Pharmaceutical engineering covers all parts of drug manufacturing, from designing a new facility to optimising the manufacturing processes and packaging solutions. The key difference between pharmaceutical engineering and other areas of engineering is the industry’s strict manufacturing regulations and standards known as the ‘Current Good Manufacturing Practice’ (CGMP)
At Europlaz, we specialise in medical device manufacturing from concept to completion all while adhering to current regulations so we can guarantee quality control. We are able to offer full support to your design team during the concept, feasibility, and development stages of your project through our advanced practices. Read more to see how we can bring your medical device design to production.
The Process of Pharmaceutical Engineering at Europlaz
Design
We will begin working with you at an early design stage to plan and design various aspects of your project such as the specification of the tooling, tool commissioning, first sample prototypes and production of batches for clinical trials.
Functional Requirements
Next, we will ensure your product meets certain functional requirements such as cost, time and assembly stages.
At Europlaz, we use the Design for Manufacturing process to provide our customers with the freedom to various product options, while meeting the functional requirements. By using the Design and Manufacturing process we are able to concentrate on quality product factors such as process, design, material, environment and compliance/testing.
Development Processes
Following the design stage, we will begin to focus on the development processes. Here we concentrate on all the steps we need to take your product from concept to completion. Some of the development processes we use to do this include CAD device design, medical device prototyping, 3D modelling, material development and selection and packaging and labelling development.
Ensuring Quality from Start to Finish
Established Quality Management System
During the development and manufacturing stages, we rely on our strict quality management system to continually produce quality products. Not only are we a high-quality medical device manufacturer certified to ISO13485:2016, we are also a registered FDA Medical Equipment Manufacturer (Reg. No. 3004180226).
We have reviewing procedures in place which are regularly used by our management team to review product objectives. We communicate our quality policy and objectives to all levels of the organisation and promote understanding, involvement and commitment amongst all employees.
The continuous improvements of our working practices enable us to go above and beyond for our customers, priding ourselves in keeping our high quality while keeping costs low.
Full Customer Support
Another way we support our customers during the development and manufacturing stages is through full customer support which starts from initial contact with Europlaz. We help our customers with process selection, material selection, component design, mould-flow analysis and medical device assembly design to manufacture quality products on your behalf.
Strength and Expertise
At Europlaz, we are able to continuously deliver quality products due to the strengths and experience of our in-house team. We have been established for over 40 years and have extensive knowledge and experience in providing development and manufacturing technologies for the medical device, diagnostic and pharmaceutical industries.
Contact us today to find out more about how our practices can help you bring your product ideas to life.
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