At the heart of many precision industries like medical and pharmaceutical sectors, cleanroom or controlled environments are protect the integrity of product, help regulate compliance, and maintain patient safety. 

Precision Environments Cleanrooms take great strides to ensure the best practices are followed with operations to avoid disruption in workflow that might jeopardize results. That doesn’t mean common errors won’t occur but changes can be made to avoid these from the start.

Controlled Environments Come with Various Components

Because there are so many components to a controlled environment, challenges exist and must be addressed such as equipment issues, contamination, temperature and humidity, and on. Precision Environments modular cleanrooms reduce the likelihood but there’s always the chance.

Humidity and temperature fluctuations

The most common controlled environmental challenge is regulating the humidity and temperature in a controlled environment. Fluctuations disrupts what are delicate processes leading to questionable reliability with research results and lower product quality.

Changing outdoor air conditions and dynamic equipment loads contribute to fluctuations in humidity and temperature.

Contamination control

Contamination control is a constant battle with microorganisms, airborne particles and other contaminant potentially infiltrating cleanrooms when issues arise with entry point seals and via other poor practices. Contaminant readily contributes to a jeopardized process.

Equipment malfunctioning

Equipment malfunctioning can be abrupt and sudden resulting in a disruption to operations.

Proper Documentation

When making documentation, it should be accurate and detailed and done in blue or black ink, never pencil. Many believe pencil is better in case changes need to be made but that’s a misconception. 

Blue or black in follows regulatory compliance. Inadequate records are confusing, compromise research integrity and breach compliance.

Poor gowning practices

Incorrect gowning is among the most common and preventable errors in controlled environments. Contaminants such as hair, skin particles, fibers from improperly worn garments can wreak havoc in a cleanroom. 

Many underestimate the time spent on the rigorous process for effective gowning from handwashing to sequencing gloves, caps, and suits. Poor gowning doesn’t only impact the operator i affects the air system, equipment, product batches, leading to expensive waste and added decontamination efforts.

To eliminate these risks, ongoing training is essential to reenforce comprehensive gowning protocol with strict monitoring to ensure compliance.

Airflow dynamics

Misunderstanding airflow dynamics is one of the biggest mistakes to avoid when working in a controlled environment. A modular cleanroom is meticulously engineered for unidirectional airflow ensuring contaminants are directed away from key zones. 

Still improperly placed workstations, unintentional obstructions or rapid movements can disrupt airflow dynamics, introducing contaminants to sensitive areas. Visit – CleanRoom Safety 101 – Safety Blog News – for tips on cleanroom safety.

Operators strive to grasp airflow’s impact on contamination. Placing material improperly can disrupt the flow, negating the HEPA filtration in the cleanroom. These issues can be eliminated with regular room layout assessments, particle monitoring, and operator education.

A clean cleanroom

Cleanroom schedules should account for hidden contamination hotspots such as filters, ceilings and ingress points to prevent cumulative risks. Operators should be equipped with the right materials to ensure the space is always thoroughly cleaned. This includes the right disinfectants.

That also means adhering to set equipment service schedule, preventive maintenance protocol which include changing filters regularly and integrity testing for HVAC equipment. Record-keeping is vital lto ensure a clear timeline for intervention.

Consider maintenance

In that same vein, many people don’t consider cleaning or maintenance when designing their modular cleanroom. Ongoing care and upkeep should be a key factor in ensuring the controlled environment’s long-term efficiency and function and optimal cleanliness.

Overlooking this aspect can ultimately lead to increased downtime and contamination risks while handling maintenance.

Cleanroom protocol

People naturally produce contaminants whether oil, flakes of skin, sweat hair within the clean room and precautions are necessary to limit their reach. Human behavior is also a factor on the room’s cleanliness. By moving too quicky or coughing or sneezing the environment is put at risk.

Certain behaviors are prohibited once inside the space to control contaminants but this doesn’t clean the room. 

• Leave personal items outside
• No gum, food or smoking inside
• No makeup, perfume or other cosmetics inside
• No running or moving quickly
• Don’t enter when ill

• Follow proper gowning/ungowning
• Practice good personal hygiene
• Cover hair
• No sitting or leaning on work surfaces or equipment
• No touching fact with gloved hands

Final Thought

Quality companies like Precision Environments Cleanrooms sets up modular controlled environments that require great attention to detail to maintain. A proactive and preventive approach to maintenance helps detect issues before significant issues arise. Click for safety guidelines in controlled environments.

By avoiding common mistakes, operators, can ensure optimal performance of their modular cleanroom, prolong equipment life, and maintain compliance with industry standards. By having the right protocol in place, a cleanroom will function as it’s intended to, safeguarding operational efficiency and product integrity.