Cleanroom Cleaning Standards, Procedures, and Protocols for Biotech and Pharmaceutical Facilities

In biotech and pharmaceutical facilities, maintaining a contaminant-free environment is paramount. Cleanrooms and laboratories are highly controlled environments where even the slightest contamination can compromise the quality of products, research outcomes, and regulatory compliance. In the San Jose and San Francisco Bay area, where many biotech and pharmaceutical companies thrive, strict adherence to cleanroom cleaning standards is essential to ensure product safety and effectiveness.

In this blog, we explore the critical cleaning standards, procedures, and protocols specific to biotech and pharmaceutical cleanrooms, detailing the regulatory requirements and providing examples of Standard Operating Procedures (SOPs) that guide cleaning operations in these facilities.

 

Understanding Cleanroom Standards

Cleanrooms are classified by the number of particles (of a specified size) per cubic meter of air, based on standards such as ISO 14644-1. Biotech and pharmaceutical facilities commonly adhere to these classifications to maintain air quality and control contamination levels.

• ISO 14644-1 Classification: The most widely used standard for cleanrooms. The classification ranges from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean).
• USP 797 and 800: U.S. Pharmacopeia standards for sterile compounding and hazardous drug handling, respectively, outlining procedures for maintaining cleanliness and reducing exposure to contamination.
• Good Manufacturing Practices (GMP): These are regulations enforced by the FDA for pharmaceutical and biotech manufacturing, focusing on cleanliness, hygiene, and contamination control.

Importance of Cleanroom Cleaning

Cleanrooms must be free of dust, microbes, chemical residues, and other contaminants to protect the integrity of the processes within. In biotech and pharmaceutical industries, contamination could result in:

• Product recalls: If contaminants are found in the products, they must be recalled, leading to financial losses and potential reputational damage.
• Regulatory non-compliance: Regulatory bodies such as the FDA and EMA (European Medicines Agency) impose strict cleanliness standards.
• Compromised research and testing: Contaminants can skew research results, making them unreliable or invalid.

Given these risks, robust cleaning standards, procedures, and protocols must be implemented to ensure the environment remains within acceptable cleanliness limits.

Cleanroom Cleaning Protocols

1. Daily Cleaning Procedures

Daily cleaning is vital to maintaining a cleanroom environment. It ensures that no significant buildup of contaminants occurs and prevents particles and microbes from reaching levels that may jeopardize cleanliness standards.

• Surfaces: All surfaces, including workbenches, walls, and equipment, should be wiped down with lint-free wipes soaked in an approved cleaning agent (e.g., 70% isopropyl alcohol).
• Floors: Cleanroom floors are cleaned daily with HEPA-filtered vacuum cleaners and mopped with sterile, non-linting mops.
• Air Showers: Personnel and equipment should go through air showers to remove particles before entering the cleanroom. These showers require daily cleaning of filters and surfaces.
• Cleanroom Garments: Workers must wear clean, sterilized garments each day and dispose of used garments in controlled waste bins.

Example SOP for Daily Cleaning:

• Step 1: Begin by HEPA vacuuming the floors.
• Step 2: Wipe all accessible surfaces with 70% isopropyl alcohol using sterile wipes.
• Step 3: Use a pre-saturated mop for all floor surfaces.
• Step 4: Check and record the pressure differential of cleanroom airlocks to ensure proper air filtration.

2. Weekly and Monthly Cleaning

Weekly and monthly cleaning targets areas that are not frequently accessed or touched but are still susceptible to contamination. This includes deep cleaning of walls, ceilings, and hard-to-reach areas.

• Walls and Ceilings: Cleanroom walls and ceilings must be wiped with approved solutions weekly to avoid particle and microbial buildup.
• Ventilation Systems: HEPA filters in ventilation systems should be checked weekly, and air ducts should be inspected for dust accumulation.
• Equipment: Laboratory and manufacturing equipment must be fully decontaminated on a weekly or monthly basis depending on usage frequency.

Example SOP for Weekly Cleaning:

• Step 1: Wipe down walls and ceilings using sterile wipes and approved cleaning solutions.
• Step 2: Disassemble non-essential equipment for deep cleaning with disinfectant.
• Step 3: Inspect HEPA filters in ventilation systems and vacuum duct grates if necessary.
• Step 4: Record cleaning data in a log for compliance tracking.

3. Spill Response Cleaning

In the biotech and pharmaceutical industries, chemical or biological spills pose a significant risk. Proper spill response procedures ensure that spills are quickly and safely contained without spreading contaminants.

Spill Response Protocols:

• Step 1: Isolate the spill area immediately, restricting access.
• Step 2: Use an approved absorbent material to contain the spill.
• Step 3: Apply the appropriate disinfectant or neutralizing agent based on the substance spilled.
• Step 4: Dispose of contaminated materials in biohazard or chemical waste containers as required by the facility’s waste management policy.
• Step 5: Conduct a final decontamination of the area and equipment, ensuring the cleaning meets cleanroom standards.

Example SOP for Spill Response:

• Step 1: Notify the cleanroom supervisor immediately.
• Step 2: Don appropriate PPE (personal protective equipment).
• Step 3: Use absorbent pads to soak up the liquid, and then clean the area with a disinfectant solution.
• Step 4: Properly dispose of used absorbent pads and any contaminated clothing in hazardous waste bins.

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Cleaning Agents and Equipment

1. Cleaning Agents

Cleanroom cleaning agents must be carefully selected to ensure they do not introduce new contaminants into the environment.

• Disinfectants: The most commonly used disinfectants are 70% isopropyl alcohol (IPA), quaternary ammonium compounds, and hypochlorite solutions. These disinfectants are effective against a wide range of microbes and are used to sanitize surfaces, floors, and equipment.
• Detergents: Detergents are used to remove organic matter and residues that could interfere with sterilization. They are usually followed by disinfectants to ensure thorough microbial removal.
• Sterile Water: In biotech and pharmaceutical cleanrooms, sterile water may be used for rinsing and mopping to avoid introducing minerals and contaminants found in tap water.

Example SOP for Disinfectant Application:

• Step 1: Ensure all surfaces are free of dust and debris before applying disinfectant.
• Step 2: Apply 70% IPA or another approved disinfectant to all critical surfaces using sterile wipes.
• Step 3: Allow disinfectant to air-dry to ensure the required contact time is achieved.

2. Cleaning Equipment

• HEPA Vacuums: High-Efficiency Particulate Air (HEPA) vacuums are crucial for removing fine particles from floors, walls, and surfaces. They are designed to trap particles as small as 0.3 microns.
• Sterile Wipes and Mops: These non-linting cleaning tools ensure that no fibers or particles are left behind during the cleaning process.
• Autoclaves: In pharmaceutical cleanrooms, autoclaves are used to sterilize equipment and cleaning tools before they are used in the controlled environment.

Example SOP for Equipment Cleaning:

• Step 1: Pre-clean all surfaces to remove visible dirt.
• Step 2: HEPA vacuum the area to remove fine particles.
• Step 3: Use a sterile, pre-saturated mop to clean floors. Change mop heads frequently to avoid cross-contamination.

Regulatory Compliance and Record-Keeping

Biotech and pharmaceutical facilities must maintain meticulous records of their cleaning procedures for regulatory compliance. This includes:

• Cleaning logs: Detailed records of the date, time, and personnel involved in each cleaning procedure.
• SOP adherence: Regular reviews of cleaning SOPs to ensure they comply with ISO standards and FDA regulations.
• Audits: Regular internal and external audits are conducted to ensure cleanroom cleaning procedures meet regulatory standards.

Example SOP for Record-Keeping:

• Step 1: After each cleaning session, record the time, date, and personnel involved.
• Step 2: Note any deviations from the SOP and explain corrective actions taken.
• Step 3: Store cleaning logs in a secure location for review during audits.

Maintaining biotech and pharmaceutical cleanrooms in the San Jose and San Francisco Bay area requires strict adherence to cleaning standards, protocols, and SOPs. To determine how SourceONE Building Maintenance can help you clean your cleanrooms and laboratories, please phone us at (408) 437-3046 or complete our Contact Us form and we will connect with you.