International teamwork for USV India

Flexible filling processes for prefilled syringes and vials

The Indian company USV Private Limited was founded in 1961, and now operates in 75 countries around the world – a success story based on entrepreneurial courage and pharmacological expertise. Since September 2019, USV has had two flexible Optima systems in commercial operation at its site in Daman (India). In this report, we show the close interaction between the expertise at Optima's Indian site and the German headquarters, and how USV benefits from this.

In January 2015, USV Private Limited placed its first order with Optima for a highly flexible, combined labelling and assembly machine for safety devices like finger flanges on syringes. Just four months later, there was a follow-up order. A highly flexible filling and closing machine was needed to replace an existing unit at USV. Following a lengthy approval process, USV can now look back on over one and a half years of industrial production with the systems.

Important for you

The flexibility required was implemented by supplying a filling and closing system as well as a safety devices system to USV in India.
Reliability, output, and filling accuracy were fully achieved.
Time-to-market has been reduced by four months.
According to the customer, USV, "excellent service" on site in India by both Optima India and Optima Pharma Germany
The perfect combination of local knowledge in India and expert backup from Germany

As a standard dosing system, USV uses rotary piston pumps in the OPTIMA SV125. In addition, USV can fall back on a five-position peristaltic pump system at any time.

Thanks to Optima, USV was initially able to save time and money through a joint Factory Acceptance Test (FAT) of the two machines in Schwaebisch Hall, reports Akshay Chikodi (Director Sales & Service at Optima India) looking back. However, by far the biggest advantage was achieved in the time-to-market. This was because the filling and closing machine was more complex in terms of qualification and approval, and was then able to be installed and qualified before the assembly machine. This meant that it was possible to save approximately four months time to start the important work for this and for media fills as soon as possible.

Flexibility is the benchmark

Akshay Chikodi says that during the development phase, the filling and closing machine was initially supposed to be adapted to individual processes that existed at USV and that were dictated by the legacy machine. This is why the unpacking of the tubs from plastic film is not currently fully automated but rather semi-automated. In the process sequence that follows, there will be complete automation: the removal of the tubs sealed with film using the OPTIMA TRR robotic arm as well as the removal of the Tyvek cover, filling with integrated 100 % in-process control and, if required, with gas flushing, including when closing the containers with stoppers. The system with its five filling stations is designed to handle a capacity of up to 10,000 containers/h.
However, what primarily sets Optima's system designs apart is their flexibility. With the OPTIMA SV125, USV processes nested ready-to-use syringes in the formats 1 ml long, 3 ml (in different versions or formats) and 5 ml. In addition, cartridges are processed. A tool-free format changeover and coded format parts mean that the system can be changed over quickly and safely.

An OPTIMA TRR Tyvek Removal Robot will soon be peeling off the protective film.

The pharmaceutical company USV in India placed the awarding of the contract on the flexibility of the filling solution. The OPTIMA SV125 currently processes nested ready-to-use syringes in the formats 1 ml long, 3 ml (in different formats) and 5 ml as well as cartridges.

Flexible filling processes for ready-to-use syringes syringes and vials. Depending on the batch sizes, the number of filling points can also be modified.

For maximum safety: In-process controls

Two filling systems cover the various product characteristics: Rotary piston pumps are installed as standard and are mainly used by USV for its peptide-based medicines. USV can fall back at any time on a five-position peristaltic pump system for other medicines, which is ready and waiting on a trolley. The in-process control ensures high filling accuracy and guarantees high product quality. The design of the machinery and the processes have been finalized in close cooperation with the project team at USV consisting of Hoshi Edulji (VP Commercial), Vijay Prabhu (Associate Vice President), Mangesh Gupte (General Manager – Projects), Shailesh Mukkirwar (General Manager – Projects) and Mahesh Italiya (Senior Assistant General Manager – Operation).

USV assesses filling accuracies for all formats against stringent acceptance criteria, reports Mahesh Italiya. In this regard, the system impresses the customers and, what's more, so far it has not experienced any significant failures. USV also processes smaller batches, so the number of filling stations on the Optima system can be reduced from five to two. The second Optima system, the automatic assembly machine, was also designed primarily with flexibility in mind. Here, a variety of formats of filled and sealed ready-to-use syringes from different manufacturers are equipped with safety devices. Firstly, the syringes pass through the OPTIMA EKK labeler with printer, including for specific printing. These are checked inline by camera. Then the OPTIMA VSM assembly machine inserts the plunger rods into the syringes. Finally, the syringes are fitted with safety devices such as finger flanges, for instance. Here, too, the achieved format range is very large.

At USV India, a second Optima system assembles safety devices. The syringes are also labelled.

The removal of the sealed foil of the tub and the removal of the Tyvek cover is done fully automatically.

Networked locally and internationally – feedback from practice

But what does this close cooperation across borders and continents look like? According to Mahesh Italiya and the project team this was one of the key arguments in awarding the contract to Optima. Cooperation is intended to bring together the local knowledge of Optima’s Indian subsidiary with the German site's in-depth pharmaceutical expertise.
What is particularly meant by local knowledge is a thorough understanding of the challenges faced in pharmaceutical production on the customer's site. This is how the German-Indian team succeeded in developing a concept that perfectly reflects these customer needs today. Again, a German-Indian Optima assembly team was on site at USV to install the equipment. The team became thoroughly acquainted with the customer-specific features and the design of the system. This was to offer benefits for servicing work later on. This international approach continued during the qualification process. Here, the Optima site in Germany provided support and backup for Optima India.

Initial training sessions were held by Optima India for the customer's staff, even before the commercial commissioning. It was also important to have direct contact with no language barriers when advising USV on which spare parts it should keep in stock. It was a matter of matching the customer's requirements and those of the machines as closely as possible, and setting up of spare parts management at the USV site in Daman, says Akshay Chikodi. Additional local training sessions took place, firstly to qualify the USV staff to take ownership of "their" Optima machines and secondly, to be able to communicate accurately should any technical questions arise. It continued with the first new format parts, which were requested as additions to the USV product range. Expert on-site advice assured safety on both sides.

Aseptic processes and rapid on-site deployment

The close proximity would particularly pay off in the event of unplanned machine breakdowns. The fact that USV and Optima India are located within the same time zone is worth its weight in gold here when sensitive biological medicines have to be processed in aseptic processes within a limited time. In addition, if required, Optima employees would be able to be on site at USV within half a day at the latest. Indian service staff have already used remote access to connect with service colleagues at the German headquarters in order to coordinate and implement solutions. Finally, Optima India carries out preventive maintenance on both systems.
"Optima India's and Optima Germany’s service performance is excellent," says Ashok Saxena (Senior VP – Operations). His overall conclusion is unambiguous: "All our expectations have been fulfilled!" According to Mahesh Italiya, USV is operating equipment that is "completely reliable" and leads to results that are perfectly reproducible. They are an important asset in driving globalization forward. In the meantime, USV has concluded international licensing agreements with renowned global companies.