Quality Our media
All Biowest equipment, chemicals and raw materials are of the highest quality.
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 thepurified water quality obtained via a process including centrifugal distillation.
- Our media are 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.
Equipments and Conditions
All manufacturing equipment used for dry powder and liquid media are made of chemically inert materials which will not contaminate the final product.
Biowest produces cell culture media following strict environmental regulations regarding cleanliness and moisture.
Humidity and temperature are monitored constantly to guarantee that all chemicals are ground into a fine powder.
The sterilization of liquid media is carried out by going through a of 0.1µm pore sized sterile filter.
Batch Size
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.
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.
Quality Control on Media :
Dry Powder Media are tested physically for osmotic effects and pH.
Endotoxin testing is performed using the Limulus Amoebocyte test. The chromokinetic test is used to verify the quality of the medium. The liquid media are tested for sterility, pH and osmolality. The biological performance test is done on different cell lines for each type of media. The endotoxin level is also tested by a chromokinetic test.
Osmolality is determined by the Freezing Point Method, following European Pharmacopeia Ph. 2.2.35.
The chemical composition and the homogeneity of the mixture are controlled by analysis of glucose or sodium in the sample.
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).
The preparation and production of customized cell culture components is another of our services.
When given the list of components needed and the corresponding quantities, we will produce the media to your requirements. There may be a short delay for this service.
