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Sera and Plasma - General Information:
 
Collection:
 
  • Equitech-Bio's fetal bovine serum (FBS) is collected using cardiac puncture.
  • All donor sera are collected from standing herds of U.S. origin.
  • All donor animals are under direct U.S.D.A.-approved veterinary care, with worming histories carefully documented.
  • To ensure lot-to-lot consistency, all sera is assayed for basic chemical constituents.
  • All serum collection is aseptic and rigorously controlled along industry guidelines.
    		•
     
    Processing:
     
    Blood collected for Equitech-Bio is allowed to clot thoroughly at refrigeration temperatures. Serum is then separated from the clot and chilled further in an ice bath to minimize microbial activity to prevent lysis. All sera is then ultra-centrifuged to remove any particulate matter. Sera is allowed no more than a single freeze-thaw cycle during processing. Only after passing rigorous quality control specifications is serum approved for production. All serum is processed in our audited and inspected facility according to Good Manufacturing Practices (cGMP). All serum processing is documented in batch production records. No clotting factors, anticoagulants, or additives adulterate the raw material.
     
    Filtration:
     
    Equitech-Bio filters each lot aseptically with validated sterile 0.2 micron or 0.1 micron pore size filters. All filling is performed aseptically under laminar flow hoods in a HEPA-filtered and tem-perature-controlled environment. All sera and plasma can be supplied raw, non-sterile filtered or sterile filtered. Please inquire for additional information.
     
    Quality Assurance:
     
    Each serum lot is statistically sampled by our Quality Control department and subjected to routine testing to ensure Equitech-Bio's high quality and consistency. If you require special testing, we will be happy to accommodate you.

    FBS is tested for the following characteristics:
     
    Physicochemical:
    • pH
    • osmolality
    • total protein
    • electrophoretic profile
    • hemoglobin
    • biochemical analysis
     
    Microbiological:
    • sterility (9CFR113.26) or (USP membrane filtration)
    • mycoplasma
    • endotoxin
    • adventitious viral agents
    • cytotoxicity (upon request)
     
    Quality Control results of all serum are shipped with a lot-specific report.
     
    Classification:
     
    All products are for research use only. Equitech-Bio has not qualified any products for any human or animal therapeutic use.
     
    Reserve Testing:
     
    Sample Size:
     
    Equitech-Bio will provide you with a free sample of serum through our reserve testing program.
     
    Minimum Reserve:
     
    Equitech-Bio normally requests that you reserve a minimum of 50 x 100 ml, or 12 x 500 ml. If a smaller amount is required, please contact us.
     
    Length of Reserve:
     
    If your testing schedule requires it, we will reserve a lot for four (4) weeks. Again, simply contact us.
     
    Animal Blood and Plasma:
     
    Equitech-Bio offers whole blood and plasma from most animal species by special request. Blood and plasma can be supplied raw, defibrinated and citrated in a variety of custom concentrations as specified by the supplier. Anticoagulants available include sodium citrate, heparin, EDTA and others.