BIOMEDICAL/PHARMACEUTICAL DRUG DELIVERY AND CONTAINERS

from Instron Accessories Catalog - 8th Edition

TIPS ON USING ENVIRONMENTAL CHAMBERS AND FURNACES

The global demand for pharmaceutical products is on the rise, fueled by higher incidence rates of chronic disease, an aging population, and the threat of future pandemics. Patients and physicians expect drug delivery containers to be devoid of defects, capable of securing the medicine throughout its transportation and deployment. Failures can pose a severe risk to the patient or result in the disposal of large quantities of much needed supplies. For these reasons, drug delivery containers and devices require stringent evaluation, enforced by global regulatory bodies, to ensure they can perform as intended.

The pharmaceutical industry relies on mechanical testing to evaluate drug delivery systems and their associated packaging. Drug delivery systems can utilize dermal, subcutaneous, intramuscular, oral, or nasal routes and come in a variety of different packaging formats. Universal testing systems are used throughout the product development process to help identify suitable materials, evaluate delivery mechanisms, perform design validation, validate manufacturing processes, and enable proper QC measures. The most common applications are related to needle-based injection systems and involve either functional testing based on industry standards such as ISO 11040 and ISO 11608 or usability testing of products to supplement human factor testing.

Application Range

• Type of tests: Tension, compression, torsion, etc.

• Type of materials: Syringes, auto-injectors, vials, cartridges, inhalers, tablets, etc

BIOMEDICAL/PHARMACEUTICAL DRUG DELIVERY AND CONTAINERS

Auto-Injector Testing

The Instron® semi-automated auto-injector test fixture measures cap removal, activation force, injection time, injection mass/volume, and lock out force of the needle shield in a single test method. Used with Bluehill® Universal software on a 6800 or 5900 Series system, users can quickly adjust test method speeds and parameters for a variety of different drug delivery systems. An optical micrometer is used to measure needle length. In addition, an audio device can be used to detect an injection or needle retraction click.

BIOMEDICAL/PHARMACEUTICAL DRUG DELIVERY AND CONTAINERS

Syringe Testing

The Instron® universal syringe fixture is designed to evaluate many of the functional properties of both primary containers and safety syringe devices. The adjustable chuck design can accommodate a wide range of specimen diameters, including the most commonly found syringe volumes [1 ml - 50 ml]. The universal nature of the design addresses the pains related to testing a wide variety of syringes, by eliminating the need to source and keep track of a selection of inserts. To address the growing need for dose accuracy measurements of prefilled and safety syringes, the fixture can be fitted with an enclosed balance that collects and sends mass data directly to Bluehill® Universal.