Follow
1.0 OBJECTIVE
To provide general hygiene instructions for personnel entering into and working within the different grades of clean area.
2.0 SCOPE
This SOP shall be applicable for Production, Engineering, Quality Assurance and Quality Control Department.
3.0 ASSOCIATED DOCUMENTS
Not applicable.
4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 All employees shall be responsible for following the instructions.
4.2 Head of Production or his Designee shall be accountable for training and implementation of the instructions.
5.0 ABBREVIATIONS AND DEFINITIONS
Not applicable.
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
6.1 Only authorized and trained personnel shall be permitted to enter the clean area.
6.2 Whenever regulatory visitors need to enter the area, they shall enter the area under the guidance of the supervisor responsible for the area. The visitors shall be dressed appropriately and behave according to the rules of the area.
7.0 PROCEDURE
7.1 GENERAL HYGIENE INSTRUCTIONS
7.1.1 All material and equipment entering or leaving the department shall go through the material airlock except when the size or shape necessitates use of doors.
7.1.2 No doors shall be opened directly into Grades B, C and D areas while exterior doors are open. This is necessary to provide positive air pressure from the higher grade through the exterior doors to the lower grade area.
7.1.3 Items shall be thoroughly cleaned of grease, dirt or other contaminants before entering the production areas. This includes trolleys, tools, toolboxes etc.
7.1.4 Cardboard and other items with high contamination potential are not allowed in production areas.
7.1.5 The operator must not directly touch raw materials, bulk products or sterilized machine parts.
7.1.6 All personnel assigned to different grade areas must wear the appropriate attire.
7.1.7 Wristwatches and jewelry must not be worn within the clean area.
7.1.8 Cigarettes, money etc. must not be kept in the protective garments or in clean area.
7.1.9 Excessive shedding of particles and organisms due to over rigorous activity must be avoided as well as unnecessary talking.
7.1.10 Personnel shall be restricted from:
Having food or drink in the area.
Use any kind of tobacco products or chewing gum.
Carrying mobile.
Carrying personal medication.
7.2 HYGIENE OF THE HANDS
7.2.1 The hands shall be well tended. No open lesions shall be discernible. Small lesions or infections must be thoroughly covered with a piece of plaster.
7.2.2 The nails must be clean and cut. Nail varnish or other cosmetics which can shed particles must not be used.
7.2.3 The hands must be washed and disinfected:
Before entering the area.
When the hands have become, dirty.
7.2.4 Protective gloves must be worn during work involving direct exposure to raw materials, primary packaging materials or bulk products.
7.2.5 Clean gloves must be worn within the clean areas. The gloves must be changed before each working operation. Damaged gloves must be exchanged immediately. Used gloves must be disposed off in a special waste bin placed in the outer part of the air lock.
