Quality

The management system secures continued development of the organization.

• We register our products according to the valid directives and requirements for all different countries. This also ensures our high quality on the market and it shall continue to be our beacon.
• Nidacon intends to always maintain the high quality of its products and, in order to achieve this, all batches are tested at Nidacon before they are cleared for the market.
• Sterility controls are performed on each batch manufactured, the endotoxin level is measured and biological efficacy tests are carried out. A batch is only released for sale if it meets specific criteria.
• Each batch is accompanied by a quality assurance certificate which records the results of the tests. Using this rigorous quality control system, we ensure that each batch meets the correct standards.
• Consequently, the customers are secure in the knowledge that our products are reliable and will provide good results when used correctly.

Physical analyses

• pH: – tested on every batch during production and after bottled product at room temperature in air.
• Osmolality: – tested on every batch during production and after.

Sterility and toxin analyses

• Microbiological growth control: – performed after production of a batch and involves bacterial and fungal growth assays. The assays are performed under a period of 2-3 weeks in order to be able to detect any growth. They are done by the Bacteriological Laboratory of Sahlgrenska University Hospital, Gothenburg, Sweden, an accredited, independent state laboratory.
• Endotoxin detection: – This assay is done with an FDA-approved, Limulus Amoebocyte Lysate (LAL) test using a quantitative spectrophotometric method in order to obtain real values with the units EU/mL, according to the U.S. Pharmacopoeia. The test is done by the accredited laboratory of the Microbiology Institute at the Sahlgrenska University Hospital of Gothenburg, Sweden.

Biological analyses

• Human sperm test: – The biological assay involves assessment of yield, motility and viability, measured both subjectively and using computer assisted sperm analysis (Thorne, IVOS – Hamilton). Each batch is tested biologically using human semen samples. The samples are separated into two parts, the one part being used for control and the second part being used for preparing sperm with the new batch. The test-batch results are compared with the results from the control.The analyses provide a count of the sperm per mL, the sperm activity is graded and the activity is also expressed as a percentage of the total sperm. All data are recorded from before and after the separation and purification, and are compared to the control, i.e. using an earlier, already approved batch.
• Human Sperm Survival test: – Prepared sperm are covered by oil and incubated overnight in 37°C, 5-6% CO². Percentage of motile sperm on day 2.
• Mouse Embryo Assay (MEA): – is used to assess the in vitro growth and development of pre-implantation embryos exposed to the test item. The assay predicts embryo toxicities in medical devices or related products to be used for assisted reproductive technology (ART).
• Mouse Embryo IVF Assay for media: – a sensitive assay mimicking the human IVF procedure. The preferred assay to screen assisted reproductive technology supplies for toxicities impairing male and female gamete fecundability and subsequent embryo development capacity. All tests are done by EggCentris – Belgium, a contract research laboratory specialised in the analysis of the reproductive function.
• Peroxide analyses: – the peroxide level is measured using a QuantiChrom™ Peroxide Assay .The improved method utilises the chromogenic Fe3+-xylenol orange reaction , in which a purple complex is formed when Fe2+ provided in the reagent is oxidised to Fe3+ by peroxidise present in the sample.
• Functional analysis/ Efficacy test: – used to prove the efficacy and function of the products.
• Visual control: – constant visual control during production, filling, labeling and final control of chosen ready packages.

ISO 13485