5 Biggest Threats to Medical Cleanrooms (and How to Prepare for Them)

In the medical industry, there’s no room for error. The slightest amount of contamination can not only result in reduced efficiency and missed development deadlines, but it can also put human lives at risk. 

Keeping your medical cleanroom airtight, fully controllable, and customized to meet your application’s ISO classification is essential in conducting safe, effective, and efficient operations. You can accomplish this by understanding and planning ahead for any risks your cleanroom may encounter. Below, we’ll outline five of the biggest threats to medical cleanrooms, as well as how you can prepare for them. 

5 Biggest Threats to Medical Cleanrooms

While some threats to medical cleanrooms are fairly common sense, others may take you by surprise. Either way, it’s important to take all into consideration throughout the design and installation processes. Here are five of the most common threats medical cleanrooms regularly face: 

1. Personnel Within the Medical Cleanrooms

Staff members are known to pose the greatest risk for cleanrooms — and medical cleanrooms are no exception. Improper or disregarded handwashing and gowning protocols can result in thousands of contaminant particles being introduced — from skin particles to hair strands, to perfumes and cosmetics. In fact, some cleanroom inspections have attributed personnel as the cause for 80% of identified particles. 

2. Medical Cleanroom Materials

Work samples and materials within medical cleanrooms can also pose a health threat to personnel. In many medical cleanroom applications, cleanroom operators work with microbiological substances that can cause serious harm if they aren’t contained and controlled properly and if operators aren’t wearing correct protective gear. From studying infectious diseases to dealing with bodily fluid samples, it’s important to be aware of potential biosecurity risks. 

3. Equipment in Your Medical Cleanroom

The machines and tools within your cleanroom pose varying levels of contamination risk. Machines often emit gas, lubricants, emissions, and other airborne particles while in use. Also, everyday tools like pens, beakers, trays — even cleaning items — can all introduce particles if not sanitized properly before use or handled appropriately during use. 

4. Dysfunctional Filtration Systems

If your medical cleanroom’s filtration system isn’t working properly, your cleanroom likely isn’t all that clean. Filtration systems — consisting of fans, pre-filters, and HEPA or ULPA filters — are responsible for treating contaminated air supplies and maintaining consistent air change rates in order to ensure good air quality. However, over time, their components can grow old and function at lower capacity, increasing the chance of higher particle counts and dead zones.

5. Static in Your Medical Cleanrooms

Static electricity in medical cleanrooms isn’t always a risk that comes first to mind — but it’s definitely one to take into account. Its “cling” effect increases the chance of attracting airborne particles to surfaces that need to remain sterile. Also, in applications involving medical device development, static can cause particles to be drawn in and permanently damage sensitive electronic components. 

How to Prepare Your Medical Cleanroom for Safe Operations

Fortunately, there are ways to prepare for and prevent each of the medical cleanroom threats listed. Although complete sterilization is virtually impossible, implementing the right tools, technologies, and procedures can help you reduce risk as much as possible. Here are a few preparation tips to consider during the design and installation processes:

Install and Maintain a Fully Functioning Filtration System

In order for your cleanroom to meet its ISO classification requirements, you need to install a quality filtration system. Make sure that your filtration system provides the required percentage of ceiling coverage and maintains consistent air exchange rates. 

And, once it’s designed and installed properly, make sure you stick to a regular filtration system inspection and maintenance schedule. Your pre-filters should be replaced at least six times per year, and your HEPA or ULPA filters should be replaced at least once every three years. If not maintained properly, your filtration system could fail and threaten control over your cleanroom environment. 

Apply the Right Type of Pressurization for Your Medical Cleanroom’s Application

Both positive and negative pressure cleanrooms have their place in the medical industry — it just depends on your specific application. Most medical cleanrooms operate with positive pressure, using HEPA filters and an external airflow pattern. However, some applications involving hazardous substances need negative pressure to prevent contaminants from escaping and causing harm to the surrounding environment. 

Include Pass Throughs in Your Medical Cleanroom Design

Pass-throughs are chambers for moving products in and out of your cleanroom. Adding one or more pass-throughs to your medical cleanroom can make transferring tools and materials quicker and more efficient. At the same time, pass-throughs reduce cleanroom traffic cross-contamination, helping to provide a less compromised work environment.

Adopt Thorough Cleanroom Cleaning Protocols

Medical cleanrooms require some of the most stringent ISO standards — and while your cleanroom may be designed with features and technologies to uphold that, you still need to do some cleaning as well. By establishing a daily, weekly, and as-needed set of cleaning tasks, you’ll ensure your cleanroom is operating at its maximum possible sterilization levels. 

While you’re cleaning, make sure to use specified cleaning products for medical cleanrooms like distilled water, neutral chemical solvents, and non-shedding cloths or wipes. How you clean is just as important as how frequently you clean. 

Implement Anti-Static Cleanroom Components

Controlling static isn’t always easy, but it is possible. There are many specialized products made for controlling static within a cleanroom, including anti-static flooring and wall panels. On top of this, a great way to control static is to adopt clothing and gowning guidelines that limit it. These could include anti-static garments, ESD cuffs, low-static shoes, or basic lab coats. 

No matter the specific environmental threats your facility and application may face, Angstrom Technology can design and install a medical cleanroom that controls and prevents them all. Contact our team to get started today.