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Quality Assurance

Serum Source International takes pride in offering a comprehensive range of premium quality animal serum used in cell culture research to industrial use.  Our production facilities are designed to meet the demands of processing biological and blood-based products in strict compliance with current Good Manufacturing Practice guidelines (cGMPs) and are registered with the Food and Drug Administration (FDA).  Each aspect of production and testing is performed and monitored by a highly trained professional staff.  Serum Source International products must meet the highest standards of performance prior to our release for sale.

All processes are performed according to written documents covering every aspect of each procedure involved.  Verification of origin, processing and testing parameters are all factors that control the quality of each batch, enabling Serum Source International to offer only products of the highest quality.

Serum Source International confidently offers a Certificate of Analysis (COA) for every lot of animal serum indicating the lot number, origin and expiration date.  Certificates of Analysis also include a complete physical and biochemical profile analysis, as well as virus and antibody testing results using the methods outlined in the Code of Federal Regulations, Title 9, Part 113.53 (9 CFR 113.53) for all Fetal Bovine Serum lots.  Micro-organism testing is completed and reported to ensure the absence of bacterial or fungal contamination using methods written by the United States Pharmacopeia (USP) and/or a similar method within Industry Standards.  Complete traceability is documented for every lot.
        
Serum Source International supplies all animal sera in compliance with cGMP Pharmaceutical Standards, United States Department of Agriculture (USDA) Guidelines and the Food and Drug Administration (FDA) Regulations.

 

Collection, Processing and Filtration

All blood is collected from abattoirs approved by the United States Department of Agriculture from only healthy animals, which received ante-mortem and post-mortem inspections and were found to be free of signs and symptoms of infectious and contagious diseases.

All serum is processed at FDA registered facilities.   The temperature is carefully controlled during all processing stages in order to maintain the integrity of the serum.  Prior to pooling, all raw serum is routinely tested for bioburden, endotoxin and hemoglobin levels, and only those containers which meet our stringent criteria are released for further processing.

The serum is filtered through a cascade series of three varying porosity 0.1µm sterile filters (triple 0.1 micron filters), using true pooling techniques to ensure complete homogeneity.  A monitored low temperature is strictly maintained during all processing steps.  Sterile filtration is completed in a validated Class 1000 (or better) environment.  Upon completion of the filtering stage, the serum is dispensed into sterile PETG bottles and immediately frozen and maintained at or below -20°C.  The complete procedure is conducted in an environmentally controlled area maintained under positive pressure with HEPA-filtered air.

 

Packaging

All serum is aseptically dispensed into manufacturer-validated, radiation-sterilized PETG (glycol-modified polyethylene terephthalate copolyester) leak proof, break resistant, durable plastic bottles, meeting USP Class VI requirements, for complete assurance of bottle sterility, materials and integrity.  Serum is routinely packaged in 50 ml, 100 ml and 500 ml bottles.

To maintain frozen conditions, serum products are shipped in insulated cooler boxes with sufficient dry ice to remain frozen during transport to end destination.  Packing blocks are used on an as needed basis per shipment to ensure bottle stability, as well as helping to minimize air space within the box.