Dr. Gustav Klein and MG2: the FAT between distance and reality

Three days to test a capsule filler for phytopharmaceutical and nutraceutical products: a success signed by Italy and Germany joint work!

Read the ITALIAN version

One of MG2 first goals consists in reaching the customer by providing the best technical solutions. This goal has become even more strategic during the present worldwide spring 2020 crisis, which severely limited the movement of both people and goods.
MG2 has successfully overcome this difficulty thanks to remote working technical solutions, chosen among the most consolidated office automation tools. Indeed, with Microsoft Teams, the video conferencing and Office 365 package remote working tool, MG2 can offer technical assistance, commercial support and advanced solutions, by using a familiar tool applicable to any business context. With this technology MG2 successfully carried out the first remote testing.

This is the case of the Factory Acceptance Test run with the customer Dr. Gustav Klein GmbH & Co. KG, a company of the Alpen Pharma Group, that is specialized in the production and distribution of herbal medicinal and homeopathic products based on traditional knowledge with benefit of state-of-the-art technologies and equipment.

Exporting to over 20 countries worldwide, the company works closely with national and international pharmaceutical companies as valuable contract manufacturer.
Dr. Gustav Klein offers the best solutions thanks to the partnership with leading market suppliers of technical equipment that share their values ​​of sustainability, trust and tradition such as MG2.
The machine at the centre of the remote FAT and the partnership with MG2 is an MG Compact capsule filler, with a maximum speed of 48,000 capsules per hour, equipped with two dosing units for powders and pellets with relevant dosing size parts, two capsule transport size parts and a statistical weight control system model SWC.
This MG2 technology will allow to fill capsules with phytopharmaceutical and nutraceutical products.

MG Compact capsule filler at the centre of the remote FAT
with Dr. Gustav Klein GmbH & Co. KG

Dr. Gustav Klein bought the capsule filler despite the COVID-19 crisis. That is why a remote procedure had to be defined to both run the FAT and carry out product validation. FATs are usually carried out at the MG2 headquarters in the presence of the customer, who checks the accuracy of both capsule filler operation and size change-over, who can touch the capsules and checks their integrity. The order is reviewed step by step, showing the customer the consistency between technical documentation and the supply. The recent hindrances to the movement, however, have forced MG2 to identify new solutions based on the integration of multimedia technologies with technical expertise of the Company staff.

A moment during the remote FAT carried out with Dr. Gustav Klein GmbH & Co. KG

“In this first remote FAT we used two video cameras,” says Eng. Fabrizio Buffoni, MG2 Area Manager, “one fixed and one on the operator. Wearable technology allows MG2 to show all the components purchased by the customer. The live procedure totally corresponds to the Factory Acceptance protocol that we usually apply. It allows, in fact, to verify that the compliance with the order and that the machine operates correctly. 
In this specific case, the customer asked to weight some of his capsules once a production batch was finished.
The capsules were then collected in three stages during one hour of production: at the beginning, at the end and in the middle of the batch production, they have been weighed one by one, subsequently emptied and weighed again. 
The goal”, continues Eng. Buffoni, “was to give the customer an evidence that the capsules had been filled as expected by him.”

The remote procedure, which covers all the steps necessary for the correct execution of a FAT, involves sharing all the documents of both validation and order confirmation, strictly following what is displayed by the two cameras.  The batch reports processed by the machine were made available to the customer in real time, thus overcoming the objective limits related to the physical distance.

The test recording, lasting 3 working days of 8 hours each, is another tool that let the customer the possibility to objectively evaluate the test.

“A key element of the FAT is the objective evaluation of the correct capsule filling” continues Eng. Buffoni, “an aspect which, in the case of the customer Dr. Gustav Klein, was highlighted by two specific tests: the SWC weight control system, which tests a capsule every 20 seconds and it was part of the supply, and a further statistics check requested by the customer.
Specifically, we manually weighed the capsules on a scale in front of the camera, thus ensuring maximum reliability and objectivity of the filling process “.
 

Furthermore, with the same remote technology, it was possible to verify all the machine documentation (user manual) and validation documentation, by connecting the customer and the MG2 specialist in charge.

Model SWC weight control system

“Usually validations are part of the packages purchased by pharmaceutical companies. In order to produce a drug, in fact, the capsule filler must be validated according to specific regulations.” – continues Eng. Buffoni – “The customer can have his own validation procedures; alternatively, MG2 can supply them. Normally, nutraceutical companies are not particularly interested in validations. But this was not the case of Dr. Gustav Klein, who decided to acquire validations too, because he is a high-quality manufacturer of food supplements and homeopathic products: that’s why we could call him a parapharmaceutical supplier.”

Quality, efficiency and proximity to the customer, well-known characteristics of the MG2 brand, have been enriched with the successful remote FAT for Dr. Gustav Klein.


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