The Italian pharmaceutical industry is internationally renowned for its high technology and innovation. To maintain its high product quality, companies operating in this sector undergo numerous controls and work under stringent procedures. One of the fundamental aspects of the production chain is chemical protection for operators that manipulate hazardous substances and, at the same time, protection of the operational processes.
Located in Concorezzo, about twenty kilometers north of Milan (Italy), Icrom is at the cutting edge of innovation in the chemical pharmaceutical sector and develops, produces and markets Active Pharmaceutical Ingredients (API) and intermediates for human use. The 50-year-old company recently opened new administrative offices, expanded its production facilities, as well as its research and development department, and soon will have new industrial buildings currently in construction. Its continued evolution has allowed Icrom to consolidate its presence world-wide, becoming a trusted partner able to provide both traditional products, as well as developing innovative and technologically complex niche solutions.
Due to the systems in use and the substances being handled or stored, the production of APIs and Intermediates – the raw materials used by generic drug manufacturers – requires intrinsically dangerous work processes for workers. To ensure personal protection of its employees, Icrom sought garments capable of providing the highest level of protection and the best comfort in terms of wearability, breathability, ergonomics, lightness and practicality. After careful research of available products on the market, the company selected DuPont™ Tyvek® 600 Plus and DuPont™ Tyvek® 200 EasySafe disposable non-woven coveralls to meet the various protective requirements for employees performing a variety of tasks in the dispensing, kilolab, and finishing and drying departments.
Dispensing operations take place in microbiologically controlled, dedicated and confined environments, with a high temperature. The procedures require careful attention: operators must access special containers to remove and weigh the amount of raw materials required for production, exposing themselves in the process to harmful powders and active ingredients.
For its international clientele, Icrom can satisfy requests ranging from a few grams to one ton per lot. In the kilolab area, where API are produced in small quantities, operations take place in tight spaces, on small machines that require high precision. Both in the dispensing area and in the kilolab, operator protection while handling hazardous chemicals is provided by the Tyvek® 600 Plus coverall suit, which offers Type 4 protection. With its reinforced seams, it provides an effective barrier against small harmful particles and biological hazards, and its ergonomic hood offers excellent adherence to the facial mask.
In the drying and finishing department, Icrom saw tangible evidence of the superior protection offered by DuPont Personal Protection coveralls. The still wet products are transferred from machinery to ovens for the drying process and, when required, subsequently micronized to obtain a granulometry corresponding to the customer’s needs. In this department, Icrom pharmaceutical products will be used as tracers and have various colors such as bright pink, phosphorescent green or cobalt blue. These very intense colors are resistant and, contrary to what has been observed with other previously used coveralls, the skin of the operator who wore the Tyvek® 600 Plus suit was not “colored” by highly volatile chemical particulates. If these products had not been colored, it would have been impossible for Icrom to observe when particles passed through the overalls, and this proved to be an important way to observe when some PPE offered better performance, while others proved scarce in performance and provided inadequate protection.
“A healthy and safe work environment is an essential, non-negotiable condition”
“A healthy and safe work environment is an essential, non-negotiable condition. This principle is transferred to our employees through a culture of interdependent safety, balancing proactivity and discipline, in order to always adhere to the internal Health and Environmental Safety Policies, and to national and international regulations. DuPont has understood Icrom’s needs at all levels of the organization: operator satisfaction, achievement of site management objectives in terms of compliance with regulatory aspects and cost management,” said Pierfrancesco Morosini, CEO of Icrom.
Icrom management and DuPont worked in close collaboration, also involving employees, to identify and select suitable protection equipment. DuPont provided support to Icrom from the early stages of development, building a relationship of trust and gaining the participation of all involved stakeholders. DuPont knew how to explain the importance of the correct use of protective equipment to reduce the possibility of contamination and has conducted training activities for all Icrom personnel.