Why Santé?


The Powered by Santé
Advantage

Facilities

• Santé Labs is the first ISO/IEC 17025:2017 accredited hemp testing laboratory in the State of Texas.

• Manufacturing of white / private label and bulk CPG finished product is produced in a class 100,000 (ISO 8) clean room to ensure no contamination.

• Environmental monitoring and process controls.

• Cutting edge facilities allow to create and scale scientifically validated and commercial ingredient delivery systems.

Skilled Staff

• Each Santé Lab member undergoes a rigorous training program in their respective field and must pass annual proficiency tests.

• Together we have a breadth of expertise in drug delivery, biology, chemistry, and food.

Quality Management System

• cGMP 21 CFR Part 111 Manufacturing of Dietary Supplements.

• All product is released according to specifications that meets critical quality attributes and presented in a detailed Certificate of Analysis that exceeds industry standards.

• Fully integrated analytical testing in an ISO/ IEC 17025:2017 accredited laboratory.

MBR / Accuracy

• Master Batch Records (MBR) and a mature quality management system (QMS) are used to ensure batch-to-batch repeatability.

• Santé labs master batch record 78 pages vs. 4 pages from leading nutraceutical manufactures.

IQ / OQ

• Manufacturing and analytical equipment has undergone IQ/OQ (Installation Qualification and Operational Qualification) which is typically not adhered to with traditional dietary supplement manufactures to ensure accuracy and OEM performance.

Raw Material

• Multi-compendial, USP, or food grade ingredients

• Raw materials are purchased from audited/ qualified vendors that meet GMP standards

• Raw materials are tested against identification and purity specifications

• We perform onsite facility audits for all cannabinoid suppliers

Supplies: Sterile Consumables

• All consumable manufacturing supplies are sterile, single use to minimize product contamination

Testing

• Raw materials and In-Process Tests (IPTs) are performed in an ISO/IEC 17025 accredited facility

• IPTs used to verify manufacturing quality

• Quality control and release testing of all finished product using GMP/ISO analytical methods

DO YOU KNOW IF YOUR WATER SOLUBLE/NANO-PRODUCT WILL WITHSTAND FDA REGULATIONS?

• Santé Labs operates in accordance with FDA Compliance as per guidance documents issued April 2018 • Santé Labs provides a nano formulation that meets shelf-life and label claim for both potency and particle size

WHAT IS YOUR PARTICLE SIZE DISTRIBUTION AND HOW HOMOGENOUS IS IT?

• Santé Labs manufactures liposomes that have been substantiated using cryogenic-SEM with a mean particle size 120 – 150 nm as measured by dynamic light scattering (DLS)

• Leveraging microfluidic technology, Santé Labs manufactures liposomes with tight precision of stable, small, and compliant particle size that does not require separate NDI codes