Procedure for Cleaning of Dispensing Booths
| Department | Production/Quality Assurance |
|---|---|
| SOP No. | SOP/Ointment/008 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for cleaning dispensing booths used in the weighing and dispensing of raw materials for ointment manufacturing. The objective is to prevent cross-contamination, maintain a controlled environment, and ensure compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel responsible for the cleaning and maintenance of dispensing booths. It includes routine and deep cleaning procedures, cleaning agent selection, and record-keeping.
3. Responsibilities
- Production Operator: Conducts cleaning as per the prescribed schedule.
- Quality Control (QC) Personnel: Inspects the cleaning process and verifies cleanliness levels.
- Production Supervisor: Ensures compliance with cleaning procedures.
- Quality Assurance (QA) Officer: Conducts periodic audits and ensures adherence to GMP.
4. Accountability
The Production Manager is accountable for ensuring that all dispensing booths are cleaned as per the defined standards and that records are maintained.
5. Procedure
5.1 Cleaning Frequency
- Routine cleaning: After each dispensing session.
- Deep cleaning: Weekly or as required based on risk assessment.
- Cleaning after spillage: Immediate cleaning in case of contamination.
5.2 Pre-Cleaning Preparations
- Ensure the booth is free from any raw materials before starting cleaning.
- Turn off power supply
to any electrical equipment in the booth.
Wear appropriate personal protective equipment (PPE), including gloves, masks, and safety goggles.
Ensure that all required cleaning materials are available.
5.3 Routine Cleaning Procedure
- Use a lint-free cloth to wipe surfaces before applying cleaning agents.
- Clean all surfaces, including walls, weighing balances, and air filters, using 70% Isopropyl Alcohol (IPA).
- Ensure the floor and weighing platform are cleaned using a vacuum cleaner or mop with a disinfectant solution.
- Dispose of any waste materials in the designated hazardous waste disposal bins.
5.4 Deep Cleaning Procedure
- Remove detachable components such as air filters and clean them with a validated detergent.
- Clean hard-to-reach areas using a sterile mop or brush.
- Sanitize all surfaces using a validated disinfectant.
- Allow the booth to air-dry before resuming operations.
5.5 Cleaning Verification
- Inspect the booth after cleaning to ensure no residue is left behind.
- Perform swab testing on surfaces to check for microbial contamination.
- QC personnel must sign off the Cleaning Log once verification is complete.
5.6 Handling of Cleaning Equipment
- Ensure all cleaning tools are dedicated to the dispensing area.
- Store cleaning equipment in a designated area after use.
- Replace mops, cloths, and cleaning solutions as per the validation schedule.
5.7 Documentation and Record-Keeping
- Maintain Cleaning Logs for each dispensing booth.
- Record the cleaning date, time, and personnel involved.
- Ensure that cleaning records are reviewed and approved by QA.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- IPA – Isopropyl Alcohol
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Verification Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Log
| Date | Booth ID | Cleaning Agent Used | Cleaned By | Verified By |
|---|---|---|---|---|
| 01/02/2025 | Booth-01 | 70% IPA | John Doe | QA Officer |
| 02/02/2025 | Booth-02 | Validated Disinfectant | Jane Smith | QA Officer |
Annexure-2: Cleaning Verification Report
| Date | Booth ID | Surface Swabbed | Test Performed | Result | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | Booth-01 | Weighing Table | Microbial Count | Pass | QA Officer |
| 02/02/2025 | Booth-02 | Airflow Grille | Particle Count | Pass | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head | All | All | Created new SOP |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head | All | All | Revised to meet new documentation standards |