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

This standard operating procedure outlines the process for environmental monitoring of the dispensing and sampling areas in the raw materials store. Key steps include: 1. Exposing soybean casein digest agar and potato dextrose agar plates in the areas for 2 hours every two weeks 2. Incubating the SCDA plates at 30-35°C for 72 hours and PDA plates at 20-25°C for 5 days 3. Counting bacterial colonies on SCDA and fungal colonies on PDA, and comparing counts to acceptance criteria of less than 1 colony forming unit for dispensing/sampling booth and less than 70 CFU for dispensing/sampling room.

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Solomon Gamanuel
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689 views

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

This standard operating procedure outlines the process for environmental monitoring of the dispensing and sampling areas in the raw materials store. Key steps include: 1. Exposing soybean casein digest agar and potato dextrose agar plates in the areas for 2 hours every two weeks 2. Incubating the SCDA plates at 30-35°C for 72 hours and PDA plates at 20-25°C for 5 days 3. Counting bacterial colonies on SCDA and fungal colonies on PDA, and comparing counts to acceptance criteria of less than 1 colony forming unit for dispensing/sampling booth and less than 70 CFU for dispensing/sampling room.

Uploaded by

Solomon Gamanuel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

Company Name:: Version No.

1
Title:

Document No: SOP for Environmental Monitoring of Dispensing Page No.


Page 1 of 4
and Sampling Area in Raw Materials
Effective Date Revision Date

SOP for Environmental Monitoring of Dispensing and


Sampling Area in Raw Materials

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
Company Name:: Version No.
1
Title:

Document No: SOP for Environmental Monitoring of Dispensing Page No.


Page 2 of 4
and Sampling Area in Raw Materials
Effective Date Revision Date

1. Purpose

The purpose of this SOP is to establish and provide procedure to ensure the control over
viable count of dispensing area and sampling in raw material store.

2. Scope

This procedure is applicable to dispensing area & sampling area of raw material store.in

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the Tech.Assistant ( Microbiologist) / Executive for the


implementation of this SOP.

5. Material and Equipment

Microbiologic test materials .


6. Procedure

6.1. Frequency of the test : Once in a fort night


6.2. Preparation of plates
6.2.1. 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) under laminar air flow bench
(III) and allow it to solidify.
6.2.2. After solidification of medium place the SCDA petri plates at 30o-35oC in inverted
position in stainless steel trays and incubate for 48 hours.
6.2.3. After incubation period, observe the plates for contamination.
6.2.4. If any contaminated plates found, discard it as per SOP. Note : Use both PDA and SCDA
plates after pre-incubation of 48 hours.
Company Name:: Version No.
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Title:

Document No: SOP for Environmental Monitoring of Dispensing Page No.


Page 3 of 4
and Sampling Area in Raw Materials
Effective Date Revision Date

6.3. Procedure for Exposing plates:


6.3.1. 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.
6.3.2. Transfer the trays to Dispensing area through material entry.
6.3.3. Expose both PDA and SCDA petri plates placing in right receptacle as per Annexure-I.
6.3.4. 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
6.3.5. Label each petri – plate with exposure time.
6.3.6. Exposure time in dispensing and sampling area: 2 hours
6.4. Procedure for incubation :
6.4.1. Incubate SCDA plates in inverted position together with control plates (unexposed) at
30-35oC temperature for 72 hrs.
6.4.2. Incubate PDA plates in inverted position together with control petri plates (unexposed)
at 20-25oC temperature for 5 days.
6.4.3. After 72 hrs count the bacterial colony in SCDA plates to identify the bacteria with help of
colonical characteristic and morphological characteristic .
6.4.4. After five days count the fungal colony in PDA plate. Identify the characteristic and
morphological characteristic .
6.4.5. Record the results in Annexure-I

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.
Company Name:: Version No.
1
Title:

Document No: SOP for Environmental Monitoring of Dispensing Page No.


Page 4 of 4
and Sampling Area in Raw Materials
Effective Date Revision Date

7. 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

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