Cleanrooms are designed to be isolated, strictly controlled and...clean. A stable environment is necessary to ensure consumer and employee safety and maintain the integrity of the product. Microbial contaminants present a threat to cleanrooms that could result in product recalls, fines, and even consumer illness or death.
What Causes Cleanroom Contamination?
The biggest threat to a cleanroom’s integrity is human error. By simply touching a contaminated surface, one employee is capable of spreading harmful microorganisms all throughout your facility. It is essential that all personnel are trained, practice good hygiene, and only use compliant equipment and cleaning supplies.
Environmental factors also contribute to a cleanroom’s vulnerability to contamination. Companies can be proactive by strictly controlling the cleanroom’s temperature, humidity, airflow, air filtration, and lighting.
Understanding Your Cleanroom’s Microbiology
Microorganisms are complex, resilient, and easily transmittable. Your company can’t afford to leave safety to chance. Industry experts like Sure-BioChem Laboratories can identify and categorise microorganisms in order to create the most efficient plan for eliminating the contaminant. SBL’s professional team will be able to determine the microorganism’s:
- optimal growth temperature
- spore production
- atmospheric requirements for survival
With a clear understanding of your cleanroom’s microbiology, SBL can recommend the optimal solution for maintaining your facilities.
Cleanroom Best Practices
Knowledge of cleanroom microbiology must be paired with trained personnel and consistent processes and protocols. The Food and Drug Administration enforces Current Good Manufacturing Practice (CGMP) regulations that require companies to establish strong quality management systems and reliable testing laboratories 1. By following CGMPs, your company reduces its risk of cleanroom contamination and avoids failed-inspection penalties.
Cleanroom protocols that can prevent contamination include:
Good Employee Hygiene - Contaminants can hitch a ride into the cleanroom through an employee’s skin flakes, hair, cosmetic products and even perfume or cologne. Companies should enforce uniform hygiene practices for any employee entering the cleanroom. Exclusive Cleanroom Supplies - Any piece of equipment that travels in and out of the cleanroom could jeopardise the controlled environment. All cleanroom equipment, tools and instruments should be compliant with company standards and designated as cleanroom-only supplies.
Proper Use of Personal Protective Equipment - Due to the COVID-19 pandemic, the entire world is now aware of how contaminants can be spread through particles of saliva. Proper face masks can protect cleanrooms from the threats posed by human coughs and sneezes. Limiting conversation in the cleanroom can also reduce the number of saliva particles emitted into the air. Employees who wear protective garments should follow procedures for dressing and undressing since contaminants are susceptible to the pull of gravity.
Aseptic Processing - Aseptic processing facilities include easily cleanable floors, walls and ceilings of smooth hard surfaces, temperature and humidity controls, and HEPA filters to filter the air supply into the cleanroom. Aseptic processes also include procedures for using sterile instruments and gloves 2.
SBL specialises in providing complete turnkey services centered around environmental microbiological monitoring and testing. Our specialists provide onsite location sampling and consulting. SBL’s experience in monitoring and analysing highly regulated environments makes us an invaluable asset to your cleanroom and the overall safety of your organisation.
