Case Study

Ophthalmic Product Package Inspection

Ophthalmic Product Package Inspection

Ophthalmic products come in a variety of package formats and have a variety of eye-care applications. The liquid filled package formats are often soft containers with snap on or torque screw caps, but also include foil lidded blister packs for single use contacts. Most contact lens solutions clean, disinfect, lubricate, and remove protein deposits from the lens while matching certain chemical properties of the ocular area. While these solutions may disinfect, similar properties to ocular fluids and increasing resilience of new bacterial and fungal strains make contamination a greater concern. Any breach, channel, or micro leak in the container closure greatly increases the risk of contamination of the ophthalmic solution.

The primary culprit to contaminated eye care solution is package defects. The soft plastic containers and snap caps are typically blow molded plastics. The area for primary concern with both torque and snap on caps is the flange area of the bottle. While visual inspection and leak testing may detect many container failure modes of an uncapped container, slight inaccuracies or marks in the flange area provide a clear path for bacteria and fungi to transfer into the product. This is both the most common and most difficult container defect to detect, and remains hidden beneath the cap once it is applied. While micro leaks as small as 5 microns can still provide a path to bacteria and fungi, the typical flange defect is much greater in size and increases the probability of infection. The most common defect mode for single use contact lens blister packs are micro channel leaks due to wrinkles in the foil lidded seal.

VIEW THE CASE STUDY!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online

PTI Packaging and Inspection Systems