Making Product Packaging Safer

Safety features on over-the-counter (OTC) medications have been evolving over the last 40 years. In the 1960s and 1970s, safety features began appearing on certain medications to prevent children from accidentally poisoning themselves.¹ However, the perceived safety of OTC’s and other products abruptly changed after the 1982 cyanide poisoning of Tylenol capsules, which resulted in the death of seven people. This event in turn, changed the field of packaging forever.

Soon after this horrific event, new FDA regulations emerged regarding tamper-resistant packaging for certain OTC pharmaceuticals, cosmetic liquid oral hygiene products, vaginal product and contact lens solutions and tablets. According to the FDA (CFR Part 211.132 (b):

Tampering can be basically divided into two forms: malicious tampering and benign tampering. Malicious tampering is of course the intentional tampering to cause consumers harm. However, benign tampering, occurring mainly at the retail level, is a much more common event. Specifically, benign tampering occurs when a consumer simply opens or ‘samples’ a product without purchasing it, and then another consumer purchases the product but is unaware of the contamination. Therefore, even benign tampering can be potentially dangerous to consumers since it compromises the safety and quality of the product.²

Tamper-evident neckbands are one device that ensures packaging security since they provide clear, ready-to-see evidence of product tampering to consumers, while complying with regulatory guidelines. As previously stated, FDA regulations involving tamper-evident devices also specify that ‘identifying characteristics’ must be applied. Placing an identifying characteristic on neckbands, such as a company or product name, is not a negative element, but rather, it provides an opportunity for product branding. Therefore, these simple, but effective tamper-evident indicators bring with them a multitude of benefits to consumers and to pharmaceutical companies.

Correctly Placed Neckband

Incorrect Neckband Placement

Incorrect Neckband Placement

Of course there is a cost associated with having neckbands, but not having one on a product or having one incorrectly attached could cost far more in the long run. Therefore, once neckbands are present on a product, they must always be present on everyone of those products, and they must be consistently placed correctly. Why is it so important to have consistent placement of the neckbands? A correctly placed neckband provides consumers with a sense of security towards a product. Therefore, neckbands are an important component of packaging and accurate inspection of them before they leave the packaging line is a crucial step in product inspection.

The efficiency of human inspection of such tamper-evident devices is limited, since inspection productivity by humans is often affected by environmental factors, such as heat, cold, lighting, fatigue and etc. However, inspection of neckbands by vision inspection systems provides constant, accurate inspection results at speeds that are just not possible for human inspectors. Optel Vision has found that inspecting the placement of the neckband by our Neckband Analyzer, (an option on our systems), prior to its shrinking in the heat tunnel, consistently provides optimal inspection and verification results.

¹ Tom Cramer, “Look Twice: How to Protect Yourself Against Drug Tampering,” FDA Consumer Magazine.
http://www.fda.gov/bbs/topics/consumer/CON00114.html

² Cliona Reeves, “It Pays to Package Well,” GFTC Newsletter, September, no. 34 (2003): 1-2