Quality Management at Sanner

Quality Management

Sanner Envelope

We have been a reliable partner to our customers for over 125 years and have been supplying large quantities of injection-molded packaging and components with consistently high quality.

We maintain successful, cooperative and sustainable relationships with our business partners. These relationships are based on trust, respect and fairness.

Every employee of the company contributes to the implementation of customer requirements and the realization of our quality concept through their daily work. We therefore attach great importance to promoting personal responsibility and regular GMP training for all employees.

The requirements of our customers are the benchmark for the quality of our products and services. Our processes and goals are based on the obligations of international legislation, standards, customer expectations, interested parties and our internal knowledge.

Our goal is to continuously improve the quality of our products, such as primary packaging and medical devices, and processes in order to avoid risks and take advantage of possible opportunities. To this end, Sanner has introduced its own improvement management based on lean principles and operates risk management at product and process level.

The Sanner quality management system is certified according to ISO 9001 (QMS in general), ISO 15378 (primary packaging for medicinal products), ISO 13485 (medical devices). We also work in compliance with the BRC standard for packaging materials. In addition, Sanner holds the certification for a systematically operated energy management according to ISO 50001.

Our validation approach is based on the V model and includes all phases from DQ to PQ. In cooperation with production, the test plan is developed by our quality staff during validation and based on a risk assessment. Our quality technology has its own quality laboratory, in which comprehensive tests in the areas of function, material and geometry can be carried out. The quality laboratory includes extensive and state-of-the-art test equipment for the geometric measurement of components, material analyzes and functional tests. In the course of increasing automation, product tests are integrated directly into our production facilities in order to guarantee our customers the highest level of product safety.

All production processes at Sanner, whether in the clean room or in the gray room, are designed to meet the requirements of the pharmaceutical and medical device industry. This not only includes GMP-compliant and ISO-certified production and 100% traceability, but also standardized FMEA processes, single batch delivery, automated, process-accompanying quality controls (IPC) and controlled change controls.

The high quality of our products is reflected in a low complaint rate of 0.3/10 million parts. In addition, our pharmaceutical packaging and drop-in desiccant solutions correspond to the current market standards and meet all regulatory requirements of the American FDA, the European Pharmacopoeia and are listed in corresponding DMFs subdivided according to product categories. Our childproof packaging is also certified according to ISO 8317 (2015), PPPA 16 CFR Part 1700.20 and is also listed in the DMF.

When selecting all raw materials, the basic requirement for Sanner is that they comply with the relevant food guidelines (both FDA and EU) (e.g. 1935/2004/EG, 10/2011/EG, 21 CFR 177.1520). For our primary packaging, which is used in the pharmaceutical and medical technology sectors, there is also compliance with the relevant USP and PhEur chapters as well as ISO 10993. Compliance with the regulations is given to our customers in the form of a declaration of conformity or a confirmation of no objection.

For our tubes, we only use low-migration inks and varnishes that meet international food standards for their effervescent tablet packaging.

Customer information & ISO certificates


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