Our product quality policy
Micronic positions quality against the background of the Total Quality concept. This stresses Micronic’s commitment to compliance with the Total Quality principles, both in theory and practice. Our principles are:
- Concentrate on the market, target groups, and individual customers;
- Know Your Customer and fulfil their individual needs and expectations;
- Continually improve and innovate based on creative initiatives;
- Quality, safety, and health are inviolably the absolute top priority;
- Commitment and open and honest communication;
- Work with realistic objectives and support these with the ‘measurement = certainty’ principle.
Micronic’s customers can always rely on our company’s dedication to delivering reliable products in compliance with the highest quality requirements.
Micronic’s policy is to have its quality efforts structurally assessed by independent organisations. If relevant, we will follow up on recommendations for further improving the quality of our business operations and products.
ISO-9001:2008
All Micronic’s businesses are certified for ISO 9001:2008.
ISO-14001:2004
Micronic manufacturing Sample Storage products, pipette tips, and other life science products, is certified for ISO-14001:2004.
Cleanroom Class 7
Micronic guarantees that the products manufactured by Micronic are manufactured 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.
RNase and DNase
The products that Micronic manufactures comply with the highest injection moulding standards and are, therefore, free of RNase and DNase. Periodically, products that Micronic manufactures are tested in this respect by an independent organisation. 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 articles to an acceptable minimum (< 4 EU/unit). Our products are periodically tested on their endotoxin level by an independent and expert organisation. Their report is available upon request.
CE label
Micronic 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, Micronic supplies products sterilised. Sterilisation is carried out in compliance with ISO 11137 using gamma radiation. Sterilisation is outsourced to an external specialist.
F.D.A. approval
All materials and auxiliary agents used to manufacture Sample Storage products are selected on quality and the highest purity levels, and all are FDA approved.
- These comply with (USA) USP XXII tests including class VI (Medical approved).
- These comply with the European Pharmacopoeia-monograph 3.2.2.
IATA
Our products comply with the IATA requirements for the transport of diagnostic specimens (UN packing instruction 602 and 650).
Storage
Our products can be stored at room temperature for at least 10 years. The storage time under the same conditions is 5 years for sterile products.
If you have any additional questions on the quality and safety of our products, please feel free to contact Micronic at sales@micronic.com.
