22/11/2018 SOP for Cleaning of Equipment and Accessories in Production Area : Pharmaceutical Guidelines

SOP for Cleaning of Equipment and Accessories in Production Area

Standard operating procedure to clean the Equipment and Accessories used for manufacturing in Production Area.

1.0 OBJECTIVE:
To lay down the procedure for cleaning of equipment and accessories in Production Area.

2.0 SCOPE:
This SOP shall be applicable for cleaning equipment and accessories in the Production Department.

3.0 RESPONSIBILITY:
3.1 ExExecution:rator
3.2 Checking : Pharmacist and Above

4.0 ACCOUNTABILITY:
HOD-Production

5.0 PROCEDURE:

5.1 CLEANING OF MAJOR EQUIPMENTS

5.1.1 Dismantle the movable parts of the major equipment.
5.1.2 Affixed “To Be Cleaned” label and transfer the movable parts to the respective washing area.
5.1.3 Clean the major equipment (Like RMG, Octagonal blender, FBD etc.), which are immovable (Clean in place) of installation as per the respe
cleaning procedure & fill the “Equipment Logbook”.
5.1.4 Affix a duly signed “cleaned” label to the cleaned equipment.
5.1.5 Assemble the cleaned and dried equipment parts to the equipment after ensuring that the equipment is cleaned & dried.
5.1.6 Use the cleaned equipment within 72 hours from the date of cleaning, wipe the equipment with a dry lint-free cloth prior to use.
5.1.7 In case the cleaned equipment is not used within 72 hours from the date of cleaning affix “To Be Cleaned” label and re-clean the equipment b
use.

5.2 CLEANING OF ACCESSORIES (Scoops, Spatulas, Sifter Sieve, Multi Mill Screen and Cad Mill Screens)
5.2.1 Transfer the accessories to the respective washing area.
5.2.2 Wash with sufficient Potable water.
5.2.3 Scrub with nylon brush using Potable water with 2.5 % “Teepol” solution.
5.2.4 Wash with sufficient Potable water, till it is free from froth.
5.2.5 Finally rinse with purified water.
5.2.6 Wipe with 70% v/v solution of Isopropyl Alcohol (IPA).
5.2.7 Wrap the cleaned and dried accessories in new polythene cover.
5.2.8 Store the cleaned accessories in the equipment staging area with a duly-signed “cleaned” label.

6.0 ABBREVIATION:
6.1 SOP : Standard operating procedure
6.2 IPA : Isopropyl Alcohol

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutic
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