Regulations for reprocessing procedures are increasingly complex. At Belimed, your success matters to us, so we offer validation services to support you from planning to implementation of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). We validate our own systems to save you from the headaches involved with third-party validation.
Cleaning, disinfection and sterilization systems are validated in accordance with the ISO 17665 (EN554), EN285, and EN ISO 15883 standards. We provide post-validation consultation and detailed documentation for all processes.
We also provide GMP qualification, including:
• Project management
• Quality plan
• Risk analyses
• GMP execution
• Factory acceptance test
• Installation and operation qualification
• Side acceptance test
• Customer-specific training programs
• Customer audits
• Software validation
• Process support and advice
Expert consultants from Belimed ensure that your success is complete with not only technology, but optimized workflow and logistics. Consultation includes taking a complete inventory of your current situation, then making recommendations for optimization and improvement and cost analysis.
Analysis of working hours, cost calculation, analysis of the sterile goods store, risk assessment and operational support are all included in the scope of consultancy.
If you’re faced with a renovation or reconstruction project that will require instrument reprocessing to continue in a different location, Belimed’s mobile and modular central sterile supply departments (CSSDs) provide the efficient, hygienic solution you need to continue running a successful CSSD.
Our solutions range from mobile container wagons to structures with two floors and 600 square meters of usable floor space. If the objective is rapid construction of new buildings, a modular CSSD can also be custom-designed as a permanent facility. We can handle planning, construction management, installation and financing for your project.