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SOP for Environmental Monitoring of Aseptic Area by Air Sampling for Viable Count using Air Sampler


Standard operating procedure of monitoring of aseptic area and Schedule of air sampling for viable count for Class 100 & 10,000 area

1.0  OBJECTIVE

       To lay down the procedure for environment monitoring of aseptic area by air sampling for viable count using air sampler.

2.0  SCOPE

       This procedure is applicable to Parenteral department where aseptic activities are carried out.

3.0  RESPONSIBILITY

3.1  Doing      :  Technical Assistant (Microbiologist) / Executive.
3.2  Checking :  Executive/ Manager

4.0  ACCOUNTABILITY

       Head of the Department

5.0  PROCEDURE

5.1  Frequency of Sampling:

When formulation and / or Filling are performed samples are to be taken during work such a way that areas with the greatest risk of  Contaminating the product is selected. Samples are to be taken as per  mentioned Frequency.
Process Activity
Location
Class
Grade
Frequency
Insulin Product 
PF modules of Insulin Filling Room
100
A
Daily

Insulin Filling & Filtration Room
10,000
B
Three Times in a Week

PF modules of Insulin Filtration Room
100
A
Three Times in a Week

Other than Insulin Filling & Filtration Room
10,000
B
Once in a week


Other than Insulin Product 


PF modules of Ampoule Filling & Filtration Room  
100
A
Three Times in a Week

Ampoule Filling & Filtration Room 
10,000
B
Three Times in a Week


5.1  Instrument : Air Sampler

5.2  Sterilize SS Lid of Sampling heads and their SS Cover in DHS at 180°C for 2 Hours and assemble the units for sampling.
5.3  Switch “ON” the equipment.
5.4  Operate the equipment as per SOP.

5.5  Sampled Volume of Air:

A.  For Class 100 & 10,000 area 60 min to draw 1000 Lit of air over the Pre incubated SCD media Petri plate.
B.  For Class 100,000 area 30 min to draw 500 Lit of air over the Pre incubated SCD media Petri plate.
5.6  After Completion of sampling period. Remove the Petri plate and incubate with control Petri plate (Unexposed) at 30°C – 35°C for 72 Hrs.   
After 72 Hrs Count the CFU through Colony counter and record the Bacterial and Fungal count in Annexure Completion of sampling period. Remove the Petri plate and incubate with control Petri plate (Unexposed) at 30°C – 35°C for 72 Hrs.
5.9    Schedule of Insulin Product: Class 100 / Class 10,000 .
Day
Location
Class
Grade
Daily

* Critical site of Filling Line of Ins. Filling Room 

PF – 12
PF – 13
PF - 14
100
A
Tuesday
Thursday
Saturday
Insulin Filling Room
Insulin Filtration Room
10,000
B
Tuesday
Thursday
Saturday
PF – 09
PF – 10
100
A

Monday
Wednesday
Friday

Green Change Room – II
Green Corridor – Sluice side.
Green Corridor – Entry side.
10,000
B
                                        
5.10  Schedule of other than Insulin Product: Class 100 / Class 10,000.

Day
Location
Class
Grade
Monday
Wednesday
Friday
Ampoule Filling Room
Ampoule Filtration Room 
10,000
B
Monday
Wednesday
Friday
PF – 17
PF – 18
PF – 28
100
A
5.11  Schedule of Insulin & Other than Insulin Class 100,000 area.  

Week
Day
Location
1st Week
Wednesday
Vial Wash Room
Friday
Cap Wash Room 
2nd Week
Wednesday
Ampoule Mfg Room
Friday
Insulin Mfg Room 
3rd Week
Wednesday
Tank Wash Room
4th Week
Friday
Ampoule Wash Room

5.12  In case of Alert / Action levels exceeding the limit of three consecutive days at the same location, inform the Head of Department, Production Head and Quality Assurance Head for necessary action.
5.13  Limit ( CFU/m3 of Air)                                                               
Grade / Class
Alert Level CFU/m3
Action Level CFU/m3
Grade A / Class 100
n/a
≥ 1
Grade B / Class 10,000
3 – 10
> 10
Grade C / Class 100,000
50 - 99
> 100
100,000 ( Prep & Wash
100 – 200
> 200

6.0   ABBREVIATIONS:  

Mfg = Manufacturing.
°C = Degree Centigrade.
PF = Particulate Filtration.
CFU/m3 = Colony forming units per meter cube.
SS = Stainless steel.
SCD = Soyabean Casein Digest


ANNEXURE
Q. C. DEPT - MICROBIOLOGY LAB.
ENVIRONMENT MONITORING OF ASEPTIC AREA – VIABLE COUNT
Air sampling – Viable Count by Air Sampler
Date Of Testing :
Day:
Inc. Temp/Period
: 30°C–35°C for 72 Hrs.   
Medium Used
: SCD Agar
Instrument
: Air Sampler 
Sample Qty of air  for
 Class 100 / 10,000
Sample Qty of air for
Class 100,000
Medium Lot No
:
ID.No

1000 Lit Air  in 1 Hrs.
500 Lit Air in 30 min.

No
Location
Class / Grade
CFU/m3   
Bacteria
Fungi

* Critical site of Filling Line of Ins. Filling Room 



01
PF – 12 (Identification Of Colonies :                                                     )
100 / A


02
PF – 13 (Identification Of Colonies :                                                     )
100 / A


03
PF – 14 (Identification Of Colonies :                                                     )
100 / A



Insulin Filling & Filtration Area
Ampoule Filling & Filtration Area
No
Location
Class / Grade
CFU/m3
No
Location
Class /
 Grade
CFU/m3
Bacteria
Fungi
Bacteria
Fungi
01
Ins. Filling Room
10,000/ B


01
Amp Filling Room
10,000/B


02
Ins. Filt Room
10,000/B


02
Amp Filtration Room
10,000/B


03
PF – 09
100 / A


03
PF – 17
100 / A


04
PF – 10 
100 / A


04
PF – 18
100 / A


         Control Plate
N.A.


05
PF – 28
100 / A


Identification of Colonies
1.
1.
2.
2.
3.
3.
4.
4.
Control Plate:
5.
Other Than Insulin Filling & Filtration Room
Insulin & Other than Insulin Class 100, 000 area.
No
Location
Class
Day
CFU/m3
Week
Day
Location/ Room
CFU/m3
B
F
B
F
01
Green Change Room – II
10,000
Monday


1st
Wednesday
Vial Wash 


Friday
Cap wash 


02
Green Corri–Sluice side
10,000
Wednesday


2nd
Wednesday
Amp Mfg


Friday
Insulin Mfg 


03
Green Corri- Entry side
10,000
Friday


3rd
Wednesday
Tank Wash


4th
Friday
Amp Wash


Identification Of Colonies :
Identification Of Colonies :

Limit (CFU/m3 of Air)  
Alert Level
Action Level
Limit (CFU/m3 of Air)  
Alert Level 
Action Level
Grade A / Class 100
N.A.
≥ 1
Grade C / Class 100,000
50 - 99
> 100
Grade B / Class 10,000
3 – 10
> 10
100,000 ( Prep & Wash)
100 – 200
> 200
                          




Analyst
Date of Report
Checked By
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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