Traceability of Plant Components now also an Issue for Gaskets

Author: Dr. Torsten Kcher, Dockweiler AG

In processing plants used for example in the pharmaceutical and food processing industry, traceability of machine components is generally desirable, often recommended and sometimes actually required by the operator or by the applicable standards. Normally, this requirement is taken very seriously for tubes, fittings and tube connections, while gaskets are often left out. This is despite the fact that modern gaskets can be easily marked as regards their origin. By opting for traceable gaskets, plant manufacturers and operators can close a gap in their safety chain that might be more significant than commonly perceived.

In critical processing areas, traceability of the plant components has become a common requirement. This applies in particular to the pharmaceutical industry, semiconductor production, biotechnology and food processing.
Each component in such a plant is individually marked, and each weld is documented

The stainless steel components from Dockweiler meet these requirements. Each component is marked as follows: manufacturer (Dockweiler), dimensions, material, Dockweiler serial number and melt. The documentation contains information regarding the material certificates ("Type 3.1"- according to DIN EN 10204:2005) and the results of the performed tests. For special parts, the welding certificates of each individual weld are available on request.
Securely archived documentation

All documents are archived in the document management system of Dockweiler. It is therefore possible to retrieve any information regarding the material (melt), welding parameters
1/3

and QA test results according to DIN EN ISO 9001 even years after the production of the component.
Traceability for gaskets?

While the rules for plant manufacturers and operators as regards the traceability of pipes, welded assemblies and other stainless steel components that are in direct contact with the product are clear and well-established, no such rules exist for gaskets.

At the moment, the identification of the gaskets on the packaging foil is deemed best practice. While this information might be of great use for the assembly and installation of the components, it does not provide any help when attempting to trace a specific part.
"Gasket autopsy" reveals vulnerability to wear

During production, gaskets are generally exposed to much greater wear than stainless steel components. Cleaning agents and media might also affect the gaskets, resulting in cracks and other damage to the gaskets, leading to leakage and/or contamination of the processed product with gasket material. In such cases, the machine operator must first evaluate whether the problem is due to incorrect installation or a gasket defect, and whether the correct gasket made from the right material has been installed. This can only be done if this information is available on the seal itself. In such situations, the current practice of providing this information on the packaging is of no use.

Standards and regulations

The fact that most manufacturers and machine operators have accepted this situation might also be due to the lack of regulations regarding the traceability of non-metal machine components. The validation rules for pharmaceutical production equipment do not mention gaskets. In contract, the European Regulation 1935/2004 on materials and articles intended to come into contact with food makes specific reference to gaskets and similar components. Section 18 or the regulation states:

"The traceability of materials and articles intended to come into contact with food should be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. Business operators should at least be able to identify the businesses from which, and to which, the materials and articles are supplied."
2/3

The ASME BPE 2009 standard is even clearer in this regard. Section SG-3.4.2 states:

"Manufacturers name and lot number shall be marked on either the seal itself or the seal package containing the seal. The lot number should enable the manufacturer to identify the raw material and processing conditions used to fabricate the article. Manufacturers are encouraged to mark the seal itself to avoid potential loss of traceability and to aid in positive identification of gaskets after removal from a process stream."
Marking of individual parts

Dockweiler meets these requirements by offering the pharmaceutical and food processing sector plants and plant components with laser-engraved gaskets. These laser tags contain the following information: manufacturer (Dockweiler), Dockweiler serial number, and material; where there is sufficient space; the marking includes the part dimensions and the flange size. In addition, a manufacturer certificate is available for each batch. The plant operator therefore has all the information necessary to respond quickly if there are any problems regarding the gaskets.
Improved operational safety

By including gaskets in the range of traceable parts and providing proper documentation for gaskets, Dockweiler has taken an important step towards greater operational safety and a lower risk of liability. The company thus takes a stand against the often heard argument that gaskets are not components that are in contact with the processed product. It is a well-known fact that gaskets at flanges and other fittings can easily come into contact with the product. It is therefore only logical that gaskets must meet the same requirements for traceability as pipelines and fittings.

Conclusion: Same standards for pipelines and gaskets

With its laser-marked gaskets, Dockweiler expands the current traceability standards for stainless steel components to gaskets. This ensures that all machine components are fully traceable and documented. In addition, plant operators benefit from improved operational safety and can be sure that the gaskets, which after all are among the most prone to wear components in a plant, meet the stringent quality requirements that apply to their processes.

Dockweiler AG, An der Autobahn 10/20, 19306 Neustadt-Glewe, Germany Tel.: +49 (0) 38757 58 0, Fax: +49 (0) 38757 58 222, info@dockweiler.com www.dockweiler.com

3/3