Precision instruments made in Germany
Sympatec's Quality Management System (QM system) is primarily designed to get the optimum performance and best system-to-system reproducibility of all our particles sizing instruments under real conditions. It is completely adapted to the requirements of the pharmaceutical industry which are in general higher than those known from the widely used ISO 9000 and subsequent standards.
Our QM system covers the development, the production, the service and the connecting work flows. Methods are standardised and validated in order to ensure that a method reliably produces the expected result within defined limits (specifications). Corresponding proof must be documented. Validation includes systematic checking of installations, equipment and processes to ensure that they are suitable for the intended purpose.
Since its introduction in 1984 Sympatec's QM system has been hardened and successfully audited by many renowned pharmaceutical companies. As these companies also check our QM system against their internal company standards, Sympatec's QM system has become a super-set of all relevant requests, resulting in audits with no or little findings.
Quality management for the production
At all necessary places calibrated test equipment for measuring and quality assurance are used. Calibrated test equipments are defined and controlled according to SOP by test equipment classes.
All instruments and instrument components are checked for their functional efficiency.
Functional tests are accomplished during production for:
- electronics (printed boards and their wiring)
- sensor, dosing and dispersing units after assembling
- supplied parts after assembling
Before a system is released with a certificate for customer operation, it is first subjected to comprehensive Production Operational Qualification (POQ) and Production Performance Qualification (PPQ). This is how we ensure to provide high-performing, precise and reliable systems with excellent repeatability and system-to-system comparability.
1. Comprehensive set of Standard Operation Procedures (SOP's)
Describing all procedures of the development, manufacturing, service and other internal work flows.
2. Life Cycle Model
All developments are based on a life cycle model, the V-model.
3. Reference Materials
The final test of the production is the Performance Qualification. All our instruments are tested with real particles in a realistic application, i.e. by measuring the particle size of reference materials.
4. Internal and External Audits
Audits are used to continuously revise, improve and check the proper function of the QM system.
1. Independency
The head of quality management reports directly to the managing director and technical director and works independently of production, development and service.
2. Identical procedures
The tests are not depending on the final application. All instruments are tested for the potential use in the pharmaceutical industry. In areas where the same evaluation procedures are used for off-line as well as for in-line applications (production), instruments are tested with the corresponding procedures allowing for maximum system-to-system reproducibility.
3. Narrow quality limits
Sympatec is using quality limits which are chosen by the corresponding ISO standards in order to obtain the best possible system-to-system reproducibility.
4. Quality first
No system will be shipped unless it has passed all test successfully.
5. Traceability
All steps of development and production are documented in written and archived for 10 years. A copy of the production documents can be also used for subsequent re-certification or qualification of our instruments in validated processes.
1. Compliant with ISO standards
All our instruments are designed to fulfil or to exceed the requirements of the corresponding ISO standards, such as ISO 13320 for Laser Diffraction, ISO 22412 for PCCS, ISO 13322-1 and -2 for dynamic image analysis and others.
2. 21 CFR Rule 11 Compliance
The operating software for all Sympatec instruments has been designed to provide all technological controls required to achieve compliance with 21 CFR part 11, including both, electronic records and electronic signatures.
3. Validation & Re-certification Support
Sophisticated procedures are available from Sympatec together with the necessary paperwork such as test sheets, the validation documents and the reference materials in order to perform re-certifications or qualifications for instruments used or located in validated processes.