Lexium provides send to end engineering and consulting solutions for medical device plant setup starting from concept to commissioning. The service offerings include conceptual design, civil structural & architectural design, basic & detailed engineering, man material flow, value engineering, qualification & validation along with site management. Our multidisciplinary team is a mix of architects, biomedical engineering, MEP engineers, regulatory and validation experts who can understand the client’s project needs from class I to class III medical device products and design facilities to comply with USFDA /EMEA/CE/CDSCO/ANVISA guidelines.
Medical device manufacturing and packaging regulations and requirements are complex and compliance is critical. Our team of Medical device clean room engineers & HVAC experts take time to understand your business, your products and your device manufacturing process to propose the perfect medical device cleanroom environment to comply with all requirements and ensure successful business operations. Our medical device clean room are certified to meet or exceed the required classification conditions in accordance with ISO 14644. Our Documentation suit and current plant design modules can help you to clear EU CE inspections and USFDA certifications with ease.
To ensure that your products remain under controlled contamination levels during your production process and packaging process our Medical device clean room guarantee to control and maintain temperature, humidity, pressure and containment levels. Our ISO 16444 calibrated medical device clean room control the introduction, generation and retention of particulate, protecting your products and process from airborne contaminants or human borne contaminants.
Neurology
Orthopedic
Cardiovascular
aparoscopy
Radiology
Software
Anaesthesiology
Combination Products
Endoscopy
IVD
Critical Care
Urology
We design, engineer and build facilities with due consideration to overall plant efficiency & compliance utilizing cost & energy saving parameters thereby reducing overall footprint and optimizing operating cost without any compromise on compliance or final quality of product.
Call us to know how we can support your new medical device facility
We look forward to partnering with you to design and build the perfect medical device factory to fit your business needs. It is our end goal that you maximize your investment in your cleanroom environment delivery products that are free of contamination there fore reducing risk of harm to patient and end users.
Contact us Today to learn more about Trunkey Medical Device Plant setup services