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

1.0 OBJECTIVE

To monitor viable microorganisms load on the surface of the parenteral processing area.

2.0 SCOPE

This SOP is applicable for monitoring of viable count on the 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 Soybean casein digest agar containing with 0.5% Soya lecithin & 4 % Polysorbate – 20 as per the following manner.
5.3.2 As per the instruction, weigh the 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 into 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 Soybean 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)

Get ready to use editable documents in MS-Word FormatView List

Share

Tweet

Share

Share