Standard Cell Culture Media
Our special media formulations vary from set standards - by the substitution of hydrated, chlorinated and/or salt forms of certain compounds.
These original formulations provide improvements in terms of product performance.
Inorganic chemicals are the finest grade available; analytical, ACS, USP, EP, FCC grade or otherwise.
All other components are evaluated by standards established by Biowest:
- The new batches of chemicals are added into the process only after undergoing strict Quality Control using the best WFI water quality attained via a process including centrifugal distillation.
- Our media is also tested for endotoxin.
- The QC department monitors and stores all in-line measures and values of resistivity.
- The freshly processed water is cooled down to 25°C before adding the powder.
Equipment and Conditions
All manufacturing equipment used for dry powder and liquid media are composed of chemically inert materials to avoid contaminating the final product.
Biowest produces cell culture media respecting strict environmental regulations regarding sanitary conditions and moisture.
Humidity and temperature are constantly monitored to guarantee that all chemicals are ground into a fine powder.
The liquid media sterilisation is carried out by use of 0.1µm pore sized sterile filter.
Batch sizes media range from:
- 1 to 10.000 liters for dry powder media
- 1 to 1.500 liters for liquid media
End Product Testing
Each batch is delivered with a Certificate of Analysis
Quality Control on Media :
Dry Powder Media are physically tested for osmotic effects and pH.
Osmolality is established by means of the Freezing Point Method, following European Pharmacopeia EU Ph. 2.2.35.
Biowest analyses representative samples of the mixture's chemical composition and homogeneity to verify the concentration of glucose or sodium.
We also perform a chromokinetic - quantitative test - method D of the European Pharmacopoeia EU Ph. 2.6.14 to determine and quantify endotoxin levels.
A biological performance test is done on cell lines corresponding to their particular medium.
The endotoxin level is also tested by a Chromo Kinetic test, a chromokinetic - quantitative test - method D of the European Pharmacopoeia EU Ph. 2.6.14.
Liquid Media are tested for sterility, pH and osmolality (following European Pharmacopeia EU Ph. 2.2.35).
These products are intended for research applications.
It is the end user's responsibility to qualify these products for their specific application.
These products are not for diagnostic use.
Their safety and efficiency have not been established for diagnostic or other clinical uses.