It would be a challenge to overstate the importance of proper cleanroom training focused on keeping the cleanroom clean. When a cleanroom fails to provide its intended purpose — providing a contaminant-free environment — the impact can be lost revenue, or worse, human lives.
A pristine cleanroom environment does not happen by accident.
To maintain your production schedule and the highest safety and sanitary condition of your cleanroom, you need to establish clear, thoughtful cleaning protocols that all personnel follow. This is the only sure way to stay compliant with industry requirements, as well.
When you have an effective cleaning process in place for all your operators to follow, you will decrease the risk of several outcomes that impact revenue and safety. Your team will reduce the risk of these three adverse outcomes.
1. Losing Cleanroom Certification
To keep your cleanroom certification and pass inspections, your team needs to follow cleaning processes that align with related regulations. This includes several key testing criteria. An inadequate cleanroom cleaning process can impact critical testing areas:
- Particle count testing
- Air pressure differences
- Airflow visualization and related tests
- Filter leakage
- Containment leakage
To establish compliance with routine maintenance requirements, your team must adhere to strict record-keeping and monitoring protocols, as well. Keeping track of when the team performed cleaning and maintenance tasks is vital.
Given the long list of regulations around cleanrooms, it may be tempting to skip cleaning steps now and then, but this approach is sure to catch up with you at some point. The strict testing criteria aim to create a safe, clean environment for everyone in the cleanroom, and inspectors take the job seriously.
What Happens if You Lose Your Cleanroom Certification?
When you lose certification or have to shut down the cleanroom to bring it up to code, you run the risk of several negative outcomes:
- Lost revenue due to stopped production
- Jeopardized relationships with third-party partners who rely on you to keep the cleanroom properly maintained and certified
- Lost confidence in the reliability and integrity of your production
- An expensive mitigation process to overcome inspection failures
2. Chemical and Radiological Threats to Production
Pharmaceutical and other production cleanroom environments represent a high level of risk for operators. Personnel in these cleanrooms frequently interact with:
- Active biological agents
- Dangerous pathogens
- Flammable cleaning substances
- Toxic chemicals
- Radioactive materials
Your cleanroom environment should protect the environment and your cleanroom team from dangerous side effects. You must establish repeatable, strict protocols around cleaning and handling of these potentially hazardous substances. A risk-based assessment is a must whenever your operators need to interact with a new, potentially dangerous material.
It is also critical to create comprehensive, straightforward plans for fires, leak containment, and accidental exposures. This includes maintaining safety equipment and maintaining clear pathways to emergency exits.
The more prepared you are, the less risk you will face for production interruptions and significant safety events.
3. Operator Safety and Health Risks
Around the world, a worker dies from toxic exposure in their workplace every 30 seconds. This alarming statistic includes millions of preventable exposures.
The effects of toxic exposure may not even show up right away. Chronic occupational diseases caused by dangerous exposures account for tens of thousands of annual deaths.
Taking the extra steps required to ensure your operators' health and safety should be a priority for any company operating a cleanroom. Without a well-established protocol in place for cleaning and handling hazardous materials, your workers are at a higher risk of:
- Encounters with mechanical irritants
- Unsafe exposure to toxic fumes and production byproducts
- Injury in a fire or exposure
- Injury caused by mishandling cleanroom equipment
- Injury caused by inadequate or improper use of personal protective equipment
- Electrical shock
- Slips and falls
In addition to protecting workers, establishing cleaning procedures and rules focused on health and safety helps keep your cleanroom compliant with industry regulations.
4. Are Your Operators Up to Speed?
Cleanroom cleaning training is essential. Cleanroom personnel are the single largest source of cleanroom contamination. Some studies show that these account for almost 80 percent of the particles found in cleanroom inspections. Contaminants include:
- Dead skin
- Clothing fibers
- Particles from lotions, deodorants, cosmetics, and perfumes
A proper cleanroom training program helps companies keep contaminants where they belong — outside your cleanroom. Comprehensive cleaning training empowers teams with the knowledge they need to understand the importance of cleanroom cleanliness.