Material Qualification Dossier
Operational Excellence Dossier
|AFS® 8/16/24 (MilliporeSigma)|
|AFS® 8/16/24 (MilliporeSigma) - FRENCH|
|Biopak® C Datasheet (MilliporeSigma)|
|Water for Clinical Chemistry (MilliporeSigma)|
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|Lab Water Purification > AFS® Clinical Laboratory Reagent Water (CLRW) Biomedical Water Systems|
AFS® systems combine complementary water purification techniques; complete pretreatment, intelligent reverse osmosis (RO), bactericidal UV lamp treatment and a final 0.22 µm filter ensure a reliable and consistent water quality. Water produced by the systems complies with the Clinical and Laboratory Standards Institute® (CLSI) guideline for clinical laboratory reagent water (CLRW). Depending on daily volume needs, different production flow rates are available (8, 16 and 24 L/h).
The systems are designed to fulfill accreditation needs (such as CAP™ 15189 accreditation to the ISO® 15189:2007 standard), and have full monitoring and water quality archiving capabilities that allow storage of up to six months of data. Optional activation of Millitrack® Essential e-Solution allows easy, rapid access to this information and also enhances data management control and provides remote system access.
User friendly & easy maintenance
Robust AFS® systems require little maintenance, which means less analyzer downtime. When maintenance is required, an intuitive icon-based display and a new pack locking system facilitate pack changes. Systems have a small footprint and can be installed wherever it is convenient in the laboratory: on a wall, on or under a bench, or on a cart.
For full confidence in your AFS® Essential system, it is delivered with a Certificate of Calibration for the built-in temperature and resistivity meters, and a Certificate of Conformity ensuring that it has been built and tested fully assembled following internal Standard Operating Procedures. The manufacturing site is ISO® 9001 v.2000 and ISO® 140001 certified.
AFS® Essential CLRW water (CLSI Clinical Laboratory Reagent Water)
|Resistivity at 25 °C||> 15 MΩ•cm|
|TOC||Typically < 30 ppb|
|Bacteria||< 1 CFU/mL|
|Silica||< 5 µg/L|
|System||Permeate Flow Rate||Peak Dispense Rate (to atmosphere)|
|AFS® 8||8 L/h||2 L/min|
|AFS® 16||16 L/h||2 L/min|
|AFS® 24||24 L/h||2 L/min|
|Feed water quality||Potable|
|Feed water pressure||1 - 6 bar|
|Feed water temperature||5 - 35 °C|
|Minimum flow rate feed||> 5 L min at 2 bar|
|Total chlorine *||< 3 ppm|
|Langelier Saturation Index||< 0.3|
|Maximum Fouling Index (SDI)||< 12|
|* For feed water with total chlorine concentration between 1 ppm and 3 ppm, Millipore suggests the use of an external PrePak.|
|Dimensions (H x W x D)||585 x 268 x 426 mm (23 x 10.6 x 16.8 in)|
|Operating weight||< 28 kg (61.7 lb)|
|Electric power supply voltage||100 - 240 V +/- 10%|
|Electric power supply frequency||50 - 60 Hz +/- 10%|
|AFS® main unit data connection||Ethernet (RJ45)|
The AFS® Essential system is tested by an independent and accredited company for compliance with the CE directives related to safety and electromagnetic compatibility. The report can be consulted on demand. The AFS® Essential system is built using components and practices recommended by UL and has been cUL marked. The registration can be verified on the UL web site ( http://www.ul.com).