SOP for Environmental Monitoring of Parenteral Processing Area by Settling Plate Count Method

1.0 Objective

To monitor viable count from settled air in to parenteral processing area.

2.0 Scope

This procedure is applicable for different part of parenteral processing area.

3.0 Responsibility

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

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Frequency of the test : Daily
5.2 Location chart for settling plate in parenteral processing area is as per Annexure - I .

5.3 Preparation of plates

5.3.1 Pour about 20 ml of sterile soyabean casein digest agar medium and Potato dextrose agar medium in each pre sterilized and dried plate (90 mm size) under laminar air flow bench III and allow it to Solidify.
5.3.2 After solidification of medium, incubate the SCDA and PDA petri plates in inverted position at 30°C – 35°C for 48 hrs.
5.3.3 After incubation period, observe the plates for contamination.
5.3.4 Discard contaminated plates as per S.O.P., if any found.

5.4 Procedure for Exposing plates

5.4.1 Mop the stainless steel trays/ petridish carrying box along with lid of trays/Petridish carrying box using 70% filtered Isopropyl alcohol (I.P.A) solution and arrange the plates after proper marking, indicating location and date of exposure in stainless steel trays/ petridish caring box.
5.4.2 Transfer the trays/petridish caring box to blue area of parenteral department through material entry.
5.4.3 Mop the exposing s.s stool with 70% filtered IPA solution. Put both the PDA and SCDA plate in each location on this SS stool .
5.4.4 Mark exposure time on each petri plate label.
5.4.5 Expose each petri plate placing in right receptacles as per location chart for four hours.
5.4.6 After exposing of both the medium containing petri plate, collect all the exposed petri plate and put in to s.s. trays/ petridish caring box and transfer to microbiology lab. through material entry.
Related: Identification of Microorganisms to Species Level

5.5 Procedure for incubation

5.5.1 Incubate SCDA plates in inverted position together with control petri plates ( unexposed) at 30-35°C temperature for 72 hrs.
5.5.2 Incubate PDA plates in inverted position together with control petri plates ( unexposed) at 20-25°C temperature for 5 days.
5.5.3 After 72 hrs. count the bacterial colony in SCDA plates ,identify the bacteria with the help of colonical characteristic and morphological characteristic.
5.5.4 After five days, count the fungal colony in PDA plates. identify the fungi with the help of colonial characteristic and morphological characteristic.
5.5.5 Record the results in annexure-I.
5.6 Limit: cfu/Plate

Area	Alert Level	Action Level
Parenteral Dept.
* Critical sites	*05	* > 07
Other sites	07	> 15

Acceptance Criteria: Bacterial colony should be within limit and fungi should be absent.

6.0 Abbreviations

6.1 cfu = Colony forming unit
6.2 oC = Degree centigrade
6.3 LAF = Laminar Air flow
6.4 I.P.A = Isopropyl alcohol
6.5 % = Percentage
6.6 hrs.= Hours
6.7 mfg.= Manufacturing
6.8 PDA = Potato Dextrose Agar
6.9 SCDA = Soyabean casein digest agar
6.10 SS = Stainless Steel

ANNEXURE-I

MICRO BIOLOGICAL DEPARTMENT

ENVIRONMENTAL MONITORING OF PARENTERAL PROCESSING AREA BY SETTLING PLATE COUNT METHOD

Date of exposure :                          Day :                                        Exposure time: 

Bacteria	Fungi
Medium Used : Soyabean Casein Digest Agar.	Medium Used :Potato Dextrose Agar.
Medium Lot.No:	Medium Lot.No:
Incubation Temp. & Period : 30°C – 35°C for 72Hrs	Incubation Temp. & Period : 20°C – 25°C for 5 Days.

Sr.No.	Location		Bacteria		Fungi	Identification
	Insulin  filling
1*	Right side of the LAF  for keeping sterile caps. ( Nr. entry door)
2*	On the Balance table
	Green Corridor
3	Right side in green corridor lobby
4	Opposite of the table for disinfectant and moping solution
5	Left side of the green corridor lobby ( Nr.green sluice door)
	Ampoule filling room -I
6*	Right side near window between ampoule filling room -I and green corridor
7*	Nr.door (Entry)
	Ampoule filtration room-I
8*	Nr.door of ampoule filtration room -I
9*	Nr.window opposite of vial filling room
	Insulin filtration room
10*	On left corner of the room.
11*	Top of LAF -3
	New windows
12	Window – I Near Material entry
13	Window – II Near Insulin filtration room – Red Area side
14	Window – III Ampoule filling room – Red Area side
15	Window – IV Ampoule filtration room – Red Area side
16	Window – V Motor room Nr. Insulin filling room – Blue Area side
	Vial and Ampoule mfg. Room.
17	On the table of stock solution of vial mfg.room.
18	On the window shelf between ampoule mfg.room and vial wash room wall
19	Control
LIMIT : (CFU / Plate)		Alert Level		Action Level
* Critical sites		*05		>  07
Other sites		07		>  15

Evaluation Of Report
Microbiologist	Date of Report	Checked By.
( Sign & Date )		( Sign & Date )

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