pharmaceutical packaging needs.
A new standard for pharmaceutical packaging excellence
The Enflex PH Series represents a significant advancement in pharmaceutical packaging machinery, with each improvement carefully designed to meet the industry's stringent hygiene and operational standards. By integrating high-grade materials, optimizing design to prevent cross-contamination, and enhancing cleanability, the PH Series sets a new benchmark for performance and safety.
For engineers, operations managers, and procurement professionals in the pharmaceutical and healthcare sectors, the Enflex PH Series offers a reliable and future-ready solution to achieve exceptional packaging quality while meeting industry compliance requirements.
Enflex, we HealthCare.