Standard Operating Procedure for Cleaning the Clean Room

1) Purpose

The purpose of this SOP is to establish a standardized cleaning procedure for the clean room to ensure it remains free from contaminants and maintains the required cleanliness levels for the production of ocular dosage forms.

2) Scope

This SOP applies to all clean rooms used in the production of ocular dosage forms within the pharmaceutical manufacturing facility, including areas for the production of eye drops, ointments, gels, and inserts.

3) Responsibilities

The responsibilities include planning and executing the cleaning procedures, documenting the cleaning activities, and ensuring that the clean room meets the specified cleanliness standards. Cleaning personnel are responsible for performing and documenting the cleaning tasks, while quality assurance personnel are responsible for verifying and approving the cleaning records.

4) Procedure

4.1 Cleaning Schedule

1. Develop a cleaning schedule that specifies the frequency of cleaning activities for the clean room.
2. Ensure that the cleaning schedule is reviewed and approved by the quality assurance department.
3. Communicate the cleaning schedule to all relevant personnel and ensure that cleaning activities are planned accordingly.

4.2 Preparation for Cleaning

1. Ensure that all cleaning personnel are trained in the proper cleaning procedures and use of cleaning agents.
2. Gather all necessary cleaning materials, including cleaning agents, disinfectants, mops, wipes, and protective equipment.
3. Verify that the clean room is free from any production activities before starting the cleaning process.
4. Wear appropriate protective clothing and equipment to prevent contamination of the clean room.

4.3 Cleaning Activities

1. Surface Cleaning:
   1. Clean all surfaces, including walls, floors, ceilings, and equipment, using approved cleaning agents.
   2. Use clean wipes or mops for each cleaning session to prevent cross-contamination.
   3. Follow a top-to-bottom cleaning approach to ensure that contaminants are removed effectively.
   4. Pay special attention to high-touch areas and equipment surfaces.
2. Disinfection:
   1. Apply an approved disinfectant to all cleaned surfaces according to the manufacturer’s instructions.
   2. Allow the disinfectant to remain on the surfaces for the recommended contact time to ensure effective disinfection.
   3. Wipe off any excess disinfectant after the contact time has elapsed.
3. Floor Cleaning:
   1. Vacuum the floors using a HEPA-filtered vacuum cleaner to remove loose particles and debris.
   2. Mop the floors with an approved cleaning solution, ensuring that the mop is regularly changed to prevent contamination.
   3. Allow the floors to air dry completely before resuming any activities in the clean room.
4. Equipment Cleaning:
   1. Clean and disinfect all equipment used in the clean room according to the equipment-specific cleaning procedures.
   2. Ensure that all detachable parts are cleaned and disinfected thoroughly.
   3. Reassemble the equipment after cleaning and verify its cleanliness before use.

4.4 Documentation

1. Record all cleaning activities, including the date, time, and details of the tasks performed, in the cleaning logbook.
2. Ensure that the logbook entries are signed and dated by the cleaning personnel who performed the tasks.
3. Submit the completed cleaning logbook to the quality assurance department for review and approval.

4.5 Review and Approval

1. The quality assurance personnel should review the cleaning logbook for completeness, accuracy, and compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved before approving the logbook entries.
3. Once the logbook entries are approved, they should be signed and dated by the quality assurance personnel.

5) Abbreviations, if any

HEPA: High-Efficiency Particulate Air

6) Documents, if any

1. Cleaning schedule
2. Cleaning logbook
3. Disinfectant usage records

7) Reference, if any

GMP Guidelines for Cleaning Procedures in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0