Why A&M STABTEST GmbH Relies on ZwickRoell
Case Study
- Customer: A&M STABTEST GmbH
- Location: Bergheim, Germany
- Industry: Medical
- Topic: Function testing of carpules, prefilled syringes (PFS) with and without needle safety device (NSD), as well as autoinjectors.
October 2023
A&M STABTEST GmbH, located in Bergheim near Cologne, Germany focuses on stability and quality control analyses of pharmaceuticals. With the use of a zwickiLine and AllroundLine machine, the laboratory expanded their portfolio with evaluation services for prefilled syringes and autoinjectors. The lab is now in a position to integrate breakaway and glide force testing of syringes and autoinjectors as part of their stability studies and batch releases.
A&M STABTEST GmbH
A&M STABTEST GmbH is a renowned laboratory, which specializes in pharmaceutical stability and release testing. The lab has been offering comprehensive services to test the shelf life of various medicines since 1995. The company focus: optimally support pharmaceutical manufacturers to ensure the quality and shelf life of their products.
The laboratory runs stability tests to evaluate the reaction of a product to various environmental conditions such as temperature, humidity and mechanical stress. The reason: these tests allow A&M STABTEST to support their customers in the development of safe and effective medicines. The results are analyzed and documented and presented to the customer in the form of detailed reports to support them in their decision-making process and further product development.
To offer customers individual and customized testing solutions and meet the strictest requirements, A&M laboratory experts have in-depth knowledge of the quality control of medicines and work in close collaboration with their customers in the pharmaceutical industry.
ZwickRoell top competences
Support and consultation from URS to qualification
Flexible implementation of customer-specific requirements in a multi-functional, modular testing solution
On the safe side with our testXpert testing software: clear test sequences, FDA CFR Part 11, reliable test results
The task
Before the introduction of ZwickRoell machines, the Bergheim-based company was faced with the challenge of outsourcing their customers’ function tests on carpules, prefilled syringes (PFS) with and without needle safety device (NSD) and autoinjectors to third-party testing labs. This approach led to high transportation costs and delays in project implementation. The declared objective of A&M STABTEST GmbH is to become a one-stop-shop for pharmaceutical analytics, increasingly including function testing of drug delivery systems.
The ZwickRoell solution
To overcome the challenge, the company integrated two ZwickRoell machines in their operational processes: the zwickiLine table-top testing machine and an AllroundLine floor-standing testing machine.
A&M chose ZwickRoell as their supplier of high-quality testing machines because of their high acceptance rate and equipment use by the pharmaceutical industry. The level of flexibility of the machines for use on the different shapes and functions of prefilled syringes and autoinjectors convinced the decision-makers of the Bergheim-based company.
“The user-friendliness of the ZwickRoell testing software testXpert allows our team to easily control the tests and simply analyze the acquired data.The possibility to set up individual test profiles and the flexibility of the machines in performing a variety of different tests are invaluable to us”, indicated Jan Stein, Head of Laboratory at A&M STABTEST.
Another decisive aspect for us was the outstanding customer service provided by ZwickRoell. Stein: “The company supported us throughout the entire process, whether in the selection of the right testing machine, during installation or when training our team. Their expertise and fast response time have given us confidence in ZwickRoell as a reliable partner.”
The Ulm-based company provided A&M STABTEST with testing machines specially designed for the requirements presented when testing prefilled syringes and autoinjectors. These tests are important in verifying the functionality of syringes during their development, their product life cycle or for batch releases.
ZwickRoell’s software played a decisive role in the validation and subsequent use of the devices for GMP-compliant testing, i.e. the quality management system used in the pharmaceutical industry, in ensuring reliable data acquisition and control.
GMP (Good Manufacturing Practice) compliant tests include a series of guidelines and standards that ensure that the production, processing, packaging and storage of medicines are in accordance with defined quality standards. Compliance with GMP guidelines is critical to ensure the quality, safety and efficacy of medicines. This is particularly important to ensure that patients are supplied with effective and safe medicines. Through consistent compliance with GMP guidelines, the safe and continuous supply of effective medicines can be ensured.
The result
The machines enable A&M STABTEST GmbH to run tests on prefilled syringes and autoinjectors, including measurement of the breakaway and glide forces. These tests are critical when it comes to proving the functionality of the prefilled syringes and autoinjectors during their development process, their product life cycle and for batch release. The laboratory now offers a comprehensive test portfolio for prefilled syringes (PFS) with and without needle safety device (NSD) with different volumes from different syringe manufacturers.
The lab has also benefited from improvements in its services since the introduction of the testing machines. By expanding their portfolio, A&M STABTEST GmbH can better support their customers in the product development process, including the evaluation of prefilled syringes and autoinjectors for specific formulations. Integration of the two machines helped speed up project development, reduced transportation costs and helped increase overall efficiency of the testing process.
“By implementing the ZwickRoell testing machines, we were able to significantly increase the efficiency and accuracy of our tests. The reproducible and reliable results we are able to achieve have helped us maintain our quality standards and bring our testing processes to a new level.The high level of quality and precision provided by ZwickRoell has helped us improve the efficiency, reliability and accuracy of our tests “, concluded Stein.
A look into the laboratory at A&M STABTEST GmbH
