Contract Manufacturing

Contract Manufacturing and R&D of Prosthetic Heart Valves

Tissue sourcing from abattoirs within and outside the EU, including GBR1 countries, using equine, bovine, or porcine origins
Design and development of proprietary methods for tissue fixation, storage, and sterilisation
Development and implementation of advanced anticalcification and detoxification treatments to enhance long-term implant performance
Precision laser cutting for consistent sizing and high manufacturing accuracy

Design and engineering of both surgical and transcatheter heart valves
Prototyping of heart valve concepts for preclinical evaluation
Comprehensive hydrodynamic performance and durability testing in accordance with international standards
Manufacture of heart valves prepared for in vivo (animal) testing
Development of sterilisation and storage methods tailored to preserve valve integrity and functionality

Sterility testing to ensure microbial safety of all tissue products
Biocompatibility testing in accordance with international standards for medical devices
Biomechanical (tensile) testing to assess the strength and elasticity of materials
Endotoxin testing to confirm the absence of pyrogenic contamination
Implementation of robust quality control protocols throughout all stages of production and testing

Classified clean room environment (ISO Level 7) ensuring controlled levels of particulate and microbial contamination
Environmental monitoring for particulate matter, microbial load, and temperature
Controlled access and gowning protocols to prevent contamination and maintain sterility
Validated clean room cleaning and disinfection procedures
Pressure cascade systems to maintain unidirectional airflow and prevent cross-contamination
Routine personnel training in aseptic techniques and clean room behavior
Air handling systems with HEPA filtration to maintain air purity
In-process controls to ensure compliance with clean room standards during production
Support for sterile manufacturing processes, including tissue processing, packaging, and final product handling

Consulting services for the development and optimisation of quality management systems
Preparation of Standard Operating Procedures (SOPs) and work instructions tailored to regulatory and operational requirements
Conducting audits to assess compliance with relevant standards (e.g., ISO 9001, GMP) and identifying areas for improvement.
Implementation and monitoring of risk management processes and Corrective and Preventive Actions (CAPA).
Establishing systems for controlled documentation and managing procedural changes.
Support in equipment qualification, process validation, and cleaning validation in line with regulatory expectations.