IPI Speaks with Alberto Negra, Technical Manager at Rotor Print about creating a pharmaceutical blister that can be recycled, but without losing the properties of the conventional blisters.
Q: Rotor Print provides all kinds of solutions for flexible packaging to the pharma industry. Can you tell our readers a brief history of the company, how you started and your growth so far?
A: The original idea for the project of Rotor Print was released during 2010. At that time, we detected some significant needs in the pharma primary packaging market. The ISO 15378 was just released in its first version in 2006, and only a few converters were able to adapt their existing facilities to those exigent requirements. Building a new plant according to these requirements was easier than adapting an existing one. Additionally, just the previous year, the merger between the two main players in the Spanish market (Amcor & Alcan) was completed and that opened an opportunity for other converters in those customers that were concentrated in the big new player.
Q: The manufacture of packaging materials for medicines requires compliance with standards of hygiene to ensure that the product is not contaminated with external elements that may alter the product. Can you tell us what these regulations are and how does your operations adhere to these guidelines?
A: The Standard required for primary packaging materials production is the ISO 15378 (current version is from 2017). This is equivalent to the traditional ISO 9001 Quality Standard plus the Good Manufacturing Practice (GMP) Standards. In this Standard of course there are a significate number of procedures to be followed, but I would like to emphasize that all the production processes are done inside a Certified Clean Room. This is very important, as there are not too many converters who have Rotogravure printers, Flexographic printers and Laminators inside a Clean Room. Most companies do the final process, slitting, in a Clean Room, while Rotor Print is doing 100% of their activity.
A Certified Clean Room is a facility built following the recommendations of ISO 16444 and are validated afterwards, achieving a minimum qualification of ISO-8. This means that you have a maximum number of particles per square meter of air inside the room, and this air is changed at least 20 times per hour. Q: Have you noticed any recent changes in the industry? What are customers looking for now? How are you addressing these changes?
A: During the last 5 years, we have been introducing new structures using more sustainable materials for flexible packaging in the food industry. The pharma market was initially reluctant to make these changes, but recently a bigger number of customers are asking how we can help them to make their blister packs, sachets or stick packs more sustainable.