spatulas, laminar air flow (LAF) hoods, and stainless steel containers used in the dispensing area of sterile injectable manufacturing.

3. Responsibilities

• Dispensing Operator: Responsible for executing the cleaning and reporting any abnormalities.
• Engineering Department: Responsible for performing preventive maintenance.
• QA Department: To verify cleanliness and compliance before equipment use.

4. Accountability

Head – Production and Head – QA shall be accountable for the effective implementation of this SOP.

5. Procedure

5.1 Cleaning Procedure

1. Ensure that the equipment is switched off and unplugged before cleaning.
2. Wear appropriate PPE such as gloves, mask, and gown.
3. Disassemble any detachable parts of the equipment.
4. Clean each part using 70% IPA and lint-free wipes or as per equipment-specific cleaning agent mentioned in Annexure-1.
5. For equipment used with hazardous materials, follow additional decontamination steps as defined in SOP/SIM/101/2025.
6. Allow cleaned parts to air dry in a clean area under LAF.
7. Reassemble and check for functional integrity.

5.2 Cleaning Frequency

• Routine Cleaning: After each batch or material change.
• Periodic Cleaning: Once per week for equipment in idle condition.

5.3 Preventive Maintenance

1. Engineering department shall maintain a Preventive Maintenance Schedule (Annexure-2).
2. Activities include:
   • Balance calibration and alignment
   • LAF filter integrity test
   • Lubrication of movable parts
   • Electrical safety checks
3. Record all maintenance in Equipment Logbook (Annexure-3).

5.4 Equipment Labeling Post-Cleaning

Affix a ‘CLEANED’ status label on the equipment, signed and dated by the responsible person. Change to ‘TO BE CLEANED’ after use or if idle beyond 72 hours.

5.5 Documentation

• Fill Cleaning Record Sheet (Annexure-4) after every cleaning cycle.
• Attach it to the Batch Record or Equipment History Folder.

6. Abbreviations

• LAF: Laminar Air Flow
• IPA: Isopropyl Alcohol
• PPE: Personal Protective Equipment
• QA: Quality Assurance

7. Documents

1. Cleaning Agent Reference List – Annexure-1
2. Preventive Maintenance Schedule – Annexure-2
3. Equipment Logbook – Annexure-3
4. Cleaning Record Sheet – Annexure-4

8. References

• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• Internal Validation Report on Equipment Cleaning

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Dispensing Operator	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cleaning Agent Reference List

• 70% IPA – General purpose use
• Detergent-based solution – For greasy residues
• Sodium hypochlorite – For microbial decontamination

Annexure-2: Preventive Maintenance Schedule

Monthly and quarterly checklist for dispensing equipment including calibration status.

Annexure-3: Equipment Logbook

Record of maintenance activities, date, remarks, and signatures.

Annexure-4: Cleaning Record Sheet

Date	Equipment	Cleaning Done By	QA Verified	Remarks
18/06/2025	Balance B-12	A. Joshi	P. Rana	OK

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial issue	New SOP	QA Head
18/06/2025	2.0	Updated with preventive maintenance and labeling procedures	GMP enhancement	QA Head