Cleanroom – pure competence


Working in a cleanroom is essential at Samaplast. This is why we have built up know-how over decades, which is always up to date. Our customers trust in it – it lets them sleep well.

Cleanroom

Production without ambient noise


Clinically clean products are a necessity for many purposes. For this purpose, we have set up two cleanrooms at Samaplast in which we manufacture these products and carry out finishing operations. This is all done to the required quality and excellence. You can rely on that.

2 cleanrooms

  • GMP compliant
  • ISO class 7 (in operation) according to EN ISO 14644

Products

  • Medical components
  • Implants
  • Instruments

Finishing operations

  • Laser marking
  • Ultrasonic welding
  • Mechanical processing
  • Modular assembly
  • Tempering (also under a nitrogen atmosphere)
  • Final packing etc.

Monitoring

Monitoring – a must

In order to make certain that manufacture and processing really do take place according to the required parameters, we have implemented a continuous monitoring system at Samaplast, which seamlessly documents each individual parameter. This is how we adhere to the manufacturing instructions (device master record etc.) in painstaking detail and guarantee comprehensive and seamless hygiene measures.
 
In order to continuously meet a high quality standard, we have implemented a further monitoring procedure for this purpose, i.e. hygiene monitoring (microbiological monitoring). This way you can be sure that we have all hygiene requirements and regulations under control.

Parameters

  • Particle concentration
  • Pressure difference
  • Temperature
  • Air moisture
  • Flow rate

Monitoring system

  • Validation according to GAMP
  • Meets the requirements of 21 CFR part 11

Hygiene monitoring

  • Adherence to the air and surface microbial count (paddle test)
  • Microbiological contamination of the medical devices (bioburden)

Ultra-pure water

Cleaning with ultra-pure water

However, we do not manufacture all products in the cleanroom, but also outside of it. Nevertheless, in the end these products have to be pure. So what do we do? We use our Hamo-T21 ultra-pure water washing machine, which connects the dirty production area with the cleanroom via a sluice.
 
In addition to our ultra-pure water washing machine, we possess a water-processing unit with which we prepare HPW (highly purified water) according to Eur. Pharm. This is necessary to supply our washing machine. Of course, this process is also optimised and validated.

Ultra-pure water washing machine

  • Cleaning
  • Rinsing
  • Drying (warm-air drying) of medical technology parts, from a size of 0.8 x 4mm
  • Titanium
  • POM
  • MBS
  • PEEK etc.

More of Samaplast

Additive Manufacturing

A step into the future

Packaging

Packaging and sterilisation