STANDARD OPERATING PROCEDURE Doc. No.

Rev. No.
CLEANING AND SANITATION OF Effectivity Date
AGITATOR Page 1 of 3
Pages

DISTRIBUTION LIST
 Department Received by Date
 Accounting
 Human Resources
 Logistics
 Marketing
 Production
 Production Planning and Inventory Control
 Purchasing
 Quality and Regulatory
 Research and Development
 Sales

REVISION HISTORY
Revision no. Date revised Reason for revision

REVIEW AND APPROVAL

Prepared by Reviewed by Noted by Approved by

JAMAILA GANOZA LEO OSIT LEAH CASTILLO SHERWIN VAFLOR

Regulatory Pharmacist Plant Manager QR Manager Manufacturing Head
31 March 2020 [Date] [Date] [Date]

Font: Arial
Font size: 10 pt
Line spacing: Single
 STANDARD OPERATING PROCEDURE Doc. No.
Rev. No.
CLEANING AND SANITATION OF Effectivity Date
AGITATOR Page 2 of 3
Pages

I. Purpose

To lay down procedures for the cleaning of equipment and accessories used in Production Area

II. Scope

This SOP is applicable for the cleaning and sanitation of Agitator used in compounding of liquids

III. Responsibilities

Production Department
 Execution: Production Operator/Compounder
 Verification: Production Supervisor/Team Leader

IV. Procedure

Cleaning of Agitator

1. Make sure electrical supply is turned off before cleaning the equipment.

2. Place “TO BE CLEANED” sticker on the equipment.

3. Manually scrub the propeller and shafting using light liquid detergent.

4. Rinse with potable water followed by deionized water. Allow to dry.

5. Completely remove dust from the housing of agitator by wiping with wet cloth followed by dry clean cloth.

6. Affix the signed and dated “CLEANED” sticker on the cleaned equipment. The previous batch that used the
equipment must be indicated in the “CLEANED” sticker.

7. Fill out Equipment Log Book after completion

8. If equipment is not used within 72 hours from the date of cleaning, affix “TO BE CLEANED” sticker on the
equipment and perform cleaning procedures again before use.

V. Monitoring

Operators/Compounder are required to clean their equipment and accessories every day after each use and
record their cleaning procedure in the Equipment Log Book. Supervisors/Team Leaders are required to verify
the cleanliness of equipment and accessories at appropriate intervals depending on the frequency of usage and
record inspection done on Equipment Log Book.

VI. Corrective Action

Quality Assurance Department shall re-train employees not found following the procedures in this SOP.

VII. Reference to Other Documents

Equipment Log Book (Code???)

VIII. End of Document

STANDARD OPERATING PROCEDURE Doc. No.
Rev. No.
CLEANING AND SANITATION OF Effectivity Date
AGITATOR Page 3 of 3
Pages