Medical labels, such as diagnostic, OTC and tamper evident labels, are in strong demand due to the competitive and ever-changing industry and regulatory landscape. GCI’s experience can help customers develop label processes to meet these challenges.
Printing medical labels correctly the first time and providing the proper traceability documentation is vital to the internal qualification and inspection processes our customers must perform in order to meet strict FDA guidelines before products can be packaged and released to the market. Like labels developed for nutraceutical products, medical labels must also be durable enough to withstand constant handling. GCI offers a range of materials to meet demanding labeling applications and achieve the desired look.
High quality medical labels are produced from first quality label materials, inks, and finishes. To help ensure your label remains legible, compliant and maintains the brand’s image, GCI’s digital and flexographic presses provide state of the art color matching capabilities and consistency along with a 100% visual inspection system process.
Diagnostic Labels and Packaging:
Graphic Communications partners with Medical and Diagnostic Testing device manufacturers whose products provide life saving research and diagnostics. This includes:
● A 40 year history of converting medical grade, heat seal Tyvek for device lidding and pouching along with other sterilizable substrates.
● In-house manufacturing of pre-screening tests for Colorectal cancer. The accuracy of which has won our customer national and international contracts.
● Labeling for systems and products which diagnose and develop treatments for cancer and infectious diseases. Features include incremental data coding, durable materials, special pattern coatings and complete traceability.
Over the Counter (OTC) Labels:
Over the counter labels are unique since they are particularly dependent on quality, accuracy, anti-counterfeiting features and traceability. GCI utilizes effective control procedures to ensure a high level of quality and brand consistency for all OTC labels.
OTC labels convey not only the brand image but important information to the consumer such as directions and warnings the consumer should be aware of prior to usage. A specific challenge OTC customers often experience is not having enough space on one label to include all the required information/languages. Two great solutions for including additional information are multi-layer booklets and extended content labels.
Tamper Evident Labels:
The packages of most medical and drug products have at least one thing in common: they must be tamper-evident. A tamper-evident package, according to the regulations of the Food and Drug Administration (21 CFR § 211.132), “is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”
In addition, the indicator or barrier must be “distinctive by design,” which means the tamper-evident feature is designed from material not readily available to the public and cannot be easily duplicated. The labeling should also include a description of the safety feature. The product label needs to include a statement directing the consumer not to use the product if the safety feature has been compromised.
GCI has extensive experience in helping customers comply with their packaging requirements using tamper-evident labels with enhance security features.
Advantages of Working with GCI:
Recognized label integrity derives from GCI’s fine tuned printing processes that ensure the customer’s label remains legible and functional during the product’s lifespan.
GCI’s systems are built and organized to support quality. GCI works consistently to ensure the customer’s label prints correctly each time with full traceability of raw materials and revisions.
Custom medical labels are a core competency for GCI. We help the customer throughout the entire label engineering, development and testing processes.
Responsive and flexible service is a given at GCI; precise compliance with our client’s specifications is combined with the flexibility to quickly adapt to changing requirements and rush orders.
Please contact GCI for any of your medical label or lidding needs.