A global pandemic has few silver linings, but one of them is certainly finding new and even better ways to do things, including supporting and serving customers. Alongside the remote and digital services GEA Homogenizers already offered, needs-must spurred our teams on to develop virtual solutions for critical milestones around testing and approvals – services we’re happy to offer customers long-term, which means more convenience, cost-savings and reducing the CO2 footprint of projects.
At the end of February of 2020, the coronavirus began making its ugly presence known in northern Italy. Less than a month later, the entire country – excepting essential services – was sent into quarantine – lockdown. For consumers and manufacturers this meant an immediate change in daily behavior, and a lot of uncertainty, as much of the country went eerily quiet.
Located in Parma, Italy, just 100 kilometers from Milan, GEA Homogenizers, which includes the GEA Process Technology Center (PTC) for homogenization, is made up of roughly 190 employees who serve customers globally across diverse industries. As news spread of the lockdown, several GEA customers began reaching out to confirm future delivery of spare parts and services fearing that our entire Parma site would be closed – perhaps for months. A handful of our Chinese customers even sent masks and other supplies to our team knowing that these items were becoming nearly impossible to source in Italy or elsewhere for that matter; a very kind gesture that GEA was able to later pay forward with a donation of 5,000 masks for healthcare workers in the immediate and surrounding regions.
In cooperation with GEA’s global crisis management team, the GEA Homogenizers site agreed to send its office staff home to work remotely. The production workers were split into three shifts, to accommodate distancing and hygiene regulations, and thus able to work in blocks of eight hours, around the clock. Government approval was given to GEA to produce specific equipment and service customers from essential sectors, which included pharma, food and dairy processing. These approvals had to be acquired weekly from the Italian government, requiring intensive coordination and reporting by GEA staff. All steps and actions were also coordinated with GEA Italy’s crisis team in conjunction with GEA’s global crisis team to ensure all protocols for health and safety were met.
As the pandemic worsened, many of our customers began ordering extra spare parts, putting pressure on stock levels which were based on historical consumption. Luckily, our robust supply chain, largely situated in Europe, facilitated the delivery of most items in a timely manner.
GEA Homogenizers: digital by default with many remote services available
Serving our global homogenization customers has always been about give a take. Many projects require detailed coordination, including site visits for key testing and approvals, with customers traveling to Parma or GEA specialists traveling to customer sites. That said, GEA has long offered many services digitally or remotely to promote the efficient and cost-effective exchange of information, data and results. This includes, for example:
- consulting customers about how to optimize their processes
- running technical feasibility studies on process conditions for customers to ensure positive end results
- demonstrating scalability from tabletop to pilot plant homogenizers
- shipping samples produced to customers for evaluation
- sending customers clear and detailed follow-up test reports and process bulletins
- walking customers through test results and analysis discussion
Necessity, the mother of invention
Given travel into Italy and out was banned during the pandemic and restrictions are still in place for some countries, it became imperative to find ways to support customers from a distance, particularly for machine and product testing. CGMP-compliant, factory acceptance tests (FAT), for example, are a necessary step before customers can accept or approve machines and normally occur at the vendor location. Site acceptance tests (SAT) involve testing the new equipment after it has been installed at the customer site to ensure it meets requirements. The GEA Homogenization team came up with solutions for streaming critical tests and approval processes, including:
- virtual laboratory testing
- virtual current Good Manufacturing Practice (cGMP) FAT & SAT
Virtual laboratory testing
GEA laboratory specialists run tests for customers on liquid products as they would under normal circumstances, with the only exception being that the process is shared via a streaming platform for customers who are offsite. This free, digital offering allows customers to watch and follow the proceedings in real-time as well as engage via video with the GEA expert. The process covers:
- technical feasibility
- formulation & product preparation
- validation of operating conditions
- test & sample preparation
- final reporting & analysis
Despite the logistical challenges caused by the coronavirus pandemic, the GEA Homogenizers team continued to serve new and existing customers with product testing at its PTC facility. In fact, one virtual laboratory test led to a purchase order from a leading pharmaceutical company in Germany during this difficult time – a testament to the trust our customers have in our team, our solutions and know-how.
Virtual cGMP FAT & SAT
To accommodate travel restrictions and new ways of working, GEA technical experts can assist customers remotely during validation via a reliable live stream connection; this includes making allowances for time differences that stretch beyond traditional working hours. GEA’s virtual FAT and SAT service can be performed entirely online in a live environment, internal or offline (documented with videos and photos), or customers may choose a hybrid solution which includes internal, offline testing combined with live streaming sessions between both parties. All options follow the same protocol as a physical validation. For the purely virtual offer, customers should allow for an extra 50% of the total time required. It covers:
- visual inspection of machines
- inspection of the entire scope of delivery
- machine performance testing
- noise control and alarm testing
- sterilization SIP testing
- cGMP documentation check
- riboflavin CIP testing (optional)
- software validation protocol (optional with PLC/HMI)
Likewise, for virtual SAT of machines and skids equipped with PLC, GEA can establish a direct connection to the units to ensure the correct onsite installation.