Guide to ISO Class 7 cleanroom cleaning procedures

An ISO Class 7 cleanroom is a controlled environment that maintains strict cleanliness levels to prevent contamination in sensitive manufacturing processes. According to ISO 14644-1, a Class 7 cleanroom must not exceed 352,000 particles per cubic meter (≥0.5 microns). Compliance with these standards ensures that industries such as pharmaceuticals, electronics, and aerospace maintain product integrity and meet regulatory requirements.

Beyond particle count limitations, cleanrooms must adhere to Good Manufacturing Practice (GMP) Annex 1, ensuring control over air changes per hour (ACPH), filtration efficiency, and pressure differentials between classified areas. These cleanrooms are equipped with HEPA filters, smooth surfaces to minimize particle accumulation, and strict gowning protocols to reduce contamination risks.

The importance of proper cleaning procedures

Maintaining rigorous cleaning procedures in an ISO Class 7 cleanroom is essential to ensure compliance and prevent contamination. Improper cleaning can lead to microbial growth, cross-contamination, and costly product recalls. In regulated industries like pharmaceuticals, contamination can directly impact patient safety and result in regulatory non-compliance.

Failing to adhere to cleaning standards poses significant risks, including:

Product contamination and batch rejection
Increased regulatory non-compliance risks
Microbial excursions requiring costly remediation
Potential reputational damage due to failed audits

A structured cleaning protocol is essential to mitigate these risks and maintain a controlled environment.

Essential tools and materials for cleanroom cleaning

To maintain compliance with ISO Class 7 standards, specialized cleaning tools and materials are required. These include:

Tool/Material	Purpose
Non-shedding mops & wipes	Prevents introduction of foreign particles
Sterile water & isopropyl alcohol (IPA)	Disinfection of surfaces
HEPA-filtered vacuum systems	Removes fine particles
Disposable or autoclave-safe cleaning cloths	Ensures sterility in cleaning practices
Pre-validated disinfectants	Complies with ISO 14644 & GMP Annex 1

Using incorrect materials, such as shedding cloths or unvalidated chemicals, can introduce contaminants rather than eliminate them, making it essential to select the right cleaning agents and tools for the cleanroom environment.

Step-by-step cleaning procedures

Cleaning an ISO Class 7 cleanroom follows a structured approach to maintain hygiene and regulatory compliance.

Pre-cleaning preparation

Before cleaning begins, personnel must wear ISO-compliant cleanroom garments, including coveralls, gloves, shoe covers, hoods, and goggles. Cleaning solutions and tools should be gathered in advance, and large debris should be removed using a HEPA-filtered vacuum.

Cleaning sequence (Top-to-bottom approach)

The cleaning process should always follow a top-to-bottom method, ensuring that airborne particles are effectively removed.

Area	Cleaning Method
Ceilings & walls	Wipe with sterile, low-lint mop & IPA
Work surfaces & equipment	Wipe with sterile disinfectant
Floors	Mop with non-shedding mop & sterile disinfectant
High-touch areas (door handles, switches)	Clean with IPA wipes

Post-cleaning validation

After cleaning, a thorough inspection is conducted to check for residues or streaks. Environmental monitoring, including particle count and surface bioburden testing, is performed to confirm compliance. Cleaning logs should be documented as per GMP and ISO 14644 standards.

Common challenges and solutions in cleanroom cleaning

Challenge	Solution
Inconsistent cleaning by staff	Implement regular training & audits
Cross-contamination from personnel	Enforce strict gowning & entry protocols
Equipment malfunction leading to contamination	Schedule routine equipment maintenance
Improper cleaning technique	Use validated cleaning protocols & checklists

Regular quality audits and personnel training ensure that protocols are consistently followed, reducing contamination risks.

Training and certification for cleanroom personnel

Advancements in technology are helping improve the efficiency of cleanroom cleaning processes. Some key innovations include:

Automated robotic cleaners reduce human contact with surfaces.
RFID tracking for garments and equipment ensures compliance with lifecycle management.
Airborne particle monitoring sensors provide real-time contamination detection, enabling proactive interventions to maintain cleanliness standards.

Leveraging these advanced technologies minimizes contamination risks and enhances regulatory compliance, making cleanroom management more effective and reliable.

The role of technology in better cleaning processes

Modern technology plays a significant role in enhancing the efficiency of cleaning processes in ISO Class 7 cleanrooms. Automated cleaning systems, such as robotic vacuum cleaners and mopping robots, can reduce the time and effort required to maintain cleanliness. These systems are designed to operate with minimal human intervention, reducing the risk of contamination from personnel.

Advanced monitoring technologies, including sensors and data analytics, provide real-time insights into the cleanroom’s conditions. These tools enable proactive interventions, allowing for adjustments to cleaning schedules and methods based on actual contamination levels. By leveraging technology, cleanroom operators can achieve a higher standard of cleanliness while optimising resource use and minimising downtime.

Ensure hygiene, safety & compliance of garments with Lindström’s cleanroom service

Maintaining an ISO Class 7 cleanroom requires more than just cleaning—it demands validated garments, controlled laundering, and traceable contamination control measures. Lindström’s cleanroom rental services provide: