1.0 Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for non-viable particle counting in the controlled environment of the sterile manufacturing and testing areas, specifically in the Microbiology Lab. Non-viable particle counting is essential to evaluate the cleanliness and control of the particulate matter in these areas to ensure the integrity of sterile products and accurate test results.
2.0 Scope
This SOP applies to all personnel involved in non-viable particle counting in the sterile manufacturing and testing areas.
3.0 Responsibilities
3.1 Laboratory Manager:
Ensuring the implementation and adherence to this SOP.
Providing necessary resources for non-viable particle
counting.
Reviewing and approving non-viable particle count reports.
3.2 Laboratory Personnel:
Following this SOP for non-viable particle counting.
Performing non-viable particle counting accurately and in a
timely manner.
Reporting any deviations or abnormalities to the laboratory
manager.
4.0 Equipment and Materials
4.1 Particle Counter: Calibrated and validated particle
counter capable of counting particles in the appropriate size range for the
controlled environment.
4.2 Cleanroom Supplies: Lint-free wipes, isopropyl alcohol,
cleanroom gloves, and any additional supplies as required.
4.3 Data Recording: Logbook or electronic data recording system.
5.0 Procedure
5.1 Preparation
5.1.1 Wear cleanroom gloves and appropriate personal
protective equipment (PPE) before entering the controlled environment.
5.1.2 Clean the particle counter according to the
manufacturer's instructions.
5.1.3 Calibrate and validate the particle counter before
each use as per the laboratory's calibration schedule.
5.1.4 Ensure that the particle counter is set to the
appropriate mode for non-viable particle counting.
5.1.5 Verify that the particle counter is in good working condition and free from any defects.
5.2 Sampling Locations
5.2.1 Identify the sampling locations within the sterile
manufacturing and testing areas based on the predetermined sampling plan.
5.2.2 Clean the sampling points using lint-free wipes
moistened with isopropyl alcohol. Ensure thorough cleaning, paying attention to
corners and hard-to-reach areas.
5.2.3 Allow the cleaned surfaces to air dry completely
before proceeding.
5.2.4 Ensure that the environmental conditions, such as temperature and humidity, are within the specified range for accurate particle counting.
5.3 Sampling Procedure
5.3.1 Turn on the particle counter and select the
appropriate sample size and sampling duration.
5.3.2 Position the particle counter probe at the designated
sampling point, ensuring that the probe is steady and properly aligned.
5.3.3 Start the sampling process and ensure that the
particle counter is functioning correctly.
5.3.4 Record the sampling location, date, time, and other relevant information in the logbook or electronic data recording system.
5.4 Data Collection
5.4.1 Monitor the particle counter display during the
sampling process to ensure accurate readings.
5.4.2 At the end of the sampling duration, record the final
particle count displayed by the particle counter.
5.4.3 Repeat the sampling process for each designated
sampling location within the sterile manufacturing and testing areas.
5.4.4 Document the non-viable particle count data, including the average particle count for each location, in a report.
5.5 Data Analysis and Reporting
5.5.1 Compare the measured particle counts with the
established cleanliness limits or acceptance criteria specified for the sterile
manufacturing and testing areas.
5.5.2 Evaluate the cleanliness of the controlled environment
based on the comparison results.
5.5.3 Document the non-viable particle count data, analysis,
and any deviations from the acceptance criteria in the report.
5.5.4 Notify the laboratory manager of any deviations from the acceptance criteria and take appropriate corrective actions as required.
6.0 Documentation and Records
6.1 Maintain a logbook or electronic data recording system
for recording all non-viable particle count data, including sampling locations,
dates, times, and results.
6.2 Retain all non-viable particle count reports and
associated documentation for the specified retention period as per the
laboratory's record-keeping policy.
Note: This SOP should be reviewed periodically to ensure its
continued relevance and effectiveness. Any updates or changes to the procedure
should be documented, communicated to the relevant personnel, and implemented
accordingly.
END OF THE DOCUMENT
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