Sterile Area Classification in Pharmaceuticals

Standard Operating Procedure of Sterile Area Classification in Pharmaceuticals is describe in this post.

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1. PURPOSE

1.1 The purpose of this SOP is to describe the classification and gowning requirement of Sterile Area.

2. SCOPE

2.1 The SOP is applicable to the classification and gowning requirement of Sterile Area.

3. RESPONSIBILITY

3.1 Operator is responsible for execution of the activities as per SOP.

3.2 Production Officer is responsible for checking the activities as per SOP.

3.3 QA Officer is responsible for monitoring the activities as per SOP.

3.4 Production Manager is responsible to ensure implementation of this SOP.

4. MATERIALS & EQUIPMENTS

5. PROCEDURE

5.1 Washing Area comes under Grade D and in washing area the hair and, where appropriate, beard is covered; protective clothing and appropriate shoes are worn.

5.2 Manufacturing Area comes under Grade C and in manufacturing area the hair is totally covered with headgear, tucked into the neck of the suit. Sterilized footwear is worn and the bottoms of the trouser are tucked into the footwear and the garment sleeves into the gloves.

5.3 In the Filling Area, the area under Laminar comes under Grade A and the background is B. In the filling area, the hair is totally covered with headgear, tucked into the neck of the suit. Sterilized footwear is worn and the bottoms of the trouser are tucked into the footwear and the garment sleeves into the gloves.

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