PVP - 1 ml

  CE Marked (CE 0086)

LPVP-001, 1 ml

Indications for Use   To restrict the motility of human sperm.
     
Storage and Shelf Life   Store at 2-8°C and protected from light. Nine (9) months from the date of production when stored unopened at 2–8°C and protected from light. Do not freeze before use. Keep away from light. Discard unused medium within 7 days after opening. Do not use after expiry date.
     
Disposal Consideration   Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste.
     
Composition  

Dialysed Ph Eur grade polyvinylpyrrolidone (PVP) in Flushing Medium. Flushing Medium is an aqueous solution containing physiologic salts, HEPES, lactate, pyruvate, glucose and human albumin solution.

     
Recommendations for Use  

For a full and detailed recommended protocol of use for PVP - 1 ml please contact us at customerservice@lifeglobal.com.

     
Quality Control Specifications  
Paramater Specification
pH 7.2-7.9
Osmolality 280-320 mOsM
Viscosity (25°C) > 170 cP
Endotoxin (LAL) < 1.0 EU/ml
Sterility Test (bacterial and fungal screen, SAL 10–3) PASS
1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture after 30 minute exposure) > 80%
PVP has been evaluated by an independent test laboratory using the ISO 10993-5/USP30-NF25 Agar Diffusion test for cytotoxicity. The product was considered non-cytotoxic.
     
Precautions and Warnings  

PVP contains small amounts of Human Serum Albumin (HSA). The Human Serum Albumin used in the preparation of this product has been heated at 60°C for ten hours.

Caution: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that PVP is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Always wear protective clothing when handling specimens.

Always work under strict hygienic conditions (e.g. LAF-bench ISO Class 5) to avoid possible contamination.

Only for the intended use. Do not resterilize.

The long term safety of Intracytoplasmatic Sperm Injection (ICSI), including the use of PVP, on children born following this procedure is unknown.

Disclaimer
The procedures described below have been found to be effective for the restriction of the mobility of human sperm for ICSI and are offered only as examples. Every laboratory must define and optimize its own procedures.