Combination products are therapeutic and diagnostic products that combine two or more regulated components that are physically, chemically or otherwise combined or mixed and produced as a single entity:

• Drug and device
• Biological product and device
• Drug and biological product
• Drug, device and biological product

Examples:

• Monoclonal antibody combined with therapeutic drug
• Device coated or impregnated with a drug or biologic
• Drug-eluting stent, pacing lead with steroid-coated tip, catheter with antimicrobial coating, condom with spermicide, transdermal patch
• Pre-filled drug delivery systems (syringes, insulin injector pen, metered dose inhaler)

Co-Packed combination products:

• Drug or vaccine vial packaged with a delivery device
• Surgical tray with surgical instruments, drapes, and anesthetic or antimicrobial swabs
• First-aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers)

Cross-labeled combination products:

• Photosensitizing drug and activating laser/light source

Combination products needs to fulfill their intended purpose, means their expected quality and safety critical parameters. They need to be designed for their intended purpose and be safe during handling. They make patients life easier, because combined products intend to be more patient friendly as uncombined products, which are more used by doctors for their proper application. They need to fulfill during batch testing their Acceptable Quality Limit (AQL) level.

The combination product market is growing, because e.g. it’s much easier for patients to use an autoinjector than a syringe and a vial. The testing machines for combination products are like the devices themselves a complex process, if they are not fully manually tested. You can set-up manual testing, semi- and fully automated testing, which depends on your average batch size and selling amount. Later, if you gathered enough testing data, you can diminish the testing size accordingly, if your devices are safe enough.