Cleaning of Equipment & Accessories in production area Standard Operating Procedure is given below.

Objective:

To describe the cleaning procedure for equipments and accessories.

Scope:

The scope of this SOP pertains to cleaning of all equipments and accessories placed in tablet section of production area.

Responsibility:

It is the responsibility of Operator and section Supervisor (Tablet) to follow this SOP as it is written.

It is the responsibility of Production Pharmacist (Tablet) to ensure that this SOP is followed in its entirety.

It is the responsibility of Production Manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary.

DEFINITIONS & ABBREVIATIONS

SOP: Standard Operating Procedure

FBD: Fluidized Bed Dryer

MATERIALS & EQUIPMENTS

5.1 Materials

5.1.1 Duster

5.1.2 Nylon brush

5.1.3 Max liquid solution (15% v/v)

5.2 Equipments 

5.2.1 Stainless steel bucket

5.2.2 Measuring jug

Procedure:

6.1 Cleaning of major equipments

6.1.1 Dismantle the movable parts of the major equipments.

6.1.2 Affixed ‘To Be Cleaned’ label and transfer the movable parts to the respective washing area.

6.1.3 Clean the major equipments (Mixers, Granulators, FBDs, Compression machines, Coating pans) which are immovable at the place of their installation as per their respective cleaning procedure.

6.1.4 Affixed a ‘Cleaned’ label to the clean equipment.

6.1.5 Assemble the cleaned and dried equipment parts to the equipment after ensuring that equipment is cleaned and dried.

6.2 Cleaning of accessories

6.2.1 Transfer the accessories (Scoops, spoons, spatulas, sieves, bowls etc) to the respective washing area.

6.2.2 Scrub them with nylon brush using max liquid solution 15% v/v.

6.2.3 Wash with sufficient De-Ionized water until free from froth.

6.2.4 Finally rinse with purified water.

6.2.5 Dry the accessories with dry duster.

6.2.6 Wrap the cleaned and dried accessories in new polythene cover.

6.2.7 Affix a ‘Cleaned’ label.