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
