Quality Control of Raw Materials 

The main hallmark of Vitrolife product portfolio is, apart from high efficiency and functionality, superior safety and quality. Advanced methods for quality control are utilized including a unique biological assay specifically designed for IVF products. This assay is the most sensitive toxicity testing available and is continuously being optimized and fine-tuned.

The production of Vitrolife IVF media, so-called aseptic processing, prohibits terminal sterilization by heat or similar methods. Aseptic processing of IVF media thus relies on adherence to the strictest cleanliness and sanitary standards of raw materials, production environment and process equipment. However, suppliers can not assure that the raw materials meet the cleanliness and sanitary standards for IVF media due to the complexity of the testing. Therefore, substantial efforts are applied by Vitrolife to test each individual batch of raw material for IVF media, including the above mentioned biological assay. Also, raw materials intended for Vitrolife’s instrument production benefit from the biological assay testing.

This rigorous testing guarantee a stable top quality level and is indeed a strategic business tool for Vitrolife. A brand new laboratory entirely devoted to the biological assay was completed in 2008 and the capacity of this laboratory is being expanded in 2011 to meet the ever increasing need of testing new raw material and products.    

Quality Control of Finished Products

Stringent quality control of raw material, production environment and process equipment in combination with continuous process controls secure the quality of finished IVF media. In addition, extensive physical testing, bacterial endotoxin assays and sterility testing, are applied as well as functional testing utilizing human sperm and mouse embryos. This complete control program results in an extremely high level of confidence in the finished IVF media.  

IVF instruments need to be functional, safe and reliable. Aspiration needles and pipettes are precision instruments equipped with minute and special designed tips where the quality is crucial. Each instrument is measured and inspected in microscope during production and biological testing is performed to verify that the instrument production is safe and nontoxic to the embryo.

Quality Assurance    

Vitrolife’s vision is to become the world leading provider to the fertility and cell therapy markets. Quality is of utmost importance to our customers and one of Vitrolife’s major competitive edges is the quality system. The organization constantly strives to improve the quality system by applying LEAN principles, continuous improvement projects, internal quality audits and regular quality reviews. The main corner stones of the quality work are:

• Customer focus - achieved by working in close relation to our customers so we can meet the expressed as well as implied needs of the customers.
• Innovation - encouraged as we are open to changes so that we always provide the best products based on the current scientific understanding.
• Qualified and involved employees - competence of our employees is maintained through continuous qualification which leads to motivation and involvement in company objectives.
• Commitment to quality - achieved through qualification and management example assuring that every employee fully understands the impact of quality on the successful use of our products.
• Effectiveness of the quality system - ensured through ongoing evaluation and improvement of the company processes.

Vitrolife’s quality system conforms to international standards and local regulations for the medical device and pharmaceutical industries to facilitate world wide market access. Example of such standards and regulations are ISO 13485:2003, ISO 9001:2008, US Quality System Requirements, Canadian Medical Device Regulations and EU Good Distribution Practice. The quality system is process-oriented and the continuous improvement work involving the two main processes (order to sales and product life management cycle) includes activities such as identifying critical process interfaces, monitor key performance indicators and regularly review all sub levels of the organization in order to optimize the efficiency of the processes.

Vitrolife is regularly audited by external authorities from all over the world such as the Notified Bodies DNV and TUV (EU), Food and Drug Administration (US), Therapeutic Goods Agency (Australia), QMI (Canada) and Medicines Product Agency (Sweden). The requirements and audit methodology varies from country to country, but Vitrolife’s quality system has proven to be dependable and accepted through numerous external audits during more than a decade.