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

1.0 OBJECTIVE

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

2.0 SCOPE

This procedure is applicable to the 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 are 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

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.
5.7 After 72 Hrs Count the CFU through Colony counter and record the Bacterial and Fungal count in Annexure Completion of sampling period. 

5.8 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

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