Interview with Vincenzo Giorgini – Rigel Life Sciences

Vincenzo Giorgini spent his first 15 years of professional life in production, 2 years as the head of injectable department and another 13 years as production manager in Schiapprelli Farmaceutici, Alfa Biotech and a further 3 years in Serono (Bari site).

In this time, he worked with all the pharmaceutical formulation (tablets, injectable solution, lyophilized products, biological with HI activity and synthetic active products).

After this he commenced his experience in a commercial role in Pall Pharma department: the first 2 years as key customer account and the last 8 Italian Pharma sale Director. After the commercial experience in a large international company, Vincenzo took a general manager position In Alco Industries company specialising in contamination control in pharma and electronic companies. In 2011 he started his experience in Rigel process and Lab, part of Rigel Life science group and now he is both a shareholder and general manager for this business unit.

His company’s mission is the contamination monitoring and management, Rigel Life Science is the largest Italian company in contamination monitoring systems, they developed their own microbiological sampler, HEBAS, and they have made integrated systems with particle counters, microbiological sampler and other critical instrumentation (temperature, humidity etc.) in critical areas used for injectable production.

Rigel Process and Lab is a business unit completely dedicated for contamination management, they have in their portfolio many solutions for critical areas, cleaning and disinfection, media ready to use, ATCC strains, a microbiology identification system and data management software.

1. You have been in the pharmaceutical sector for more than 25 years. How has the industry evolved?

I remember my first experience in production, I was the head of injectable department, when the quality was liability of the alone QC department. Only at the end of 80’s I felt there was a total quality approach in process controls.

During the last 20 years, thanks to the incoming and fast growth of information technologies, the concept of quality has begun to involve each department related to the production of drugs: manufacturing, quality control, logistics and so on.

2. At the same time, your Rigel Life Science career has already spanned a decade. How has the company evolved since you arrived?

When I arrived in Rigel in 2010, it was a very young and small company, based in Rome with a small office in Milan. After 10 years, Rigel employee count is about fifty employees in 3 different facilities:

• in Rome, with head quarter, finance and administration dept. technical service and software development dept.
• in Milan, with two different building for consumable warehouse and logistic
• in France, with a sales office

During this period, we have grown up not only in dimensions, but also in quality, range of products and reference.

It has been a great experience that gratifies me every single day

 

3. Tell us a little bit more about yourself. What new projects are you currently involved in?

In the company I am the Process and Lab Division Director, based in Milan.

Our mission is to have a complete portfolio of solutions for the contamination management: cleaning and disinfection of the manufacturing areas, microbiological sampling, analysis and identification of the microbiological data and, data management.

We are always looking for innovative solutions and new technologies to enlarge our proposal to our customers.

4. How was the Rigel Process & Lab division born?

Rigel Process and Lab is an independent business unit of Rigel Life science, born in 2011. We decided to create this division to identify better two different sides of Rigel:

• Rigel Life Sciences that offer environmental monitoring systems and instruments to control the level of contamination in cleanrooms.
• Rigel Process and Lab that provides all the consumables required for monitoring and undertaking control contamination levels in production areas.

5. Why did you decide to include SherpaPharma environmental monitoring software in your product portfolio?

I think SherpaPharma Environmental Monitoring software is an excellent tool to schedule, organize and control all the microbiological laboratory activities. It is a precious instrument for data monitoring and data management.

SherpaPharma monitoring software matches perfectly with our standard quality requirements of our portfolio and increases our proposal for pharmaceutical customers.

6. Why is it so important to carry out correct Environmental Monitoring?

Because it is a fundamental and a regulatory requirement. Also it is the analysis tool that better represents the level of control and reproducibility of the process.

7. What types of common deficiencies or areas for improvement in Environmental Monitoring do you discover when you perform an audit / advice for clients?

Usually, we find messy and not easy usable data that is a bad “business card” for any auditors. Again, data are worked far too much slowly and sometimes there are discrepancies between row data and registered data.

8. How do they react when they see what you can contribute to them with the installation of SherpaPharma in the laboratory or clean room?

It depends on the interlocutor: management and quality assurance people are very interested, however, quality control technicians and microbiologist are curious and a little fearful

8. What motivates your clients to consider changing the traditional way of managing Environmental Monitoring to introduce a global solution like Sherpa?

In management, the chance to evaluate trends and records directly, safely and in a such quick time is very much appreciated.

For the Quality Assurance department is very important for them to significantly reduce the number of manual recordings and mistakes that arise from manually manipulated data transfer, as well as the ability to print immediate reports to be linked to batch records with all the data related to each batch of product.

Laboratory operators and microbiological lab. Managers appreciate so much the time they save to manage the microbiological data in terms of acquisition, registration and evaluation.

The amount of real time that is saved is strongly felt from any individual involved in the process of data manipulation.