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| 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 clean 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 marking | Micronic labware products comply with the CE label Class | |
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.
