QUALITY ISO 9001

During 2019, Embryocloud team has been working to achieve the certification of quality UNE-EN ISO 9001:2015 which defines the criteria for a Quality Management System and is the only standard in the family that can be audited against with the goal of voluntary compliance or to become third party registered.

EmbryoCloud achieved the ISO certificate with registration number 203033/A/0001/UK/SP and will have next external audit by the end of year 2021.

QUALITY CONTROL
Culture media
Reproductive fluids

After formulation culture media are tested for quality
control followed by sterilization by filtration and storing in sterile
containers.

Batches accepted must fulfill these parameters:

  Natur
ARTs PIG-Swim Up Medium
pH 7.4-7.8
Osmolarity (mOsm/kg) 320-340
Endotoxin (EU/mL) <0.15
Sterility No growth
Sperm count (millions/mL) after
swim-up*
 
fresh
ejaculated pig spermatozoa
>1
frozen-thawed
pig spermatozoa
>5

*Following the instructions provided in MSDS. The rate can vary depending of the quality in the original seminal sample. 

 

Sanitary rules are strictly followed during
collection of oviductal and uterine fluids.

After collection and processing all samples are
subjected to quality controls being accepted the samples within the following
ranges:

  Natur ARTs-OF Natur ARTs-UF
pH 7.0-7.6 7.0-7.6
Osmolarity (mOsm/kg) 280-320 280-320
Endotoxin (EU/mL) <0.15 <0.15
Sterility No growth No
growth
Bovine Embryo Assay (BEA) >80% cleavage rate >25% blastocyst
formation
Porcine Embryo Assay (PEA) >70% cleavage rate >20% blastocyst
formation