Precision in Cleanliness: Standard Operating Procedure (SOP) for Non-Viable Particle Count – Locations, Limits, and Frequency

• by Bhagya Lakshmi N
• 12 Nov 2009
• Coaching

Maintaining a clean and controlled environment is paramount in pharmaceutical manufacturing. This article introduces a detailed Standard Operating Procedure (SOP) for Non-Viable Particle Count, outlining specific locations, limits, and frequency of monitoring. Explore the systematic approach to ensuring cleanliness in critical areas, adhering to compliance standards, and safeguarding product quality.

A Standard Operating Procedure (SOP) for non-viable particle count is essential for monitoring and controlling airborne particulate contamination in critical areas of controlled environments, such as cleanrooms or pharmaceutical manufacturing facilities. This SOP outlines the procedure for conducting non-viable particle counting, including locations, limits, and frequency. Please customize it to suit your specific facility and regulatory requirements.

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Standard Operating Procedure (SOP) for Non-Viable Particle Count

Objective: To establish a standardized procedure for conducting non-viable particle counting in critical areas of controlled environments, ensuring compliance with cleanliness standards and maintaining product quality.

Scope: This SOP applies to all personnel responsible for conducting non-viable particle counting in the facility&39;s controlled environments.

Responsibility:

• The Environmental Monitoring (EM) Coordinator or designated personnel are responsible for implementing and overseeing this SOP.
• Qualified personnel, trained in particle counting, are responsible for conducting particle counting.

Materials and Equipment:

• Particle counter(s) calibrated per manufacturer&39;s recommendations.
• Clean, lint-free wipes or cloths.
• Approved cleaning solutions for the particle counter.
• Personal Protective Equipment (PPE), including gloves and lab coats.

Procedure:

1. General Precautions:

   a. Ensure that the particle counter(s) are calibrated and validated according to the manufacturer&39;s specifications.

   b. Perform any necessary pre-use checks on the particle counter(s) as per the manufacturer&39;s instructions.

   c. Put on the appropriate PPE, including gloves and lab coats.

2. Location Selection:

   a. Identify the critical areas within the facility where non-viable particle counting is required. These locations should be determined based on the facility&39;s risk assessment and regulatory requirements.

   b. Document the selected locations in an Environmental Monitoring Plan (EMP) or equivalent document.

3. Frequency of Testing:

   a. Determine the frequency of non-viable particle counting for each location based on risk assessment, regulatory guidelines, and internal quality standards.

   b. Typically, high-risk areas may require more frequent monitoring (e.g., daily or weekly) compared to lower-risk areas (e.g., monthly or quarterly).

4. Particle Counting Procedure:

   a. Ensure that the particle counter is set to the appropriate sampling time and flow rate according to regulatory requirements and the facility&39;s SOPs.

   b. Start the particle counter and place it in the center of the selected location at the predetermined sampling height.

   c. Allow the particle counter to sample for the required duration, ensuring that it remains undisturbed during sampling.

   d. Record the particle count data, including the number and size of particles per cubic meter (as required by regulatory standards).

   e. If any anomalies or unusual readings are observed during sampling, investigate and document potential causes.

5. Data Analysis:

   a. Analyze the particle count data to determine compliance with established cleanliness limits and quality standards.

   b. If the particle count data exceeds established limits, initiate appropriate corrective and preventive actions (CAPA) as per the facility&39;s SOPs.

6. Reporting:

   a. Document the results of the particle counting, including location, date, time, particle count data, and any corrective actions taken.

   b. Report any out-of-specification results to the appropriate personnel and regulatory authorities as required.

7. Cleaning of Equipment:

   a. After use, clean and sanitize the particle counter(s) per the manufacturer&39;s recommendations and facility SOPs.

8. Documentation and Record Keeping:

   a. Maintain records of all particle counting activities, including results, locations, and any associated CAPA.

   b. Retain records in a secure and organized manner for regulatory compliance and internal auditing purposes.

Training:

Ensure that all personnel involved in non-viable particle counting are trained on this SOP, particle counting techniques, and the importance of cleanliness and data integrity.

References:

Reference relevant regulatory guidelines, industry standards, and internal quality standards that pertain to your specific operations.

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This SOP provides a framework for conducting non-viable particle counting in critical areas of controlled environments. Customize it to your specific facility requirements, cleanliness limits, and regulatory obligations. Regularly review and update the SOP to ensure it remains current and effective.