Product Testing & Quality Control

Every batch of product is sent to an independent laboratory for microbial testing both before and after packaging. Our regulatory approved heat treatment process ensures that our products are free of pathogenic organisms that could potentially cause diseases such as Johne’s, Tuberculosis, Brucellosis, Leucosis, Salmonellosis, E. coli infection, and others. Before approval for sale, each product batch is tested for potency and purity to ensure immunoglobulin and microbiological specifications are met.

Every batch of product we have made since 1995 was culture negative for Mycobacterium avium subspecies paratuberculosis (MAP), the cause of Johne’s Disease.

Since the immune globulins (Igs) are the most important immune molecules naturally found in colostrum, potency is based on measuring the concentration of IgG. The most accurate and reliable way of measuring IgG is by using a laboratory test called the radial immunodiffusion (RID) assay. The RID test used is specific for bovine IgG and will detect only functional antibodies.  We use an RID that is standardized using a reference reagent provided by the USDA. This ensures that our RID is always tested against a standard reagent that does not change over time, and provides highly accurate and reliable results.

Within each grade of our colostrum, protein, fat, lactose, and energy levels show consistency from batch to batch. The level of key vitamins and minerals are also monitored.

• We measure and monitor the concentration of important antimicrobial factors, including lactoferrin, lactoperoxidase, and lysozyme.
• Levels of key growth factors, such as insulin-like growth factors 1 and 2 and epidermal growth factor are also monitored.
• When requested by customers, we measure other important components, such as trypsin inhibitor.

To ensure product safety, samples of all manufactured batches are fed to calves. This ensures that there is no health or toxicity risk. We have never had a batch cause an adverse reaction in calves or fail this safety test.

Potency testing each batch of product ensures that therapeutic specifications are met. This is based on demonstrating that recipients have therapeutic levels of bioactive IgG in their blood after being fed the product. All of our products filed with the CFIA and USDA have undergone reviewed and filed efficacy testing in newborn, colostrum deprived calves at the recommended dose, and then taking a blood sample a day after feeding.

During efficacy studies, the level of IgG in the calves’ blood is measured by RID to be sure that it has reached target therapeutic levels. If it has, this confirms that the product will be effective under field conditions if administered according to package instructions.

SCCL adheres to the extensive compliance and regulatory standards of the Canadian Food Inspection Agency (CFIA) – Canadian Centre for Veterinary Biologics (CCVB), United States Department of Agriculture (USDA) – Center for Veterinary Biologics (CVB), Canadian Food Inspection Agency (CFIA) – Safe Food for Canadians (SRCR), Natural and Non-prescription Health Products Directorate of Health Canada (NNHPD), Health Canada Good Manufacturing Practices (GMP), The National Animal Supplement Council (NASC), GMP+, OMRI USA, GMP/HACCP, European Union Trade Control and Expert System.

Learn more about the standards that SCCL products must follow.