Are you prepared to meet the increasing demands and bring the medical products to market safely and quickly?

As we approach the release of anticipated COVID-19 vaccines, are you prepared to meet the increasing production demands and bring your drug delivery products to market safely and quickly?

As well as the huge volumes of PPE being produced, there is a growing number of products that require testing to ensure they are safe and best suited for their purpose. Here are just a few:

• Blister Pack Testing
• Child-Proof Medicine Bottle Testing
• Luer Lock Testing
• Needle-Based Injection System Testing
• Single Use Syringe Testing

Blister Pack Testing
Pharmaceutical tablets and capsules are commonly packaged in blister packs that protect the enclosed tablets and capsules from moisture and contamination. This optimizes the product stability and maximizes its shelf life. The two primary components of a blister pack are the rows of cavities, typically made of thermoplastic, and the lidding seals that can be made of paperboard, aluminum, or plastic. However, in pharmaceutical packages, aluminum foil is most frequently used. It is important for manufacturers to ensure that the blister pack does not break too easily, yet it needs to be brittle enough to allow consumers to break by hand, in order to dispense the tablets or capsules. Many pharmaceutical companies utilize a variety of blister pack sizes to accommodate various pill diameters, posing a challenge for testing.

Child-Proof Medicine Bottle Testing
Child-resistant (C-R) packaging, such as child-proof medicine bottles, reduces the risk of children being poisoned due to the ingestion of adult medicines that could be potentially hazardous when consumed in large amounts. In the pharmaceutical industry, C-R packaging encompasses both prescription medicines and over-the-counter medicines. Some common medicines and consumer products that require C-R packaging include acetaminophen, aspirin, ibuprofen, and mouthwash. The challenge with C-R packaging is to ensure that the force and torque required to open the package is too high for a child to open, but not too high for an elderly person or someone suffering from a joint disorder, such as arthritis.

Luer Lock Testing
A Luer slip is a tapered cone that connects to a tapered cavity. A Luer lock contains a Luer slip fitting with threads that can be connected. Luer lock and Luer slip connections have historically been tested to ISO 594-1 and ISO 594-2. However, based on the rising concerns of accidental misconnection of small bore connectors, such as Luer locks, ISO 80369 was established in 2016. ISO 80369-20 addresses the general test methods, while ISO 80369-1 through 80369–7 specify the general requirements for different connectors. ISO 80369-7 replaces ISO 594 for connectors involved in intravascular and hypodermic applications. Of the eight testing annexes in the standard, the following are applicable to mechanical testing: ease of assembly of the connector, separation force of the connector, connector unscrewing torque, and resistance to overriding of the connector.

Needle-Based Injection System Testing
The testing of needle-based injection systems, or auto-injectors is most commonly based on ISO 11608, which specifies requirements and test methods for these drug/device combination products. While there are seven annexes within the standard, ISO 11608-5 identifies the requirements for testing the product in its final use case. The final use case of an auto-injector entails a patient removing the auto-injector safety cap, positioning the injector, and pressing down on the device to inject the drug. The injector should automatically release the accurate dose of medication in the appropriate amount of time. Both the manual action made by the patient and the automatic functions of the auto injector must be quantified during a test. This can lead to cumbersome test setups, customized software programs, and in some cases, multiple computers or data acquisition systems.

Single Use Syringe Testing
Plastic single use manual syringes require the evaluation of the force profile associated with expelling fluid from the syringe barrel. The most common tests are breakaway and glide force testing. Breakaway force measures the initial peak force required to begin plunger movement. Glide force is the average force required to continue depressing the plunger.

Syringe testing can be performed to the ISO 7886-1 standard. While there are several annexes in ISO 7886-1, Annex D and Annex E are most common for mechanical testing. Annex E specifies a test method for quantifying the forces needed to activate the syringe plunger. Annex D describes a test method for liquid leakage at the syringe piston under compression to ensure the closure system can withstand inadvertent over-pressurization. This test requires that the syringe be pre-filled, capped, and then tested axially under compression while a side load is applied to the plunger. After a 30 second force hold, the syringe must be checked for leaks.

The Solution
Instron®  , the leading global manufacturer of testing equipment for the materials and structural testing markets offers testing machinery to preform tests such as compression, cyclic, fatigue, impact, multi-axis, rheology, tensile, and torsion.

Instron^®   product line includes: universal, dynamic & fatigue, impact, rheology, HDT and Vicat, automated testing systems, torsion testers, Structural Durability testing and Crash Simulation Systems. 

For more information on testing solutions for medical products visit www.instron.co.uk

26/11/2020