SOP FOR ENVIRONMENTAL MONITORING BY SWAB & PERSONAL MONITORING

1. OBJECTIVE:

To lay down a procedure for environmental monitoring by swab and personal monitoring.

• SCOPE:

This procedure is applicable for procedure for environmental monitoring by swab and personal monitoring .

• RESPONSIBILITY:

Microbiologist

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Preparation of Medium:
  • Peptone Water: Prepared the peptone water as per manufacturerinstructions and sterile by steam sterilization at 121⁰C for 15 – 20 minute.
  • Soybean Casein Digest Agar: Prepared the soybean casein digest agar medium as per manufacturerinstructions and sterile by steam sterilization at 121⁰C for 15 – 20 minute.
  • Swab Sticks: Use the redimade of swab sticks or prepared the swab sticks by non absorbent cotton fold on swab sticks and sterile by steam sterilization at 121⁰C for 15 – 20 minute.
  • Microbiological Environmental Monitoring of Surface by Swab Method:
  • Take the swab stick and rub on the specified location to cover approx. 24-30 cm² area which is to be monitored.
  • During swabbing, swab should not be overlapped, it should be discontinuous. After sampling mop the sampled area with 70% IPA by 2 – 3 times and ensure the swabbed area should be cleaned and sanitized by IPA 70%.
  • After sampling, aseptically close the swab stick.
  • Carry out the sampling for all locations after completion of work Transfer the swab in MLT Room. The estimation of microbial count is done by plating of appropriate aliquot on or in specified media. (Soybean Casein Digest Agar).
  • Incubate the plates at 20 to 25⁰C for 72 hours and then at 30 to 35⁰C for 48 hours.
  • After completion of incubation, count the colony by usage colony counter and record maintain.
  • Microbiological Environmental Monitoring of Surface by Contact Plate Method:
  • Prepared the SCDA medium as per manufacturer instructions. And pour in the contact plate. And stand for solidify. 
  • Take the contact plates. Open the lid of contact plate take the sample by pressing the plate smoothly on the surface which has to be monitor, after sampling, close the lid of plate.
  • During surface sampling press the contact plates with uniform pressure to make contact of the entire media surface.
  • Sanitize the sampled area with 70% IPA & mope the surface with lint free mope.
  • After sampling carries out the contact plates for incubation.
  • Incubate the contact plates at 20 to 25⁰C for 72 hours and then at 30 to 35⁰C for 48 hours.
  • Record the observations of Surface monitoring by contact plate in Format No. F-SOP/MB/046/02-01.
  • Personnel Monitoring By Finger Dab Method:
  • Take the Soybean Casein Digest Agar Media plates. Open the lid of Soybean Casein Digest Agar Media plates. Gently pressing the four fingers & thumb of Right hand on media surface. Follow the same procedure for Left hand on second plate of soybean casein digest agar media.
  • After take the sample; discard the glove and wear the new gloves.

1. After sampling, close the lid of plates. And sanitize the gloves with 70 % IPA.
   1. After sampling carries out the contact plates for incubation.
   1. Incubate the contact plates at 20 to 25⁰C for 72 hours and then at30 to 35⁰C for 48 hours.
   1. Record the observations of Personnel Monitoring by finger dab method in Format No. F-SOP/MB/046/03-01.
   1. Acceptance Criteria for Total Aerobic Microbial Count
   1. Surface monitoring by Contact plate and Swab Method ( 25 cm²)

Grade	Alert Level	Action Level	Limits
A	–	–	<1 cfu
B	3 cfu	4 cfu	5 cfu
C	15 cfu	20 cfu	25 cfu
D	30  cfu	40 cfu	cfu

1. Surface monitoring by Contact plate Method (25 cm²)

Grade	Alert Level	Action Level	Limits
A	–	–	<1 cfu
B	3 cfu	4 cfu	5 cfu
C	15 cfu	20 cfu	25 cfu
D	30 cfu	40 cfu	cfu

1. Personnel monitoring by Finger Dab Method

Grade	Alert Level	Action Level	Limits
A	–	–	<1 cfu
B	cfu	4 cfu	5 cfu

1. Corrective and preventive actions:
   1. If count goes up to alert level and action level take the preventive action as per mention below.
   1. Frequency of Environmental Monitoring for Production Department:

Surface Monitoring By Contact Plate	Surface Monitoring By Swab	Personnel Monitoring (Finger tab)
Monthly	Monthly	Monthly

1. Frequency of Environmental Monitoring for Microbiology Department:

Surface Monitoring By Contact Plate	Surface Monitoring By Swab	Personnel Monitoring (Finger tab)
Every 15 days	Every 15 days	Every 15 days

1. Environmental monitoring should be completed within ± 7days of scheduled date.
   1. REFERENCES:

USP-36 General chapter 1116 & Schedule M

• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the microbiology departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           Microbiology Department

Display Copy                 :           Microbiology Department (If Required)

• REFERENCES:

In-House

• ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
MB	Microbiology
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department
IPA	Isopropyl Alcohol
%	Percentage
SCDA	Soybean Casein Digest Agar