COVID-19 is currently challenging our technical professionals in terms of traveling for set-ups and the commissioning of the delivered equipment to our customers worldwide. However, our customers are also suffering from travel restrictions, which make it difficult to carry out a joint Factory Acceptance Tests (FAT) on the manufacturer’s site. A FAT is a process to approve that the equipment aligns with the specifications made for design and functions, before it is dispatched to our customers.
In 2020, video FATs (live and offline) were truly proven and established, but with video Site Acceptance Tests (SAT) it is not that easy. They are more challenging, as they determine the equipment’s functionality at the user’s site after its installation and therefore must be carried out live and require skilled personnel on customer site. Furthermore, language barriers have to be considered.
In the past few weeks, three multiple-day remote SATs took place at one of our Russian customers. Both Syntegon Pharma Solid sites were involved: Waiblingen and Schopfheim, where Hüttlin GmbH (a Syntegon company) is located.
In all three cases, the participants consisted of an on-site customer engineer and a local engineer of our official sales representative in Russia (Polo AG). A Syntegon commissioning team in Waiblingen and Schopfheim respectively, step-by-step provided guidance for machine set-up via video conference. Upfront the customer prepared the delivered equipment with the corresponding parts and the required media supply.
For team Waiblingen it was the first live video support for an installation of its capsule filling machine type GKF Capsylon 705. Approx. five hours after starting, the customer was already able to run empty capsules on day one. On day two several different dosing discs, format sizes and placebo products were run successfully by video guidance. Further testing was continued on the third day and could already be wrapped up at lunchtime, in order to close the installation session.
Hüttlin GmbH also successfully conducted the remote SAT for a laboratory fluid bed processor, type Solidlab 2, as well as a laboratory high-shear mixer type Mycromix.
The installation and IQ/OQ was finished within three days for the Solidlab 2 and two days for the Mycromix. Based on video support from Schopfheim, the customer was able to generate a recipe and run successful placebo trials with bottom and top spray granulation systems on the Solidlab 2.
For detailed training of the operators and the performance of the qualification documents, a Syntegon fitter will additionally be sent to the customer site, as soon as travel requirements are fulfilled. Despite all modern technologies and communication tools, the team spirit was the key success factor in reaching our common goal – spasibo to everybody who was involved in this event.