BPB MEDICA™ operates with state-of-the-art production machinery and equipment, and the entire production process is carried out in-house (from design to final packaging) in our Italian production plant. This allows us to be able to offer our customers a wide range of services and customization to find the best solution to their needs.
PRODUCTION PROCESS CONTROL: Complete manufacturing process carried out internally, from design to final packaging.
RESEARCH & DEVELOPMENT: Constant research in order to increase production and quality standards while developing new products.
OEM & PRIVATE LABEL SERVICES: À la carte production, with customer’s brand name and custom colour. Full-service support of Regulatory and Quality documentation.
MARKETING SUPPORT: Video tutorial, case report, presence at the major medical congresses, organization of training and courses.
QUALITY & REGULATORY DEP: Our primary aim is product quality and providing painstaking service. Our regulatory and quality teams conduct rigorous tests for this purpose.
PERMANENT STOCK: Top-selling items are always available in stock and can be shipped within 24 hours.
The production and assembly of our medical devices are carried out in our ISO 8 cleanroom, with the use of the latest technology and strictly in compliance with regulations. Our state-of-the-art clean room is fully equipped for biomedical manufacturing and assembly with the highest standards, including extremely advanced equipment for carrying out the processes and controls in process, such as:
- Catheter manufacturing
- Manual and automatic assembling
- Video microscope and UV control
- Tailored production solutions
A 100% statistical control is performed by department staff before products can be released for the subsequent packaging and labelling steps.
Medical device packaging is conducted inside the cleanroom environment to grant sterility maintenance and protection against microbial penetration. In our production plant, we adhere to the highest quality standards and satisfy customer-specific requirements. All the packaging of our medical devices is made in our production plant and customization on client request is always possible, and our Technical Office is available for the design and development of tailored packaging solutions.
- Single and double packaging
- Manual and automated pouch sealer
- Manual and automated sterile barrier blister packaging
- Primary and secondary labelling
- Tailored packaging solutions
Before being released for the final sterilization step, the products undergo a validation test to ensure package integrity by department staff.
BPB MEDICA™ is committed to containing the environmental impact of the manufacturing process and covers most of its energy requirements from the solar energy obtained from the rooftop photovoltaic (PV) solar cells. During the production process, effective measures are taken to reduce energy and materials consumption, to effectively reduce environmental pollution.
The processing of finished and semifinished products involves several critical steps that are subject to specific controls to be certain that they are adequate and meet the specifications set. These processes consist in:
- Tip grinding
- Sandblasting and echogenic marker application
- Electropolishing and washing
- Laser marking
Before being released for the subsequent assembly steps, the products are carefully checked employing a visual stereo microscopic control and a dimensional control performed by department staff.
Our internal moulding department allows us to be able to offer our customers OEM products with greater control over the design, from manufacturing through process development. Our experienced staff works closely with our customers to develop new products, from prototypes through full-scale production.
Our plastic injection moulding capabilities include:
- Horizontal moulding
- Vertical moulding
- Silkscreen printing on plastic components
- Semifinished and finished product control
Following the moulding of the components in some cases, depending on the product being processed, it is necessary to carry out the pre-assembly of the components, before carrying out the final assembly in the clean room. Before being released for the subsequent manufacturing steps, the products are carefully checked by department staff.
BPB MEDICA™ medical devices are sold internationally in over 70 countries. The top-selling items are always available in stock and can be shipped within 24 hours, if necessary, to grant our customers the shortest delivery time and a top-level after-market service. The warehouse is managed using a specific computerized management program, and the movement and storage of the products follows FIFO rules.
The sterilized finished product is held in the appropriate green area of the warehouse destined for the released finished product.