Particularly high quality and hygiene standards apply to products intended for the medical sector. Contamination of the sensitive items must be ruled out along the entire route between production and use. Special packaging is used for this purpose, which in turn must meet the highest hygiene requirements.
As a system supplier for medical packaging, the Swiss company MEDIPACK AG relies on production in clean rooms. The digital printing and die-cutting line has now also been relocated to a controlled cleanroom environment.
High demands on hygiene
MEDIPACK AG specializes in packaging for customers in the medical and pharmaceutical sectors. From the development of molds to the production of packaging and contract filling, the company offers individually tailored complete solutions. The majority of production steps are carried out under clean room 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, which he has managed since 1997:
“Our customers are often specialists in the development of 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 supply the products and we take care of the entire packaging process. A lot of packaging is individually designed and produced.”
One major advantage is the high level of cleanroom facilities at the Schaffhausen site, which have been continuously increased in recent years, “Most production processes take place in our own cleanrooms. This enables us to guarantee full compliance with hygiene regulations. We produce our own thermoforming film for our blister packs. This is also produced at Cleanroom. This allows us to rule out the possibility of foreign particles entering the system. This has massively improved our quality,” says Artusi.
Digital printing in Cleanroom
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 in-house production. With this in mind, the Swiss company has gone one step further and has also installed the production line with digital printing and die-cutting machine in its own Cleanroom.
By now also carrying out digital printing under controlled cleanroom conditions, we can offer the entire chain of the manufacturing process without any gaps,” says Reto Artusi, convinced of the renewed increase in quality.
State-of-the-art, energy-efficient cleanroom system
The Swiss company opted for a Cleanroom from the neighboring company Schilling Engineering for its expansion. The 50 square meter, modern CleanCell4.0® cleanroom system guarantees cleanroom air quality of cleanroom class ISO 8.
ULPA class U15 high-performance filters 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 continuous air changes. An innovative recirculation and return air system within the cleanroom walls ensures precise cleanroom purging. Medipack’s Cleanroom requires a connected air conditioning system for the high-quality printing process and is operated at a constant temperature and humidity. The cooled and filtered air is fed back into the recirculating air circuit in an energy-efficient and filter-friendly manner.
The safe infeed and outfeed of employees and materials is a core element of every cleanroom concept. This takes place via separate airlock systems. Employees enter 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 airlock and the double-packed end product is safely transported out via the material airlock.
The cleanroom system is equipped with 900 lux LED lighting. The GMP Cleanroom light strips newly developed for the CleanCell4.0® are integrated flush into the aluminum profiles and produce a very bright yet pleasant light. The wall and ceiling modules of the cleanroom 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 future developments:
“Our growth confirms that our investments are the right ones. The medical technology market demands ever more individual solutions, sometimes in small quantities. However, safety and quality must never be compromised. 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. It’s a good match.”