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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 viable count of dispensing area and sampling in raw material store.

2.0  SCOPE

       This procedure is applicable for dispensing area & sampling area of 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 fort night 

5.2  Preparation of plates

5.2.1  Pour about 20 ml of sterile soyabean casein digest agar medium and potato dextrose agar medium ineach 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 30o-35oC in inverted position in stainless steel trays and incubate for 48 hours.
5.2.3  After 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 material entry.
5.3.3  Expose both  PDA and SCDA petri plates placing in 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 30-35otemperature for 72 hrs.
5.4.2  Incubate PDA  plates in inverted position together with control petri plates (unexposed) at 20-25oC temperature for 5 days.
5.4.3  After 72 hrs count the bacterial colony in SCDA plates to identify the bacteria with help of colonical characteristic and morphological characteristic .
5.4.4  After five days count the fungal colony in PDA plate. Identify the characteristic 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
       oC = Degree centigrade
       LAF= Laminar Air flow
       I.P.A= Isopropyl alcohol
       % = Percentage
       hrs.=Hours 
       RM.= Raw material store
       SCDA = Soyabean Casein Digest Agar             
       PDA = Potato Dextrose Agar

Related: Identification of Microorganisms to Species Level



ANNEXURE – I
MICROBIOLOGY DEPARTMENT
ENVIRONMENT MONITORING OF DISPENSING & SAMPLING AREA OF R.M. STORE
DATE :                                                                                              TIME OF EXPOSURE :
BACTERIA
FUNGI
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


Acceptance criteria :- Bacterial colony should be within Limit & Fungal colony should be Absent.

Comment :
Microbiologist
Date of Report
Checked By
(Date & Sign.)

(Date & Sign.)
 
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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