Validation companies

We provide pre-assembled kits for determining residual protein, which is used to assess the effectiveness of manual reprocessing procedures. These are specifically designed for reprocessing procedures in the medical disciplines of dentistry, ENT, urology, and gynaecology.

Various sets are available for use in the validation of automated processes involving thermal disinfection. These sets are designed for use with washer-disinfectors, combination devices, and washer-disinfectors for containers, trolleys, and/or hospital beds. These sets contain a specific number of Crile clamps, SDS solution and dental test specimens (separately for internal and external cleaning), as well as test specimens for container and trolley washers, depending on the application. The sets also include a comprehensive explanation, a sample information sheet and transportation equipment.

We offer testing of clinically used and reprocessed Da Vinci instruments for validation, re-qualification, and routine control purposes. SMP is a recognised test laboratory of Intuitive Surgical and has over 20 years' experience handling instruments used in robot-assisted surgery.

Various test specimen sets are provided and evaluated in order to assess the cleaning and disinfection performance of chemo-thermal processes. These include protein test tubes and Enterococcus faecium test tubes for washer-disinfectors for endoscopes, as well as test kits for flexible endoscopes and for analysing feeding and final rinse water. The range of services offered is completed by fully prefabricated sets containing an Enterococcus faecium suspension, in accordance with the current specifications of the AK-BWA (Working Group on Bed Frame and Trolley Decontamination Systems).

To validate steam sterilization processes in accordance with EN 285, customer-specific test specimens contaminated with Geobacillus stearothermophilus are provided and evaluated as part of routine control. These specimens are used to verify sterilization more effectively and meet the latest requirements in accordance with DIN EN ISO 17665-1 under realistic conditions.

To ensure the quality of the packaging process for reprocessing medical devices, the tensile strength of the seal seam is tested in accordance with DIN EN ISO 11607-1 and -2. These tests provide a standard-compliant assessment of the mechanical strength of the seal seam and demonstrate the reproducibility and safety of the packaging process as part of the validation and performance qualification process.

Standardised hygiene kits are provided and evaluated for microbiological testing of drying cabinets for flexible endoscopes. Sampling is carried out in accordance with the requirements of DIN EN ISO 16224, including both surface and air quality testing.