How We Actually Achieved Sterile CBD

CBD and other cannabinoids have been a staple in the wellness space for years. But the conversation around sterile CBD is still relatively new. For a long time, the industry hit a technical wall: the particle size of CBD simply kept it from being able to pass through a sterile filter. Even with the advent of water-based nanoemulsions, the particle size remained too large to achieve true sterility.

The team at PICO IV set out to solve this specific problem. With our patent-pending pico-emulsion process, not only were we able to get the particle size small enough, but we created a rigorous manufacturing process that makes sure the CBD pico-emulsion remains sterile, from extraction to packaging.

Here is a transparent breakdown of the standards we follow and the science behind our process.

1. Starting with the Right Raw Materials

Our sterility begins with the quality of the base extract and the hemp. We source federally and state-compliant hemp plants grown exclusively in the United States.

Before any formulation begins, the raw extract undergoes a multi-stage purification process to remove plant waxes, chlorophyll, and other botanical impurities. This ensures we are starting with a clean, consistent base that is physically ready for the next phase of development: pico-emulsification. By refining the raw materials first, we eliminate the bulk of the contaminants that typically complicate the sterilization process.

2. Breaking the "Particle Size" Barrier

Historically, the biggest challenge in sterilizing CBD was particle size. In order to use the types of filters required for medical-grade sterility, you have to be able to pass the liquid through an incredibly fine mesh. If the particles are too large, the filters clog, or the solution loses its potency.

Our patent-pending process changed the math. By achieving a consistent, pico-sized particle size, we created a solution that is physically capable of being sterilized through filtration without losing its potency. This is the foundation that allows us to meet the requirements necessary for clinical use.

3. Controlled Manufacturing Standards

Sterility is about more than the product itself; it’s about the environment where that product is handled. Every manufacturing facility that is part of the PICO IV process operates under current Good Manufacturing Practices (cGMP).

Furthermore, these facilities are ISO certified to ensure that every batch is handled in a controlled environment. This rigor is what prevents environmental contamination, like airborne particulates or microbes, from entering the product during the critical packaging and sealing stages. In short, the environment is completely controlled at every step of the journey.

4. Precision Dual-Stage Filtration

To ensure our solution is free of impurities and contaminants, we utilize a two-stage filtration process that actually exceeds standard requirements.

• Stage 1: The solution passes through a 0.45-micron filter.

• Stage 2: It then passes through a 0.1-micron filter.

For reference, a 0.1-micron filter is incredibly fine—fine enough to physically remove the vast majority of microbes. By using this dual-stage approach, we exceed standard FDA filtration requirements for sterile products, providing a level of precision that hasn’t yet been achieved in the CBD space.

5. Independent Validation

While we hold ourselves to the highest standard, we know it isn’t enough for you to just take our word for it. Every single batch is independently tested to confirm it is free from contaminants. Specifically, we test to ensure the solution is clear of:

• Residual solvents

• Heavy metals

• Mycotoxins

• Microbials

• Endotoxins and exotoxins

This testing is in addition to our standard potency analysis, ensuring that what is on the label is exactly what is in the vial.

Total Transparency

We believe "trust, but verify" is the best way to move through the world, especially in the health and wellness industry. We publish the Certificates of Analysis (COA) for every batch we produce so practitioners can see the results for themselves before a product ever reaches their practice.

Transparency is key to everything we do here. We have implemented these rigorous testing protocols so that you can focus on your patients with total confidence. You can access the COAs for our product here.