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What factors influence the cost of assembling cleanrooms for medical device manufacture?

Cleanroom Assembly Cost Factors

Unveiling cleanroom assembly costs

Cleanroom assembly is a critical stage of the intricate manufacturing process of medical devices, where stringent cleanliness standards are meticulously upheld to ensure patient safety and product excellence.

As a dedicated contract medical device manufacturer, Meridian Medical understands the significance of transparency and trust in building strong relationships with our clients. In this blog, we shed light on key cleanroom assembly cost factors, addressing questions such as how much does it cost to build a clean room? And, what are the key issues to be considered in designing a cleanroom?

Cleanroom Classifications

Cleanrooms are classified based on the permissible levels of airborne particulate contamination. The higher the required cleanliness level (Class 1 being the cleanest), the more rigorous the design, construction and maintenance of the cleanroom. As the cleanroom classification increases, the associated costs of meeting and maintaining these stringent requirements also rise. Single use medical devices are typically produced in class 7 and class 8 facilities.

Cleanroom Size and Layout

Cleanroom assembly costs are directly affected by the desired size and layout of the cleanroom. Larger cleanrooms, while accommodating more personnel and equipment, require greater filtration capacity and therefore energy consumption. An efficient layout optimised for workflow minimises unnecessary movement and ensures productivity.

HVAC Systems and Filtration

Heating, ventilation and air conditioning (HVAC) systems play a pivotal role in maintaining a controlled cleanroom environment. High-efficiency filtration, such as HEPA and ULPA filters, is essential for removing particles from the air. The cost of advanced HVAC systems and filtration must be considered in cleanroom assembly expenses.

Contamination Control

Strict contamination control measures, including gowning requirements and hygiene protocols for personnel, must be enforced in cleanrooms. The cost of specialised cleanroom garments, employee training and regular monitoring contributes to the overall cleanroom assembly cost.

Cleanroom Equipment and Tools

Specialised cleanroom-compatible equipment, tools and materials are essential for assembly. Stainless steel, non-porous surfaces and materials resistant to microbial growth, and repeated cleaning ensure compliance with cleanroom standards. These specialised components may have higher upfront costs but are crucial for maintaining the cleanroom’s integrity.

Cleanroom Certification and Validation

Regular cleanroom certification and validation is essential to ensure that the facility meets the required cleanliness standards. The costs of third-party testing, routine calibration and validation services are necessary to verify and maintain compliance.

Stringent Quality Assurance

Ensuring the quality and integrity of medical devices assembled in cleanrooms demands robust quality assurance practices. The implementation of quality control systems, traceability measures and documentation to meet regulatory requirements may add to the overall cost.

Influences on cleanroom assembly costs

At Meridian Medical, we prioritise openness and fostering trust with our customers. Understanding the factors that influence cleanroom assembly costs for medical devices is fundamental when it comes to providing high-quality and cost-effective solutions. Cleanroom classification, size, HVAC systems, contamination control, specialised equipment, certification and quality assurance are all factors in determining the overall cost. By adhering to stringent cleanliness standards and employing efficient practices, we ensure that the medical devices we manufacture are not only trustworthy, but also adhere to the most rigorous safety and compliance standards.

Meridian Medical is an established and experienced contract medical device manufacturer specialising in a wide range of medical devices. We offer design, regulatory assistance, cleanroom injection moulding, cleanroom assembly, contact packaging and sterilisation Management. We have over 30 years’ experience supplying UK and European companies.

To find out more about how Meridian Medical can help you with your medical device manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.

Published 13/02/2024

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