A new 6.000 sqm Plant for drug production
The Zambon Pharma case

DESIGN AND BUILD A NEW 6.000 sqm PLANT FOR DRUG PRODUCTION EXPANDING, ON THREE LEVELS, AN EXISTING INDUSTRIAL COMPLEX, TO MEET ALL THE REQUIREMENTS RELATED TO GMP, TO THE CLASSIFICATIONS OF THE AREAS INVOLVED, TO THE ARCHITECTURAL PROJECT, DESIGNED BY A WORLD-RENOWNED ARCHITECT, AND TO URBAN AND MOTORWAY CONSTRAINTS.

THESE WERE THE CHALLENGES FACED BY PLANEX TO MEET THE REQUESTS MADE BY A LEADING COMPANY IN THE PHARMACEUTICAL SECTOR, AMONG THE TEN MOST IMPORTANT IN ITALY.

A truly important and ambitious project, started in June 2018 and completed in August 2021, during COVID-19 pandemic, which also include the new filling lines in classified areas, microbiology laboratories and warehouses for the production of one of the pharmaceutical group’s best-known product.

The context clearly required a very high level of preparation in many areas of expertise and specialization: management of the authorization process and GMP requirements, pharmaceutical plant design (classified areas, HVAC, pharmaceutical fluids, electrical and special systems, process automation, data management), design and implementation of structural engineering, traditional plant engineering (thermo-cooling plants, pumping, fluid distribution and disposal, transformation and distribution of electricity, protection from atmospheric discharges, etc.), site security engineering, Project & Construction Management, IQ/OQ/PQ.

In the beginning the customer realized that, on one hand, it was important to refer to a single contact responsible for all engineering while, on the other, it was equally strategic been able to count on the best specialists for every engineering discipline. It was therefore crucial founding an organization dedicated to excellence, able to organize a varied team of specialists of different engineering disciplines, and to overcome the obsolete verticistical logics by espousing the most modern organizational matrix paradigms.

In this way it is possible to provide the customer with qualified and direct references with each expert, while maintaining control over the entire project.

SO HOW IS IT POSSIBLE TO MANAGE
THE WHOLE PROJECT’S PROCESSES?

WHOM TO CONTACT FOR THE MANAGEMENT AND COORDINATION OF A MULTIPLE PROCUREMENT?

HOW TO ORGANIZE AND INTEGRATE SUCH A HETEROGENEOUS WORKING TEAM?

HOW TO KEEP TIME AND COSTS UNDER CONTROL?

HOW TO MANAGE A COMPLEX BUILDING SITE DURING COVID-19 PANDEMIC?

Many large national and international organizations offer engineering services; however, it is known that such companies are based on rigid internal organizations in which few senior technicians have to manage ranks of junior designers with the risk of having the project entrusted to young and inexperienced figures or to slow down enormously the workflows, recurring to formal and standardized processes.

The customer, by addressing to Planex, decided to opt for an effective and effificient solution; the careful selection of high technical level partners permitted to build, and coordinate with its senior-partners, a stable and competent team of highly motivated professionals. Only a non-top-down network and a well-coordinated organisation can provide this kind of efficiency.

The project started in June 2018 according to schedule, following a “zone and transition diagram”, and has been concluded in August 2021. It involved:

Over 300 documents resulting from more than 9.000 hours of work.
Structures, plants and architecture were modelled in BIM, creating information-rich models that provided contractors with perfectly coordinated designs capable of eliminating unexpected and interference.
The construction has engaged over 8.000 hours of work for Planex and has seen over 120 official reports for the Work management and the safety coordination made with thousands of email communications.
Have been managed and approved over 120 subcontracts.
Have been examined and approved over 130 mechanical and 140 electrical technical data sheets.
The work is completed, tested, qualified and currently being validated.
Despite Covid-19 pandemic, the budget was absolutely respected without including significant extra costs.
The developed BIM model will be the basis for plant management and maintenance with the support of the Asset Information Model, which will be a great and innovative support for GMP compliance.

It is therefore a great success for Planex that, with a team of the highest level and a state-of-the-art structure from all points of view, has proved again able to realize large projects, resulting in a highly competitive solution even in the world of “Big Engineering”.

The author is one of the founding partners of the engineering company Planex s.r.l. since 2002 and for over 30 years, has been involved in the engineering processes of pharmaceutical plants and buildings. His career starts in 1989 with the design and construction activities for a new department of freeze-dried injectable products of the Lepetit company, which at the time belonged to the DOW Chemical group, and continues nowadays with the design and construction management of the new production site M. Polo of the Zambon Group, the site Masterplan of an ITALFARMACO S.p.A plant, the creation of a new production department of Fresenjus Kabi S.p.A., various interventions within the EVOTEC Aptuit research center in Verona.

During his career he has also worked on other type of extremely complex buildings; he has taken care of the realization of the new productive site for Pastificio Rana S.p.A. in San Giovanni Lupatoto – Verona, the new Cetacean pavilion for the Aquarium of Genoa, the testing of Isozaki Allianz tower systems in Milan and many more.