ComplianceBuilder: Electronic Documentation for FDA

Instron understands that the Food and Drug Administration (FDA) requires biomedical testing results generated through software to comply with 21 CFR Part 11. Knowing this, Instron provides ComplianceBuilder as a solution to manage your electric records. Xybion, creator of ComplianceBuilder, discusses its features:

"If you are testing medical devices, pharmaceuticals, or any other product that requires the submission of data to the FDA and you are collecting that data electronically, you are required to adhere to FDA 21 CFR Part 11 Compliance. In short, Part 11 defines how any electronic documentation submitted to the FDA or required to be kept to comply with any FDA regulation shall be regulated and controlled. Failure to adhere to these regulations can result in hefty fines for your organization, and delays in delivering your products and services to the market.

ComplianceBuilder, a stand-alone, add-on package that runs with Instron’s Bluehill^® Software, provides a data management solution designed to facilitate full compliance for your Instron systems. When test method or sample files are created, modified, or deleted, ComplianceBuilder stores the files in a secure data repository. The ComplianceBuilder file management system allows users to quickly and easily monitor all of these changes, which can be consolidated into an audit trail for FDA audits in just a few clicks. All file versions can easily be retrieved at any time from the database. Electronic signatures can be implemented to authorized personnel for device and authority checks, per the Part 11 requirements."

If you have questions on this subject, feel free to contact your local Instron representative to discuss further. Read more

Wedge Action Grips: Which is Moving?

Wedge action grips are a very popular choice for gripping high-strength materials, such as metals and composites, because the strong clamping force ensures that specimen slippage is eliminated. All wedge grips work by multiplying a relatively small input force into a higher clamping force. In all wedge grips, the opening and closing of the jaw faces are achieved by the relative motion between the grip body and the jaw faces. However, there are two distinct wedge grip designs – “moving jaw face” and “moving grip body”. Their difference lies in which component is kept stationary and which is moving.

For “moving jaw face” wedge grips, the jaw faces move to clamp the specimen while the grip body remains stationary. As the upper jaw faces move down and the lower jaw faces move up to grip the specimen, a compressive preload is introduced into the specimen. This may cause the specimen to be damaged or buckle even before starting a test. Many modern testing machines can alleviate this problem by automatically moving the crosshead to relieve the specimen of the compressive preload. However, when using this feature, it is important to note that how much the crosshead will move is dependent on the specimen stiffness.

On the other hand, for a wedge grip that incorporates the “moving grip body” design, the grip body moves vertically to close the jaw faces. The jaw faces do not move vertically during the opening or closing of the grip. This design feature helps to minimize any axial compressive preload applied to the specimen during clamping*. The other advantage of having the jaw faces remain vertically stationary is that it is possible for a user to preset the exact vertical position and grip separation at which the specimen will be held when clamped. For these reasons, the “moving grip body” design is widely regarded as preferable to the “moving jaw faces” design.

* Even with a “moving grip body” design, there may still be some small preload on the specimen but this would be purely due to the interaction of the jaw face teeth with the specimen and is much smaller than the compressive preload caused by a wedge grip with a “moving jaw faces” design.

 

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TERM: Cell Culture to Characterization

TERM research is poised to change healthcare as we know it.  This cutting-edge technology is developing personalized medicine and demands the tools and solutions that are able to keep up. Instron is delivering those solutions.

There are three major steps to developing TERM products:

1. Benchmarking: establishing functional goals based on native physiology

2. Cell Culture: successfully stimulating live cells to grow a functional tissue

3. Characterization & Evaluation: evaluating the resulting product and determining if the safety and efficacy benchmarks determined in the native physiogly have been achieved.

Instron’s instrument platform delivers the necessary solutions to achieve these three steps:

1. Both electromechanical and dynamic instruments coupled with clean test chambers and submersible grips can be used for benchmarking native physiology.
 
2. Instron bioreactors can be used for cell culture.

3. Electromechanical and dynamic frames coupled with bioreactor chambers can be used for final characterization. Read more