Biocidal Product Testing Service

Third-party testing service for microbiological analysis of medical devices, including sterility assurance and bioburden testing. Conducted according to ISO/IEC 17025 standards with CMA and CNAS certification.

Rapid microbiological control service for pharmaceutical and medical device manufacturers. Provides objective microbial enumeration results with 15-minute turnaround, enabling accelerated product release and reduced quarantine periods.

Evaluation service assessing bacterial adhesion and biofilm formation on medical device surfaces to validate antifouling coating efficacy.

Comprehensive sterility testing for cell lines and biological materials to detect bacterial, fungal, and other microbial contamination. Critical quality assurance service for medical device and diagnostic development.

Comprehensive sterilization process validation service for multiple sterilization methods. Provides biological indicators and validation documentation for regulatory compliance.

Comprehensive biological safety evaluation service for medical devices ensuring compliance with ISO 10993 standards. Includes toxicological risk assessment and biocompatibility testing through validated in-silico methodologies and data analysis.

Comprehensive biocompatibility evaluation of blood purification devices according to DIN EN ISO 10993-1 and related standards. Multi-parameter testing including cytotoxicity and hemocompatibility.

Comprehensive pharmaceutical facility validation including suspended particle measurement, temperature/humidity monitoring, pressure differential testing, microbial sampling, air velocity measurement, and HVAC system efficiency verification. Ensures compliance with pharmaceutical manufacturing standards.

Third-party biological monitoring service that processes and incubates biological indicators from healthcare facilities. This service provides outsourced validation and documentation of sterilization process effectiveness.

Validation and performance evaluation service for polymerase chain reaction diagnostic systems. Conducted with fresh and frozen samples, including data analysis and final regulatory reports.

Expert sterilization validation service that implements sterilization confirmation according to standards to ensure products have no viable microorganisms. The service covers design qualification (DQ) and performance qualification (PQ) phases with FDA, CE, and NMPA registration compliance.

Testing and certification service for antimicrobial effectiveness of medical devices, pharmaceuticals, and healthcare products. Provides DAkkS-accredited microbiological analysis, biocompatibility testing, and cleanroom validation to ensure product safety and regulatory compliance.