The reliable medical packaging partner
Patient safety is the highest priority. Our services are accordingly designed, embracing the entire value chain and taking into consideration the increasing cost pressure on hospitals and healthcare.
Packaging Development
- Develop Packaging Concept
- Label Design & Printing
- Assembly & Testing
Our solutions focus on usability, functionality and compliance with regulatory requirements. Sterile packaging systems in medical technology can be designed as single or multiple barriers and can be expanded into a complete logistics-friendly packaging system.
Packing Medical Devices
- Packaging Material Sourcing
- Cleaning & Rinsing
- Quality Inspections
- Packaging
After production, medical devices must be subjected to a suitable cleaning and disinfection process to remove microbiological impurities and germs. Various packaging solutions can then be applied, such as blister, pouches or vials.
Sterilization
- Managing Contract Sterilization Providers (ETO, Gamma)
- Sterilization Protocols
- Auditing Sterilization Suppliers
The pre-packaged and coded medical products are sterilized by a certified company according to the requirements. All common procedures are available. The material properties of medical devices are the most important factor in the selection of the appropriate sterilization process.
Validations
- Cleaning Validationparticles, chemical residues, microbial contamination, etc.
- Packaging Process Validationtightness, seal strength, burst test etc.
- Sterilization Validationproof of the efficiency of sterilization at different loads and dose ranges
- Biocompatibilityproof that the medical device and packaging do not cause mutual, possibly undesired reactions to the patient's organism
- Stability Studiesshelf life over the entire storage period of a medical device
- Transport Validationsimulation of impacts due to transport, fall, climate etc.
These procedures include proof of efficiency, sterilization at different loads and dose ranges, securing biocompatibility of the medical device and packaging, as well as shelf life and transportation stability.
Warehouse & Logistics
- Climate-Controlled Warehouse (GMP)
- Supply Chain Management
- International Shipping
We offer GMP and climate-controlled warehouse to ensure that products are handled and stored properly, while appropriate documentation is maintained. If desired, we also handle your warehouse and logistics processes.
Combined Products
- Packaging combined products as defined by Medical Device Regulation (MDR)
Different requirements, one solution: when a drug and a medical device are combined as a single unit, or a new indication-specific medical device is created by combining different medical devices, as defined by Medical Device Regulation (MDR), Blue Medical can provide the necessary regulatory framework to package and market your product.
We provide extensive consulting services and would like to figure out which solutions are best suited to your needs