SOP of cleaning of equipment and accessories in Production

1.0 OBJECTIVE:
To lay down the standard operating 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 Execution: Operator
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 respective cleaning procedure & fill the
“Equipment Log book”.
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 before 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 iso propyl 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