Cleaning and Rinsing
CTL Biotec provides customized cleaning and rinsing processes tailored to the specific needs of our clients’ products. We can either recommend and develop the most effective processes or take over already validated methods from our clients. Each cycle is individually designed, adjusted, and validated to ensure it meets the required standards. All processes are executed in ISO 7 clean rooms.
Sterile Barrier Packaging
With over 17 years of experience, ISO Class 7 qualified clean rooms and extensive sterilization and validation knowledge, CTL Biotec offers unparalleled sterile packaging services. We provide comprehensive support from design to delivery, ensuring all packaging requirements are met.
Packaging Services
Outsourcing packaging services, from design to mass production, enables companies to focus on their product development while leaving the packaging to experts. This is particularly advantageous for startups and medium-sized companies. CTL Biotec specializes in guiding clients through packaging solutions to maintain sterility from production to patient delivery.
Packaging Validation
All sterile barrier system packaging processes must be validated, demonstrating barrier integrity over the product’s intended shelf life and during transportation. CTL Biotec follows a standardized validation approach that meets global quality requirements (ISO, ASTM, and ISTA compliance). Our validation experts provide all necessary tests, standards advice, and complete validation reports ready for submission.
Boxing
Boxing involves the packing of medical devices into shelf and shipping boxes. CTL Biotec specializes in creating and implementing custom solutions tailored to meet specific client needs.
Sterilization
While CTL Biotec does not handle the sterilization process in-house, they collaborate closely with professional external sterilization labs. CTL Biotec manages and validates all sterilization processes externally, ensuring that all work aligns with the client’s requirements and regulatory standards. They provide comprehensive documentation to ensure regulatory compliance and safety.