Raising the Bar - Medical grade testing
ZyCal Bioceuticals Manufacturing Company is the only facility in the world to produce Cyplexinol® - Nature’s BMP-Complex, the active ingredient in Ostinol® Bone and Cartilage Stimulating Proteins. Each batch is produced in our cGMP, FDA-inspected ultra-clean facility by highly trained technicians. Moreover, each batch of Cyplexinol® must undergo and pass the same rigorous testing process performed by orthopedic medical companies ensuring their surgical tissue-growth products can turn on stem cells and grow new tissue. Every batch of Cyplexinol® must undergo the same, live animal model testing, by an independent laboratory. The testing requires 45-80 days to complete, with histological results showing de novo bone and cartilage tissue growth. This testing is the gold standard used by surgical companies and guarantees that every batch of Cyplexinol® is biologically active, can turn on stem cells, and grow new bone and cartilage tissue, provides healthcare professionals with an unparalleled level of efficacy and puts Ostinol® in a class of its own.
Tested, tested and tested again
In addition to the stem-cell activation testing, each batch undergoes over 30 tests by independent laboratories including moisture, microbiology (yeast and mold) and heavy metal to ensure safety and stability as well nutritional biochemistry for protein, fat, mineral (calcium) and other critical tests guaranteeing each batch meets and exceeds the required specification.
Cyplexinol® is packaged in micro-batch, vacuum-sealed foil pouches as it awaits encapsulation. When needed, each batch is shipped with a Certificate of Analysis to our FDA audited encapsulation company, where it is retested upon arrival, encapsulated and retested again. Once product is bottled and shipped to ZyCal, it is received, quarantined and yes, retested again to ensure no possible contamination during shipping. At ZyCal ensuring the highest quality products in production and testing is key to who we are.
Microbiology levels
When conducting microbiology testing, there are known pathogenetic bacteria such as E.coli that a zero-level is the only acceptable level. This standard is universally accepted by all nutritional supplement and food companies. Then there are non-pathogenic bacteria which is not harmful at low to moderate levels that all food and supplement companies accept. The level of bacteria is counted as cfu (colony forming units) and most supplements accept a level of 10,000 cfu, while raw meat sold in the supermarket can 30,000 cfu or higher, with the International Commission on Microbiological Specifications for Foods (ICMSF) setting the acceptable levels as high as 100,000 cfu.
At ZyCal Bioceuticals Manufacturing Co, we set the acceptable level in Cyplexinol® ingredient at 1,000 cfu - 10X less than most supplement companies and our yeast and mold levels set at 100 cfu or less – again 10X less than industry levels of 1,000 cfu. At ZyCal Bioceuticals, purity, efficacy and excellence are at the hallmark of what we produce.
Facility Testing
Water First, air second
At ZyCal Bioceuticals Manufacturing Company, LLC., the testing for manufacturing Cyplexinol® is so rigorous that we even test the quality of water coming into our facility, ensuring the pH of the water meets and exceeds Environmental Protection Agency guidelines as well as test form coliforms by a certified independent laboratory.
Next we test and confirm, by a certified independent laboratory, the air quality in every one of our manufacturing process rooms.
Quality as a Natural Part of our Business
Record Keeping
ZyCal Bioceuticals Manufacturing Company implements such stringent tracking in the manufacturing of Cyplexinol® that we are able to trace the Cyplexinol® in every bottle of Ostinol® back to the batch of 100% natural, grass-fed, hormone-free batch of bones delivered.
Monthly Quality Management Meeting
Each month ZyCal Manufacturing conducts a Senior Management meeting on the Quality Management System ensuring meticulous attention to every detail.
Internal and External Audit
Throughout the year, scheduled, planned, and executed Good Manufacturing Practices (GMP) audits occur to ensure we deliver on the Quality promise which has a profound impact on increasing the trust we have built with all stakeholders while continuously improving our processes and products.
About the Director of Quality
Mary Brower has over 35 years of experience in the Medtech industry, specializing in Quality and Operations roles at Viant Medical, Perma Pure, Nextremity Solutions, and Endoluxe. She brings a wealth of knowledge and expertise in Quality Systems deployment, FDA compliance, and manufacturing excellence.
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.