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CellCuraCellCuraCulture media product rangeCulture media product range
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Manufacturing standardsManufacturing standards
EN 13485 for medical device manufacture
ISO 9001 - quality management system to to consistently provide an FRP
product that meets customer and statutory and regulatory requirements,
and to address customer satisfaction through the effective application of thesystem.
QSR - FDA equivalent to EN13485 for medical devices
Our contract manufacturer has been ISO-certified since 1999according to the ISO9001 and then ISO13485 (including
CMDCAS) standards.
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Manufacture schematic for CellCura mediaManufacture schematic for CellCura media
Reverse Osmosis(RO)/De-Ionsied (DI)Ultra Pure Water
18 MegaOhmResistivity
Exclusively Pharma grade
(Ph. Eur) raw materials
Impeller mixed in disposable
liners in vessels
Filter sterilise with 0.1micron filtration
Aseptic filling in Nalgene (MDF) bottles
Random QC sampling
from batch ISO 6001
including 1st & last from
batch
Final batch
quarantined
Batch released when allQC tests have met
acceptance criteria
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CellCura quality control testsCellCura quality control tests
Sterility Broth enrichment test done at 22C and 37C for bacteria,
yeast and fungi
Osmolarity - 285mOsmol/kg + 3 physiological concentration for
reproductive cells
pH physiological balance for reproductive cells between 7.2 7.4(5% versus 6%CO2 in the incubator?)
Buffers:
- Sodium bicarbonate
- HEPES (N-2-Hydroxyethylpiperazine-N'-2-Ethanesulfonic Acid)
Endotoxin less than 0.1EU/ml an IVF industry standard Mouse embryo test
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CellCura quality control testsCellCura quality control tests
Mouse embryo test the industry standard for in vitro test for
functionality
CellCura produces are tested with the most commonly used mouse
strain B6C3F1 x B6D2F1
Pooled samples Control and test each use 21 embryos of which 70% of control
embryos must reach blastocyst for validity of test.
Direct and in direct exposure methods
Checked at 24 hours for development to 2 cells
Checked at 96 hours for development to expanded blastocystRoutinely CellCura medium achieves 90-100% on MEA tests
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CellCura Culture media productsCellCura Culture media products generalgeneral
specificationsspecifications
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CellCura Certificate of AnalysisCellCura Certificate of Analysis
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PF IUI mediumPF IUI medium
Exclusively Pharma grade
component formulation
Uniquely standardised
formulation and performance
Fully defined formulation
based on in vivo physiology
No foreign proteins in uterus
Good results with non-
selected patients
Lowest Endotoxin rating
product available worldwide
Full shelf life available to
customer
No pre-order schedule
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Sperm preparation productsSperm preparation products
Exclusively Pharma grade
component formulation
Uniquely standardised
formulation and performance
Fully defined formulation
based on in vivo physiology
No foreign proteins in uterus
53 babies born
Lowest Endotoxin rating product
available worldwide
Full shelf life
No pre-order schedule
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GradiARTGradiART
Exclusively Pharma grade
component formulation
Uniquely standardised
formulation and performance
Easy and effective separation
of progessive motile spermpopulation which is better that
industry standard product
Lowest Endotoxin rating product
available worldwide
Full shelf life No pre-order schedule
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PF culture mediumPF culture medium
Exclusively Pharma grade
component formulation
Uniquely standardised formulation
and performance
Fully defined formulation based on
in vivo physiology No foreign protein exposure in
culture or in uterus at transfer
53 babies born sibling oocyte
studies show better performance
than HSA containing media
Lowest Endotoxin rating productavailable worldwide
Full shelf life
No pre-order schedule
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PF ICSI productsPF ICSI products Oil, Hyaluronidase, PVPOil, Hyaluronidase, PVP
Exclusively Pharma grade
component formulation
Physiological formulations
Uniquely standardised
formulation and performance
No proteins
53 babies born
Lowest Endotoxin rating product
available worldwide
Full shelf life
No pre-order schedule
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CellCura PF Products Use schematicCellCura PF Products Use schematic
Oocytes Sperm
Embryo
Embryo day 2/3
Embryo day 5
GP 700 PF
Gamete
handling
medium
GP 700 PF
Gamete
Handling
Medium
GP200/300
PF GradiART
GA 100 PF
Flush
medium
GP400 PF IUI Medium
EM100
PF Culture medium 0-5 days
ICSI/IVF
GP700 PF GHM
Gxxxxx PF Hyaluronidase
Gxxxxx PF PVP
GXXXX PF Oil
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Thank You !
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Protein Free Media is now Available in India
Please Contact:
Feron Life Sciences (P) Limited,
203, Akashdeep Building,
26, Barakhamba Road,
New Delhi 110001
Phones: +91-11-23736356 ~ 57
Fax: +91-11-23730458
E-Mail: [email protected]
