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By Hans Lehmann, May 13, 2015

The importance of manufacturing and quality control for high quality product performance

Quality is the #1 value at Vitrolife and is totally integrated in the organisation. The company was founded on the idea that high and consistent product quality improves the take-home baby rates for our customers.

Quality at Vitrolife

Quality is not just a word for us; it goes into everything we do and is particularly important for manufacturing and quality control of our products.

The aim of our quality system is to ensure that we deliver high quality products that enable good results with as little fluctuation as possible. Our quality control process covers all the steps from incoming raw materials to final products. One example of our stringent controls is a 100% visual inspection of every needle tip under microscope prior to packing and sterilisation.

2015_Needle_portfolio_blog_image_1

Apart from our extensive mouse embryo assay program media products are also tested for;

  • bacterial endotoxin
  • sterility
  • pH
  • osmolality

Some products are subject to other biological testing such as sperm survival test or cumulus cell removal assay instead of the mouse embryo assay. 

Controlled manufacturing secures quality

We manufacture our products in clean rooms and our facilities are continuously monitored for particles, micro-organisms and air flow to secure a clean environment.

Many of our products are handmade by skilled operators with many years of experience. More than 20 years ago, Vitrolife played a big role in the development of the technique allowing gynaecologists to perform ultrasound-guided egg collection. We have since then continued to fine-tune our manufacturing process for needles and would like to welcome you to see for yourself. 

 Watch movie showing   our quality manufacturing 

 

Topics: IVF laboratory control, Embryo culture & transfer, IVF community insights

Written by Hans Lehmann

As Director of QC, QA and RA, Hans makes sure Vitrolife follow regulatory requirements, standards and guidelines. Hans has a long history with Vitrolife and has been involved in numerous projects such as development of new products, global registrations and quality improvements.

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