Fette Compacting and Hisun Pharmaceutical achieve the impossible

Subsequent to receiving an order for a P2020 tablet compacting machine on 23 March, it took Fette Compacting China less than one month to complete the machine delivery, installation and training at Hisun Pharmaceutical. As a result, it’s made a significant contribution to ramping up Favipiravir production in China to help fight COVID-19.

In all areas of the world, the global COVID-19 pandemic has seen the pharma industry refocus on epidemic prevention and control of the infection. The World Health Organization (WHO) is sparing no effort to call on all nations to strengthen unity and cooperation to fight the virus and prevent its spread. The scientific world is unrelenting in its search for a vaccine, while continuing investigations on how to treat patients. This global approach has significantly accelerated the development of therapeutic drugs for the treatment of COVID-19.

Zhejiang Hisun Pharmaceutical Co. (Hisun) is a leading pharmaceutical manufacturing company in China. During clinical trials in the early phase of the outbreak in China, Hisun’s oral solid dosage drug Favipiravir showed positive effects in the treatment of patients and good clinical efficacy with no significant side effects.

Fette Compacting’s premises in China

The antiviral agent Favipiravir, originally developed for the treatment of flu, was approved for manufacturing and marketing in Japan in March 2014, under the trade name Avigan. The clinical trials in Shenzhen and Wuhan showed that Favipiravir can help to shorten the recovery time for mild and middle-severe COVID-19 infection cases. Furthermore, a positive effect of shortening the fever duration of infected patients was observed. On 15 February 2020, the Chinese Food and Drug Administration (CFDA) officially approved Favipiravir as the first drug with potential efficacy in the treatment of COVID-19 and it’s now recommended for guided treatment programmes in China.

Even if not formally approved by health authorities in Europe or the US, and in the absence of an effective and widely used vaccine to treat COVID-19 anywhere in the world, countries such as Italy have also approved the use of the drug.

MANUFACTURING THE FIRST BATCH

Amid the epidemic situation and after the formal CFDA approval, the setting up of mass production became a race against the clock. With time-to-market being of the essence, Hisun, together with the involved authorities, initiated common steered efforts to ensure the production of Favipiravir within the required quality and safety measures. A unique and elite task force was formed, consisting of market supervision authorities from the region, GMP inspectors and Hisun’s experts, to track and supervise the entire process of the first Favipiravir tablet batch production from the raw materials to the finished drug.

The task force team worked around the clock to guide the standard production of the drug. Hisun’s pharmaceutical experts worked closely with the drug supervisors 24/7 in an effort to overcome multiple challenges, such as epidemic control-related traffic control limitations and staff shortages. After the initial production commenced on 16 February, the first 22 transport cartons of Favipiravirwere completed on 18 February, designated for hospitals in Wuhan and contributing to the treatment of COVID-19 in the Chineseepicentre of the outbreak.

A P2020 tablet compacting machine from Fette Compacting

Coordinated by the joint prevention and control mechanism of the State Council of the People's Republic of China (PRC State Council), Hisun has since provided drug support to many countries after the epidemic rose to pandemic status with the worldwide spread of the infection. For its great achievements in such a short period, Hisun was also acknowledged by the PRC State Council. Although tremendous, it became clear the actual Favipiravir production output would have been far too low to cover the regional and global demand for COVID-19patient treatments.

A MISSION IMPOSSIBLE

With an 8 P series and one 102i lab machine already running in its OSD plant, Hisun was already very satisfied and familiar with FetteCompacting’s technology. Needing to ramp up its production and improve efficiency on the shortest terms, Hisun approached FetteCompacting China for a suitable solution with quick implementation. The challenging task was to supply a new P2020 Fette Compactingtablet press for Favipiravir tablet production with SAT within one month.

For the Fette Compacting Chinamanagement team, there was no doubt thatthe challenge had to be mastered, given the main goal in the critical situation. Even under normal conditions, this mission would be‘almost impossible’. Yet, at the time, things were far from normal – Fette CompactingChina had just reopened operations on 18 February after 25 days of hard lockdown to control the spread of the virus. Whilereopening under strict coronavirus prevention and control measures, the regional supply chain was still not fully functional. Inland travel restrictions were still in place, requiring remote communication and customer emergency services. The inbound transportation for importing crucial machine production parts from Germany was seriously affected by vastly reduced airfreight and the suspension of train transportation.

FAST-TRACKING DELIVERY

After a quick holistic analysis of all the options and the availability of production parts, FetteCompacting China’s management team made the request from Hisun a top priority. On23 March, it made a commitment to Hisunto deliver the new P2020 machine in the shortest possible time.

Due to comprehensive measures put in place and close monitoring, the normal production time of three to four months for a new P2020tablet press was reduced to only one month, fully supported by all of Fette CompactingChina’s departments and resources. The next hurdles to overcome were the epidemic prevention policies and travel restrictions, preventing representatives from the customer to inspect the machine at Fette CompactingChina’s competence centre before delivery as usual. So, the factory acceptance test took place online using a video acceptance service broadcast to the Hisun inspection team.

By this time, all tests and adjustments of the tablet press and peripheral units have been executed in strict accordance with the FAT standard and customer’s customised special requirements, in a highly efficient way.

After the standard rework and machine cleaning, all parts were disinfected and packed according to the high standards FetteCompacting upholds. This is to ensure the utmost protection of health and safety under epidemic prevention and control, including the documentation of all steps.

A SIGNIFICANT AND SUCCESSFUL SITUATION

During this time, travel restrictions had been partly relieved due to the stabilised epidemic development status in the neighbouring Jiangsu and Zhejiang provinces. Upon arrival of the machine at the Hisun plant in Taizhou(Zhejiang province) on 3 April, the FetteCompacting engineers installed the newP2020 in the newly reconstructed pressroom.

Subsequent to the completion of the residual construction work within Hisun’s tablet pressing area, on 18 April FetteCompacting China’s customer service team commenced the required high-quality service for debugging, testing and start-up of the new P2020. On 20 April, the SAT and all peripheral training on the new tablet press had been completed fully and according to Hisun’s requirements. This enabled the customer to finish the remaining performance qualification in time to start commercialFavipiravir tablet production on the newly delivered P2020.

With the support of Fette Compactingexports, the performance qualification at the customer's site was concluded on 25 April, only 33 days after the initial order negotiation. This is certainly a unique case in a very trying time amid the worldwide COVID-19 pandemic. But it can serve as an excellent example of how high customer focus, shared resolve and close cooperation between all parties can overcome even the biggest challenges. What’s more, is everyone involved in the project gained immense motivation from the remarkable success and their contribution to the fight against COVID-19. •

Fette Compacting – www.fette-compacting.com