SOP for Aseptic Behavior in clean area.

This Document describes (Standard Operating procedure) SOP for Aseptic Behavior in clean area

SOP for Aseptic Behavior in clean area.

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Aseptic Behavior in clean area
• This procedure is applicable production Department personnel who is working in clean area.

II. Responsibilities:

• All production personnel shall be responsible to follow and implement this SOP for Aseptic Behavior in clean area.

III . Introduction and Procedural Part :

Procedural part for Aseptic Behavior in clean area :

• Personnel with open wounds; rashes, boils or any other skin ailment must not be permitted to work in aseptic area.
• Personnel suffering from upper respiratory tract infection, cold, cough; hay fever, diarrhea etc. must not be allowed to work in aseptic area.
• Personnel should come forward and inform concerned In-charge for appropriate action.
• Periodic health checks for above-mentioned conditions should be done for every one-year by a registered medical practitioner.
• Entry to aseptic area is restricted to qualified personnel only. Personnel shall be qualified by –
  • • Training and evaluation for Entry and Exit procedure for aseptic area and Behavior in aseptic area.
    • Gowning Qualification.
    • Media fill validation.

Personnel hygiene:

• Operators shall be checked for requirements of personnel hygiene daily before start of work.
• Personnel should keep their hair short and shave regularly in order to minimize the hazards of contamination through hair.
• Personnel shall ensure that their nails are regularly trimmed.
• Personnel shall remove all their personal belongings from their Pockets and Jewelry & watches and keep them safely in a locker before entering the clean rooms.

Gowning:

• Personnel working, supervising, controlling and maintaining should follow proper gowning procedure before entering into aseptic area.
• Sterilized garments are transferred to garment cubicle in Airlock II.
• Follow respective SOP for entry and exit procedure of aseptic area.
• Aseptic area garments must be kept in SS bin situated in Airlock IV when leaving the aseptic area.

Aseptic techniques:

• Aseptic room doors must be kept closed at all times they may open only to admit one person or product at a time.
• Contact sterile materials only with sterile instruments.
• Personnel should keep his hands away from vial openings; vials should be handled from bottom using forceps.
• Do not touch aseptic area garments. If touched disinfect hands with disinfectant provided.
• Movement in the aseptic area should be minimum, slow and rhythmic because movement increases particulate and bacterial shedding.
• Keep the entire body out of the path of laminar air flow; personnel should not disturb the path of laminar air flow.
• Do not stand with hands on the waist.
• Do not use components that have fallen out on the floor.
• Personnel should not reach over or lean over open vials on the line.
• Talking should be avoided and whenever necessary should be slow and limited.
• For communication with people outside aseptic area, use sign language.
• Product containers should not be exposed unnecessarily to environment should be opened only under LAF.
• Operators shall place material intended for use in filling line under respective LAF workstation.
• Only sterilized papers should be used in the aseptic area.
• No pencils or erasers should be used in aseptic area.
• Glassware and stoppers generate particulates and must be handled with care.
• Materials, containers and equipment introduced in to aseptic area must be sterilized prior to entering aseptic areas.
• Number of persons working in aseptic area shall be minimum. Inspection and control procedures shall be conducted from outside these areas.
• Open the doors using upper arm.
• Operators shall not take their seat close to their respective workstation.
• No flaking or corrosive material shall be allowed in the area.
• Movement in and out of aseptic area should be restricted to qualified persons.
• In case of spillage, the powder shall be cleaned at the end of the shift or during break.
• All gloved hands shall be sanitize before entering to area and after each intervention & periodically after every half an hour.
• All housekeeping items shall be transferred through Dynamic pass box for washing and sterilization.
• Persons engaged in maintenance work or process adjustments or rectification of minor faults to equipment must observe the same precautions and hygienic standards as production personnel.
• Waste bins shall be emptied at regular intervals.
• Above all are the Aseptic Behavior in clean area and Aseptic Techniques in clean area.