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Tube Configurator

Product Quality Information


ISO 9001
Micronic operates a corporate integrated Quality Management System (QMS) that is certified to ISO 9001:2015.

ISO 14001
Reducing our impact on the environment is an integral part of our continuous improvement efforts. The environmental policy of Micronic is determined by our headquarters in the Netherlands, which is certified to ISO 14001:2015.

Certified Class 7 c
lean room

Micronic labware is manufactured and assembled in-house in a NEN-EN-ISO 14644-1 Class 7 certified clean room environment (which is comparable to the US Federal Standard 209E Class 10,000).


Virgin material and approvals

For the manufacturing of its long term sample storage labware products Micronic uses solely virgin plastic raw material. The raw materials and auxiliary agents are selected based on the specifications that satisfy the high quality requirements of our products. The materials are FDA approved and comply with the (USA) USP XXII tests, including class VI (Medical approved), and the European Pharmacopoeia-monograph 3.2.2 unless communicated otherwise. Material components used to produce Micronic labware can be traced via the lot number indicated on the packaging.

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, DNase and endotoxin (pyrogen)

By maintaining the highest possible hygiene level during our production processes, Micronic manufactured labware is free of any detectable RNase or DNase contamination and the endotoxin level of produced and packaged labware is limited to an acceptable minimum (< 0.01 EU/ml). Our products are periodically tested on RNase, DNase and their endotoxin levels by independent expert organizations.


CE markingMicronic labware products comply with the CE label Class 1. In this respect the European Directive 98/79/EC (In Vitro Diagnostic Medical Devices) is the leading standard.

Sterile products

Upon request, Micronic products can be supplied sterilized. Sterilization is carried out using gamma irradiation or ethylene oxide treatment ensuring a SAL of 10‑6.

IATA

Our products comply with the IATA requirements for the transport of diagnostic specimens (UN packing instruction 602 and 650), assuming that our products are properly used (closed).

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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