Entry and Exit procedure for Aseptic filling area
Aseptic filling area
This article describes about (Standard Operating procedure) SOP on Entry and Exit procedure for Aseptic filling area in Pharmaceutical Industry.
SOP on Entry and Exit procedure for Aseptic filling area
I. Purpose & Scope:
- To provide a general methodology to be followed while Entry and Exit in Aseptic filling area
- Applicable to all personnel who are working in Production, Quality control and quality Assurance Department
II. Responsibilities:
• All Production, Quality control and quality Assurance personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part :
Precautions :
- Only authorized person should be allowed to enter into Aseptic filling area.
- Persons entering in Aseptic area should not be more than two persons at a time.
- New person entering the area first time, shall be accompanied and monitored by an authorized person. New person shall not participate in any aseptic activity of aseptic area till training and completion of gowning qualification.
- Visitors shall enter the filling area along with authorized person only.
- List of the authorized personnel for entry to the Aseptic filling area shall be specified and shall be authorized and displayed at entrance.
Entry procedure from corridor to Change Room-I :
- Enter into the Change Room I of Aseptic filling area by using finger access system of each individual. When multiple persons enter the Change Room I simultaneously.
- It shall be ensured that each person swipes his finger on the biometric access system before entry into the Change Room I.
- Record the details of entry and exit of each individual into Aseptic filling area along with status of personal monitoring / Finger dab in specified format
- Disinfect the hands with 0.22 micron filtered 70%v/v IPA solution
- Remove foot wear, factory uniform in sitting position in such a manner that bare foot should not touch ground and keep them in the shoe rack and garment cubicle respectively. Wipe bare foot with foot wiper previously soaked with disinfectant solution.
- Use foot cover or cloth shoe covers kept inside the cleaned rack of Aseptic filling area and crosses over the bench without touching ground.
- Disinfect the hands with 0.22 micron filtered 70% IPA solution provided.
Entry procedure from Change room-l to Change Room-II :
- Press the green coloured door release, push button, to release the door interlock and enter into Change Room II by pushing the door with elbow (after entering ensure that the door is closed properly).
Note: Ensure that, sterile garment storage cubicle blower and UV light are ON. Care should be taken to prevent contamination of external surface of the gloves.
Entry procedure from change room-II to change room-III :
- Disinfect the hands with 0.22 micron filtered 70% v/v IPA solution.
- Pick up a pair of sterile elbow size hand gloves from the gloves box. Put on the gloves up to wrist and dispose the wrapper in the waste bin provided.
- Pick up a clean and sterilize inner wear from the sterile garment cubicle and keep them in cross over bench.
Wear sterilize inner wear in the following manner:
- Open the Tyvek bag and take out the set of sterile garment and put the empty bag on cross over bench and place garments over the bag and dispose the Tyvek bag in waste bin.
- Put on the Hood and then fasten the nose covering. Then wear Kurta, on a way to cover the lower portion of the Hood.
- Remove foot cover or cloth shoe covers from foot and keep in waste bin.
- Wear trouser and place lower portion of the Kurta inside it and then fasten around waist. Tie the booties around the leg. Keep the empty bag in the Garment bin.
- Check entire attire on the mirror provided ensuring all hair and body parts are covered. Then disinfect hands with 0.22 micron filtered 70% v/v IPA solution
Pick up a bag of sterilized garment and safety goggles from the garment cubicle and wear the garment in the following manner:
Note: Ensure that, sterile garment storage cubicle blower and UV light are ON. Care should be taken to prevent contamination of external surface of the gloves.
- Open the garment cubicle and take a Tyvek bag containing pre-sterilized garment (hood, sterile suit and booties) and goggle.
- Dispose the empty Tyvek bag in waste bin.
- Open zip of the ‘Dacron bag’ and remove the set of sterile garment. Place the ‘Dacron bag’ on the cross over bench and put all the garments on it.
- Put on the hood and then fasten the nose covering.
- Open the zipper of the sterile suit and hold the sleeve ends to the garment waist. (Ensure that, the sterile suit should not touch to the floor).
- Place each foot through the folded trouser. Once both the legs are in the trouser, place each arm carefully in the folded sleeves and pull upper portion on such way to cover the lower portion of hood.
- Completely zip the zipper of the gown.
- Unfold the folded arms of garment and fasten the sleeve end adjustment.
- Tuck the sleeve end in hand gloves and roll the gloves over the sleeves of the garment up to elbow.
- Sit on cross over bench. Wear sterilized booty on one leg and tuck the lower portion of suit in booty and tie string of the booty. Swing over the leg with booty on the other side of cross over bench; follow the same procedure with other leg. Place the empty bag in the bin provided for empty bag.
- Wear safety sterilized goggles.
- Check entire attire on the mirror provided and also check that the hood is properly tucked into the sterile suit. If any of the body parts get exposed, correct if it is required. Disinfect the hands with 0.22 micron filtered 70% v/v IPA solution.
- Press the green colour door, release push button of interlock and enter into Change Room III by pushing the door with elbow (after entering ensure that the door is closed).
Entry procedure for Change Room-III to aseptic corridor :
- Check entire attire in the mirror provided ensuring all hair and body parts are covered.
- Pick up second pair of powder free sterile hand gloves from gloves box and put on over the previous elbow size hand gloves. Dispose the wrapper in the waste bin provided.
- Disinfect the hands with 0.22 micron filtered 70% v/v IPA solution.
- Press the green coloured door release push button of interlock and enter into sterile corridor by pushing the door with elbow (after entering ensure that the door is closed).
EXIT PROCEDURE:
- Press the green coloured door release push button.
- Pull the door and enter in to Change Room III.
- Take the Swabs of garments by the Micro plate.
- Press the green coloured door release push button.
- Pull the door and enter in to Change Room II.
- Cross the cross over bench.
- Take the empty inner garment bag and outer garment bag from garment bin.
- Access the finger on biometric finger access system to release the door interlock and enter into Change Room I by pulling the door”. When multiple persons exit the Change Room II simultaneously, it shall be ensured that each person swipes his finger on the biometric access system before exiting the Change Room II.
- Cross the cross over bench.
- Remove the goggles and keep the goggles in the container provided.
- Remove the gloves and dispose in used garment bin.
- Remove the garment, place them in the bag and dispose the bag in the respective used garment bin provided with poly bag.
- Wear factory garment and shoe.
- Press the green colour door release button.
- Pull the door and exit from Change Room I.
Note :
- Maximum No. of persons allows in the filling area: 05 persons in each Filling Room.
- Gowning qualification should be done for all the persons entering the filling area.
- At the end of every working shift remove all used garments from the bin, put it in poly bag and send them to approved laundry.
- All goggles should be sterilized in autoclave every day after cleaning.
- Cleaned garments received from approved laundry should be sterilized.
Annexure :
Annexure I : Record of Entry/ Exit of each individual in Aseptic area
Annexure II : List of Authorized persons to enter in Aseptic Area
Annexure I
Record of Entry/ Exit of each individual in Aseptic area
| Name of Person | Department / visitor organization name | Entry Date | Entry Time | Reason for Entry | Sign | Personnel monitoring/ Finger Dab | Exit Date | Exit time | Reason for exit | Sign | Remark |
Note: Put ‘PM’ in case of Personnel monitoring and ‘FD’ in case of figure dab and ‘NA in case if not applicable.
Checked By: Rechecked By: Verified By:
(Production Department) (Microbiology Department) (Quality Assurance)
Sign/ Date:___________ Sign/ Date:___________ Sign/ Date:___________
Format II
List of Authorized persons to enter in Aseptic Area
| Sr. No. | Name of Authorized person | Department | Employee no. |
PREPARED BY APPROVED BY NOTED BY
Department Head GM- Quality GM Operation
Date: Date: Date:
