Seamless Laser Marking

Improve imprinting on softgels through advanced vision inspection

On the market today, it is estimated that more than half of pharmaceutical drugs have hydrophobic active ingredients, which are not soluble in water. Because these drugs are difficult to formulate into tables, Soft Gelatin Capsules (softgels or SGC’s) are a key solid dosage delivery method for hydrophobic drugs. Softgels are created through a process called encapsulation, where two halves of the capsule containing molten gelatin and the active ingredients are combined and cooled to solidify the seams. Great lengths have been taken to minimize the visual presence of the seam on the softgel by the manufacturers, which in turn, creates a significant challenge for pharmaceutical labeling companies. 

In 1995, the FDA established the regulation CFR Title 21 Part 206, which states all solid dosage drugs must be marked or imprinted with a code imprint (any single letter or number, or any combination of letters and numbers and symbols). However, the seam of a softgel is difficult for a machine to track and imprinting a mark or print “on the seam” can create illegibility and may affect dissolution¹. If a softgel reaches the consumer with an illegible brand imprint on the seam, then it stands to reason that the capsule may not be compliant with CFR Title 21 Part 206. The problems surrounding softgel seams were prohibitive to laser marking on pharmaceutical SGC’s until Ackley Machine Corporation developed a patented technology to meet this challenge. 

No drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product’s size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product.

— CFR Title 21 Part 206

Ackley’s Seamless Softgel Laser Marking utilizes in-line fluorescence vision inspection to detect the seam of a softgel and enables the system to correct the orientation of individual products prior to laser marking. This advanced technology positions each capsule so the logo or identification is laser marked on the top of the soft gelatin capsule—and never touches the seam. With confidence in a consistent and legible mark, brands are assured that their products are compliant with regulation and that their products will perform reliably.

Ackley’s Optional Seamless Laser Marking:

• Prevents false rejects
• Improves brand & identification consistency and visibility
• Provides cost savings through fewer wasted products
• Allows for advanced inspection capabilities

Ackley’s advanced Seamless Laser Marking for Soft Gelatin Capsules protects the manufacturer, brand and consumer while providing continuous imprinting and production of pharmaceutical products. To learn more about this capability and find out if it’s right for your bulk products, contact our sales team today!

¹The Pharmacopeial Forum: Volume 39