SOP for Environmental Monitoring of Dispensing and Sampling Area in Raw Materials : Pharmaceutical Guidelines

SOP for Environmental Monitoring of Dispensing and Sampling Area in Raw Materials

Standard operating procedure to ensure the control over viable count of dispensing area and sampling in raw material store using pre-incubated PDA or SCA and SCDA plates.

1.0 Objective

To ensure the control over the viable count of dispensing area and sampling in raw material store.

2.0 Scope

This procedure is applicable for dispensing area & sampling area of the raw material store.

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: Once in a fortnight
5.2 Preparation of plates
5.2.1 Pour about 20 ml of sterile soybean-casein digest agar medium and potato dextrose agar medium in each pre-sterilized and dried plate (90 mm) under laminar air flow bench (III)and allow it to solidify.
5.2.2 After solidification of medium place the SCDA Petri plates at 30°-35°C in the inverted position in stainless steel trays and incubate for 48 hours.
5.2.3 After the incubation period, observe the plates for contamination.
5.2.4 If any contaminated plates found, discard it as per SOP.
Note: Use both PDA and SCDA plates after pre-incubation of 48 hours.
5.3 Procedure for Exposing plates:
5.3.1 Mop the stainless steel trays /stand along with lid using 70% filtered IPA solution and arrange the plates after proper marking indicating location and Date of exposure in stainless steel trays.
5.3.2 Transfer the trays to Dispensing area through the material entry.
5.3.3 Expose both PDA and SCDA Petri plates placing in the right receptacle as per Annexure-I.
5.3.4 Mop the exposing S.S. stool with 70% filtered IPA solution expose both the PDA and SCDA plate in each location on the S.S. stand at working height
5.3.5 Label each Petri – plate with exposure time.
5.3.6 Exposure time in dispensing and sampling area: 2 hours
5.4 Procedure for incubation :
5.4.1 Incubate SCDA plates in inverted position together with control plates (unexposed) at 30-35°C temperature for 72 hrs.
5.4.2 Incubate PDA plates in inverted position together with control Petri plates (unexposed) at 20-25°C temperature for 5 days.
5.4.3 After 72 hrs count the bacterial colony in SCDA plates to identify the bacteria with help of colonial characteristic and morphological characteristic.
5.4.4 After five days count the fungal colony in PDA plate. Identify the characteristics and morphological characteristic.

5.4.5 Record the results in Annexure-I
LIMIT:
Location
Alert level
Action level
Dispensing & sampling booth
1
> 1
Dispensing & sampling room
50
> 70
Acceptance criteria:-
Bacterial Colony should be within Limit and Fungal colony should be Absent.

6.0 Abbreviations

cfu= Colony forming unit
°C = Degree centigrade
LAF= Laminar Air flow
I.P.A= Isopropyl alcohol
% = Percentage
hrs.=Hours
RM.= Raw material store
SCDA = Soybean Casein Digest Agar
PDA = Potato Dextrose Agar 

ANNEXURE – I
MICROBIOLOGY DEPARTMENT
ENVIRONMENT MONITORING OF DISPENSING & SAMPLING AREA OF R.M. STORE
DATE :                                                                                              
TIME OF EXPOSURE :
BACTERIAFUNGI
Medium Used       : SCD Agar
Medium Used        : Potato Dextrose Agar
Medium Lot.No    :
Medium Lot.No :               
Incubation Temp  : 30°C  to  35°C
Incubation Temp : 20°C to 25°C
   Incubation Period : 72 Hrs.
Incubation Period :  5 Days
Sr.No. LOCATION
BACTERIA
FUNGI
IDENTIFICATION OF ORGANISMS
1




2




3




4




5




6




7




8




9




LIMIT



Alert Level
Action Level
*   Under Booth
1
>1
     Under Room
50
70





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.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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