BS, Dietetics and Nutrition
Printing companies must abide by all government regulatory requirements regarding medical labels. Healthcare companies must do the same, and they incorporate technologies such as smart labels to do so. These labels might come with temperature tracking, track-and-trace capabilities, and other features. What should every person know about medical labels today?
Medical Label Requirements
Medical Labels are required to share critical product information, and they must be easy to read. Printing companies must make it possible for certain data to be changed on the labels, such as the expiration date and batch number. Government authorities need information such as this for product recalls. Healthcare providers may also request additional features. Detachable sections are helpful for medical records, while integrated hangers are needed for infusion bottles that will be suspended.
These labels are designed to protect, inform, and secure products. They ensure the integrity of the product while safeguarding the patient from harm. To guarantee this, government authorities have implemented rigorous industry regulations and safety criteria.
Every label must comply with local regulatory requirements and perform reliably. When making these labels, manufacturers must consider the application method and environmental conditions. Often, the labels are made using films that can be applied to vials and syringes. This material withstands cold temperatures and humidity, which are common environmental conditions during medication storage.
Smart Labeling
Smart labeling is a fairly new technology that allows healthcare providers to spend more time with patients. These labels allow organizations to track drugs and medical supplies to minimize theft and waste while better controlling inventory. The use of these labels leads to accelerated inventory taking. Workers can precisely identify chargebacks and minimize the waste associated with expired items. This is important because high-value supplies are common throughout the industry.
Durability Considerations
Manufacturers must ensure product labels are durable, as a missing or damaged label could mean the difference between life and death in the healthcare industry. This label provides critical information healthcare workers need, such as dosage and safety information. The label must be durable enough to last the product’s full lifetime and remain legible throughout this period.
Manufacturers might need to choose a label material that works with tight mandrel containers. In certain situations, the material must undergo testing and certification to ensure it has low leachable qualities, or the manufacturer might need to ensure it will remain adhered in low and high temperatures. Furthermore, they may need to prove the material will resist sterilization conditions.
Creating Effective Medical Labels
Medicine labels fall under the category of main packaging materials because they may come into indirect contact with a medication through its container. If any part of the label leaches into the drug, the patient may be at risk of toxicity or interaction with the label material. In addition, any leaching could impact the efficacy or stability of the medicine.
A manufacturer must consider more than just the label material. The adhesive used with the label is also important. This label must adhere to the package reliably, so the adhesive has to be strong. The manufacturer must also consider mechanical abrasion and environmental factors when choosing the adhesive.
Furthermore, the product may undergo sterilization procedures after the label is adhered. Certain label materials cannot be sterilized. To prevent problems, all adhesives used in healthcare labels must be FDA-approved and comply with the agency’s toxicological standards.
Complex Regulations
Improper labeling of medications could be deadly to users. The European Union implemented the Falsified Medicine Directive, while the United States enacted the Drug Supply Chain Security Act to ensure medications remain safe as they move from the manufacturer to the consumer. Labeling challenges came with these regulations. Manufacturers now create labels to monitor and trace medications. They also allow for serialization and trademark protection.
The pharmaceutical industry needs the highest-quality labels, as patient safety relies on them. For this reason, any label manufacturer must adhere to cGMP standards, which will ensure patients receive the highest level of care.
