1.0 PRINCIPLE
Pharmaceutical products can be contaminated by other pharmaceutical products, by cleaning agents, by micro-organisms or by other materials (e.g. dust, lubricants, raw materials, intermediates etc.) In many cases, the same equipment may be used for processing different products. To avoid contamination, adequate cleaning procedures are essential.
2.0 PURPOSE
1.1 This standard operating procedure outlines the proper procedure to clean the dispensing equipments e.g. scoops, spatulas and utensils etc.
3.0 SCOPE
3.1 It is applicable in the Raw Material Store.
4.0 RESPONSIBILITY
4.1 Warehouse Incharge
4.2 Warehouse Officer
4.3 Dispensing Supervisor
5.0 PROCEDURE
1 For every drug substance dedicated equipment (Scoop, spatulas, etc.) are used.
2 Dispensing equipment used for excepients is not dedicated; however, cleaning procedure for all the equipment is same.
3 Immediately after completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box that has been labeled, used scoops / spatulas for cleaning.
4 After completing the dispensing operation, the dispensing equipment contained in the box is removed from dispensing area for cleaning. The operator should wear rubber gloves before commencing cleaning.
5 Equipment is scrubbed with 2% teepol solution and rinsed under running tap. To remove sticky substances, the equipment are rinsed with hot water and scrubbed with 2% teepol solution. After rinsing under running tap water, the equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% Isopropyl Alcohol and dried.
6 The cleaned and dried equipment is wrapped in aluminum foil and covered with Kraft paper. A label “I AM CLEAN” is affixed.
7 The ready to use equipment is stored in a closed box for future use.
