Personnel Practice & Hygienic Behavior of Personnel Working in Aseptic Area | Standard Operating Procedure

The Standard Operating Procedure (SOP) of Personnel Practice & Hygienic Behavior of Personnel Working in an Aseptic Area is as below:

Purpose:

To define the procedure to be followed for all personnel concerned with sterile product production processes.

Scope:

This SOP applies to understand the aseptic techniques and the responsibility of personnel present in sterile areas to avoid contamination in the Sterile Department at the factory premises of XXX Pharmaceuticals Ltd. It ensures that to do or not to do in the sterile area.

Definition:

None.

Responsibility:

Routine responsibility for ensuring that this procedure is implemented as & when necessary rests with the following personnel:

1. Deputy Production Manager
2. Officers (Sterile)
3. Supervisor (Sterile)

Method:

• Before entering in sterile area personnel should understand the responsibilities of their position and know aseptic techniques.
• Traffic into and within the clean room should be restricted to authorized personnel who should not walk around the room unnecessarily.
• Movement in the sterile area should be slow and rhythmic.
• Once inside the sterile personnel should remain until the break or lunch period.
• Nervous relief-type mannerisms such as head-scratching or rubbing hands, face, or parts of the body must be consciously avoided.
• Loud unnecessary talk through the mask should be avoided. Laughing, whistling, singing, and shouting increase the number of bacteria emitted from the mouth.
• Horseplay is strictly forbidden in the sterile area.
• Eating, drinking, chewing & smoking, or storage of food, drink, smoking material, and personal medication should not be permitted within sterile areas.
• Staff should be required infections & skin lesions. Supervisory staff should look for the signs & symptoms of these.
• No pencils or erasers should be used in the sterile area. Ballpoint pens are suggested.
• The gown, foot cover, head cover, or mask can not be opened in the sterile area.
• No one who is physically ill, especially with a stomach or respiratory disorder may enter the sterile area.
• All verbal communication with people outside the sterile area should be
• Accomplished through the use of an intercom.
• All sterile vials, bottles & ampoules must be handled in covered trays.
• Product containers should not be exposed unnecessarily to the clean room environment.
• Personnel should keep their hands away from vial/bottle opening; Vials/bottles should be handled from the bottom.