01
Precision Molding
High-precision optical molds are crafted using medical-grade steel tooling. This guarantees exact base curves, edge contours, and optical power uniformity for every production run.
Contact Lens Manufacturing Process & Quality Control
GMP & ISO 13485 Certified Facility
Precision Engineering & Medical Device Safety
At BLMG Optical.Ltd., we manufacture daily, monthly, quarterly, and yearly disposable colored contact lenses in a Class 100,000 cleanroom environment. Every lens is crafted as a regulated Class III medical device, combining automated cast-molding tech with bio-compatible pigment encapsulation for international brand owners and optical distributors.
Standard Operating Procedure
Our 8-Step Automated Production Workflow
A fully auditable manufacturing standard engineered to deliver optical clarity, physical durability, and repeatable batch consistency.
02
Bio-Pigment Printing
Approved non-toxic pigments are applied using advanced Sandwich Technology. The color pattern is locked between protective monomer layers so pigment never touches the human cornea.
03
Polymerization Curing
Computer-controlled UV and thermal curing systems stabilize the hydrogel monomer network, giving the lens its target water content, elasticity, and oxygen permeability (Dk/t).
04
Automated Demolding
Automated precision robotics separate the cured lens from its mold without physical stress, eliminating micro-cracks, surface abrasions, and edge deformities.
05
Hydration & QC
Lenses are fully hydrated in purified saline solutions. 100% of production undergoes high-definition automated visual inspection to check optical power, dimensions, and cosmetic purity.
06
Cleanroom Packaging
Lenses are placed into medical-grade blister packs with buffered saline solutions under Class 100,000 cleanroom standards, followed by heat-sealed aluminum foil lids.
07
Autoclave Sterilization
Sealed blister packages undergo high-pressure steam terminal sterilization at 121°C following ISO 17665 protocols, ensuring total microbial inactivation and long shelf-life safety.
08
Labeling & Traceability
Outer packaging receives automated batch numbers, expiration dates, barcode markers, and regulatory compliant labels customized for target import markets globally.
Factory Insights
Inside Our Cleanroom Facilities
Take a visual tour of BLMG Optical.Ltd.'s cleanroom operations, automated machinery, and quality assurance checkpoints.
Stage 1 & 4: Automated Casting & Demolding
Stage 5: 100% Microscopic Quality Inspection
Stage 6 & 8: Blister Packaging & Final Labeling
Quality Assurance
Rigorous Medical Device Testing Matrix
To satisfy US FDA, European CE, and global health authority standards, every batch produced by BLMG Optical.Ltd. undergoes comprehensive laboratory verification.
| Test Parameter | Standard / Method | Quality Target | B2B Compliance Value |
|---|---|---|---|
| Biocompatibility | ISO 10993 Cytotoxicity Test | Zero cellular toxicity | Ensures long-wear ocular health & safety |
| Color Fastness | Rubbing & Solvent Extraction | Zero pigment migration | Pigment is permanently sealed inside hydrogel |
| Dimensional Accuracy | Optical Comparator Inspection | Diameter ±0.1mm / BC ±0.05mm | Consistent fit and mechanical comfort |
| Sterility Assurance | ISO 11737 / ISO 17665 SAL 10^-6 | 100% Sterile field validated | Guarantees multi-year shelf storage compliance |
| Optical Power | Focimeter / Lensometer Scan | Diopter ±0.25D precision | Crystal-clear visual acuity for prescription SKUs |
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