SOP applies to all injectable filling machines used in sterile areas, including vial filling, syringe filling, and ampoule filling machines, at the [Insert Facility Name].

3. Responsibilities

• Production Operator: Perform cleaning as per SOP and record all activities.
• Production Supervisor: Monitor cleaning operations and verify completion.
• QA Executive: Verify cleanliness visually and through swab/rinse tests where applicable.
• Validation Officer: Conduct cleaning validation as per validation protocol.

4. Accountability

The Production Head is accountable for ensuring this SOP is followed and that equipment is cleaned, verified, and released for use as per the validated procedure.

5. Procedure

5.1 Preparation Before Cleaning

1. Ensure machine is powered down and disconnected from utilities.
2. Wear cleanroom garments and personal protective equipment (PPE) as per gowning SOP.
3. Retrieve the latest approved cleaning checklist from the document control system.

5.2 Cleaning Steps for Product Contact Parts

1. Dismantle all product contact parts such as filling needles, tubing, manifolds, piston pumps, etc.
2. Transfer parts to the designated cleaning area in covered trays.
3. Soak parts in WFI with 0.5% non-ionic detergent for 15 minutes.
4. Scrub with sterile nylon brushes ensuring removal of visible residues.
5. Rinse with WFI until no foam or detergent residue remains.
6. Visually inspect for cleanliness and log results in Annexure-1.

5.3 Cleaning of Non-Product Contact Areas

1. Wipe surfaces with 70% IPA using sterile lint-free wipes.
2. Ensure corners, crevices, and control panels are wiped thoroughly.
3. Log cleaning activity in the Cleaning Record (Annexure-2).

5.4 Drying and Storage

1. Allow parts to air dry under LAF (Laminar Air Flow) or use a filtered hot air dryer.
2. Transfer dry parts to sterile storage with appropriate labeling including date and time.

5.5 Reassembly and Line Clearance

1. Reassemble cleaned parts on the filling machine as per the equipment SOP.
2. QA to verify cleanliness and approve machine for the next use by signing the Line Clearance Checklist (Annexure-3).

5.6 Cleaning Frequency

• Type A Cleaning: Performed after every batch or product changeover.
• Type B Cleaning: Performed at the end of the production shift or if machine is idle for more than 24 hours.
• Type C Cleaning: Deep cleaning performed weekly, includes validation swabbing.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPA: Isopropyl Alcohol
• WFI: Water for Injection
• QA: Quality Assurance
• LAF: Laminar Air Flow

7. Documents

1. Cleaning Verification Log – Annexure-1
2. Daily Cleaning Record – Annexure-2
3. Line Clearance Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• ICH Q7 – Good Manufacturing Practice Guide
• FDA Guidance for Industry – Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Cleaning Verification Log

Date	Part Name	Cleaned By	Checked By	Remarks
18/06/2025	Needle Set	Ravi Yadav	Sunita Reddy	Clean

Annexure-2: Daily Cleaning Record

Date	Machine ID	Shift	Cleaned By	Checked By	Remarks
18/06/2025	FILL-MC-002	A	Manish Patel	Neha Sharma	Completed

Annexure-3: Line Clearance Checklist

Machine ID	Area	Cleared By	Date	QA Approval
FILL-MC-002	Filling Room-1	Praveen Joshi	18/06/2025	Approved

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
18/06/2025	2.0	Added Annexures and cleaning categories	Annual Review	QA Head