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SOP for Environmental Monitoring of Parenteral Processing Area by RODAC Plate and Swab


Standard operating procedure to monitor viable micro – organisms load on the surface of parenteral processing area.

1.0  OBJECTIVE

    To monitor viable micro – organisms load on the surface of parenteral processing area.

2.0  SCOPE

       This SOP is applicable for monitoring of viable count on surface of parenteral processing area by swab and RODAC plate method.

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  Sampling Frequency :

Sr. No
Location
Frequency.
01
Class 100 and 10,000- Ins filling & filtration Room
Three times / weeks
02
Class 100 and 10,000 Area other than above
Once in a week
03
Class 100,000 Preparation Room.
Once in a week
04
Class 100,000 Other area & wash Area.
Once a fortnight







5.2  Requirement

       For RODAC plate : Sterile RODAC plates with SCD agar + 0.5% Soya lecithin & 4 % Poly - sorbate –20
       For Swab : Sterile Swab sticks, sterile normal saline solution.

5.3.  Preparation of Sterile RODAC plate

5.3.1  Preparation of Soyabean casein digest agar containing with 0.5% Soya lecithin & 4 %  Polysorbate – 20 as per following manner.
5.3.2  As per the instruction, weigh specified quantity of media powder in a beaker, whose capacity is double than the final volume of media to be prepared.  
5.3.3  Add also 0.5% of Soya lecithin & 4 % Polysorbate – 20 as per medium quantity.
5.3.4  Add appropriate quantity of distilled water and mix it properly.
5.3.5  Check the pH of the medium and set the pH using 0.1 N HCl / 0.1 N NaOH if required.
5.3.6  Heat and dissolved the medium constituents with constant stirring to avoid charring.
5.3.7  In the molten state, distribute the specific volume of the media in to the appropriate glass container.
5.3.8  Seal the mouth of the glass container using cotton plug only.
5.3.9  Affix the label with Name of media on each container.
5.3.10  Cover the cotton plug with wrapping paper.
5.3.11  Unless specified, sterilize the media at 121°C for 20 min as per SOP.
5.3.12  After completion of the sterilization cycle, pour sterile Soyabean casein digest agar + 0.5 % Soya –Lecithin & 4 % Polysorbate – 20 in each pre – sterilized and dry plate under Laminar air flow bench till convex surface achieved and allow it to solidify.
5.3.13  After solidification of medium, incubate the RODAC  plate at 30°C – 35°C for 48 Hrs.
5.3.14  After incubation observe the plates for contamination and contaminated plates must be discarded.
5.3.15  Tag the label as Date of preparation of Medium , Medium Lot. No, Date of use Before on sterile RODAC  plate and store in refrigerator.

Related: Identification of Microorganisms to Species Level

5.4.  Procedure for Surface testing by RODAC plate

5.4.1  Mop the outer surface of RODAC plates with 70% Isopropyl alcohol and transfer them to the Parenteral Department.
5.4.2  Open the RODAC plate and contact them on sampling site ( surface) as per schedule.
5.4.3  After contact close the RODAC plate and spray the disinfectant solution on the sampling surface and mop it with sterile cloth / mopper.
5.4.4  After sampling, incubate the plates at 30°C – 35°C for 72 Hrs, and then record the results in terms of CFU / plates in Annexure – I , II, III, IV. 

5.5  Procedure For Surface testing by Sterile Swab sticks

5.5.1  Swab should only be used when it is not possible to use RODAC for the swab test. A cotton stick ( swab ) should be preferred. The swab should be moistened in sterile saline or sterile water & rubbed on the sampling site and then rubbed in a SCD agar plate. All operations made in the sampling area.
5.5.2  After sampling incubate the plates at 30°C – 35°C for 72 Hrs and then record the results in terms of CFU / plate in Annexure – I.
Limit : Results CFU per sample.
Class
Location
Alert Level 
Action Level
100
 * Critical sites ( Filling line , Needle , Cap Track )
* 1
* > 1
Other sites
1 – 3
> 3
10,000
Above Floor level
3 – 5
> 5
At floor level
7 – 10
> 10
100,000
Pre & Wash
Above Floor level
15 - 25
> 25
At floor level
25 - 50
> 50
100,000
 Other area
Above Floor level
25 – 50
> 50
At floor level
50 – 100
> 100

Acceptance criteria : Bacterial Colony should be within  Limit or Fungi should be  Absent.
5.6  Following sites are to be covered within week.


Day
No of sites
Location
Class
Tuesday Thursday
Saturday
Insulin filling Room
1
* Inside PF for sterile cap Cabinet
100
2
Top of PF for sterile cap Cabinet.
10,000
3
* (A) Filling line, (B) Needle, ( C) Cap Track
100
4
Balance Table
10,000
5
Wall Nr Door
10,000
6
Floor Nr filling line
10,000
7
Window – V Motor Room – Nr Ins. Filling Room
10,000
Insulin filtration Room
8
* PF Bench
100
9
Floor
10,000
10
Wall Nr. Door.
10,000



Day
No of sites
Location
Class
Monday
Green corridor
1
Wall Nr door
10,000
2
Floor Nr sterile area entry
10,000
New window
3
Window – I Material entry – Red area side.
10,000
4
Window – II Opp Insulin filtration  - Red area side.
10,000
Green change Room – II
5
Wall Nr door
10,000
6
Swing Over Bench
10,000
7
* Inside PF for keeping sterile dress.
100
Day
No of sites
Location
Class
Monday
Wednesday
Friday
Ampoule filling Room
1
* From filling Machine
100
2
* From Filling machine
100
3
Wall Nr door.
10,000
4
Floor.
10,000
5
Window – III Ampoule filling – Red area side
10,000
Ampoule filtration Room 
6
From PF Bench
100
7
Floor
10,000
8
Floor table
10,000
9
Wall Nr door.
10,000
10
Window – IV Ampoule filtration – Red area side
10,000



Day
No of sites
Location
Class
once in a Fortnight

1ST  week

&

3RDweek

of

Wednesday
à  Insulin Mfg Room ___
1
Floor
100,000
2
From S.S Table
100,000
à Ampoule Mfg Room
3
Floor
100,000
4
From S.S Table
100,000
à Vial wash
5
Floor
100,000
6
Wall Nr door.
100,000
à Ampoule wash
7
Floor
100,000
8
Wall Nr door.
100,000
à Cap wash
9
Floor
100,000
10
Wall Nr door.
100,000
à Tank wash
11
Floor
100,000
12
Wall Nr door.
100,000



6.0  ABBRIVATION

°          =    Degree centigrade
%        =    Percentage
S.C.D  =    Soyabean Casein Digest 
Hrs.     =    Hours.
CFU    =   Colony Forming Unit.
Prep.   =    Preparation
PF       =    Particulate filter
S.S      =    Stainless steel
Nr       =    Near

    ANNEXURE – I

Q.C DEPARTMENT
MICROBIOLOGY LAB.
S.O.P No.: _________

ENVIRONMENTAL MONITORING OF PARENTERAL PROCESSING  AREA

Surface Testing ( RODAC / SWAB)

   Date :                                                    Day  :                               Time of Exposure:

Medium Used : SCD Agar + Soya lecithin (0.5%) + Polysorbate – 20 ( 4.0%)
Medium Lot. No.:
Activity.:-
Incubation Temp & Period.: 30°C – 35°C 

Sr.No
Location
  CFU/Plate
LIMIT
CFU/Plate
Ampoule Filling Room
Class
Bact.
Fungi
Class
Location
Alert
Action
1
* From Filling Machine  -
100
2
* From Filling Machine  -
100
100
* Critical sites
1
> 1
3
Wall Nr Door. 
10,000
4
Floor.
10,000
5
Window – III Amp filling Room
10,000
Ampoule Filtration Room
10,000
Above floor level
3 - 5
> 5
6
From PF Bench
100
7
Floor
10,000
8
Floor Table
10,000
At floor level
7 - 10
> 10
9
Wall Nr Door.
10,000
10
Window – IV Amp filtration Room
10,000
11
Control Plate
   --
Identification of Colonies : -  
1.)
2.)
3.)
4.)
5.)
6.)
7.)
8.)
9.)
10.)
11.) Control Plate.

Evaluation Of Results:
Microbiologist

Date of Report

Checked By
( Sign & Date)
( Sign & Date)

ANNEXURE – II

Q.C DEPARTMENT

MICROBIOLOGY LAB.
S.O.P No.: ___________

ENVIRONMENTAL MONITORING OF PARENTERAL PROCESSING  AREA

Surface Testing ( RODAC / SWAB)

    Date :                                                Day  :                                        Time of Exposure:

Medium Used : SCD Agar + Soya lecithin (0.5%) + Polysorbate – 20 ( 4.0%)
Medium Lot. No.:
Activity.:-
Incubation Temp & Period.: 30°C – 35°C 

Sr.No
Location
  CFU/Plate
LIMIT
CFU/Plate
Insulin Mfg Room
Bact.
Fungi
Class
Location
Alert
Action
1
Floor
100,000
2
From S.S Table
100,000
100,000
Above floor
At floor
15-25
25- 50
>25
>50
Ampoule Mfg Room
3
Floor
100,000
4
From S.S Table
100,000
Vial wash
100,000
Above floor level
25 - 50
> 50
5
Floor
100,000
6
Wall Nr door
100,000
Ampoule wash
At floor level
50-100
> 100
7
Floor
100,000
8
Wall Nr door
100,000
Cap wash
9
Floor
100,000
10
Wall Nr door
100,000
Tank wash
11
Floor
100,000
12
Wall Nr door
100,000
13
Control Plate
--
Identification of Colonies : -  
1.)
7.)
2.)
8.)
3.)
9.)
4.)
10.)                   
5.)
11.)
6.)
12.)
13.) Control Plate
Evaluation Of Results :


Microbiologist

Date of Report

Checked By
( Sign & Date)
( Sign & Date)

       ANNEXURE – III

Q.C DEPARTMENT
MICROBIOLOGY LAB.
S.O.P No.: __________

               ENVIRONMENTAL MONITORING OF PARENTERAL PROCESSING  AREA

Surface Testing ( RODAC / SWAB)

Date :                                                 Day  :                                          Time of Exposure:

Medium Used : SCD Agar + Soya lecithin (0.5%) + Polysorbate – 20 ( 4.0%)
Medium Lot. No.:
Activity.:-
Incubation Temp & Period.: 30°C – 35°C 

Sr.No
Location
  CFU/Plate
LIMIT
CFU/Plate
Green Corridor
Class
Bact.
Fungi
Class
Location
Alert
Action
1
Wall Nr Door.
10,000
2
Floor Nr Sterile Entry 
10,000
100
* Critical sites
     Other sites
1
1 – 3 
>1
>3
New window
3
Window – I Nr. Material entry 
10,000
4
Window – II Opp Ins. Filtration
10,000
Green Change Room – II
10,000
Above floor level
3 - 5
> 5
5
Wall Nr door 
10,000
6
From Swing Over Bench.
10,000
7
* Under PF for keeping sterile dress
100
At floor level
7 - 10
> 10
8
Floor.
10,000
9
Control Plate
  --
Identification of Colonies : -  
1.)
2.)
3.)
4.)
5.)
6.)
7.)
8.)
9.) Control Plate.



Evaluation Of Results:

Microbiologist

Date of Report

Checked By
( Sign & Date)
( Sign & Date)


        ANNEXURE – IV

Q.C DEPARTMENT
MICROBIOLOGY LAB.
S.O.P No.: ________

ENVIRONMENTAL MONITORING OF PARENTERAL PROCESSING  AREA

Surface Testing ( RODAC / SWAB)

     Date :                                                Day  :                                         Time of Exposure:

Medium Used : SCD Agar + Soya lecithin (0.5%) + Polysorbate – 20 ( 4.0%)
Medium Lot. No.:
Activity.:-
Incubation Temp & Period.: 30°C – 35°C 

Sr.No
Location
  CFU/Plate
LIMIT
CFU/Plate
Insulin Filling Room
Class
Bact.
Fungi
Class
Location
Alert
Action
1
Inside PF for sterile Cap Cabinet.
100
2
Top of PF for Sterile Cap Cabinet
10,000
100
* Critical Sites
1
> 1
3
* Filling Line
100
4
* Needle
100
Other Sites
1 - 3
> 3
5
* Cap Track
100
6
Balance Table
10,000
7
Wall  Nr Door.
10,000
10,000
Above floor level
3 - 5
> 5
8
Floor Nr filling line
10,000
9
Window – V Nr Motor Room
10,000
Insulin Filtration Room
At floor level
7 - 10
> 10
10
PF Bench
100
11
Floor
10,000
12
Wall Nr.Door
10,000
13
Control Plate
    --

Identification Of Colonies :- 
1
8
2
9
3
10
4
11
5
12
6
13 Control Plate -- 
7

Evaluation Of Results:


Microbiologist

Date of Report

Checked By
( Sign & Date)
( Sign & Date)
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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