GEA successful remote FDA line revalidation for an important dairy company beats Covid-19 lockdown
In 2018 one of the most important players in Latin America, manufacturing high-quality dairy products and fruit juices for over 75 years, purchased from GEA an Aseptic Blow Fill (ABF) system which obtained approval from the US Food and Drug Administration (FDA) to process Grade A milk. The dairy plant has a production capacity of 648 tonnes/day.
The challenge
In early 2020, the dairy company decided to adopt a lighter-weight preform which would result in stable supplying strategy and at the same time optimize the overall TCO by saving 1.3 g of PET on each produced bottle thanks to the flexibility offered byGEA ABFtechnology. This would save around 132 tons of PET a year worth approximately €250,000.
The company knew that the plant would need to be revalidated using the new preforms as it operates under strict FDA regulations. In preparation for the revalidation, the company purchased an adequate supply of required material to run the validation process for the new bottle. All was set for a smooth revalidation process of the plant followed by continuous production with the new lighter-weight bottle. But then Covid-19 hit!
If the line validation hadn’t been carried out due to lockdown restrictions, the material that had already been purchased for line ri-validation purposes would have gone to waste and moreover the production too would have had to be stopped due to lack of preform availability issues.
The GEA solution
GEA has recently introduced its extended Remote Support Filling platform which is an online service designed to provide remote support to customers for high-speed troubleshooting and process optimization. It was not primarily intended to be used for plant validation, but its great potential and immediate positive feedback received from already benefitting customers immediately suggested its application also for this type of process.GEA in fact had already matured the experience in using remote technology and digital connectivity, so everything was in place to perform a successful remote revalidation even according to the strict regulation of the FDA requirements.
We knew that we could make it work even during such new challenges. We obtained support from the FDA and its Process Authority Team and decided to do what we could to help. It was an important milestone for the customer, so we had to support them to achieve their goal.- Massimiliano Chiari, Head of Service Sales at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
- Massimiliano Chiari, Head of Service Sales at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
The operations took place in January 2021. The revalidation process resulted to be less complicated than validating a new plant for the first time, but still challenging when performed remotely.
The result
The revalidation process of the dairy plant was completed smoothly, with the same time as if it had been done on site. The plant is now in full production with the lighter weight bottle reducing PET consumption, cutting costs for the company and reducing its environmental impact. It was a challenging process but handled remotely to the full satisfaction of the all the main subjects involved in the process, including the FDA authority.
Luigi Tomasoni, Aseptic System Validation Manager at GEA, appreciated the skills and expertise of customer’s engineers and operators onsite as, he says, the remote revalidation would have been much more difficult without their help and support. “We were able to perform this remote validation because our customer’s team on site can easily operate onGEA ABF” he said. “We needed just one person there from GEA.”
Luigi explained that having a skilled and professional team on site in a pre-requisite. “These trials require the processing of a huge amount of testing samples, with different features in terms of both inoculum concentration and inoculation sites,” he said. “It is important that each testing set is clearly identified and segregated from others. The loading sequence of the testing sets is also important to so the trials are managed as fast as possible. Furthermore, each time a test set is processed, a review of critical parameters recorded during the run is done to confirm that the run is valid and that no deviations occurred: a skilled team on site knows this and can provide a better support to the remote team.”
Remote Support
GEA now provides the dairy company with remote technical support through its Remote Support Filling platform with connections to the PLC (Programable Logic Controller) and HMI (Human Machine Interface) and using augmented reality andGEA Remote Eye Wear. It provides its customer with the back-up of a complete GEA team including a mechanical engineer, line validator and software engineers for both the blow molding machine and the filling machine.
More in the future
This revalidation process has also been a progressive result for GEA. Gianluca Ortalli is the company’s Area Sales Manager. In his opinion the experience of handling the revalidation remotely has left GEA even better placed to resolve problems for customers in the future.
It means that we are better positioned to help customers if they experience difficulties or extreme conditions such as those we’ve had recently.- Gianluca Ortalli, Area Sales Manager at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
- Gianluca Ortalli, Area Sales Manager at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
Luigi agreed: “In case of need we are ready to repeat this process remotely again,” he said.
Being determined
Facing new challenges can be overwhelming, but with experience gained by the GEA team, with a great attention to each single detail and a strong will, all the risks can be managed and properly controlled. “We want to do everything we can for our customers, especially when they have a problem,” said MassimilianoChiari is Head of Service Sales for GEACentre of Competence for Blowing, Filling & Packaging (Sensitive Beverages).
That sometimes means we must think differently, be brave and take each new opportunity. We need to accept that customer service is an art, not a process. I was proud to say, ‘let’s do it’, and show that we would never give up.- Massimiliano Chiari, Head of Service Sales at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
- Massimiliano Chiari, Head of Service Sales at GEA Centre of Competence for Blowing, Filling & Packaging (Sensitive Beverages)
