Automating Quality Inspection for Multinational Medical Devices Manufacturer

EPICs automated vision inspection solution enabled the medical device manufacturer to achieve significant improvements in efficiency, quality, and regulatory compliance. Each stage of the solution contributed to the customer’s success by ensuring that only high-quality, correctly assembled, and accurately labeled products reached the market. 

Hygienic Process System Design

Project

Overview

  • Industry: Medical Devices
  • Company Size: Over $1B Annual Revenue
  • Location: Indiana, USA
  • Customer Use Case: Absence / Presence, Label Inspection, Track & Trace

Customer’s

Challenge

A leading multinational medical devices manufacturer faced a significant operational challenge in their production process. The company relied heavily on manual labor for packing, assembling, and verifying their products. This labor-intensive process was particularly cumbersome for their new product line, a kit comprising of 2 to 4 components. 

As the medical device industry is highly regulated, stringent inspections are critical. Ensuring that every piece of equipment and labeling matches its specifications is critical due to the life-saving nature of the products. Incorrect or missing components, improper sealing, or mislabeled products can lead to severe consequences, including patient harm, regulatory penalties, and damaged reputations. Verifying product packing is not a step that can be skipped or compromised. To maintain their high standards of quality, safety, and compliance, the manufacturer needed an automated solution that could handle these tasks with precision and consistency. 

Epic

Solution

EPIC Systems stepped in to address this challenge by implementing an advanced vision inspection solution, designed with four critical stations to automate and streamline the process: 

1. Component Verification and Seal Integrity: The first station was equipped to verify the presence and correctness of each component in the kit, ensuring that every kit contained the necessary elements. It also checked the integrity of the seal, ensuring that the latch was properly closed for both sanitary purposes and as a tamper detection measure. Maintaining seal integrity is crucial for patient safety, as it prevents contamination and ensures the product has not been tampered with. Additionally, this station’s rigorous verification of component presence and absence was critical to prevent assembly errors and guarantee that only correctly assembled kits moved forward.

2. Print and Apply: The second station automated the labeling process. It received the label data, printed the labels, and applied them accurately to the corresponding kits, ensuring that each kit was labeled correctly according to its specific configuration.

3. Optical Character Recognition (OCR): At the third station, the system performed OCR to verify the printed characters on the labels. This step was integral to meeting regulatory requirements for track and trace. It checked critical information such as expiration dates, manufacturing dates, and part numbers, ensuring that all details were correct and legible. Accurate tracking and tracing are mandated by regulations to ensure that products can be monitored throughout their lifecycle, from production to end-user. This precise verification provides accurate and reliable information to healthcare professionals and patients.

4. Rejection Handling: The final station was a rejector that identified and removed any kits with errors, whether due to incorrect components, improper sealing, or labeling inaccuracies. This ensured that only perfectly assembled and labeled kits proceeded to the next stage of production. 

Project

Impact

  • Increased Efficiency: By automating the verification, sealing, labeling, and inspection processes, the customer significantly reduced the time required for each production cycle. This led to a substantial increase in overall production efficiency.
  • Enhanced Quality Control: The standardized inspection process minimized the risk of human error, ensuring that each kit met the company’s rigorous quality standards. The precise verification of components, seals, and labels guaranteed that only high-quality products reached the market.
  • Reduced Labor Costs: Automation eliminated the need for extensive manual labor, allowing the company to reallocate their workforce to more strategic and value-added tasks. This not only reduced labor costs but also improved employee productivity.
  • Regulatory Compliance: The system’s ability to verify every character in the label’s string ensured compliance with regulatory requirements, thereby avoiding potential legal and financial repercussions.  

unlock your manufacturing potential

Connect with an EPIC engineer to discuss how our solutions can revolutionize your business.

More Client

Success Stories

Multi-Skid Process System for a New Time-Release Fragrance Technology

Multi-Skid Process System for a New Time-Release Fragrance Technology

EPIC’s innovative solutions and meticulous project management enabled the successful design, fabrication, and delivery of multi-skid systems, addressing many challenges faced by the consumer fragrance company and ensuring seamless production of their new product.

Our Solutions

EPIC Systems is a multidisciplinary engineering integrator specialized in industrial automation for process manufacturers. We deliver solutions in the following areas:

Process Systems

Machine Vision

Robotics

Industrial Automation