Pharmaceutical-grade
from first step to final release.
Every BioMed Labs Iron patch is manufactured under a quality system built on pharmaceutical principles — rigorous raw material control, in-process testing, and full batch traceability.
GMP-aligned manufacturing
Processes designed to current Good Manufacturing Practice principles
Pharmaceutical-grade excipients
All excipients sourced to pharmacopoeial or equivalent specification
Controlled cleanroom environment
Patch assembly performed in classified cleanroom conditions
Validated analytical methods
Test methods validated for specificity, linearity, and reproducibility
Batch-level traceability
Full documentation chain from raw material to finished product
Stability programme
Ongoing real-time and accelerated stability studies support shelf-life claims
Six stages of control.
Quality is not a final inspection — it is built into every stage of the manufacturing process, from the selection of raw materials through to finished-goods release.
Raw Material Specification
Every active and excipient ingredient is sourced to pharmaceutical-grade specification. Ferrous Lactate is selected for purity, particle size distribution, and batch-to-batch consistency before entering the manufacturing process.
Microcrystal Characterisation
Each production batch undergoes microcrystal size analysis using laser diffraction and scanning electron microscopy. Target particle geometry is verified against specification before patch assembly proceeds.
Patch Assembly & Coating
Microneedle arrays are formed under controlled cleanroom conditions. Coating uniformity, needle height, and tip geometry are measured at defined intervals throughout the assembly run.
In-Process Testing
Dissolution rate, adhesion force, and transdermal flux are measured at multiple in-process checkpoints. Out-of-specification results trigger hold and investigation protocols before the batch advances.
Final Release Testing
Finished batches are held pending full release testing: identity, assay, dissolution, microbial limits, and packaging integrity. No batch is released until all specifications are met.
Documentation & Traceability
Full batch records are maintained from raw material receipt through to finished goods release. Every production step, test result, and deviation is documented to support traceability and continuous improvement.
Controlled dissolution.
Predictable delivery.
The microcrystal formulation is engineered to dissolve at a controlled rate once the microneedle array contacts the epidermis. Particle size, coating composition, and needle geometry are all specified to achieve a consistent dissolution profile across batches.
In-vitro dissolution testing is performed on every production batch. Results are compared against the validated specification range before release is authorised.
View platform technologyKey quality parameters
Regulatory note
BioMed Labs Iron is a complementary health product. It is not a registered therapeutic good and no TGA registration or approval is claimed. Manufacturing processes are designed to pharmaceutical-grade principles as a quality commitment, not as a regulatory classification.
Ready to try BioMed Labs Iron?
60 microcrystal patches per box. $129. Free shipping.