Nutrient Pad Sets – Quality Assurance
Both the manufacturing process as well as the quality controls for the nutrient pad sets are integrated in the M&S quality management system according to DIN EN ISO 9001:2015 and are based on GMP guidelines and DIN EN ISO 11133.
Each batch of cellulose cardboard that is used as substrate for the NPS is tested for thickness (according to DIN EN ISO 20534), grammage (according to DIN EN ISO 536) and water absorption capacity (in-house test method). It is also tested for growth-inhibiting substances.
The Petri dishes in which the impregnated nutrient pads are placed are manufactured under clean room conditions and their sterility is checked regularly.
The imprignation solutions are produced using components from certified suppliers only. The weighed portions of the individual components of the formulations are documented with their batch numbers to guarantee their traceability. The adjustment of the pH-value is also recorded. Processing continues as soon as the solutions have been produced, i.e. the cardboard pads are then impregnated.
The drying process that follows impregnation takes place under controlled conditions.
A service provider certified in accordance with EN ISO 13485:2012 performs the sterilisation of the NPS in a validated process.
During the final inspection of the finished products, their sterility, recovery rates and if necessary any colour reactions with positive and negative microorganisms are tested. The NPS only leave our premises if they fulfil all of the requirements.
The batch-related M&S quality certificate that accompanies every package confirms that the M&S quality standards have been checked and met.