Manufactured to the standard we'd demand ourselves
BioLife supplements are made to combine GMP compliance, NSF/ANSI 455-2 certification, and 21 CFR Part 11 electronic record integrity — then verified by third-party laboratories.
- GMP Certified
- NSF/ANSI 455-2
- Third-Party Tested
- Non-GMO
- Gluten-Free
- Clean Label
Three pillars of compliance
NSF/ANSI 455-2
Our facilities meet the NSF/ANSI 455-2 standard for dietary-supplement manufacturing — covering facility design, equipment calibration, personnel training, and document control.
21 CFR Part 11
Compliant electronic record and signature systems keep all manufacturing data, test results, and batch records secure, auditable, and tamper-evident.
cGMP · 21 CFR Part 111
All production follows current Good Manufacturing Practices as defined by the FDA — personnel qualifications, facility maintenance, equipment validation, and process controls.
A six-step manufacturing process
- 01
Raw Material Receipt
All incoming botanicals and ingredients are quarantined upon arrival. Each lot undergoes identity verification using macroscopic and microscopic analysis before acceptance.
- 02
Incoming Testing
Raw materials are tested for potency (HPLC-UV), heavy metals (ICP-MS per USP <232>/<233>), microbiology (USP <61>/<62>), and residual solvents (GC-MS). Only materials meeting all specifications are released.
- 03
Blending & Granulation
Ingredients are precisely blended using validated mixing protocols. In-process checks occur every 15 minutes to ensure content uniformity with RSD ≤ 5.0% per USP <905>.
- 04
Encapsulation
Encapsulation is performed in temperature- and humidity-controlled environments with HEPA filtration. Weight checks are conducted at regular intervals to maintain fill accuracy.
- 05
Finished Product Testing
Every production lot undergoes full-panel testing: potency assay, content uniformity, disintegration (USP <2040>), heavy metals, microbiology, and stability screening.
- 06
Release & Distribution
Only lots passing ALL specifications are released. Retain samples are stored for shelf life plus one year. Each unit carries a traceable lot barcode for full chain-of-custody.
Testing protocol specifications
Every finished lot is held to documented specifications before release. Retain samples are stored for shelf life plus one year.
| Test category | Method | Specification | Standard |
|---|---|---|---|
| Potency Assay | HPLC-UV | Label claim ±5% | In-house validated |
| Content Uniformity | HPLC-UV (10 doses) | RSD ≤ 5.0% | USP <905> |
| Heavy Metals | ICP-MS | Pb ≤ 0.5, As ≤ 0.3, Cd ≤ 0.2, Hg ≤ 0.1 ppm | USP <232>/<233> |
| Microbiology | Plate count / TPC | Within USP limits | USP <61>/<62> |
| Residual Solvents | GC-MS Headspace | Per ICH Q3C limits | ICH Q3C |
| Disintegration | USP apparatus | ≤ 30 minutes | USP <2040> |