Our quality system is based on several different standards and regulatory frameworks. The advanced tests performed at Vitrolife are continuously developed and improved to ensure high and consistent quality. With a comprehensive design method and high quality in the product components, the tests are verifying that the product is correct before released. 

Below we have listed tests performed for each product and if you are eager to learn more about our quality testing, contact us at fertility@vitrolife.com 


SPERM PROCESSING

MicroCell
Our test “Chamber Depth Verified by Laser Interferometry “ verifies that analyses always provide the same conditions and eliminates deviation.

• Chamber Depth Verified by Laser Interferometry • Capillary Action Loading Pattern • Visual Inspection • Microscopic Inspection •

SpermGrad™
The test of density is of particular importance to conduct a successful separation of the semen sample. 

• Human sperm recovery assay • Density • pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins •

SpermRinse™
• pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins • Mouse embryo assay (MEA) • 

SpermFreeze Solution™
• Human sperm survival assay • pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins • 


OOCYTE RETRIEVAL NEEDLES

The design process for our oocyte retrieval needles is of utmost importance, both for the clinics and for the patients. The most important of all our tests for the needles are to make sure that the sharpness and the dimensions meet specifications. 

• Mechanical integrity • Sterility Assurance Level • Bacterial Endotoxins • Mouse embryo assay (MEA) •


G-SERIES™ CULTURE MEDIA AND ADDITIONAL CULTURE MEDIA

Our media are tested with the industry-leading Vitrolife 1-cell MEA test. By using the best toxicity test for gametes, we secure that all media from Vitrolife are safe throughout the procedure.

• pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins • Mouse embryo assay (MEA) •

 


OVOIL™

The human sperm oil assay is performed to confirm that no toxicity exists. 

• Sterility Assurance Level • Bacterial endotoxins • Mouse embryo assay (MEA) • Micro droplet mouse embryo assay • Human sperm oil assay •


MICROMANIPULATION PIPETTES

For our pipettes, visual inspection and control of dimensions are two tests that stand out among the others. An experienced technician inspects every pipette manually to guarantee their mechanical integrity before release. This means that all pipettes meet the specified tolerances and that they are free from glass fragments and other residues.

• Visual Control • Dimensions • Sterility Assurance Level • Bacterial Endotoxins • Mouse embryo assay (MEA) • 


MICROMANIPULATION SOLUTIONS

ICSI™
We control the viscosity in our ICSI solution, as this is a vital feature for an ICSI treatment, and needs to be maintained and predictable. 

• Viscosity test • Sterility Assurance Level • Bacterial endotoxins • Human sperm motility recovery assay for ICSI • Microscopic evaluation •

HYASE-10X™
The cumulus cell removal assay for our HYASE solution is essential to validate the performance of the product.

• Cumulus cell removal assay • pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins •


VITROLIFE LABWARE

Vitrolife Labware are uniquely produced and certified for human IVF. Vitrolife Labware are tested with the industry-leading Vitrolife 1-cell MEA test. By using the best toxicity test for gametes, we secure that all labware from Vitrolife are safe throughout the procedure.

• Sterility assurance level • Bacterial endotoxins • Mouse embryo assay (MEA) • Human sperm survival assay • 


TIME-LAPSE SYSTEMS

All our time-lapse systems are part of our extensive quality control program and EmbryoScope, EmbryoScope+ and Primo Vision are offering laboratory quality control for increased safety in our customers clinics.

Primo Vision™ Time-Lapse Embryo Monitoring System 

• Functional test • Motor current test • Optical test including evaluation of mouse embryo images • Final QC system integration test •

EmbryoScope™ Time-Lapse System and EmbryoScope+

• Visual inspection • Electrical safety compliance test • Setup and calibration • Functional test • Burn in test • Release and calibration test • Mouse embryo assay (MEA) •


SLOW FREEZE AND VITRIFICATION MEDIA

Our slow freeze and vitrification media are tested with the industry-leading Vitrolife 1-cell MEA test. By using the best toxicity test for gametes, we secure that all slow freeze and vitrification media from Vitrolife are safe throughout the procedure.

• pH • Osmolality • Sterility Assurance Level • Bacterial endotoxins • Mouse embryo assay (MEA) • 


VITRIFICATION

Rapid-i Vitrification System

Our vitrification system is tested together with our devices and vitrification media to ensure optimal handling and reliable results. Our Rapid-i Vitrification System is tested with the industry-leading Vitrolife 1-cell MEA test. By using the best toxicity test for gametes, we secure that the products from Vitrolife are safe throughout the procedure.

• Sterility Assurance Level • Bacterial endotoxins • Dimensions • Mouse embryo assay (MEA) •