At a manufacturing site specializing in solid-form drugs, producing 11 billion tablets per year, manual cleaning had become a major bottleneck. Complex and time-consuming tasks - such as washing multitip punches, dust collectors, and containers - were difficult to standardize.

The inconsistency between operators led to variable results, posing risks for compliance. The FDA's stringent guidelines for manual cleaning validation increased the pressure, with audits required after each production cycle.

Revalidating the visual inspection method for over 200 operators every two years was simply unsustainable.

The Agitation: Time and Resource Drain

The manual cleaning process took an enormous amount of time-cleaning just 150 multitip punches would take up to 4 hours.

This not only slowed production but required constant operator involvement, leading to fatigue, potential errors, and increased operating costs. Furthermore, meeting FDA compliance became increasingly complex as it required ongoing audits and residue monitoring due to the inherent variability in manual methods.

The Solution: Automating Cleaning with IWT Pharma

We introduced an automated cleaning solution for key production equipment-dust collectors, bottom knobs, punches, weighing nets, and containers. By automating these processes, we ensured reproducible, validated cleaning results every time, eliminating the variability of manual operations.

Now, 150 multitip punches can be cleaned in just 40 minutes, with no operator supervision needed during the cycle. This approach not only saved time but also reduced labor costs and ensured compliance with FDA regulations.

Automated cleaning systems are the future of efficient, compliant pharma production. Learn how IWT Pharma can help you streamline your processes and enhance reliability.