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• Eppendorf Tubes are a simple and safe standard for 0.5 ~ 2.0 mL sample preparation. For larger volumes, 15 mL or 50 mL conical tubes are used, but intermediate sample volumes may cause problems. Large conical screw cap tubes must be used, but they are impractical, inconvenient, and prone to contamination. 5.0 mL tubes are available in snap-cap and screw-cap formats for sample preparation, incubation, storage, and other applications to select the best tube to meet a variety of requirements.
• Prevention of contamination is an important issue in forensic DNA analysis. In order to minimize contamination risk, the forensic field has established strict internal regulations. ISO 18385 is expected to provide greater safety.
• This ISO standard sets requirements for manufacturers of products used in forensic DNA analysis. Eppendorf Forensic DNA grade products are manufactured to meet the high level requirements of this standard.
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• High quality manufacturing
• Forensic DNA Grade products are consumables used for DNA purification, sample preparation, PCR setup and sample storage. The following high quality standards for Eppendorf's manufacturing processes are the foundation for meeting the strict requirements of ISO 18385.
• Highly automated manufacturing facilities to minimize direct contact between workers and products
• Strict cleaning procedures and protocols to minimize contamination risk
• Positive pressure facilities to prevent dust intrusion
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• Process controls
• The manufacturing area is strictly monitored to ensure clean conditions at all times. Eppendorf operates an effective quality assurance system to meet the standards and guarantees required of manufacturers such as ISO 13485. In addition, additional controls have been added to meet specific requirements for Forensic DNA Grade consumables. For example, each surface of the manufacturing facility is monitored for the presence of human DNA, and multiple spot checks are performed on each batch during the manufacturing cycle to ensure uniform quality and purity.
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• Restricted access
• Access to the manufacturing area of Forensic DNA Grade consumables is strictly restricted and controlled. Worker training and compliance with work wear regulations are mandatory.
• Packaging matters
• Eppendorf's comprehensive approach takes into account not only manufacturing and application content, but also product handling in the lab. Of course this includes packages. For products used in forensic science, the packaging is designed to support the features of the product due to handling that is not prone to contamination or misalignment. That is, the packaging of the Eppendorf Forensic DNA Grade product provides special attention to the following points:
• Clearly labeled product boxes as well as individual packaging prevent misplacement
• The number of consumables per package is adjusted for each product: EppendorfForensic DNA Grade Consumables are packaged individually or as a number per package depending on the workflow
• Even if all consumables are not used at once, resealable packaging is used to prevent contamination
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• Monitored purity
• Eppendorf consumables represent the highest quality and performance. These products, bearing the new purity grade « Eppendorf Forensic DNA Grade «, are also made in line with this approach. Test parameters and sensitivity levels meet ISO 18385 requirements and are strictly controlled.
• All tests to verify the purity standards to be guaranteed are carried out by third-party laboratories that comply with ISO 17025 standards for conformity required in forensic science.