Container closure systems testing can easily be overlooked in the drug development pipeline, but is a critical step in ensuring a successful product that meets regulatory standards. Not only do the packaging systems need to be tested as a whole, but the materials of construction must also be evaluated individually. Read on to find out why Infinity Labs is the superior choice for clients’ container closure systems testing needs.

US Pharmacopeia (USP) chapter 661 details the standards and the testing methods for these evaluations of container closure systems, with subchapters devoted to the materials of construction, as well as evaluating the packaging system as a whole.

This testing is necessary to initially determine whether the materials of construction have components in them that may extract off of the drug or device, and then to evaluate whether the system is damaging to the material, or extracting off significant portions of material.

It’s easy for clients to underestimate the importance of ensuring their container closure systems are thoroughly tested. Ultimately, there is a lot of science that goes into what might seem like a straightforward analysis. Different container closure systems come with their own unique set of challenges, and these challenges can be compounded depending on the drug product form contained within them.

For instance, a liquid drug product might be largely aqueous in water, and therefore there’s little interaction to be expected between the drug substance and the plastic storage device. However, sometimes it’s discovered that there is interaction that occurs, and it’s necessary then to quantify the extent of interaction that is happening.

In order to ensure safety under standard storage conditions, typically the plastic storage devices are tested under exaggerated conditions. In these scenarios, a mock drug solution, typically water, is contained in the storage device while the device is heated up, so that any materials that might come out of the device can be identified and quantified

While many companies offer container closure systems testing, Infinity Labs pride themselves on their commitment to ensuring client satisfaction. Their quality standards exceed regulatory requirements, to ensure that all testing is done accurately and appropriately.

In addition to their commitment to quality, Infinity Labs offers superior turn around times to clients, to keep their projects moving forward, no matter what stage in the development pipeline they’re in.

While container closure systems testing can be done at various points in the development timeline, it’s a key component needed in order for companies to complete their agency filing. For clients who have done the work, and devoted countless hours and resources to the successful development of their product, it’s imperative that this last step doesn’t end up being the thing that derails the project. Infinity can handle these tight deadlines when other larger companies can’t, with the capabilities for rush order turn-around times to keep clients on track. Container closure systems testing is routinely done at Infinity Labs, and their familiarity with the process allows them to proceed smoothly through all stages of testing, from preparation to performance.

Infinity works with many different types of clients, from those involved in the drug development process to those involved in producing packaging materials to sell to pharmaceutical customers. Because of the robust nature of the systems and processes at Infinity Labs, drug development clients can be confident that they’ll be provided with accurate results quickly for assurance that their chosen container closure system will not cause problems with their product when it reaches the patient. Additionally, packaging producers can be assured that the customers buying their product are confident that their packaging is not going to have problems when they put their drug product in, and that they’re safe for the end user.

Clients looking for tailored container closure systems testing services are invited to reach out to Infinity Labs to learn more about how they can help you, no matter what stage of development you’re in