Securely packaged – Cleanroom packaging solutions

In deep-drawn blisters, the medicinal parts are sterilely packaged and delivered to their destination.

The digital printing is carried out in a CleanCell4.0® cleanroom of ISO 8 class.

For products intended for the medical sector, especially high standards of quality and hygiene regulations apply. Contamination of sensitive items must be excluded throughout the entire process from production to use. Special packaging serves this purpose, which in turn must meet the highest hygienic requirements.

The Swiss company MEDIPACK AG, as a system supplier for medical packaging, relies on production in cleanrooms. Recently, the line for digital printing and die-cutting has also been moved into a controlled cleanroom environment.

High Hygiene Standards

The company MEDIPACK AG specializes in packaging for customers in the medical and pharmaceutical sectors. From the development of molds, through the production of packaging, to contract filling, the company offers tailor-made comprehensive solutions. Most of the production steps are carried out under cleanroom conditions. In various cleanrooms at the Schaffhausen site, not only is contract packaging performed, but also films and blisters are produced in controlled environments of cleanroom classes 7 and 8 (ISO 14644-1).

Managing Director Reto Artusi explains the philosophy of the family business he has led since 1997: "Our customers are often specialists in developing medical parts, but packaging itself is no longer their core competence. We step in here because we provide the expertise and infrastructure. Our customers deliver the products, and we take care of the entire packaging process. Many packages are designed and manufactured individually."

A major advantage is the extensive equipment of cleanrooms at the Schaffhausen location, which has been continuously expanded in recent years. "Most production processes take place in our own cleanrooms. This allows us to guarantee the seamless compliance with hygienic regulations. For our blister packaging, we produce our own thermoforming film. This is also manufactured in the cleanroom. As a result, we can exclude the entry of foreign particles into the system. Our quality has improved significantly because of this," says Artusi.

Digital Printing in the Cleanroom

The success of the steadily growing company, which currently employs 191 staff, lies not only in delivering a comprehensive package from a single source but also in seamless quality control through in-house production. In this sense, the Swiss company has gone a step further and installed the production line with digital printing and die-cutting machine in its own cleanroom.

"By now performing digital printing under controlled cleanroom conditions, we can offer the entire manufacturing process chain seamlessly," says Reto Artusi, convinced of the further increase in quality.

State-of-the-Art, Energy-Efficient Cleanroom System

For their expansion, the Swiss chose a cleanroom from the neighboring company Schilling Engineering. The modern cleanroom system, CleanCell4.0®, covering 50 sqm, guarantees a cleanroom air quality of ISO class 8.

High-performance filters of ULPA class U15 filter particles and microorganisms from the ambient air. The low-particle air is supplied into the cleanroom and displaces airborne particles through continuous air exchanges. An innovative recirculation and return air system within the cleanroom walls ensures precise cleanroom purging. The cleanroom at Medipack requires connected climate technology for the high-quality printing process and is operated with constant temperature and humidity. The cooled and filtered air is returned into the recirculation loop in an energy-efficient and filter-friendly manner.

The safe entry and exit of employees and materials are central points of any cleanroom concept. They are carried out via separate sluice systems. Employees enter the cleanroom through a specially furnished personnel sluice, where they change their clothing. The material needed for production is introduced via an actively rinsed material sluice, and the double-packaged end product is safely conveyed outside through the material sluice. The cleanroom system is equipped with a 900 Lux LED lighting. The newly developed GMP cleanroom light bands for CleanCell4.0® are integrated flush into the aluminum profiles and produce a very bright yet pleasant light. Wall and ceiling modules of the cleanroom are connected with a silicone-free sealing clip system. Thanks to the modular design and patented connection, the cleanrooms from Schilling Engineering can be easily reconfigured or expanded.

Reto Artusi already looks to future developments: "Our growth confirms the correctness of our investments. The medical technology market demands increasingly customized solutions, often in small quantities. However, safety and quality must never be compromised. The expansion of our cleanroom capacities is worthwhile for us. With Schilling Engineering, we have found a reliable partner who shares the same quality mindset. That fits very well."