SOP For Personnel Gowning Qualification
This document describes SOP For Personnel Gowning Qualification i.e. procedure for the personnel entering into Aseptic processing area of sterile facility and Sterility testing area of Microbiology section.
SOP For Personnel Gowning Qualification
I: Purpose and Scope:
The purpose of this SOP is to lay down a qualification procedure for the personnel entering into Aseptic processing area of sterile facility and Sterility testing area of Microbiology section.
This Standard operating procedure is applicable for Sterile injectable facility and Sterility testing Area of Microbiology section of Quality Control Department
II: Responsibility:
Officer QC/ Executive QC/ Production Officer/ Production operator/ Designee responsible to follow the SOP
III: Introduction and Procedure for Pw
The personnel qualification for the personnel entering into the aseptic processing area of Sterile injectable facility or Sterility testing area of microbiology section shall be qualified by undergoing three kinds of tests;
- Training on Aseptic area behavior and importance
- Physical Gowning procedure verification
- Gowning procedure qualification by microbiological method
IV: Training on Aseptic area behavior and importance:
- The personnel whose are intended to go into the both the area are must aware of the aseptic area behavior and their importance.
- Prerequisites like:
- Personnel must be shaved properly.
- Hair must be trimmed.
- Nails must be trimmed.
- Ornaments like Ring/chains/Watches/threads are not allowed to take in to the aseptic area.
- Mobile phones are not allowed.
- Personnel should not have cough cold, sneezing problems and other illness.
- Person must not have any open cuts, wounds and open lesions.
- Person must not have any skin diseases.
- Must apply disinfectant/sanitizing agent whenever enters into the area.
Aseptic area behavior and importance :
- Personnel must wear the sterile garment.
- Elbow size glove must wear after complete gowning.
- Hair must be covered completely at any part of the body.
- Avoid exposure of the body to the area.
- Do not touch floor, wall while and after wearing the garment.
- Minimize the contact of the surfaces with the hand gloves.
- Avoid brisk walking. Follow slow movements.
- Should not make loud/whistle voice.
- Avoid Chewing tobacco or other supplement.
- Do not laid down on the floor.
- Intimate to the in-charge if any un-comfort and come out the area.
- Microbiologist Record the details in Annexure I.
- Viable and non viable particles are the main agents of the contamination in clean rooms.
- Personnel are the main source of contamination.
- Personnel are tending to shed particles, these particles may carry viable organism.
- Viable and non viable particles are the particles which will spoil the integrity of the aseptic area.
- Because of the wrong practices and behavior may lead to the higher viable and non-viable particle generation.
Physical Gowning Procedure verification :
- Personnel those are intended to enter into the aseptic area, they must undergo training and qualification of the Physical Gowning procedure verification.
- The personnel are taken into the office room of the lab/production and there training on gowning procedure will be given.
- There the personnel are provided with mock area entry/exit facility. The person must wear gown and display all the steps properly.
- Personnel must not skip or miss any step and must follow gowning sequence.
- Personnel must not touch any part of outer surface of the garment/glove while wearing garment.
- A trained supervisor shall monitor all the above steps.
- After complete satisfactory gowning procedure display, personnel allowed to go into the further microbiological qualification test.
- Record the details in Annexure I.
Gowning qualification Procedure by Microbiological method:
- After successful completion of the above 2 steps i.e. training on Aseptic area behavior and importance and physical Gowning Procedure verification the person is allowed to undergo gowning qualification by Microbiological method.
- The person is taken into the room by following the procedure given in Annexure I. Microbiologist shall followed the gowning procedure with qualified person.
- Observe the all steps of qualification persons by Microbiologist.
- After enter into the aseptic area, Microbiologist shall performed personnel monitoring of qualification person .For details of personnel monitoring method of clean area Record the result of personnel monitoring in Annexure II.
- Perform this qualification entry procedure three times. First entry should be done in the presence of Microbiologist and other two entries should be performed individually. Record the observation in Annexure I.
- These personnel monitoring plates shall be transfer to microbiology lab for further testing and incubation.
- For incubation details and acceptance criteria of the method refer respective SOP.
- If the all three times results are within the limit, the person is qualified to enter into the aseptic area.
- If the person is failed to show the one of the result within the limit, he is not qualified to enter into the aseptic area. Perform the requalification of this person by retraining.
Frequency for Gowning Qualification :
- Initial Qualification: Whenever a new person entry is required.
- Re-qualification:
Case-I: A person who fails to show aseptic practices/Gowning procedure/excessive microbial count in regular personnel monitoring
Case-II: A person who not regular attendee to the aseptic area gowning procedure (Above working 6 months) willing to go into aseptic area.
Case-III: A person who availed longer medical leaves more than a month and willing to go into aseptic area.
Annexures:
Annexure I : Personnel Qualification Report
Annexure II : Personnel monitoring Report for Gowning qualification
Annexure –I
Personnel Qualification Report
| Name of Person: | Department: | ||
| Employed No.: | Date of Joining: | ||
| Date of Training: | Trainer Name: | ||
| Qualification For: | Physical status: |
- A) Traning on Aseptic area behavior and importance:
Name of Trainee :—————————– Name of Trainer:—————————-
Sign: ———————- Sign: ———————-
Date:———————— Date:————————
Remark:—————————————————————————————————
—————————————————————————————————
- B) Training on Physical Gowning Procedure :
Training given in:——————————–
Name of Trainee :—————————— Name of Trainer:——————————-
Sign: ———————- Sign: ———————-
Date:———————— Date:————————
Remark:—————————————————————————————————
———————————————————————————————-
———————————————————————————————
Personnel Qualification Report
- C) Gowning qualification Procedure by Microbiological method:
| Sr. No | Hygenic conditions | Status (Yes/No/NA) | Observed By/Date |
| 1 | Personnel must be shaved properly. | ||
| 2 | Hair must be trimmed properly. | ||
| 3 | Nails must be trimmed properly. | ||
| 4 | Ornaments like Ring/chains/Watches/threads. | ||
| 5 | Person has illness like cough or sneezing. | ||
| 6 | Person has any open cuts, wounds or open lesions. | ||
| 7 | Person has any skin diseases. |
- I) Personnel hygiene Check list:
- II) Check list for Entry/Exit Procedure in Sterile Aseptic area of Manufacturing:
| Entry Procedure : | |||
| Sr.No | Entry Procedure | Status (Yes/No) | Checked By/Date |
| 1 | Open the door of Air Lock I and enter inside. Make the entry in entry/exit log record for entering in aseptic area. | ||
| 2 | Remove the foot wear and dress, put it into the
Cupboard. |
||
| 3 | Sanitize the hands with 70%IPA. Push the door of Air Lock II by elbow and go through the footmat and enter inside Air Lock II. | ||
| 4 | Sanitize the hands with 70%IPA or Sterilium. Wear small size sterile hand gloves. | ||
Personnel Qualification Report
| Entry Procedure : | |||
| Sr.No | Procedure | Status (Yes/No) | Checked By/Date |
| 5 | Take sterile garment pack from cupboard. Perform the gowning procedure in below sequence;
i) Wear Head gear ii) Wear Boiler suit iii) Wear Booties iv) Wear Elbow size sterile hand gloves v) Wear Goggle |
||
| 6 | At each activity of gowning sanitize the hands with filtered 70%IPA | ||
| 7 | Open the door of Air Lock II and enter inside the Air Lock III. | ||
| 8 | Observe the properness of gowning in the mirror and sanitize the hands with filtered 70% IPA. Push the door of Air Lock III with elbow and enter into the sterile Passage. | ||
| Exit Procedure : | |||
| 1 | Exit from sterile passage into Air Lock IV by pulling the door. | ||
| 2 | While exit from sterile aseptic area perform personnel monitoring by contact plate method. | ||
| 3 | Perform degowning procedure as below sequence;
i) Remove Goggle and Elbow size sterile hand gloves ii) Remove Booties iii) Remove Boiler suit iv) Remove Head gear v) Remove small size sterile hand gloves |
||
Personnel Qualification Report
| Exit Procedure : | |||
| Sr.No | Procedure | Status (Yes/No) | Observed By/Date |
| 4 | Discard removed garments in dedicated container and open the door of AirLock IV and enter into Air Lock I. | ||
| 5 | Wear the dress, footwear and update the exit time in entry/exit log record for exit. | ||
III) Check list for Entry/Exit Procedure in Sterility testing area of Microbiology section:
| Entry Procedure : | |||
| Sr.No | Procedure | Status (Yes/No) | Observed By/Date |
| 1 | Push the door of Air Lock I and enter inside. Remove the foot wear in SS bench. | ||
| 2 | Cross over the bench and enter into Air lock II. Remove the street cloths and apron. Keep onto the hanger. | ||
| 3 | Open the door and enter into Airlock III. Sanitize the hands with 70%IPA. Wear Sterile Hand gloves. | ||
| 4 | Take Sterile garment pack and wear the garment as given below. | ||
Personnel Qualification Report
| Entry Procedure : | |||
| Sr.No | Procedure | Status (Yes/No) | Observed By/Date |
| 5 | Perform the gowning procedure in below sequence;
i) Wear Head gear ii) Wear Boiler suit iii) Wear Booties iv) Wear Elbow size sterile hand gloves v) Wear Goggle |
||
| 6 | At each activity of gowning maintain the hygienic condition and at each activity sanitize the hands with filtered 70% IPA. After completion of gowning procedure enter into sterility area. Before entering next area ensure that the previous door is closed. | ||
| 7 | During exit, Enter into the Airlock III and perform the Personnel monitoring. | ||
| Exit Procedure : | |||
| 1 | Exit from sterility testing area and enter into Air Lock III. Perform the Personnel monitoring. Perform the degowning procedure in Airlock III. | ||
Personnel Qualification Report
| Exit Procedure : | |||
| Sr.No | Procedure | Status (Yes/No) | Observed By/Date |
| 2 | Perform degowning procedure as below;
i) Goggle ii) Elbow size sterile hand gloves iii) Booties iv) Boiler suit v) Head gear vi) small size sterile hand gloves |
||
| 3 | Then enter the Air Lock II by opening the door. Wear street cloths and apron. | ||
| 4 | Leave the Air Lock II by opening the door. Cross over the bench and enter into Airlock I. | ||
| 5 | After enter into the Air Lock I, Wear footwear and leave the Airlock I by pulling the door. | ||
Annexure II
Personnel monitoring Report for Gowning qualification
| Name of Person : | Date of monitoring : | ||
| Time of monitoring : | Entry Number : | ||
| Inhouse Media lot no : | Department : | ||
| Incubation temp : | Incubator ID : | ||
| Incubation temp : | Incubator ID : | ||
| Observation Date : | Observed by : |
| Location | Bacterial count
(Limit:<1cfu/55mm plate ) |
Fungal count
(Limit:<1cfu/55mm plate ) |
| 1) Right Hand Fingure (RH) | ||
| 2) Left Hand Fingure (LH) |
- Finger Dab Method :
- Gowning monitoring by contact plate method :
| Location | Bacterial count
(Limit: 5cfu/55mm plate ) ( Limit for total location) |
Fungal count
(Limit:<1cfu/55mm plate ) ( Limit for total location) |
| 1) Head gear | ||
| 2) Chest | ||
| 3) Thigh (RT/LT) | ||
| 4) Armpit (RA/LA) |
Negative Control: Growth observed / not observed
Conclusion: The Microbial count by Personnel monitoring method are found Satisfactory/Not Satisfactory.
Observed By: Checked By:
Date: Date:
