Inkjet Printing for Pharmaceutical Applications

Pharmaceutical production is one of the most regulated industries in the U.S. Regardless of whether drugs are available OTC or by prescription, the FDA requires that certain information be included on labels.

This guide shows how to comply with FDA regulations.

Pharmaceutical production is one of the most regulated industries in the United States. Since its formation in 1906, the Federal Drug Administration (FDA) has continuously created and enforced laws regarding drug manufacturing, distribution, and product packaging. Regardless of whether pharmaceuticals are available over-the-counter (OTC) or only through prescription, the FDA has established regulations that dictate what information must be included on the product’s label. Failure to include the required information can lead to expensive recalls and reputation-damaging actions taken by the FDA.

To help companies avoid these consequences, InkJet, Inc. offers the hardware and ink necessary to label packages following FDA regulations. Here are the strengths and benefits of utilizing inkjet printing for pharmaceutical applications.

Regulations to Consider

The FDA enforces multiple labeling regulations that explicitly apply to those in the pharmaceutical industry. The Fair Packaging and Labeling Act (FPLA), for example, maintains that all drug packages state:

The included contents (e.g., aspirin, acetaminophen, etc.)
The name and location of the manufacturer or distributor
The package’s net quantity in terms of weight, measure, or numerical count

The FPLA applies to all pharmaceutical products, but there are far more labeling requirements when looking at drugs on a case-by-case basis. Over-the-counter products must follow rules established by the FDA’s OTC Drug Review, while prescription drugs are beholden to the Physician Labeling Rule (PLR). Although specific rules can vary on the drug itself, common requirements include:

A list of active Ingredients
A list of inactive ingredients
General purposes
Directions for use
Applicable warnings
Control numbers
Expiration date

Much of the information required by the FPLA, OTC Drug Review, and PLR is static and won’t change from one batch to another. This information is best displayed on printed labels that are applied to every bottle, box, etc.

However, for constantly evolving information (e.g., control numbers, expiration dates, etc.) it is easier and more efficient to directly mark the package—this is where InkJet, Inc. can help.

Primary Package Marking

Drug packaging occurs on production lines that move at hundreds of feet per minute. To mark packages moving at these high speeds, companies need reliable, powerful printers that can operate uninterruptedly. That’s why many companies choose continuous inkjet (CIJ) printers like the DuraCode Keyboard and DuraCode Touchscreen for their pharmaceutical applications.

Continuous inkjet printing is ideal for pharmaceutical applications because the printers are capable of:

High-Speed Printing: CIJ printers, like those in the DuraCode series, can label products moving at speeds up to 1,000 feet per minute. This is three times quicker than most other common inkjet printing options. These printers are designed for 24/7 operation which is further assisted by the fact that ink bottles can be changed while the printer is in operation.
Reliable Operation: CIJ printers are not only designed to meet industrial coding needs, but they can also withstand industrial environments. For example, DuraCode printers are built with an IP55 industrial stainless steel structure that offers some protection from dust and humidity.
Versatile Application: CIJ printers are compatible with a wide variety of inks, allowing them to print both porous and non-porous substrates. This versatility is compounded by a contact-free printing method that enables CIJ printers to mark both flat and curved surfaces with ease.

Woman holding a pharmaceutical bottle about to take a pill

A print and production line labeling a cardboard box

Secondary and Tertiary Package Labeling

Labeling isn’t just a concern with primary packages—secondary and tertiary packaging must also be marked with the appropriate information to either align with FDA requirements or to ensure supply chain traceability.

Secondary packaging (i.e., the exterior container that holds the product’s primary packaging) is often marked with the same continuous inkjet printing technology that codes primary packaging. Tertiary packaging, however, is often better marked by other methods.

Tertiary packaging is designed to protect products during transportation. The most common tertiary packaging forms are cardboard boxes and pallets:

For cardboard boxes, like those used to ship products, high-resolution case coding printers like the Precision Series 72 are ideal. For printing on inner packaging used to house the products, Anser is preferred. High-resolution case coders are specifically designed to work well with non-porous substrates, including cardboard. Companies use case coders to make high-contrast graphics and machine-readable barcodes that help ensure the successful transportation of the products within.
For pallets, print and apply labelers like the EvoLabel are particularly well-suited for marking. EvoLabel systems are easily integrated into industrial production lines and offer several features that boost both productivity and worker safety. These systems are capable of:
- Continuously printing/applying in both portrait and landscape mode
- Sensing human presence to prevent workplace injuries
- Detecting incomplete palates
- Validating barcodes