Clean room production – highest certified cleanliness.

For the medical and pharmaceutical industry. Functional parts and packaging: Pöppelmann produces plastic parts and assemblies in the highest standards of cleanliness under certified clean-room conditions (DIN EN ISO class 7, GMP Standard - C).

Since October 2004, Pöppelmann FAMAC® has been producing under cleanroom conditions. The injection moulding machines and all control cabinets, auxiliary devices etc. are located outside of the clean room. This reduces the power requirements and operating costs of the air conditioning. Retrofits and subsequent extensions of the machine can be carried out without any restrictions so that customers’ requirements are accommodated in a flexible manner. The tooling area outside the cleanroom is easily accessible for tool change and maintenance purposes without influencing the work process in the clean room and thus the quality of the plastic components. If an injection moulding machine or an additional system gets damaged, it will not result in a contamination of the cleanroom. Filter systems ensure a particle and germ concentration pursuant to DIN EN ISO 14644 – Class 7 and Class C of the EC GMP, i.e. less than 350,000 particles/m3 down to a size of 0.6 µm.

Laboratory vessels, with and without lids, for centrifugal use.

Laboratory vessels, with and without lids, for centrifugal use.

Spin columns.

Spin columns.

Filter plates.

Filter plates.

Reaction vessels.

Reaction vessels.

Inhaler with individual components.

Inhaler with individual components.

<p>Laboratory vessels, with and without lids, for centrifugal use.</p>
<p>Spin columns.</p>
<p>Filter plates.</p>
<p>Reaction vessels.</p>
<p>Inhaler with individual components.</p>

The advantages of cleanroom conditions at a glance:

  • Clean. Less than 350,000 particles/ccm (down to a size of 0.6 μm).
  • Safe. Autonomously operated clean rooms with separate air-conditioning and filtering system.
  • Flexible. Consignment of individual parts and assemblies as well as installation.
  • Qualified. DIN EN ISO 14644 Class 7, GMP Standard - C.
  • Economical. Compact layout, low operating costs.
  • Certified. Quality management system pursuant to DIN EN ISO 13485:2010.

When you need it extra clean: our cleanroom production.

Clean air is supplied to the tool area via a laminar flow module. After demoulding, the good parts drop onto a fully enclosed conveyor belt suitable for use in clean rooms. Optionally, a handling robot may be used to demould complex or sensitive parts and to place them onto the conveyor belt. The injection moulded parts are transported on conveyor belts into the clean room for further assembly and packaging – if necessary with separation of cavities. Over there, they are individually custom-packaged in special clean room bags.

Reinraum Produktion EntnahmerobotorFully automatic handling system.
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Do you have any questions? The FAMAC® team will be happy to answer them.


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