Life science companies that operate in restricted conditions understand that maintaining a cleanroom is not an option; it’s a necessity. When manufacturing drugs, handling biologics, or assembling medical devices, the risk of contamination must be dealt with utmost care. That’s where ISO 14644 comes in. This standard, recognized worldwide, outlines the rules for classifying, testing, monitoring, and cleaning cleanrooms to maintain a contamination-free environment.
At Servicon, we clean life sciences cleanrooms to meet or surpass ISO 14644 requirements. Our science-based methodology, combined with professionals who have been trained in the sector, and digital documentation systems, makes us the ideal cleaning partner for biotech, pharmaceutical, and medical device companies seeking compliance, readiness for audits, and operational efficiency.
An Overview of ISO 14644
The ISO 14644 set of standards covers cleanrooms and other controlled environments that are similar. It sets standards for airborne particle purity, monitoring, testing, and business operations. For businesses that make sterile or sensitive goods, following these rules is often required by law. Failing to follow them can lead to expensive shutdowns, product recalls, or loss of certification.
The two most talked-about elements of the ISO 14644 standard are:
- ISO 14644-1 sorts air purity based on how many particles are in it
- ISO 14644-2 establishes standards for regular monitoring and testing.
Adhering to these regulations requires more than just installing HEPA filters and monitoring air exchanges; it also necessitates a comprehensive approach to managing indoor air quality. Processes for cleaning surfaces, controlling contamination, and maintaining clear records of actions are crucial.
Classification Levels and Cleaning Protocols
According to ISO 14644-1, cleanrooms are classified by the number of particles in the air. ISO Class 1 is the cleanest, and ISO Class 9 is the dirtiest. Each class has set restrictions on the number of particles and their sizes in a cubic meter. The lower the class number, the more severe the cleanliness rules are.
Cleaning protocols are designed around these classifications:
- ISO Class 5–6 settings, which are often used for aseptic filling or microelectronics, require very low particle counts. You have to clean surfaces with approved, non-shedding wipes and sterile cleaning products many times a day
- ISO Class 7–8 cleanrooms usually enable less risky procedures, but they still need to be cleaned every day with certified disinfectants and lint-free materials
- ISO Class 9 may include general support spaces that don’t require frequent cleaning but still require robust contamination controls.
Servicon technicians are taught how to follow specific rules for each type of job, such as how to mop in one direction, prevent cross-contamination, and maintain a clean-to-dirty workflow. We also employ color-coded tools, double-bagging procedures, and mobile checklists that are updated in real-time to ensure people adhere to the rules.
Surface Contamination Limits
ISO 14644 primarily addresses particles in the air, but surface contamination is equally important. When microbial and non-viable particles build up on cleanroom surfaces, they can make products less sterile and break GMP rules.
Cleaning methods in cleanrooms must remove surface contaminants without generating particles or damaging materials. This means using:
- Wipes that are already soaked in isopropyl alcohol or hydrogen peroxide
- Mops that don’t react and don’t leave lint behind
- Mop heads and other single-use cleaning instruments.
Servicon utilizes ATP testing, UV inspection, and particle counts to ensure that surface contamination remains within permitted levels. These quality control methods help our life science clients stay in line with ISO 14644 and reduce the likelihood of unfavorable audit results.
Daily/Weekly Cleaning Standards
The rules for cleaning cleanrooms vary depending on the level of classification and the applicable regulations. But the following are standard practices:
Daily Cleaning Tasks:
- Wipe off any flat surfaces and areas that receive frequent use, such as benches, equipment, and doorknobs.
- Use a cleanroom-approved method to mop the floors
- Clean pass-throughs, airlocks, and areas where people put on gowns
- Clean the exterior of the equipment, ensuring the validated settings remain undisturbed.
Cleaning Tasks for the Week:
- Clean walls, doors, and other vertical surfaces
- Dust light fixtures, vents, and other things that are above your head (if ISO Class allows)
- If necessary, use sporicidal chemicals to disinfect more deeply
- To keep microbes from becoming resistant, switch up your cleaning products.
Servicon creates customized Standard Operating Procedures (SOPs) tailored to each facility’s level of risk, class of cleanroom, and operational schedule. These SOPs facilitate daily tasks while also enabling traceability and ongoing improvement.
Cleaning Procedures and Records
Documentation is a crucial component of adhering to ISO 14644. Facilities must be able to demonstrate how often, how, who cleans, what cleaning products are used, and what results are achieved.
Our digital technology enables Servicon teams to log cleaning work in real-time from their phones. We can send this data as part of our compliance package or integrate it with the client’s systems. It includes:
- Cleaning logs with time stamps
- Tracking materials
- Certifications for technician training
- Reports on deviations and corrective actions.
We also develop and maintain SOPs that are tailored to your facility and align with your quality system, whether based on GMP, FDA, or ISO standards. This proactive documentation architecture not only helps you meet ISO 14644 standards, but it also prepares your site for government audits and inspections.
What Are the Cleanroom Cleaning Requirements for ISO 14644 Compliance?
ISO 14644 states that cleanrooms must maintain clean air and surfaces by adhering to specific class-based particle limitations. To satisfy these standards, institutions must have a cleaning program that includes
- Cleaning surfaces regularly with products that don’t shed
- Disinfection procedures that fit the type of room
- Daily and regular deep cleaning
- Regular monitoring of the environment
- Written down SOPs and cleaning logs.
Using a universally applicable checklist will not ensure compliance. You need a cleaning plan that is based on research and can adapt as the facility’s demands and regulations change. Servicon’s cleanroom cleaning services are designed to meet these evolving needs.
What’s the Difference Between Terminal Cleaning and Routine Cleanroom Cleaning?
To keep the cleanroom at the ISO 14644 level, it is cleaned on a regular basis, either daily or weekly. It means cleaning surfaces, mopping floors, and disinfecting the outside of tools. These tasks are planned, written down, and carried out without stopping production or processes that have been shown to work.
On the other hand, terminal cleaning is a more thorough operation that usually happens after production stops, batch changes, or contamination events. Cleaning the terminal includes:
- Cleaning and disinfecting from the ceiling to the floor
- Taking apart and cleaning all equipment
- Use of sporicidal or sterilizing agents
- Thorough testing and validation of the environment.
Servicon offers both services, sending qualified personnel who know how to run a cleanroom, regulate bioburden, and write validation documents.
Partnering with a Tech-Savvy Cleanroom Cleaning Provider
Life science companies are facing increasingly complex and stringent regulations. It’s essential to work with a cleaning company that understands the science and has the tools to demonstrate compliance with the rules.
Servicon employs data-driven solutions, automation technologies, and technician training that comply with the highest industry standards to enhance the innovation of cleanroom cleaning. We are more than just a cleaning company; we are your compliance partner. We assist clients in establishing a culture of contamination control and managing the requirements for ISO 14644.
Are you ready to improve the standards of your cleanroom? Call Servicon today to find out how our top-notch cleaning and contamination control services may help your life science business.
