Standard Operating Procedure for Sanitizing the Manufacturing Area

1) Purpose

The purpose of this SOP is to establish a standardized procedure for sanitizing the manufacturing area to ensure a contamination-free environment for the production of ocular dosage forms.

2) Scope

This SOP applies to all manufacturing areas 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 sanitization procedures, documenting sanitization activities, and ensuring that the manufacturing area meets the specified sanitization standards. Sanitization personnel are responsible for performing and documenting the sanitization tasks, while quality assurance personnel are responsible for verifying and approving the sanitization records.

4) Procedure

4.1 Sanitization Schedule

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

4.2 Preparation for Sanitization

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

4.3 Sanitization Activities

1. Surface Sanitization:
   1. Sanitize all surfaces, including walls, floors, ceilings, and equipment, using approved sanitizing agents.
   2. Use clean wipes or mops for each sanitization session to prevent cross-contamination.
   3. Follow a top-to-bottom sanitization 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 sanitized 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 Sanitization:
   1. Vacuum the floors using a HEPA-filtered vacuum cleaner to remove loose particles and debris.
   2. Mop the floors with an approved sanitizing 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 manufacturing area.
4. Equipment Sanitization:
   1. Sanitize and disinfect all equipment used in the manufacturing area according to the equipment-specific sanitization procedures.
   2. Ensure that all detachable parts are sanitized and disinfected thoroughly.
   3. Reassemble the equipment after sanitization and verify its cleanliness before use.

4.4 Documentation

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

4.5 Review and Approval

1. The quality assurance personnel should review the sanitization 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. Sanitization schedule
2. Sanitization logbook
3. Disinfectant usage records

7) Reference, if any

GMP Guidelines for Sanitization Procedures in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0