Case Study
Padagis impresses FDA inspectors with exceptional workwear hygiene
Padagis impresses FDA inspectors with exceptional workwear hygiene powered by Polytex automated solution
Background
Padagis - formerly a Perrigo company - is a leading manufacturer of generic prescription and quality over-the-counter medicines. The company owns six production, packaging and distribution facilities in the US and Israel and employs 1400 people.
Customer Testimonials
Challenge
As a pharmaceutical company, Padagis undergoes regular FDA and EU inspections, including thorough reviews of safety and hygiene related processes. Maintaining a high standard of workwear hygiene is vital for continued regulatory approval of its factories.
Beyond the need to pass inspections, hygiene is always a top priority for Padagis, so it adheres to Good Manufacturing Practices (GMP) guidelines. David Avisaru, Purchasing Manager, explains what that means at Padagis. “Workers that enter the production floor or the packing, warehouse, or weighing areas have to change their clothing every day. If their clothing gets dirty, the employee must return the dirty item immediately and get a clean, new item right away.”
At Padagis, workers require different combinations of pants, shirts and towels, according to their specific roles. The company wanted to automate workwear distribution to streamline processes for laundry staff and factory workers, optimize workwear hygiene, and gain more control of its workwear. It looked for a single solution that would both automate the full cycle, from dispensing clean clothing to collecting returned items, as well as provide reports for management analysis and regulatory reviews. Crucially, to ensure a high standard of hygiene in line with GMP and FDA requirements, the solution needed to minimize human handling of clean clothing before it is dispensed to workers.
The solution
In 2018, Padagis implemented the Polytex automated workwear management solution, installing two dispensing units and one return unit in its main production site, which are operated through Polytex’s advanced software and cloud management system. Twice a week, items are washed and then individually packaged by an external workwear provider, before being returned to Padagis.
The Polytex dispensing units are refilled twice a day. Only the Purchasing Manager and two team members have access to the dispensing units. Each factory employee is assigned workwear according to their job. At the start of each shift, and whenever they need to change clothes, workers use their employee ID card to activate the dispensing machine to provide the exact workwear items needed, in the right size. The clean items are dispensed robotically, untouched by human hands.
Benefits
With its Polytex automated workwear management solution, Padagis maintains the highest standards of hygiene and ensures the right workwear is always available and easily accessible to staff.
Hands-free, automated operations support frequent employee workwear item changes – even mid-shift – improving overall hygiene and helping with multiple regulatory processes, including FDA and EU inspections.
While the inspections cover many other aspects of the business, David’s team is in charge of decontamination of the facilities and is tasked with proving that clothing and uniforms are clean inside and out. “We’ve had the machine for six years and already have had two FDA inspections, which we passed successfully,” he says.
David appreciates having a single, comprehensive solution that is easily managed. “Polytex is one machine that serves all departments, each according to its own requirements,” David continues. “In the computer, we define the allocation for each employee according to their role. The packing department employees just need a coat. The warehouse, manufacturing, and weighing staff get a coat, pants, and a towel. We fill the machine according to the requirements, and then the machine provides the items when the employee swipes their ID their card.”
The organizational differences made a strong impression during a recent site inspection. “The FDA inspectors are used to seeing coats in different sizes on a cart,” David explains. “So, when they saw the unit, they were very enthusiastic to see that everything is inside. They saw how the machine works by sizes, pants, small, large, and that everything is organized nicely.
In particular, the FDA inspectors were impressed that only three authorized people can access the clothing in the machine. That’s the thing with Polytex, no employee touches anything,” notes David. “The inspectors were enthused because it shows the factory is very organized, working according to protocols, and is improving. They were so pleased that in the concluding discussion, the Polytex machine was the first thing they mentioned, saying that it was outstanding.”
The usage reports generated by the Polytex solution also help Padagis with the FDA inspection process, as they document how frequently employees change their uniforms.
Overall, Padagis is keen to recommend Polytex to other companies that are subject to FDA inspection. David concludes: “We recommend Polytex to any factory. Thanks to the strict organization of clothing, the hands-free process, and the reports, it’s a big plus for regulatory compliance. And it gives you peace of mind. You just fill it in the morning, and then there is nothing to do until midday. You have quiet, and that’s a big deal too!”
