From NEW Machine Order to SAT for FAVIPIRAVIR Tablet Production in less than one Month
The global pandemic of COVID-19 has changed the focus towards epidemic prevention and control of the infection in all areas of the world. The WHO is sparing no effort to call all nations to strengthen unity and cooperation to fight the epidemic disease spread. The scientific world has been searching for weeks for a coronavirus 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 infection, targeting to improve the cure rate and to reduce the death toll as top priority.
Zhejiang HISUN Pharmaceutical Co., Ltd. is one of the leading pharmaceutical manufacturing companies in China. During clinic trials in the early phase of the epidemic outbreak in China, HISUN’s OSD drug FAVIPIRAVIR has shown positive effects in treatments of patients and good clinical efficacy with no significant side effects. The antiviral agent FAVIPIRAVIR, originally developed for flu treatment, has been approved for manufacturing and marketing in Japan in March 2014 under the tradename AVIGAN already. The clinical trials in Shenzhen and Wuhan have shown 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 has been observed. The Chinese Food and Drug Administration CFDA has officially approved FAVIPIRAVIR on February 15, 2020. As the first drug with potential efficacy in the treatment of against COVID-19 approved by the CFDA during the epidemic outbreak, the drug is recommended for guided treatment programs 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, also countries such as Italy have decided to approve the use of the drug.
Amid the epidemic situation, the setup of the mass production has become a race against the clock after the formal CFDA approval. With time to market being of the essence, HISUN together with the involved authorities have initiated common steered efforts, in order to ensure the production of FAVIPIRAVIR with the required quality and safety of the drug. A unique and elite taskforce consisting of local market supervision Authorities, GMP inspectors and HISUN experts has been formed to track and supervise the whole process of the first FAVIPIRAVIR tablet batch production from the raw materials to the finished drug.
Packing line of Favipiravir in the Hisun Pharmaceutical plant
The taskforce team has worked around the clock to guide the standard production of the drug. Hisun Pharmaceutical Experts have worked closely together with the drug supervisors 24/7, while still multiple challenges have had to overcome, such as epidemic control related traffic control limitation and staff shortage. After initial production start on February 16, the first 22 transport cartons of FAVIPIRAVIR have been finished on February 18, designated for hospitals in Wuhan and contributing to the treatment of COVID-19 in the Chinese epicenter of the epidemic outbreak.
According to Li Yue, Head of the Medical Science Department and General Manager, Zhejiang Hisun Pharmaceutical has provided drug support to many countries after the worldwide pandemic infection spread, coordinated by the Joint Prevention and Control Mechanism of the China State Council.For the great achievements in a short period, HISUN has obtained high acknowledgement from the P.RC. State Council.
Delivery of the first batch of HISUN Favipiravir to Wuhan
After the tremendous initial achievements, it became obvious, that the actual FAVIPIRAVIR production output would have been far too low to cover the local and global demand for COVID-19 patient treatments. With 8 P series and one 102i Lab machine in their OSD plants, HISUN has been already very satisfied and familiar with the Fette Compacting technology. Targeting to ramp up their production and to improve efficiency on shortest terms, HISUN has approached Fette Compacting China for a suitable solution with quick implementation. The challenging task was to supply an additional new P2020 Fette Compacting tablet press for the FAVIRIPAVIR tablet production with SAT within one month.
Acknowledgement and Appreciation to HISUN from the P.R.C. State Council
For the Fette Compacting China Management Team, there was no doubt that the challenge had to be mastered, given the higher goal in the critical epidemic situation. Even under normal condition almost a “mission impossible”. Moreover, at this time everything has been far away from normal:
Fette Compacting China had just re-started its operation after 25 days on February 18, 2020 from epidemic control related to China wide work suspension. While starting operation under strict epidemic prevention and control measures successfully, the local supply chain was still not fully functional. Inland travel restrictions had been still in place, requiring remote communication and customer emergency service. The inbound transportation for the import of crucial machine production parts from Germany was seriously disturbed by vastly reduced airfreight capacities and suspension of train transportation.
After a quick holistic analysis of all options and production parts’ availability, Fette Compacting China’s Management Team has defined the demand from Hisun Pharmaceutical as top priority. On March 23, 2020 the commitment has been made to HISUN to deliver the new P 2020 machine in the shortest possible time by any means.
The production status of the machine has been monitored 24/7, putting the “one-to-one” follow up principle in place for production status, production capacity improvements and operational efficiency. The focus has been on securing the tight timeline, while maintaining high-quality in machine production.
Close follow-up of the machine production with involved departments
Due to the comprehensive measures and close monitoring, the normal production time for a new P2020 tablet press of 3-4 months has been reduced to only 2 weeks, fully supported by all Fette Compacting China departments and resources. The next hurdle to overcome were the epidemic prevention policies and travel restrictions that had been still in place at this time, hindering customer’s representatives to inspect the machine in the Fette Compacting China’s Competence Center before delivery as usual. In that situation, the FAT was witnessed via online video acceptance service by the HISUN inspection team. By this, all tests and adjustments of the tablet press and peripheral units have been executed in strict accordance with the FAT standard and customer’s customized special requirements, in a highly efficient way.
Final assembly of the P2020 for HISUN Pharmaceutical
After the standard rework and cleaning of the machine, all parts have been disinfected and packed according to the high standards, Fette Compacting upholds to ensure utmost protection of health and safety under epidemic prevention and control, including documentation of all steps.
FAT at the Fette Compacting Competence Center
In the meanwhile, the public travel restrictions had been partly relieved due to the stabilized epidemic development status in the neighboring Jiangsu and Zhejiang Provinces. Upon arrival of the machine at the HISUN Plant in Taizhou (Zhejiang Province), the Fette Compacting Engineers rushed to the site to install the new P2020 in the newly re-constructed pressroom on April 3rd 2020. After residual construction works in the tablet pressing area of the HISUN Plant have been finished, the Fette Compacting China’s Customer Service team started the required high-quality service for debugging, testing and start-up of the new P2020 on April 18, 2020. On April 20, 2020, the SAT and all trainings for the new tablet press with all peripheral have been fully accomplished according to the requirements of HISUN. This has enabled the customer to execute the remaining Production Qualification (PQ) in time, to start commercial FAVIPIRAVIR tablet production on the newly delivered P2020 in April 2020 still.
Starting from the P2020 Tablet Compacting Machine order negotiation on March 23rd, 2020, it took less than one month to finish the Machine production, delivery, SAT and Training of the new P2020 tablet press and all peripheral equipment for the FAVIPIRAVIR production in the HISUN Pharmaceutical plant:
The new P2020 producing Favipiravir tablets at the Zheijiang HISUN Pharmaceutical plant
Certainly a special case in a very special time amid the worldwide COVID-19 pandemic. But it can serve as an excellent example how high customer focus, common spirit, and close cooperation between all parties can overcome even biggest challenges! Furthermore, everyone involved in the project have gained high motivation by this remarkable success and the contribution to the COVID-19 defeat battle.
Fette Compacting China always upholds a strong customer focus, high competencies and high-quality services, following its vision:
“Leading through most Innovative Technology & Excellent Solutions for better Health and Lives”