Standard Operating Procedure of Good Practices In Sterile Area in Phamraceuticals SOP is describe in this post.
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1. PURPOSE
1.1 The purpose of this SOP is to describe the good practices in Sterile Area.
2. SCOPE
2.1 The SOP is applicable to the personnel working in the Sterile Area.
3. RESPONSIBILITY
3.1 Area supervisor is responsible for conducting 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
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5. PROCEDURE
5.1 Before entering any clean environment, personnel should understand the responsibilities of their position.
5.2 Personnel must not wear cosmetics, nail polish or jewelry and proper attire is required for entering the sterile area.
5.3 Traffic into and within the sterile area should be minimum and restricted to authorized personnel only. Personnel should not walk around the room unnecessarily.
5.4 Movement in the sterile area should be slow and rhythmic.
5.5 Once inside the sterile area, personnel should remain until the break or lunch period.
5.6 Nervous relief-type mannerisms such as head scratching or rubbing hands face or parts of the body must be consciously avoided.
5.7 Loud, unnecessary talk through mask should be avoided. Laughing, whistling, singing, and shouting increase the number of bacteria emitted from the mouth.
5.8 Horseplay is strictly forbidden in the sterile area.
5.9 No eating of food, chewing gum or tobacco or smoking is permitted in the sterile area.
5.10 No pencils or erasers should be used in the sterile area.
5.11 No one, who is physically ill, especially with a stomach or respiratory disorder, may enter the sterile area.
5.12 All verbal communication with the people outside the sterile area should be accomplished through the use of special communicator.
5.13 Doors must be kept closed during processing except for entry and exit of personnel.
5.14 Material entering the sterile area must be sterilized or adequately sterilized where sterilization methods are not possible.
5.15 Glassware and stoppers generate particulates and must be handled with care.
5.16 No cleaning of a sterile room or equipment is to be done while processing a product in that room.
5.17 Components that have fallen onto the floor must not be picked up and used.
5.18 All aseptic manipulations should be done under Class 100 area i.e. laminar flow hoods.
5.19 During aseptic filling, at periodic intervals gloved hands should be sanitized by IPA 70% solution.
5.20 All unneeded materials must be promptly removed at the end of each workday.
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