Standard Operating Procedure for Air Sampling for Environmental Monitoring
SOP Version: 1.0
Purpose:
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for air sampling during environmental monitoring in the pharmaceutical manufacturing facility. Air sampling is conducted to assess the microbial contamination in critical areas, equipment, and utilities, in compliance with relevant pharmacopeias and pharmaceutical references.
Scope:
This SOP applies to all personnel involved in air sampling activities as part of environmental monitoring in the pharmaceutical manufacturing facility. It covers the preparation, sampling, handling, and analysis of air samples, ensuring accurate and reliable results for microbial contamination assessment.
Responsibilities:
Quality Assurance (QA):
Ensure compliance with this SOP and related procedures.
Provide oversight and guidance on air sampling activities.
Review and approve air sampling results and reports.
Microbiology Laboratory:
Perform analysis of air samples following approved procedures.
Maintain and calibrate laboratory equipment used for analysis.
Document and report air sampling results accurately.
Manufacturing Personnel:
Execute air sampling procedures in designated critical areas, equipment, and utilities.
Adhere to proper aseptic techniques and safety measures during air sampling.
Report any deviations or incidents related to air sampling to QA.
Procedure:
Air Sampling Preparation:
a. Review the air sampling schedule for the designated areas, equipment, and utilities.
b. Ensure availability of appropriate air sampling devices, such as active or passive samplers.
c. Verify that personnel involved in air sampling are adequately trained in aseptic techniques and safety procedures.
Sampling Equipment Setup:
a. Assemble and set up the air sampling device as per the manufacturer’s instructions.
b. Ensure proper calibration and verification of the air sampler, following the approved procedure.
c. Record the necessary information, such as equipment identification and calibration details.
Sampling Procedure:
a. Disinfect hands and don appropriate personal protective equipment (PPE) before initiating the sampling process.
b. Position the air sampler at the designated location, considering airflow patterns and critical areas.
c. Activate the air sampler as per the approved procedure, ensuring appropriate sampling duration and flow rate.
d. Ensure that the air sampler is not obstructed and remains undisturbed during the sampling period.
e. Record the sampling details, including the location, date, time, and sampling duration.
Air Sample Handling:
a. After completing the air sampling, carefully deactivate the air sampler and remove it from the sampling location.
b. Disassemble and clean the sampling equipment as per the approved cleaning procedure.
c. Place any collection media (e.g., agar plates) into appropriate containers for transport to the microbiology laboratory.
d. Label each container with unique identifiers, including the sampling location, date, and time.
e. Complete the required documentation, including sample log and chain of custody records.
Air Sample Analysis:
a. Transfer the air samples to the microbiology laboratory without delay, maintaining appropriate temperature conditions.
b. Perform microbial analysis of air samples following approved test methods and procedures.
c. Record all observations and results accurately, ensuring appropriate documentation and data integrity.
d. Notify QA of any out-of-specification results or deviations from established acceptance criteria.
Data Evaluation and Reporting:
a. Review and verify all air sampling data for completeness and accuracy.
b. Compare the results against established acceptance criteria and reference standards.
c. Prepare air sampling reports, including trends, deviations, and corrective actions.
d. Submit the reports to QA for review and approval.
Abbreviations:
PPE: Personal Protective Equipment
Documents:
Air Sampling Schedule
Air Sampling Log and Chain of Custody Records
Test Methods and Procedures
Air Sampling Reports
References:
[Insert relevant pharmacopeia reference]
[Insert relevant pharmaceutical industry guidelines or standards]
Note: The references should be specific to the applicable regulations and guidelines in your region.