Outsourcing contact lenses from China has been an increasing trend in the recent years. Ophthalmic product manufacturers in the region have grown significantly in terms of research and development and production capabilities. However, regulations on these products have become more stringent as well. To counter this, it is extremely important that the most relevant inspection processes are utilized.
InTouch has a rich background in dealing with ophthalmic devices, particularly contact lenses. The following are just a few of the inspection protocols that InTouch uses for these products:
Materials Inspection
Contact Lens Materials Inspection – This pre-production inspection process verifies that the materials for the production of soft and rigid glass permeable lenses are approved by FDA or equivalent regulatory agency and are similar to those declared by the manufacturer. Since contacts are considered medical devices, the FDA requires that new materials be approved first before they are sold in the USA.
Visual Inspection
Color Check – This ensures that lens colors are the same with those found in approved samples or equivalent in the Pantone color chart. This protocol includes visibility tints, eye color enhancers, and opaque contacts.
Lens Diameter Check – Verifies the diameter of contact lens by using applicable devices including the V-gauge and the reticule (hand magnifier).
Optical Zone Diameter Check – Measures optical zone diameter of RGP lenses using specialized tools such as the reticule and the shadowscope.
Base Curve Radius Check – Measures the base curve radius of RGP lenses using the radiuscope or the keratometer.
Lens Power Check – Measures corrective or refractive power using a lensometer and other measuring devices. This includes the additional corrective power in bifocal contacts; and cylindrical and axis power in toric lenses.
Thickness Check – This verifies the three thickness measurements applicable to RGP lenses using a thickness gauge or other relevant tools. The thickness measurements include center thickness, edge thickness, and junction thickness. It is very important that this process is strictly implemented as contacts that are too thick normally results to less air reaching the cornea, a primary cause of complications and discomfort.
Edge Quality Check – Evaluate edge quality of RGP lenses by using the stereomicroscope, the shadowscope, or the biomicroscope. Look for any sign of damage such as chips and broken parts, and for deviations in edge shape and thickness.
Performance Testing
UV Protection Check – Verify the UV Protection level of the ophthalmic product. Different regulations and UV protection ratings are used in UK, New Zealand and Australia, Europe, and the USA. The American National Standards Institute (ANSI) Z80.20 covers the guidelines for rating UV-blocking contacts.
Wettability Check – This process verifies that the lens is highly hydrophilic so that it does not disrupt the tear flow in the eye. If the product is made from materials that are hydrophobic, it is important that it receives an additional coating to increase its surface wettability.
Specific Gravity Check – This verifies that the specific weight of the lens is the same with that of tear. Lens made from materials having specific weights significantly different from that of the human tear may move up or down and would cause complications and discomfort.
Semi-Permeability Testing – This measures the propensity of the lens to allow enough air to reach the cornea. It is important that enough air passes through the contacts to prevent any adverse health effect to the eye.
Labeling and Packaging Inspection
Pre-Packaging Check – Verify that effective sterilization procedures are carried out on the product to maximize shelf-life. Testing of the manufacturer`s sterilization procedures may be recommended, if necessary.
Retail Packaging Inspection –Verifies that the product`s retail packaging is tamper-resistant, provides adequate protection to the lens, and that the solution in which the product is immersed is sterile and biocompatible.
Shipping Boxes Check – Verifies that shipping boxes provide the necessary cushioning and protection to the contact lenses to ensure that the products are able to withstand normal handling and shipping procedures. If necessary and applicable, the Carton Drop Test may be used in this process.
Labeling Check – Verify that product and all packaging materials contain the all the labels, instructional materials, and markings required by regulatory bodies, as well as those intended for marketing purposes.
These are just some of the relevant contact lenses inspection protocols. To know more about the requirements and recommendations applicable to your product, please contact InTouch.
