Carmell In-House Manufacturing Suite
Carmell's products are manufactured in rigorous compliance with current Good Manufacturing Practice (cGMP) guidelines .
Carmell Secretome is exclusively produced in our state-of-the-art facility in Pittsburgh, PA. This facility is equipped with highly trained engineers and scientists, ensuring that the manufacturing process is executed with precision and expertise.
The commitment to cGMP processes is evident in every step of Carmell Secretome's production. From the qualification of equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to in-process controls such as lyophilization timing, stirring rates, and temperature monitoring, the emphasis on quality is unwavering. These measures not only guarantee consistent product quality but also significantly reduce the risk of contamination.
Carmell Secretome's manufacturing process includes a dedication to safety and efficacy. The product undergoes two sterilization processes, accompanied by a battery of release testing, including endotoxin testing, to ensure that every batch meets the highest standards of safety.
Environmental monitoring, encompassing bacteria, yeast, and mold assessments, underscores Carmell’s commitment to maintaining a pristine manufacturing environment. Our comprehensive procedures and controls extend from sourcing and receiving raw materials to in-process monitoring, release testing, and post-delivery requirements. This holistic approach ensures that Carmell not only meets but exceeds industry standards, setting a precedent for excellence in the cosmetic manufacturing landscape.
ISO Class 7 Cleanroom
Our commitment to safety is further reinforced by our manufacturing facility's compliance with 3rd Party Certified Cleanroom standards (ISO 14644-1 Class 7), originally designed for medical device and pharmaceutical manufacturing.
Testing Programs
Carmell’s testing strategy begins before the manufacturing suite is even staged for processing. All raw materials used to make the Secretome go through an intensive ordering and receiving process to ensure they meet Carmell’s requirements to be used in making top quality products. Platelet-enriched plasma sourced from US registered blood banks undergoes a standard panel of testing, including testing non-reactive (negative) for the following: hepatitis B, hepatitis C, HIV I/II, human t-lymphotropic virus, west nile virus and syphilis. We also have additional viral testing requirements, including those for hepatitis A and parvo B19. Serology testing is performed on cell counts for an acceptable range of platelet levels for consistent product performance. There are also requirements for maximum allowable limits of red blood cells and white blood cells to avoid potential immunogenicity effects. Collection date, storage conditions, and other physical parameters are also tracked to ensure quality and consistency.
Throughout the manufacturing process, there are multiple times that batch samples are taken to be quality control tested against predetermined parameters using validated test methods. These include product properties such as protein content, appearance, moisture content, particle size, and endotoxin detection. Utilizing these methods as checks and balances leads to a consistent product from batch to batch. There are also real-time measurements and observations taken by those manufacturing the product to ensure our established critical process parameters that we have selected to ensure product quality and consistency are achieved.
Carmell cosmetic products undergo final product testing. These tests have been designed to ensure the safety and quality performance of our product from lot to lot. The pH of human skin ranges between 5.4-5.9. Each product is adjusted for pH in our Class 7 cleanroom to ensure the product is within range for ideal absorption before final packaging. All cosmetic products are measured for their unique flow resistance properties to confirm they are in accordance with our qualified in-house standards.
The safety of all Carmell products is confirmed with an extensive panel of microbial testing. The integrity of each formulation is confirmed by sampling each batch for specific bacteria strains that have been known to cause harm in the cosmetic industry such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans. A microbiological examination is also performed to measure the total viable aerobic count present. Our results our held to the rigorous European Pharmacopoeia (EP) standards. That exceeds the requirements of cosmetic testing within the US today.