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The FDA requires manufacturers to maintain Device History Records (DHR). Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain. The Device History Record is meant to be a collection of records containing all…Details
How to Determine Torque Process Limits to Achieve a Perfect Seal If you have ever tried to open a bottle and struggled like the man in this video, you have witnessed firsthand the undeniable truth that, sometimes, brand owners and bottlers overtorque their caps. When caps are difficult to open like the one we see…Details
Merck has issued a recall on their Temodar and Temozolomide Bottles due to the possibility of cracked caps. The child-resistant closure requirement ensures protection of children by preventing their access to these medications. Cracked caps cause this closure to become ineffective, putting children at risk of poisoning. The recall is publicly available for more information.…Details
Do you need FAT, SAT, or IQ/OQ/PQ protocol? No problem. With Mesa Validation services, you get the most efficient solution around. There will be no more waiting for your provider to develop validation-related documentation, because we already have a detailed protocol specifically written for use with our machines. We have the necessary experience needed with…Details
Mesa Labs is pleased to announce the addition of a new suite of validation services and the launch of the new website validation.mesalabs.com. Utilizing products such as Mesa’s Biological Indicators and real-time DataTrace data loggers, Mesa puts its extensive experience to work ensuring that your equipment, systems and processes are working as intended, properly and…Details
There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…Details
Manual closure torque testing has poor ergonomics and has been plagued with errors from operator-induced variation such as: angular speed, topload, cap gripping pressure, etc. While automated torque testers eliminate the ergonomic concerns, they often require a trained mechanic to adjust the hardware and software configuration when changing over from one product to another. To…Details
In an ideal situation, the setpoint should be based on consumer group and package testing results. The following steps will guide you through the process: Determine application versus release torque quotients. In batches of 50, apply torque to 50%, 75%, 100%, 125% and 150% of the cap diameter (in mm) divided by 2. For example:…Details