First high-speed turn-key PMK 150 line in Japan
Due to its long tradition and patients’ acceptance of patch treatments, Japan has developed into the second largest market for general transdermal systems in the world, with a sales volume of more than 500 million US dollars per year. In Japan patches are available for a wide variety of applications, for many indications, and with different active ingredients.
Nipro Patch is one of the biggest players in the country’s market for external-use pharmaceuticals and an expert in the field of TTS/TDS products. In addition to Nipro Patch’s existing sites in Kasukabe and Hanyu, a new plant for transdermal patches was built in Odate in northern Japan last year, featuring a high output production line including coating, converting, pouching, stacking and bundling.
For Harro Höfliger and partner Mutual Corporation this meant a high-speed turn-key PMK150 line, designed for web converting and primary packing into individual sachets, including stacking, unique sachet stack bundling and secondary packaging into folding cartons. Key elements to consider and integrate included the careful use of resources, minimum waste, high production yield, and flexibility with regard to future market demands and new patch designs.
Optimized use of materials and fast tooling changeovers
With the PMK150 – a 2-lane high-speed system – Nipro Patch manufactures both an innovative 24-hour patch containing Tulobuterol for the treatment of asthma and bronchitis, and a Lidocaine patch as a local anesthetic in a twin sachet perforation design. Unique features, such as very small patch sizes without overlapping release liners and clean score cuts for the liners, optimize use of materials. Special backing webs in combination with delicate sachet poly materials and pattern sealing require attention with regard to process and inline registration.
Special features and design elements installed on the machine include:
- Unique auto splicer executions followed by a patch laminate cut & place/slip system to maximize use of the active webs when cutting the individual patch.
- Easy to clean machine parts to factor in the adhesive (PSA) behaviors of the different formulations and the possibility to carry out tooling changeovers within a few minutes in order to keep set-up times and downtimes short.
- Comprehensive camera inspection systems for quality and process monitoring. The recorded data provide transparency in the batch report and in all subsequent operation data systems for continuous product and process improvements.
- Exact placement of the Lidocain patch and twin sachet filling – including perforation – by means of a flexible and format-free paddle. During high-speed operation, this process is monitored by a vision system.
Challenges met by Harro Höfliger were the processing of a full range of format sizes from small patch and sachet size to bigger format ranges, as well as different roll stock materials. In addition, late stage customization was incorporated, i.e. inline printing and vision verification of patch and sachet. Particular attention was paid to details like perfect positioning of the tear notches, optimization of the residual oxygen quantity in the sachet by applying nitrogen gas in combination with the accompanying plate sealing unit, and an intuitive “Japanese” operator control.