2020 SPECIALTY SUPPLEMENT OF THE YEAR

Skinesa's Rigorous Testing Protocol

Skinesa's Rigorous Testing Protocol

June 17, 2022

Skinesa's Rigorous Testing Protocol

 

Skinesa® adheres to a rigorous production process to ensure both high yields and shelf stability. Our testing process is focused on producing a high quality, near pharmaceutical grade product consistently. To guarantee quality control throughout the whole production process, we document the entire lifecycle of our product and the probiotics in it using our multi-step process documented below. 

 good manufacturing practice

Stage 1: Each of the proprietary probiotic strains in Skinesa® is grown in a pharmaceutical grade laboratory that is specifically designed to produce the highest levels of purity and potency.  After producing the probiotic strains, each strain is then independently tested for purity before mixing the final blend in our European labs.  Once the blend is mixed it is sealed in airtight, moisture resistant bags and shipped via refrigerated airfreight to the United States for final encapsulation and bottling.  

Stage 2: Upon arrival in the US, the mixed probiotic blend is shipped from the airport to our production facilities via a refrigerated truck. Once onsite, samples are tested for both DNA/RNA fingerprinting (confirms that all strains exist and are active) as well as CFU enumeration (confirms the correct quantity of colony forming units are alive and uninjured in the probiotic). Additionally, Skinesa tests the batch upon arrival using flow cytometry ( A Laser that counts live, dead and injured cells). If the batch passes all of the required potency, allergen and sterilization tests the batch is then placed in the production refrigeration room and is ready to be encapsulated.   

Stage 3: If the probiotics are in the production refrigeration room for more than 7 days they are tested again for CFU just prior to encapsulating them. 

Stage 4: After encapsulating and bottling the probiotics (using full desiccant lined bottles) we collect random samples and test them to confirm that at the time of manufacture we exceed the CFU count on the bottle and nothing in the manufacturing process killed the probiotics. This way we insure that when a customer receives and uses Skinesa® they will have the product at full potency. Additionally, we keep a set of archival bottles from each lot and ship them off for shelf stability testing. This testing allows us to confirm that a batch will maintain the CFU count on the bottle up to the best before date that we have printed on that batch. The target for this is 2 years from production. 

Stage 5: During warm months we work with select customers to test the maximum temperature that their probiotics experienced during delivery. We do this by adding special temperature probes in their shipments. These probes take up to 8,000 readings during the shipment process.  If we find that a certain regions delivery temperatures exceed 108 degrees for more than 2 hours. We then ship to that region via climate controlled methods.  

Stage 6: Stability Testing

As previously mentioned, we take samples from each batch after production and put them through a barrage of heat and pressure tests that equate to the worst case scenario that the product might endure over the course of 2 years. Once the sample has endured these extreme conditions we then test the probiotics to ensure that enough of the probiotics are alive to state that after 2 years the CFU count on the bottle would still be accurate. 

Ultimately, Skinesa® recognizes that our rigorous testing process may be one of the most expensive and grueling in the industry but we believe that this process is critical to delivering a high quality product to our customers. 



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