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Tube Configurator

Product Quality Information


ISO 9001:2008
All Micronic's businesses are certified for ISO 9001:2008.


ISO 14001:2004


Micronic Manufacturing, which produces the sample storage labware, is certified for ISO 14001:2004.


Certified Class 7 c
lean room

Micronic guarantees that its labware is manufactured and assembled in a clean room environment (US Federal Standard 209E Class 7). Periodically, our clean rooms are certified for this standard by an independent expert. The certificate is available upon request.

FDA approved and virgin materialMaterials and auxiliary agents used to manufacture sample storage labware are FDA compliant and are selected on quality and the highest purity levels. Micronic uses solely virgin material.

Extractables

The materials used for Micronic tubes are the result of extensive research. One selection criteria is that no measurable amount of extractables should leach into samples.

RNase and DNase

The labware that Micronic manufactures complies with the highest injection moulding standards and is therefore free of any detectable RNases or DNases. Periodically, products are tested in this respect by an independent organization. The test report is available upon request.

Endotoxin (pyrogen) By maintaining the highest possible hygiene level during its production processes, Micronic is able to limit the endotoxin level of produced and packaged labware to an acceptable minimum (< 0.01 EU/ml). Our products are periodically tested on their endotoxin level by an independent and expert organization. Their report is available upon request.

CE labelMicronic products comply with the CE label Class 1. In this respect the European directive 98/79/EC is the leading standard. Material Safety sheets are available for all our products.

Sterile products

Upon request, products manufactured at Micronic can be supplied sterilized. Sterilization is carried out using gamma radiation or EtO treatment.


IATA

Our products comply with the IATA requirements for the transport of diagnostic specimens (UN packing instruction 602 and 650).


If you have any additional questions on the quality and safety of our products, please feel free to contact Micronic at sales@micronic.com.



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