Quality and quality control

Raw materials

Raw materials used are of the highest quality obtainable and exceed or comply with the European and/or United States Pharmacopoeia. If this quality is not obtainable ProVitro selects the best quality on the marked and quality tests all available batches.

Water

Quality exceeds WFI (water for injection).

Specification of water used:

• 18.2 MΩ
• Endotoxin < 0.01 EU/ml
• TOC < 2 ppm

Human Serum Albumin (HSA)

SpermWash® and SpermFilter® gradient medium contains HSA. The HSA used is pharmaceutical grade approved for intravenous therapy and is obtained from a US licensed source. It meets United States Pharmacopoeia (USP), European Pharmacopoeia (USP) and Japanese specifications.

The supplier guarantees:

• No confirmed pathogen transmission in 6 decades
• Rigorous screening of every donor, every unit of donated plasma, and every plasma pool (HBSAg, HCV, HIV-1, HIV-2).
• Validated and robust virus clearance step for both enveloped and non-enveloped viruses.
• Four different viral reduction steps.
• Virus clearance steps exceeds regulatory authorities expectations.
• Confirmed removal of prions during manufacturing.

Whilst, an extremely remote risk of transmission of viral disease and a theoretical risk of transmission of prions cannot be ruled out (Creutzfreldt-Jakob disease, CJD or the new variant nvCJD). It must, however, be emphasized, that no transmission of viral disease, CJD or nvCJD have ever been identified with albumin.

Packages

The medium is supplied sterile filtered in pharmaceutical grade borosilicate glass bottles compliant with the European and United States Pharmacopoeia. The bottles are sealed with Teflon-coated rubber stoppers and tamper proof aluminium seals. Bottles are packed in white virgin fibre pharmaceutical cartoons. Both the bottles and the cartons have labels showing the name of the product, product number, intended use, batch number, storage condition and expiration date. Every carton contains an insert with a full product description and instruction for use.

Labels

Both the bottles and the cartons have labels showing the name of the product, product number, intended use, batch number, expiration date and storing condition. Graphical symbols used on the labels are in accordance with the European Standard for labelling of medical devices (EN 980:2003). To download the meaning of these symbols, please click here.

Quality control

Each batch is QC-tested according to USP and Ph. Eur. specifications:

• pH test
• Osmolality
• Endotoxin (LAL test)
• Sterility test
• Sperm Survival Test (not specified in USP and Ph. Eur.).

The Sperm Survival Test ensures no compromised survival of spermatozoa incubated in test medium for 18 hours at 35°C as compared to a control medium. Because ProVitro only produces media intended for andrology we have not implemented the Mouse Embryo Assay (MEA test). It is a matter of controversy whether the MEA test is predictive in human ART.

A Certificate of Analysis (CoA) of each batch is available upon request, click here.