nuvalore GmbH: Using the zwickiLine for Force Testing
Case Study
- Customer: nuvalore GmbH
- Location: Leimen, Germany
- Industry: Medical and Pharmaceutical
- Topic: Introduction of Quality by Design (QbD) approach in force testing helps nuvalore GmbH optimize product development.
nuvalore GmbH: Quality by Design for accelerated drug development
nuvalore GmbH, based in Leimen, Germany, supports pharmaceutical companies in accelerating their drug development by applying Quality by Design (QbD) principles. Quality by Design is a systematic approach to the development of pharmaceutical products that ensures that all relevant quality requirements are integrated into the development process right from the start. The aim of this approach is to improve the efficiency and safety of products and reduce the risk of errors and quality problems.
With a team of experienced scientists, nuvalore GmbH offers comprehensive laboratory services that combine science and quality. The company values partnerships with its customers that are characterized by trust, innovation and excellent customer service. nuvalore GmbH goes beyond traditional laboratory analysis and creates customized solutions to increase the efficiency and quality of drug development.
The nuvalore GmbH portfolio:
- Drug product development and optimization: development of new drugs and improvement of existing products to maximize their efficacy and safety
- Analytical method development and validation: development and validation of precise analytical methods that meet the high standards of the pharmaceutical industry
- Routine laboratory analysis according to Good Manufacturing Practice (GMP) principles: carrying out routine analyses, including visual and functional tests as well as tests to determine breakaway and glide forces for combination products
The task
Wanted: robust testing system to improve product quality
In the dynamic pharmaceutical and life sciences industries, innovation and quality are essential. In view of ever shorter project times and growing requirements, companies must develop their products increasingly quickly and with maximum precision.
In this context, statistical design of experiments (DoE) is becoming increasingly important as part of the QbD approach, because DoE makes it possible to test various parameters that affect both product development and the development of analytical methods.
A key aspect of this is the evaluation of the main and interactive effects of these parameters on measurement results, including force measurements of primary packaging materials and combination products. For nuvalore GmbH, the main challenge was to find and establish a robust testing system that delivers consistent and reproducible results.
The reason: this is the only way to guarantee the quality of a product, from the first representative batch (RepBatch) to the point of market approval.
The ZwickRoell solution
Found: zwickiLine for consistent test results
The definition of the design space contains critical information that is relevant during the development phases up to the marketing authorization of a parenteral medicinal product.
Thanks to the zwickiLine, the company now has a robust testing system with which numerous parameters from product development, which can influence the measurement result, can be identified during the statistical test execution. With the ability to set robust test parameters on the testing machine, it is now possible to define experimental designs. This makes variations in product parameters visible and defines a safe operating range, and ensures that future settings of product parameters always stay within the defined specifications.
The result
Achieved: efficient quality control and product development in the GMP laboratory
“We use the zwickiLine in our GMP laboratory to generate precise results for statistical test planning. This enables us to develop reliable methods such as breakaway and glide force methods for parenteral drug products. This innovative approach not only promotes flexibility, but also helps to reduce deviations, such as out-of-specification (OOS) or out-of-trend (OOT) results,” says Anamarija Curic, Managing Director of nuvalore GmbH.
The zwickiLine supports nuvalore GmbH in the examination of clinical test specimens such as prefilled syringes (PFS), cartridges and autoinjectors. As a start-up, the young company is thus able to exploit the full potential of combination products (medical devices) right from the start. Curic: “ZwickRoell's qualification service package, which closes all gaps in the quality management system, is also particularly helpful.”
“ZwickRoell's service is impressive, from initial contact to qualification of the system and preparation of the results report. We look forward to continuing our collaboration and to many parenteral drug products being measured on our zwickiLine.”
Dr. Anamarija Curic, Managing Director nuvalore GmbH
ZwickRoell testing machines at nuvalore GmbH
