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How Rubikon was able to fulfill track and trace regulatory requirements across several countries with the help of VISIOTT TPS?
Firm: Рубикон
Location: Vitebsk / Belarus
Industry: Pharmaceutical
The Story of Traceability – Chapter 1
Established in 2010, Rubikon is one of the main players in the Belarus pharmaceutical industry. Rubikon produces medicine in soft, solid, and liquid forms including tablets, suppositories, and injectables.
With a focus on quality and a commitment to serving clients around the world, Rubikon exports its products from its GMP-certified plant to Russia, Uzbekistan, Kazakhstan, and Kyrgyzstan.
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To fulfill traceability requirements in the countries exported to, it became necessary for Rubikon to find a solution provider that can satisfy quality requirements as well as have a sophisticated knowledge of regulations in different countries. This is where VISIOTT TPS was able to offer its expertise.
VISIOTT TPS’s solutions are GMP, GAMP 5, and 21 CFR Part 11 compliant which guarantees quality for the client and the consumer. At the same time, VISIOTT TPS’s solutions are integrated with regulatory authorities in Russia, Kazakhstan, Uzbekistan, and Kyrgyzstan. This allows Rubikon to continue exporting its products to these markets without facing impediments, which is the main advantage offered by VISIOTT TPS.
What solutions were purchased and what was the process from start to finish?
After receiving a recommendation regarding VISIOTT TPS’s quality and services, Rubikon contacted VISIOTT TPS for a meeting to discuss potential solutions to its individual case. After the requirements were thoroughly understood, VISIOTT TPS proposed its solution to Rubikon which consists of a Flat Carton Serialization Station (FCSS-100), Semi Automatic Aggregation Station (SMAS-100), and Plant Manager Software.
Flat Carton Serialization Station | FCSS-100
FCSS-100 is capable of serializing and verifying up to 250 flat cartons per minute and is relatively small in size making it a compact solution. The serialization codes printed are in the form of a 2D Data Matrix and are verified by OCR/OCV technology. If a code is faulty, the machine can reject the flat carton with a special mechanism. Flat Carton Serialization Station can print regular 2D Data Matrix codes and can also print special crypto codes required to satisfy the regulations in Russia, Kazakhstan, and Uzbekistan. The main benefit secured for Rubikon by FCSS-100 is the flexibility and versatility of the application. Regardless of the form of medicine or production schedule, the machines can serialize the flat cartons offline and prepare them for packaging later.
Semi-Automatic Aggregation Station | SMAS-100
The semi-automatic aggregation station Semi-Automatic Aggregation Station is one of the flagship products provided by VISIOTT TPS. The station helps Rubikon save time and improve productivity with its multilayer scanning technology. The specially designed camera zooms in and focuses on the products inside the cardboard box. After reading all the 2D Data Matrix, additional layers of medicine can be added and scanned as well. When all the 2D Data Matrixes are captured, an aggregation code is printed automatically and can be applied by the operator. Once the number of boxes for a pallet is complete, the same machine prints the pallet aggregation code automatically.
VISIOTT Level 3 Plant manager
VISIOTT’s plant manager software allows the production and management of traceability codes and can be integrated with over 70 ERP systems including 1C and SAP. Additionally, the software’s ready integration with all regulatory authorities in the world like Chestny Znak, Asl Belgisi, Kazakhtelecom, SFDA, EMVO, and Tatmeen, offered Rubikon an advantage in reaching customers in countries where regulations are required.
Do You Think The Story Is Over? | Next Steps
After the appropriate solution was carefully selected and the offer was approved by Rubikon, VISIOTT TPS began manufacturing the machines. After the machines were ready, a FAT was conducted with Rubikon’s presence on VISIOTT TPS’s premises to ensure the client’s satisfaction with the solution’s performance. Following that, the machines were shipped to Rubikon and a SAT was conducted to verify that the requirements had been met and the machines worked as planned on site. The last stage was the integration between VISIOTT TPS’s software and the Russian, Kazakh, Uzbek, and Kyrgyz regulatory authorities. The entire project was completed in approximately 5 months and Rubikon employees were offered training on how to use the machines.
VISIOTT TPS, More Than Just a Solution
VISIOTT TPS believes in establishing trustful relationships with clients. This is why VISIOTT TPS offers more than just hardware and software, VISIOTT TPS offers everything a client needs for successful and painless operation including consultation, training, after-sales support, spare parts, and adaptability to new regulatory requirements.
Don’t forget to contact us if you have questions or would like to have your very own success story with VISIOTT TPS!
