This presentation includes information about environmental monitoring, various methods for sampling and execution.

1. ENVIRONMENNTAL
MONITORING
1. Kishan Raj Sharma
Microbiologist, QC Department
2. Prakash Ghimire
Senior Officer, QA Department
PRESENTED BY
1
Biogain Remedies Pvt. Ltd.
Patthardanda, Tilottama-16, Rupandehi, Nepal

2. INTRODUCTION
 Environmental monitoring is the processes and the activities that need
to take place to characterize and monitor the quality of environment.
 It is part of GMP
 Monitoring
 Testing
 Feedback to the microbiological quality level in aseptic environment.
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

3.  MICROBIAL MONITORING
 Viable monitoring: Testing for the detection and enumeration
 Bacteria, yeast and mold.
 Non-viable monitoring: Particle count
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

4. SOURCE OF CONTAMINATION
 Air
 Personnel
 Equipment
 Cleaning agents
 Containers
 Water and compressed gases
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

5. WHERE?
Mfg Area/ dedicated location
WHEN?
 The air and surface monitoring should be conducted during the
aseptic processing/operation.
 Personnel monitoring when the operator leaves the process area
 Product contact surface would be monitor at the end of filling
operation.
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

6. WHAT?
Testing /accuracy conclusion of the particular area
WHO?
The trained personnel/Microbiologist
HOW?
As per current practise
SOP/GMP/GLP/Protocols/Docs
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

7. METHOD FOR MICROBIAL MONITORING
Methods
Surface
monitoring
Air sampling
Contact plate
method
Swabbing
method
Touch plate
method
Surface rinse
method
Passive air
sampling
Active air
sampling
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

8. CONTACT PLATE METHOD
 Surface sampling
 Tryptone soya agar
 Contact plate was pressed on the area to be tested
 Wipe with 70% IPA to remove any residue
 Incubate for 48 hrs at 30-35°C and then for 72 hrs at 20-
25°C
 Used for testing product contact surface, floors, walls and
equipments.
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

9. SWABBING METHOD
 Collected by removing a sterile swab from sterile
tube
 Testing surface was swabbed with sterile swab
 incubation
 Used for testing irregular surfaces.
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

10. ACTIVE AIR SAMPLING
 Air sampler placed in center of room at height of 1 meter
above the floor
 Air sampler was disinfectant with 70% IPA
 One thousand litres of air were collected
 Incubate for 48 hrs at 30-35°C and then for 72 hrs at 20-25°C
 Colonies were counted.
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Reuter centrifugal
sampler
BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

11. PASSIVE AIR SAMPLING
 Expose petriplates containing tryptone soya agar
medium
 Cover with lid
 Incubate for 48 hrs at 30-35°C and then for 72 hrs at
20-25°C
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

12. MONITORING CRITERIA
 Daily monitoring: Micro, LAF/UV passbox/ room
 Monthly monitoring: MFG area/Equiments/Drain points
 Quarterly monitoring: Compressed Air
 Half yearly: Operators/Personal Hygiene monitoring
 Yearly monitoring: HAVC (heating,ventilation and air
conditioning)
 Occasional monitoring: As and when required
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

13. REFERENCE RANGE OF COLONY FORMING UNIT
 0-5 colonies: very slight colonies(considered excellent
 6-15 colonies: Slightly (considered good)
 16-30 colonies: Moderate (borderline acceptable)
 31-50 colonies: Significant (poor)
 >50 colonies : Heavy(unacceptable)
 TNTC: To numerous to count(unacceptable)
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

14. CONTAMINATION CONTROL
 Contaminants are the presence of anything in the
manufactured product.
 Contaminants can be
 Product or substance other than product
manufactured
 Foreign products
 Particulate matter
 Micro-organisms
 Endotoxins
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

15. SOURCE OF CONTAMINATION
 Personnel and their activities
 Skin, hair, saliva, clothing materials,coughing,
handling,cosmectics etc
 Accessories tools and equipments,glasswares
 Environmental contaminants: air ,water, chemicals,
vapours, building materials etc
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

16. TYPES OF CONTAMINANTS
 Particulate contaminants: viable and non viable particles
 Physical factors: Temperature, Humidity Pressure,
Radiation, Vibration
 Chemical contaminants: All other contaminants that are
not solid
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

17. EFFECTS
 Product damage
 Yield reduction
 Time and economy loss
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

18. CONTROL
 Controlling form personnel
 Controlling from tools and equipment
 Controlling from environment
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

19. CONTROL OF CONTAMINATION FROM PERSONNEL
 Training
 Education
 Head cover, face masks and plastic boots
 Disinfectant soap
 Goggles
 Air showers
 Growing rooms
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

20. CONTROL OF CONTAMINANTS FROM
ACCESSORIES
 HEPA
 Airlock
 Clean rooms
 Sterilized glasswares
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

21. CONTROL OF CONTAMINANTS FROM
ENVIRONMENT
 Centralized air handling or fan filter units
 Clean benches: horizontal and vertical laminar air flow
 Careful materials and equipment selection
 Gloves provide better protection from outside contamination.
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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal

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BIOGAIN REMEDIES PVT. LTD.
Patthardanda, Tilottam-16, Rupandehi,
Nepal