Tarzana, CA 91356
Phone: (800) 799-5873
Fax: (818) 345-9011
QUALITY SERA
quality control
Quality Control verifies that operations, processes, finished product testing, component testing, and release mechanisms are maintained in compliance with Current Good Manufacturing Practices (cGMP's). Personnel are well qualified and fully trained in all procedures and the manufacturing facility is designed to efficiently facilitate processes in a controlled environment. All documentation is maintained and reviewed by Quality Assurance.
collection
Blood is colleted at a United States Department of Agriculture (USDA) approved facility from animals examined by a qualified veterinarian prior to slaughter and are USDA inspected following slaughter. Collection by cardiac puncture and venipuncture is done directly into bags using proprietary aseptic processing techniques. An alternative technique is by abattoir open collection where processing eliminates the use of bags. The bags are constructed of materials that meet USP Class VI requirements for plastic components. Only serum from disease free animals is processed. Donor animal sera are collected from veterinarian inspected controlled herds.
processing
Prior to pooling, serum is routinely screened for Endotoxin and Hemoglobin and only that which meets our stringent criteria is released for processing. The serum pool is clarified through a series of varying porosity filters to 0.2 micron, and in the case of Fetal Bovine Serum, an additional triple 0.1 micron. During processing the serum temperature is maintained at 2-8 degrees C. Sterile filtration is in a class 100 environment and the finished product is immediately frozen and stored at -20 degrees C or below.
FINAL PRODUCT QUALTY CONTROL
mycoplasma
Screened for the presence of Mycoplasma by the large volume procedure, CFR Title 9 part 113.28, and the fluorescent DNA staining method using Hoechst stain.
bacteriophage
Screened by plaque assay using two Susceptible host strains of E. coli.
viral testing
Sera are tested according to CFR 9 part 113.46-53
hemoglobin
Reported in mg/dl (mg%)
protein electrophoresis
Characteristic protein electrophoretic profile.
sterility
Final fill samples are taken using a statistical sampling plan and handled aseptically according to CFR Title 21 part 113.26 and USP XXII.
growth promotion
Cell growth promotion is routinely performed on each lot of serum and media.
endotoxin
The level of endotoxin present is determined by the Limulus Amebocyte Lysate (LAL) gel clot assay, according to the method described by Associates of Cape Cod.
certificate of analysis
A Certificate of Analysis is available for each lot of product, which summarizes the Quality Control test data.