We visited one of the facilities of Novartis in the Siena region of Italy. There are two Novartis sites in this region: one in Rosia, where they have a QC laboratory, and one in Siena, where they have an R&D laboratory.
Good morning Dr. Francesco Corbini and Dr. Denise Sacchini. Thank you for inviting us to interview you.
I was very impressed by the beauty of Rosia, which is next to Siena, a UNESCO World Heritage Site. The architectures of your laboratories are also artistic and fully match the surrounding environment. I heard that your plant in Rosia was designed to minimize the impact to the environment, utilizing solar panels for self-produced energy, and the facilities are designed to save energy and minimize CO2 generation.
I feel a connection between your company and us, because SHIMADZU was founded, and maintains its headquarters, in Kyoto, which is one of the most historic cities in Japan.
Dr. Sacchini Denise
Bacterial Vaccines Quality Control Technician for Cleaning Validation Analysis
Novartis Vaccines & Diagnostics
Rosia, Siena, Italy
Dr. Francesco Corbini
Bacterial Vaccines Quality Control Specialist for Clean Utilities Monitoring
Novartis Vaccines & Diagnostics
Rosia, Siena, Italy
*Affiliates and titles of the interviewee are current as of the time of reporting.
Dr. Francesco Corbini, please introduce your study and your role in the lab.
I’m Francesco Corbini. I have worked at Novartis as a chemist for 10 years. I started in Novartis as a QC operator, and have been in charge of the monitoring of water systems. Now I am a supervisor for the monitoring of the pure water system and also for cleaning validation. With respect to cleaning validation, I handle both the rinse water sample and the swab sample, which are sampled in all equipment in all sites.
Thank you. Dr. Denise Sacchini, please introduce your study and your role in the lab.
I’m Denise Sacchini. I have also worked at Novartis as a QC operator for 10 years. I am in charge of the cleaning validation, including the TOC analysis of both pure water and rinse water.
How do you use the TOC-V?
We have five TOC-Vs in our laboratories in this region, four in Rosia and one in Siena. All TOC-Vs are equipped with the ASI-V auto-sampler with a sample stirrer. We analyze the TOC in pharmaceutical water in compliance with the pharmacopoeia. We also measure the TOC of pure waters, such as water for injection (WFI), purified water, and condensed clean steam.
How many people in your lab use the TOC-V, and how often?
Six operators work with the TOC-V, and they use it at least 3 days a week. They usually run it for 10 hours or more each day, but more than 30 hours in some cases.
We perform a system suitability test each day as well as calibration once a month. We also have a maintenance program, which includes a yearly PT validation and preventive maintenance every 6 months.
Why did you choose the TOC-V?
We were using an in-line TOC analyzer that uses the wet-chemical oxidation technique. However, we now prefer the combustion-type TOC analyzer because we are concerned about the oxidation efficiency, and therefore we replaced our previous TOC analyzer with the SHIMADZU TOC-V. Actually, we still use this wet-chemical TOC analyzer, but just for the in-line monitoring purpose of the pure water system. We are sticking with the SHIMADZU TOC analyzer hereafter.
What are the advantages and benefits of TOC-V?
The main advantage of the SHIMADZU TOC-V is its high oxidation efficiency of organic compounds. We have always been very comfortable with the catalytic oxidation technique.
Please let us know your impression and opinion after the actual installation of TOC-V.
The SHIMADZU TOC-V is very sensitive and reproducible, and its software is very easy to use.
Please let us know your idea about the needs to be improved, added and enhanced for TOC-V.
Actually, we are interested in the Solid Sample Module SSM-5000A for the cleaning validation purpose. In this regard, we would like to have an auto-sampler for the SSM-5000A because we need to analyze a large number of samples. We can save a lot of time if we have the auto-sampler.
Thank you for your interesting information, Dr. Corbini and Dr. Sacchini.
I heard that your facility in Siena has a history longer than here, and it is worth visiting to learn more about your company. I regret that I cannot visit Siena at this time, but I will try to find another chance to do so. Thank you again, Dr. Corbini and Dr. Sacchini, and see you then !
Comments about the interview
The decomposition efficiency of organic compounds is, in a sense, the most important feature that is required for a TOC analyzer. SHIMADZU’s 680℃ catalytic combustion technique was developed about 30 years ago, and is successfully implemented in the TOC-V and TOC-L (＊ The combustion-type TOC-V was succeeded by the TOC-L in January 2011).
SHIMADZU ITALIA S.r.l.
SHIMADZU ITALIA S.r.l.(Milano), equipped with a dedicated demonstration laboratory, supports the full lineup of SHIMADZU's analytical and measuring instruments.