Vitrolife’s dedication to quality control is ultimately reflected in the quality of products and services offered. A commitment founded on deep knowledge and genuine devotion.
Why is quality control important?
The aim of quality control is to ensure good quality products leading to optimal results with minimal fluctuations. Quality control is vital to guarantee the function of each individual product. It is essential for safety and to minimise the risk for the mother, embryo and ultimately the baby.
Quality control at Vitrolife
All Vitrolife products go through an extensive quality control program designed for human embryos. Our manufacturing processes and thorough testing is well-documented. In fact, our quality control program has been an industry leading standard for 20 years, and remains a cornerstone of our business.
In brief, our quality control procedure covers the following:
- Extensive selection of raw material and stringent quality testing leading up to high LOT-to-LOT consistency. All raw materials are tested according to internal raw material specifications prior to release to production.
- Classified manufacturing environment, qualified personnel, validated protocols for manufacturing, continuous and extensive validation and calibration of all methods and equipment.
- All products are tested according to finished product specifications by the following tests; functional, biological, physiochemical and visual, prior to release to the market.
- Results are documented in a Certificate of Analysis which is accompanying the products to the customer.
This level of quality is assured by our quality system that conforms to international standards and regulations for products within human IVF.
Your benefits from our comprehensive testing
Our customers must know that they can rely on our products and this is guaranteed through our extensive quality program and stringent quality testing. To offer clinics products that are ready-to-use, meaning carefully pre-tested and evaluated saves both time and effort for our customers.
Using our extensively controlled products increases the clinical success rate by preventing toxic or harmful components from entering the culture system.