Quality Assurance

In Fluka's corporate policy, quality assurance is among the priority objectives. This also explains the clear-cut structure of the quality assurance organisation which is superimposed on the normal corporate structure. Quality assurance measures have long been a tradition with Fluka. All Fluka products are always supplied with clear specifications. Both the catalogue packages and the large containers are labelled with product and batch numbers.

Products that have recently been introduced into the product range are subjected to clearly defined test cycles until the necessary experience has been gained with regard to product stability and package tolerance. An EDP-controlled stock management system periodically initiates product-specific tests. Quality control checks adhere to specifications for every individual batch, with particular attention paid to appearance, solubility, physical data, assay, identity check and application-relevant tests.

With the use of our laboratory data system, we can ensure that any batch can only be released by the competent person (Analytical Product Manager). Analytical data are stored for more than 20 years and thus enable an uninterrupted retraceability of the products history. On request, we supply the batchspecific analytical data, in the form of an analysis certificate, along with the product.

Each product for microbiology is routinely analyzed in our laboratories for appearance, solubility, identity and the various product-specific characteristics given in the specifications. The biological character of many ingredients for culture media makes it difficult to produce raw materials of constant quality from batch to batch. Therefore the following problem areas are carefully checked before, during and after production:

• choice of raw materials
• standardisation of products
• final analysis of products

All microbiological culture media are routinely checked for colour, homogeneity, pH, clarity and gel strength. Solid media are autoclaved and cooled down to 50 ⁰C, poured in a beaker and the pH is measured in the solid state with a pH-electrode at the temperature indicated. Liquid media are autoclaved, cooled down to the temperature indicated and the pH is measured as above.

Your quality requirements are the driving force to us for providing you with the quality you need!

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