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Cleanroom production in accordance with ISO Class 8 Prototypes and small series – manufactured cleanly and sterilely

System construction space

500 x 400 x 300 mm


all commercially available thermoplastics, TPE (thermoplastic elastomers)


ISO-8 cleanroom production including primary and secondary packaging. Contact-plate microbial monitoring before, during and after batch production.

Lead time

4–9 weeks

Injection molding production in the cleanroom is in many cases an indispensable factor in meeting all the requirements of the market, especially in the field of medical and laboratory technology, but also in microelectronics, life science, etc. The goal is bacteria- and germ-free production of prototypes or small series. Ideally, the entire production process at 1zu1 takes place in the cleanroom, which has separate material and personnel locks . 

However, sterility isn't everything. The aim is to guarantee quality, reliability and cleanliness right through to the finished, packaged and sterile product. To this end, we invest heavily in both expertise and construction technology for our youngest department.

Our cleanroom capabilities

  • Prototypes for product development 
  • Small series production in the cleanroom
  • Short manufacturing and delivery times
  • Manageable costs and top quality

Your added value

As “prototypers” in injection molding, we are used to requirements with extremely short deadlines. The mold technology corresponds to that of our injection molding with aluminum molds. Thanks to the use of cleanroom injection molding production at 1zu1, plastics projects with this requirement can be implemented in almost the same time window as projects without cleanroom requirements. Decisive advantages in the test phase or in the market launch of your sterile products are cost benefits through aluminum tooling and rapid conversion in cleanroom injection molding. This way you are always one step ahead with 1zu1.

Your advantages

  • Aluminum mold tooling with time advantage: RAPID cleanroom projects means you are faster on the market.
  • ISO Class 8 in accordance with ISO 14644-1
  • Three encapsulated Arburg lines with 70 and 100 tons clamping force for components with edge lengths from 20 mm to 150 mm 
  • Complete injection molding possible
  • Bacteria- and germ-free production of prototypes or small series
  • Short production and delivery times (cleanroom plastic parts from 4 weeks delivery time incl. tooling)
  • Manageable costs because they are calculable, fixed price quote
  • Cleanroom validation by the customer possible
  • Cleanroom-approved equipment including separate airlocks (material and personnel airlock)
  • Additional services through sterile packaging (double) and labeling

In a cleanroom, the concentration of airborne particles is controlled. It is designed to minimize the number of particles introduced into the room or created and deposited in the room. In the cleanroom, parameters relevant to cleanliness such as temperature, humidity and pressure are controlled as required.

Surface monitoring (contact plate samples) is a technique for determining the contamination of objects and people.

There are nine cleanroom classes according to ISO 14644-1. These cleanroom classes are divided into classifications from ISO Class 0 - ISO Class 8.

1zu1 cleanroom: injection molding machines and more

With the continuously expandable cleanroom injection-molding department at our Dornbirn site, 1zu1 is taking a decisive step forward: Three encapsulated ARBURG systems with a clamping force of 2x70 and 1x100 metric tons enable us to produce sterile prototypes or small series. 

Our ISO Class 8 injection-molding machines are housed in a separate room, which cannot be seen from other areas. this means we can fine-tune or sample prototypes with the customer confidentially. Subsequently, the production of the injection molded parts is ramped up. Here, 1zu1 is also equipped with the latest injection molding technology for smaller parts with an edge length of 4 to 5 mm (15 metric tons clamping force) and for larger parts up to approx. DIN A5 size (160 metric tons clamping force).

The human hygiene factor

Machines are one thing. The human factor is the other: our employees adhere to rigorous hygiene regulations. They wear sterile work suits, cleanroom shoes or overshoes, hair nets and mouth protection. Cleanroom conditions are ensured by means of sophisticated filter technology, laminar flow areas for workpiece removal and packaging, as well as continuous process monitoring.

We can naturally package your sterile products in accordance with your packaging instructions with primary and secondary function. The cleanliness, sterility and germ load are continuously checked and documented in writing before, during and after the production of your batch by means of wipe testing.

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