Medical Device Cleanrooms – Design Requirements

November 9, 2020

Cleanrooms play a vital role for medical device manufacturers in ensuring that their products are safe to bring to market. Medical devices are built for use in healthcare settings where hygiene and the need to prevent contamination is a high priority. These devices work hand in hand in helping healthcare providers diagnose and treat patients improving their quality of life.

Cleanrooms & medical devices - so where do we begin?

Medical device manufacturing is a heavily regulated industry where companies work to produce a safe product without risking the health of a patient. To understand a little more detail about medical device manufacturing lets go back to the basics. The FDA defines a medical device as

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia. It is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”

Medical devices fall under three classes. Those classes are class 1, 2, and 3. Class 1 devices provide the lowest risk to a patient. An example of these products are medical tape or bandages.

Class 2 devices are devices such as infusion pumps, surgical drapes or powered wheelchairs which pose a moderate risk to a patient.

Class 3 devices provide the highest risk to a patient. These devices support or sustain human life, may prevent, or impair human health or even present potential risk of illness or injury.

The FDA regulates the sale of medical device products and monitors the safety of all regulated medical products. The regulatory requirements for medical devices fall under ISO 13485 and ISO 14971. This requirement is designed for use throughout every step of a product’s lifecycle, including service and delivery.

Manufacturers are expected to demonstrate their quality management processes and ensure best practices in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical device industry. Medical devices are designed and produced to penetrate the skin or interact with the body which is why it is so crucial for these tools to be compliant.

So, how do cleanrooms support medical devices?

Medical device manufacturers face numerous challenges when designing and operating a cleanroom. Cleanrooms must be designed to control airborne particles as well as microorganisms which can cause contamination putting the patient at risk. Environmental controls are imperative to the success of the implementation of a device so designing a cleanroom that is spot on is crucial to developing a safe product.

When planning a facility, you should consider size and location to help maintain, clean, and operate activities inside the cleanroom. Size is an important variable because you will need appropriate space for equipment, materials, and personnel so cross contamination does not happen. Like with any other cleanroom design you need to consider temperature, humidity, air flow, and other environmental conditions that may be a risk to contamination, a compromise to the product or to the overall environment in the cleanroom.

What cleanroom classifications are used for medical devices?

Medical device manufacturing typically performs in an ISO 5 (Class 100) to ISO 8 (Class 100,000) cleanroom. Medical device packaging typically is conducted in an ISO 7 (Class 10,000) or ISO 8 (Class 100,000) cleanroom with an ISO 8 (Class 100,000) gowning room.

Cleanrooms are complex and every design should be handled on a project to project basis. We have seen as device complexity grows and particles become more problematic, facilities lean towards a cleaner classification than what is necessary right now to future proof their build for the evolving process requirements.

How can AdvanceTEC Help?

Are you looking for a cGMP cleanroom that is tailored to your specific ISO class requirement, follows FDA guidelines, that is fitted with your specific process requirement? Or are you looking to scale up a manufacturing facility to provide devices to market faster? Great! AdvanceTEC’s in-house team of experts are here for whatever your project needs. We start by understanding your objective and utilize our Cleanroom IP and Open Market Zero Compromises offering to deliver you the best performance at the best cost. We provide the options and you make the choices!

Bryan Phelan
Managing Partner, Director of Customers

As managing partner, Phelan is responsible for ensuring client satisfaction, shaping the company’s strategic direction, and managing all compliance aspects of the organization.

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