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Celia Health has their own own FDA approved R&D lab, and manufacturer in CA. They are a lab, FDA approved to ship to all 50 states.
Lab:
- Products are made from cell cultures (made in the lab) & all natural materials (human & yeast cell cultures)
- They are manufactured from the synthesized formulation from scratch at a facilitated attached to our lab
- All products are made in the US, in our FDA approved R&D lab
- CGMP (Current Good Manufacturing Practice) compliant
- COAs and Contaminant Sheets are made for any batch order
- Our products are tested in in the lab, in 5 different ways before and after production
Shipping:
- All products are shipped from a fully compliant fulfillment center
- All products are shipped within two days & shipped on ice
- All products can be shipped with reconstitution & dosing kits such as saline + needles
Lab Testing:
Below is an overview of how the lab does their testing on every product.
- Raw material testing: Each peptide is first tested for purity using HPLC to ensure it meets our specification before use.
- Batch testing: After the formulation is prepared, a 5mL sample is taken from the batch and tested for concentration and consistency.
- Finished product testing: During the bottling and filling process, samples are pulled from the beginning, middle, and end of the run. These three samples are tested individually.
In total, five tests are performed for each production run: one on the raw compound, one on the batch sample, and three on finished product units. All results must meet the batch’s expected concentration and purity.
They use an Agilent 1260 HPLC system with a 5-point calibration curve, referencing standards from Sigma-Aldrich, to accurately determine the concentration of each peptide.
For injectable products, we also conduct additional safety testing for microbial contamination and endotoxins to ensure sterility and compliance with safety standards which will be shown on the COA.