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9 June 2025
Tight cleanroom dimensions were a limitation for Shawpak in an overseas installation for medical device packing, with form-fill-seal linked up to a flexible blister thermoformer.
Shawpak was approached by an overseas medical device manufacturer facing a significant challenge: cleanroom space. The supplier was able to help by developing a complete primary and secondary packaging system within a tightly-restricted footprint. The brief demanded high throughput, stringent quality control and zero compromise on regulatory compliance, all while maintaining seamless integration.
Shawpak supplied its Linear Blister Form-Fill-Seal (FFS) system, tailored to produce a male-formed rigid blister directly from rollstock. This serves as the primary pack for a delicate medical device. After the device is loaded, a Keyence vision system ensures correct positioning and the presence of critical device features.
The blister is then sealed with a Tyvek lid, inline printed by a high-definition printer, and inspected again using advanced Keyence vision technology to detect any print or material defects. This precision-first approach ensures that no compromised pack can proceed to the next stage, Shawpak explains.
The sealed primary pack is automatically transferred to a die-cutting station to shape the outer pack profile. A Universal Robots collaborative robotic arm then removes the completed pack, separates trim waste, and deposits the finished unit into the next phase of the process. The cobot’s agility is instrumental in navigating the confined workspace, says Shawpak, performing dual tasks of waste management and product handling with ease and efficiency.
The cobot then loads the primary pack into a Shawpak Rotary Thermoforming 62-25 machine, also equipped with high-definition printing and Keyence vision for print inspection. Here, a secondary flexible blister is thermoformed around the primary rigid pack, completing a dual-pack configuration said to ensure both protection and compliance.
By placing the compact RT62-25 machine at a 90-degree angle to the linear FFS system, Shawpak says it has achieved a tightly-integrated system with an exceptionally small footprint — a key requirement for the customer’s limited cleanroom space.
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