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Product Quality Information

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

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-ISO14644-1 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.

Laser-etched codes

The Micronic 2D Data-Matrix codes and 1D barcodes are produced conform industry standards. The 2D Data-Matrix code (which adheres to the ECC200 standard) and 1D barcode (type 128B) are laser-etched into the code area and are guaranteed unique.

Product quality control

Products produced by Micronic are tested according to AQL inspection level G2 and AQL value 0.4.

CE marking

Micronic labware products are developed and manufactured in compliance with the European Directive 98/79/EC for In Vitro Diagnostic Medical Devices, Annex III.

Sterilization

Upon request, Micronic products can be supplied gamma irradiated or ethylene oxide treated.

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.