Standard Operating Procedure for Microbial Air Sampler
1) Purpose
The purpose of this SOP is to provide guidelines for the operation and calibration of the Microbial Air Sampler used in the clean room environment for manufacturing ocular dosage forms.
2) Scope
This SOP applies to all Microbial Air Samplers used to monitor microbial contamination levels in the air of clean rooms during the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities include the operation, calibration, and maintenance of the Microbial Air Sampler. Facility engineers are responsible for following this procedure, and the maintenance team is responsible for calibration and periodic checks.
4) Procedure
4.1 Start-Up Procedure
- Ensure the Microbial Air Sampler is properly installed and calibrated.
- Verify that the sampler is set up according to the sampling plan and location.
- Record the initial readings of microbial counts for each clean room area.
4.2 Operation
- Perform routine microbial sampling according to the sampling plan and schedule.
- Follow the manufacturer’s instructions for sample collection and analysis.
- Record microbial counts and any deviations from specified limits.
4.3 Calibration
- Calibrate the Microbial Air Sampler annually or as per the manufacturer’s recommended schedule.
- Use calibrated microbial standards and follow documented procedures for calibration.
- Record calibration results and adjustments made in the calibration logbook.
4.4 Maintenance
- Perform regular inspections to ensure the Microbial Air Sampler is clean and free from physical damage.
- Replace filters and other consumable parts as recommended by the manufacturer.
- Document any maintenance activities performed in the logbook.
5) Abbreviations, if any
None
6) Documents, if any
- Calibration logbook
- Maintenance records
7) Reference, if any
GMP Guidelines for pharmaceutical manufacturing facilities and clean room environmental monitoring.
8) SOP Version
Version 1.0