The medical industry must meet greater standards for quality and documentation in comparison other industries. Manufacturers of medical products must guarantee a consistently high quality standard in production and long-term reliability of delivery as well as comply with the legal framework. Quality control comprises not only development and production but also the packaging of the medical components.
Several recently completed projects in the medical packaging industry illustrate this point:
Fully automated function testing of autoinjectors to EN ISO 11608-5
An autoinjector is a medical instrument (medical device) with which liquid medication can be administered. ZwickRoell’s solution performs the following fully automated tests:
- Removal force of the safety cap
- Activation force and displacement of the autoinjector
- Injector timing
- Evaluation of the administered drug volume, including the last drops using an integrated high-resolution scale
- Effective needle length for injection
- Safety function of the needle guard
Fully-automated solutions range from easy-to-use smart robots only used for feeding and removing the injector to complex robotic systems which are used to load specimens into multiple testing machines in parallel. With the latter, fully automated daily checks can be implemented, results/events can be uploaded into the customer's IT system automatically (for example via an OPC interface), or the injectors can be sorted due to specified tolerances.
Plastic medicine bottles that are filled with medicine for children feature a childproof seal to ensure they cannot be opened without (adult) supervision. The cap cannot be removed unless a combination of compressive and torsional loading is used. The testing system determines exactly these parameters. It consists of a small materials testing machine with 1 kN nominal force plus a 2 Nm torsion drive. The roboTest L robotic testing system has a magazine for 30 medicine bottles that are processed fully automatically. After the test, the medicine bottles are placed back in the magazine.
The glide force test is based on the following standards: EN ISO 7886-1, ISO 11499 and ISO 11040-4. The breakaway force and glide force are important parameters used to select the most suitable syringe. These forces may not exceed or fall below certain limits to ensure that a safe drug dose is administered. The forces are influenced by the viscosity of the drug and the size of the cannula. The smart robot solution is used here as well. The robotic gripping arm takes one of the 30 syringes from the magazine table, places it in the testing machine and starts the determination of the glide force. After the test, the robot places the syringe back in its original location in the magazine.
Fully automated tests on pharmaceutical pens
The most important requirements when testing medical products are the reproducibility of results and the minimization of operator influences. To meet these requirements, ZwickRoell has developed automated systems for testing pharmaceutical pens (for example, for insulin). These pens are similar to writing pens and are frequently filled with insulin cartridges. Single-use pens are disposed of after the contents of the cartridge are dispensed, whereas reusable pens can be used year after year. DIN EN ISO 11608 Parts 1 to 3 is the standard used for quality assurance tests on insulin pens and cartridges. As with the autoinjectors, the fully automated solutions range from simple smart robots used for feeding and removing to robots that operate multiple machines in parallel.
Key benefits of automation
The autoEdition3 control software controls the robotic testing system. It is based on the basic principles of Industry 4.0: Decentralized intelligence, parallel processes, standardized interfaces and real-time optimization. The roboTest testing systems allow ZwickRoell to achieve higher specimen throughput in comparison to traditional, sequentially controlled systems.
In the medical and pharmaceutical industry, everything must be completely backwards traceable for several years. ZwickRoell 's testXpert III testing software provides the additional functionalities necessary to meet these requirements. This software option from ZwickRoell allows complete, tamper-proof documentation of all actions performed in testXpert III. The user defies the level at which actions are to be logged and explained according to his requirements. In individual cases this may, for example, mean that each change made to a test-relevant parameter such as test speed is recorded in full. Together with the user management already integrated in testXpert III, this option provides the ideal tool for fulfilling the requirements from FDA 21 CFR Part 11 (regulation of the US Food and Drug Administration). Providing easy access to quality characteristics as well as protection from tampering at the same time allows manufacturers to optimize their processes and sustain improvements in product quality for safety-related products.
Automatic daily check tools
Daily check tools are used to regularly check sensors for force, weight, or displacement. They recognize systematic measurement errors in the sensors and notify the responsible person immediately. Normally, this takes place at least every 24 hours. In addition to the manual version in which the user engages and monitors the daily check tool, ZwickRoell also offers a fully automated version in which all of the steps are handled via automation. The results are traceably recorded in a log file. If the results are bad, the system stops and the user is notified.
Qualification support A significant element of process validation in the medical and pharmaceutical industry is the technical review of individual plant and devices. This qualification is also required for ZwickRoell materials testing systems used in the medical and pharmaceutical industry, because systems are subject to various legal requirements (for example, under Medical Devices Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11). ZwickRoell supports the qualification of materials testing systems in the DQ (design qualification), IQ (installation qualification), and OQ (operational qualification) processes by offering comprehensive and, if requested, individually tailored qualification documentation, as well as in the practical performance of qualification on site. OPC connection The determined parameters and measured values are collected on a central computer to be signed by the responsible employee. Live data (e.g. events such as “all specimens processed”) can be transmitted directly via the OPC interface.