High demands on hygiene
MEDIPACK AG specialises in packaging for customers in the medical and pharmaceutical sectors. From the development of the moulds to the production of the packaging and contract filling, the company offers individually tailored complete solutions. A large part of the production steps are carried out under cleanroom conditions. Not only is contract packaging carried out in various cleanrooms at the Schaffhausen site, but films and blisters are also produced in controlled environments of cleanroom class 7 and 8 (ISO 14644-1).

Managing Director Reto Artusi, explains the philosophy of the family business he has been running since 1997:
"Our customers are often specialists in developing medical parts, but packaging itself is no longer their core competence. This is where we come in, because we offer the expertise and the infrastructure. Our customers deliver the products and we take care of the entire packaging process. A lot of packaging is individually designed and produced in the process."

A major advantage is the high level of cleanroom equipment at the Schaffhausen site, which has been continuously increased in recent years, "Most production processes take place in our own cleanrooms. This enables us to guarantee complete compliance with hygiene regulations. For our blister packs, we produce our own thermoforming film. This is also produced in the clean room. This means that we can exclude the possibility of foreign particles entering the system. Our quality has improved massively as a result," says Artusi.

Digital printing in the clean room
The success of the steadily growing company, which currently employs 191 people, lies not only in the delivery of an all-round package from a single source, but also in the seamless quality control provided by production within its own four walls. With this in mind, the Swiss company has gone one step further and also installed the production line with digital printing and die-cutting machine in its own clean room.

By now also carrying out digital printing under controlled cleanroom conditions, we can offer the entire chain of the manufacturing process without gaps," Reto Artusi is convinced of the renewed increase in quality.

State-of-the-art, energy-efficient cleanroom system
For their expansion, the Swiss opted for a cleanroom from the neighbouring company Schilling Engineering. The 50-square-metre, modern CleanCell4.0® cleanroom system ensures ISO 8 cleanroom air quality.

High-performance filters of ULPA class U15 filter particles and microorganisms from the ambient air. The low-particle air is flushed into the cleanroom and displaces airborne particles from the room in permanent air changes. An innovative recirculation and return air system within the cleanroom walls ensures precise cleanroom flushing. Medipack's cleanroom requires connected air-conditioning technology for the high-quality printing process and is operated at a constant temperature and humidity. The cooled and filtered air is thereby fed back into the recirculating air circuit in an energy-efficient and filter-friendly manner.

The safe entry and exit of staff and material is a key point of every cleanroom concept. This is done via separate airlock systems. Employees enter the cleanroom via a specially furnished personnel airlock where they change their clothes. The material required for production is brought in via an actively rinsed material lock, and the double-packed end product is safely guided out via the material lock.

The cleanroom system is equipped with 900 lux LED lighting. The GMP cleanroom light strips newly developed for the CleanCell4.0® are integrated flush in the aluminium profiles and produce a very bright yet pleasant light. Wall and ceiling modules of the clean room are connected with a silicone-free sealing clip system. Thanks to the modular design and the patented connection, Schilling Engineering's cleanrooms can be easily converted or extended.

Reto Artusi is already looking to the future:
"Our growth confirms the correctness of our investments. The medical technology market demands ever more individual solutions, sometimes in small quantities. However, safety and quality must never be sacrificed. The expansion of our clean room capacities is worthwhile for us. In Schilling Engineering, we have found a reliable partner who shares our commitment to quality. That fits well together."

This article was published: Contamination Control Report 1/2019