Objective:
To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area.
Scope:
This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area
Responsibility:
Chemist or above of Microbiology Laboratory.
Head – Microbiology Section.
Accountability:
Head – Quality Control
Head – Quality Assurance
Procedure:
For Aseptic Processing Area
The need of personnel qualification to work in Aseptic Processing Area shall be identified by Head-Microbiology Department. in coordination with Head-Microbiology and Head- Production (Injectables) based on their requirement in the concerned area.
The personnel shall mainly include from production, microbiology and maintenance departments.
All the identified personnel shall be qualified initially and re-qualified minimum once in a year.
The qualification activity shall be performed in two phases.
Phase-1 (Preliminary Qualification): This shall include Class room training of the person, written test, Gowning demonstration, Trial gowning and Preliminary monitoring of the person for Viable Count.
Phase-2 (Final Qualification): This shall include observation of person activities in aseptic processing area and Monitoring of the person for Viable Count after performing the activities in the Aseptic Processing Area. This phase of qualification shall be performed during routine production or during process simulation (media fill) studies.
Preliminary Qualification
A person I operator shall undergo classroom training by Head-Microbiology and Head-Injectable Production.
The training shall include the following topics:
Basics of microbiology.
Disinfection and sanitization.
Sterilization.
Personal hygiene.
Aseptic gowning, entry, behavior in aseptic processing area.
Relationship of manufacturing and handling procedures to potential sources of product contaminations.
Consequences of product contamination.
Training procedures may include relevant SOP procedures, Slide and or power point presentations.
An attendance record shall be maintained for the training of the person.
After classroom training the person shall be evaluated by a written test, as per questionnaire (model) given as which shall include ten objective type questions from each relevant topic.
The questions may be changed from person to person and or session to session.
Person shall be given maximum of three chances to qualify the written test.
After successful training the person shall be given demonstration on aseptic gowning by the Head-Production (Injectable) or Head-Microbiology or their nominees.
After aseptic gowning demonstration, the person shall undergo trial gowning procedures. The gowning trials shall be observed by Head-Microbiology.
After sufficient practice the person shall be allowed to enter into change rooms of aseptic processing area as per SOP No.: (up to changing of sterile gown). The gowning procedure shall be checked by the microbiologist.
After complete dressing of sterile gown the person shall be monitored for viable counts in all locations (as per the procedure given in SOP on Viable Particle Monitoring — Sterile Product Manufacturing Facility) by microbiologist using surface contact (RODAC) plates and the person shall be allowed to exit from the exit change rooms.
The viable particle count shall be monitored in all locations (as per schematic diagram) and the results shall be recorded.
This monitoring shall be repeated for at least three consecutive days (preferably at different times).
The results of this viable monitoring shall be reviewed by Head-Microbiology.
Head—QA Department shall evaluate Preliminary qualification report and qualify the person for Phase-2.
Final Qualification
After preliminary qualification the person shall under go Final qualification to work in aseptic manufacturing area during media fill trial I routine production.
The person shall be allowed to enter and work in aseptic manufacturing area for at least two hours.
The activities of the person shall be observed and recorded by both Microbiology and Production (Injectables) Heads.
After each day I shift of activity the person shall be monitored for viable counts for at least four locations (locations of both hands are mandatory) using the procedure followed during preliminary qualification.
The results shall be recorded in ‘Personnel Monitoring Report given in SOP on Viable Particle Monitoring — Sterile Product Manufacturing Facility’.
The monitoring shall be performed at least three consecutive days, for final qualification.
The results of this viable monitoring shall be reviewed by Head-Microbiology and attached to ‘Final Qualification Report’.
Final Qualification report shall be evaluated by Head-QC Department and approved by Head-QA Department.
Head—Microbiology shall intimate the qualification result to person who was undergone the qualification tests and shall receive the signature on duplicate copy of intimation.
Copy of intimation shall be sent to Head-Production (Injectables)
All the documents generated during personnel qualification shall be compiled in the form of file and submitted to QA.
The qualification sequence is represented by a schematic representation.
Acceptance Criteria
The person should score more than 90% of marks in each written test.
The viable particle monitoring results during preliminary monitoring shall be with in the specified levels as mentioned.
The person shall wear and maintain the aseptic gown properly and should work properly.
The viable particle results during monitoring for final qualification shall be with in the specified levels mentioned in ‘Personnel Monitoring Report given in SOP on Viable Particle Monitoring — Sterile Product Manufacturing Facility’.
For Sterility Testing Area
Personnel qualification for Sterility testing area shall also be done using almost same procedure with some of changes mentioned below.
Head-QC shall identify the need for qualification of personnel for sterility testing area, in coordination with Head-Microbiology.
The personnel shall mainly include from microbiology and maintenance departments.
The qualification activity shall be performed in two phases, following the same procedure mentioned in qualification for aseptic processing area.
Class room training shall be given by Head-Microbiology and the training shall include the following topics Basics of microbiology.
• Disinfection and sanitization.
• Sterilization.
• Personal hygiene.
• Aseptic gowning, entry, behavior in sterility testing area.
• Aseptic testing and sources of contaminations during sterility testing.
After sufficient gowning practice the person shall be allowed to enter in to change rooms of sterility testing area following concern entry and exit SOP (up to changing of sterile gown). The gowning procedure shall be checked by the experienced microbiologist.
After complete dressing of sterile gown the person shall be monitored for viable counts in all locations (as per the procedure given in SOP on Viable Particle Monitoring — Sterility testing area) by experienced microbiologist using surface contact (RODAC) plates and the person shall be allowed to exit from the exit change rooms.
For ‘Final qualification’ the person shall be allowed to enter and work in sterility testing area for at least two hours.
The activities of the person shall be observed and recorded by Head-Microbiology.
After each day I shift of activity the person shall be monitored for viable counts for at least four locations (locations of both hands are mandatory) using the procedure followed during preliminary qualification.
The results shall be recorded in ‘Personnel Monitoring Report given in SOP on Viable Particle Monitoring — Sterility Testing Area’.
Acceptance Criteria
The person shall get more than 90% of marks in each written test.
The viable particle monitoring results during preliminary monitoring shall be with in the specified levels as mentioned.
The person shall wear and maintain the aseptic gown properly and should work properly.
The viable particle results during monitoring for final qualification shall be within the specified levels mentioned in ‘Personnel Monitoring Report given in SOP on Viable Particle Monitoring — Sterility Testing area.
List of Annexure
References(If any):
Not Applicable
Reason for Revision
New SOP
Abbreviations:
QC: Quality Control
SOP: Standard Operating Procedure
Check list for Aseptic Processing Area
| Activity | Ok | Not Ok |
| Press door interlocking of sump, open the door with elbow, enter and remove plant uniform and footwear. | ||
| Press door interlocking of first change room with elbow and enter | ||
| Rinse the hands with Sterillium | ||
| Wear primary garment in following sequence in first change room, by taking care to avoid contact with floor -Cap Shirt and trouser Booties. | ||
| Press door interlocking of second change room with elbow and enter | ||
| Sanitize the hands with Sterillium | ||
| Wear the pre-sterilized hand gloves in second change room, in a manner that the bare hands shall not touch outer surface of gloves | ||
| Sanitize the hands with Sterillium. | ||
| Press door interlocking of third change room with elbow and enter | ||
| Open the garment cubicle and take the bag consisting of sterile secondary garment | ||
| Wear sterile garment in following sequence, by taking care to avoid contact with floor.
Head gear without touching outer surface Boiler suit Goggles |
||
| Ensure that loose ends of head cover are tucked inside the boiler suit | ||
| Sit on the cross over bench | ||
| Tie up one booty and cross the leg on other side of the bench | ||
| Tie up the other booty without touching the bench by hand and cross over bench | ||
| Discard the empty bag in the waste bin provided in the change room | ||
| Look into the mirror to check the proper gowning and ensure that no body part is exposed | ||
| Press door interlocking of buffer change room with elbow and enter | ||
| Sanitize the gloved hands with disinfectant and wear secondary gloves and disinfect again. |
Check list for Sterility Testing Area Gowning
| Activity | Ok | Not Ok |
| Show access card to interlocking system to enter into change Room-1. Remove apron, cap and place street garments in the dedicated cubicle. | ||
| Remove the lab slippers and keep them aside. Sanitize the hands with 70% IPA. Press door interlocking switch of change room-2 with elbow and enter. Sanitize the Hands with Sterillium . | ||
| Wear primary garment in following sequence in change room-2, by taking care to avoid contact with floor
Head gear Jacket trouser Booties. |
||
| Press door interlocking switch of change room-3 with elbow and enter.Sanitize the Hands with 70% IPA | ||
| Switch OFF the UV Light of the garment cubicle and Open the door. Pick and wear a pair of Sterile gloves aseptically. Sanitize the gloved Hands with 70% IPA. | ||
| Pick up a bag of Sterile garment containing headgear ,boiler suit. Open the bag and wear Head gear first, followed by Boiler suit and booties. | ||
| Tie the boiler suit over the belly with the help of the string provided. Close the garment from top to bottom with zipper. Wear the booties. | ||
| Sanitize the Hands with 70% IPA. Pick up and wear goggles from the cubicle. Sanitize the Hands with 70% IPA. | ||
| Press door interlocking switch of change room-4 with elbow and enter. Check in the mirror for proper gowning. | ||
| Press door interlocking switch with elbow and enter the Sterility Testing Area. |
PERSONNEL QUALIFICATION FOR ASEPTIC PROCESSING/STERILITY TESTING AREA
Final Qualification Report
| Name of Trainee: | |
| Code: | |
| Designation: | |
| Department.: |
| Tests | Status | Remarks | |
| OK | Not OK | ||
| Preliminary Qualification | Qualified/Not Qualified | ||
| Activities in Aseptic Processing Area | Proper/Not Proper | ||
| Viable Count in final Qualification | Within acceptable level/Not within acceptable level | ||
Put (√) mark in appropriate column.
Reports attached/Not attached.
Remarks:______________________________________________________________
Result:Qualified/Not qualified to enter and work in aseptic processing/Sterility Testing area.
Requalification Due:
Evaluated By(Head-QC): Approved By(Head-QA):
PERSONNEL QUALIFICATION FOR ASEPTIC PROCESSING/STERILITY TESTING AREA
Intimation
To
Mr.____________________________ Code No.:______________________________
Designation:______________________ Department:_____________________________
Reports attached/Not attached.
Remarks:______________________________________________________________
__________________________________________________________________________
Result:Qualified/Not qualified to enter and work in aseptic processing/Sterility Testing area.
Requalification Due:
Evaluated By(Head-QC): Approved By(Head-QA):
Observation of Personnel activity in Aseptic Processing Area
| Name of Trainee: | ||
| Code: | Designation: | |
| Department.: | ||
| Activity | Yes | No |
| Is the Person moving /working in the aseptic processing area slowly and rhythmically? | ||
| Is the person disinfecting the hands before and after touching any surface? | ||
| Is the person leaning over any sterile material? | ||
| Is the person sitting on any surface in the aseptic processing area? | ||
| Is the person picking any material lying on the floor? | ||
| Is the person sneezing / spitting / coughing in the aseptic processing area? | ||
| Is the person keeping all the sterilized materials in the safe place? | ||
| Is the person performing any activity, which may alter the sterility of the product? | ||
| Is the person laughing or talking in aseptic processing area? |
Put (√) mark in appropriate column
Remarks:___________________________________________________________________
Observed By (Head-Injectable Production):
Checked By(Head-Microbiology):
Observation of Personnel activity in Sterility Testing Area
| Name of Trainee: | ||
| Code: | Designation: | |
| Department.: | ||
| Activity | Yes | No |
| Is the Person moving /working in the sterility testing Area slowly and rhythmically? | ||
| Is the person disinfecting the hands before and after touching any surface? | ||
| Is the person leaning over any sterile material? | ||
| Is the person sitting on any surface in Sterility Testing area? | ||
| Is the person picking any material lying on the floor? | ||
| Is the person sneezing / spitting / coughing in the aseptic processing area? | ||
| Is the person keeping all the sterilized materials in the safe place? | ||
| Is the person performing any activity, which may alter the sterility of the product? | ||
| Is the person laughing or talking in Sterility Testing Area? |
Put (√) mark in appropriate column
Remarks:___________________________________________________________________
Observed By (Head-Injectable Production):
Checked By(Head-Microbiology):
Preliminary Qualification Report
| Name of Trainee: | |
| Code: | |
| Designation: | |
| Department.: |
| Tests | Status | Remarks | |
| OK | Not OK | ||
| All relevant training attendance | Attended/Not Attended | ||
| All written tests | Attended/Not Attended | ||
| Aseptic Gowning | Proper/Not Proper | ||
| Viable Count in preliminary Qualification | Within Acceptable level/ Not within Acceptable level | ||
Put (√) mark in appropriate column.
Remarks:______________________________________________________________
Result:Qualified/Not qualified for final qualification.
Reviewed By(Head-Microbiology):
Evaluated By(Head-QC):
Report of Viable Particle Count(Preliminary Qualification)
| Section | Areas | |||
| Time of test | From | Activity | ||
| To | Microbiology Ref. No. | |||
| Medium Used | Medium Lot No. | |||
| Tested on | Reported on | |||
| Incubation | ||
| Temperature | Time | Incubator I.D. No. |
| 20 – 25oC | From: To: | |
| 30 – 35oC | From: To: | |
| Name of Person , Code, Department and Designation | Location Code
|
Total viable Count (CFU’s / Contact Plate) | ||||||
| After 72 hrs | After further 48 hrs | Total Viable count after
5 Days |
||||||
| Bacterial | Fungal | Bacterial | Fungal | |||||
|
|
RH |
|||||||
| LH | ||||||||
| RC | ||||||||
| LC | ||||||||
| FR | ||||||||
| FL | ||||||||
| RA | ||||||||
| LA | ||||||||
| RE | ||||||||
| LE | ||||||||
| AR | ||||||||
| AL | ||||||||
RB |
||||||||
| LB | ||||||||
| Observation done by | ||||||||
| Date of observation | ||||||||
Acceptable levels:
| Location
Code |
Location Name | Acceptable level of Total Viable Count (CFU’s / Contact Plate) |
RH |
Right hand |
< 1 |
| LH |
Left hand |
< 1 |
| RC |
Right Chest |
3 |
| LC |
Left Chest |
3 |
| FR | Fore head-right | 3 |
| FL | Fore head-Left | 3 |
| RA | Right arm pit | 3 |
| LA | Left arm pit | 3 |
| RE | Right Elbow | 3 |
| LE | Left Elbow | 3 |
| AR | Abdomen-Right | 3 |
| AL | Abdomen-Left | 3 |
RB |
Right booty | 5 |
| LB | Left booty | 5 |
Interpretation: The Personnel monitored for viable counts by Contact Plates are within / Not within the acceptable levels.
Comments: _________________________________________________________________
Done By: Checked By:
Date : Date :
PERSONNEL QUALIFICATION FOR ASEPTIC PROCESSING/STERILITY TESTING AREA
Written Test
| Name of Trainee | |
| Code | |
| Designation | |
| Department | |
| Topic | Basics of Microbiology |
| Trainer | |
| Mode of Training |
Maximum Marks: 10 Minimum qualifying marks: 9 Duration: 15 minutes.
Each Question Carries 1 Mark. Indicate correct answer with appropriate alphabet in the box.
Q 1. Microbiology is the study of ______________________________
- A) Microchips
- B) Micro finance
- C) Micro organisms
- D) Micro processors
Q 2. Bacteria are _________________________________
- A) Eukaryotic organisms
- B) Prokaryotic organisms
- C) Non of above
- D) Both ‘A’ and ‘B’
Q3. is endospore forming bacterium ___________________________
- A) Bacillus
- B) Pseudomonas aeruginosa
- C) Escherichia coli
- D) Non of the above.
Q 4. Phototrophs require __________________________ as energy source.
- A) Carbon
- B) Reduced inorganic compounds
- C) Organic compounds
- D) Light
Q 5. Sterilization Means____________________
- A) Process to remove sub visible particles
- B) Process to remove visual particles
- C) Process to kill or remove insects
- D) Process to kill or remove living microorganisms
Q 6. Sterilization in autoclave is ________________
- A) Chemical sterilization method
- B) Sterilization by filtration
- C) Sterilization by irradiation
- D) Moist heat sterilization
Q 7. Pathogen ____________________________
- A) Produce infectious disease
- B) Doesn’t produce infection
- C) Prevent infection
- D) Reduce infection
Q 8. Bacterial Endotoxins are______________________
- A) Antibiotics
- B) Pyrogenic substances
- C) Antipyretics
- D) Anti inflammatory agents
Q 9. Bacterial Endotoxins are released from
- A) Fungus’
- B) Virus
- C) Gram -Ve bacteria
- D) Gram +Ve bacteria
Q 10. UV sterilization is an example for _______________________
- A) Chemical sterilization
- B) Dry heat sterilization
- C) Irradiation
- D)Moist Heat Sterilization
