COOK Medical IVF Media Instructions For Use Manual page 3

MEDIA
GENERAL PROCEDURE
The following is a general procedure for using Cook IVF Media products. Each laboratory should
establish procedures and protocols that are optimized for the individual medical facility.
The media is intended to be used by Embryologist/Andrologists or medical specialists who
have received specialized training in embryology and laboratory techniques. The user of these
products should read and understand the Instructions for Use and Precautions, and be trained
in the correct procedure before performing the procedure.
SPECIFICATIONS AND QUALITY ASSURANCE
These products are supplied 'STERILE'. These products are sterilized by terminal filtration to
give a sterility assurance level (SAL) of 10
Each lot of product is tested for:
• Endotoxin by LAL
• Biocompatibility by MEA
• Osmolality and pH (with the exception of K-SICO-50-2 and K-SIPV-200-5)
• Sterility
All sterility results are provided on lot specific Certificate of Analysis, available upon request.
Reuse or re-sterilization may create risk of contamination of culture environment and/or cause
patient infection.
STORAGE AND STABILITY
All culture media products must be stored in their original, unopened containers and
refrigerated at 2-8°C. When stored as directed, Cook IVF Media products are stable until
the expiration date shown on the vial label. These products cannot be re-sterilized after
opening. Discard after use. Reuse or re-sterilization may create risk of contamination of culture
environment and/or cause patient infection.
DO NOT USE PRODUCT IF:
• Packaging appears damaged or the seal is broken
• Solution appears turbid
• Expiry date has been exceeded
PRECAUTIONS
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 proven virus transmissions with albumin manufactured to European
Pharmacopoeia specifications by established processes.
It is strongly recommended that every time Cook IVF Media 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.
The risk of reproductive/developmental toxicity due to the use of IVF media has not been
determined and is unknown.
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ENGLISH