Norwood, MA – Instron is happy to announce the discharge of the subsequent era Autoinjector Testing System for full performance testing of pen and autoinjectors to ISO 11608. Developed in shut partnership with pharmaceutical corporations and CDMOs, this method measures quite a lot of important efficiency necessities, together with cap elimination, dose accuracy, activation pressure, injection time, needle depth, and needle guard lockout.
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The power to carry out an entire sequence of exams on one system, moderately than a number of programs, simplifies testing, information consolidation, and the validation course of, and streamlines tech switch to manufacturing websites.
The addition of easy autoinjector take a look at strategies to Instron’s Bluehill Common software program empowers customers to simply develop and alter take a look at strategies. The consumer merely selects which exams (cap elimination, injection, and/or needle guard lock out verify or defeat pressure) are to be run and units the specified parameters. The system then robotically runs by means of the take a look at sequence and supplies outcomes together with cap elimination and activation forces, injection time, needle depth measurements at first and finish of injection, click on detection, delivered quantity, and security verify outcomes.
Picture Credit score: Instron
“All through the event of this method, the consumer interface and expertise has been a serious focus,” explains Theresa Smith, Product Supervisor at Instron. “Our clients in improvement settings require flexibility as they work with new gadgets and mixed merchandise. With this method, they’ll simply and shortly change setups to check completely different gadgets or carry out problem testing. On the identical time, our Bluehill software program presents the simplicity and traceability that’s wanted in manufacturing settings. It may be a problem to design for these very completely different features, so this method’s adaptability is de facto thrilling.”
Bluehill Common for autoinjectors additionally improves compliance with Good Manufacturing Practices (GMP) by integrating system suitability testing (SST) into its workflow. SST prompts customers to carry out every day verification checks on the load cell, machine imaginative and prescient digicam, and scale. The system solely permits gadget testing to proceed as soon as these checks have been efficiently accomplished. SST particulars are recorded within the Traceability module’s audit log, providing a sturdy and searchable report.
To simplify tech switch, Instron’s Bluehill Central lab administration software program may be added to streamline administration and switch of each gadget and SST take a look at strategies between testing programs in the identical lab and different websites around the globe.
Instron additionally presents companies, together with on-site calibrations and IQOQ companies, to assist testing labs speed up their validation course of.
Autoinjector Testing System | Semi-Automated System for Testing Pen and Autoinjectors to ISO 11608
About Instron
Instron is a number one world producer of testing tools for the fabric and structural testing markets used to guage supplies starting from organic tissue to superior high-strength alloys. Instron programs carry out quite a lot of exams similar to compression, cyclic, fatigue, influence, multi-axis, rheology, tensile, and torsion. Instron is an entirely owned subsidiary of Illinois Device Works Inc. For extra data, go to www.instron.com.
