ENVIRONMENTAL MONITORING OF MANUFACTURING AREA

1. OBJECTIVE 

    To lay down a procedure for Environmental Monitoring of Manufacturing Area.

      2. SCOPE

This SOP shall be applicable to ‘O’ Area & Class 10,000 (Liquid filling) area at XYZ Pharmaceutical  Ltd.

     3.RESPONSIBILITY

3.1        Execution: Officer, Executive and above-QC Department.

3.2        Checking : Asst. Manager and above-QC Department.

        4.ACCOUNTABILITY

 Head of the QC Department 

       5. PROCEDURE   . 

1. Environment monitoring of manufacturing area shall be done by following method.

• Active air sampling for viable count
• Passive air sampling for viable count (SPC)
• Surface monitoring.
• Particle count for non viable particles.

1. Manufacturing area  shall be monitor for microbiological environment as per following plan

     5.3        Active air sampling for viable count:

      5.3.1   Pre  requisite :

• Active Air Sampler  
• Soyabean Casein digest Agar Media plate.
• Potato Dextrose Agar / Sabouraud Dextrose Agar Media plate. 

5.3.2    Once in a two month, use PDA or SDA plates in addition to SCDA plate

5.3.3    Prepared media as per SOP No SQG -050 & following information shall be mention on the media  plate.

1. Carry the media plates in the area to be sample in a closed box (moped by using 70% IPA) to avoid any contamination.
2.  Collect the air sample near the critical operation / machine  at working hight in ‘O’area & liquid filling area as per  sampling  location lay out .

5.3.6   Operate the air sampler as per respective SOP. and sample 250 litre /1000 litre air per location. 

5.3.7   After completion of sampling, remove the petri plate from the sampler and carry to microbiology       laboratory in a closed box to avoid any contamination.

1. Incubate the plate (s) along with one negative control (unexposed plate) of the same media lot at 30°C – 35°C for 48-72 hrs. for bacterial count and at 20°C – 25°C for 5 days for fungal count. 
2. After completion of the incubation period count the number of colonies present on the plate.  
3. Negative control (Unexposed Plate) should not have any growth. 
4. Record the results of ‘O’area  & Liquid filling area .     

Passive air sampling for viable count (Settle Plate Method) 

5.4.1      Pre requisite :

• Soyabean Casein digest Agar Media plate of 90 mm dia (SCDA).
• Potato Dextrose Agar / Sabouraud Dextrose Agar Media plate of 90 mm dia.

1. Once in a two month, use PDA or SDA plates in addition to SCDA plate.
2. The media plate shall be prepared as per respective SOP
3. Following information shall be mention on the media  plate.

1. Carry the media plates to the area to be sample in a closed box(moped by using 70% IPA)  to avoid any contamination.
2. Near return riser open the lid, expose the media plates placing on sampling stand, for 2 hrs in  ‘O’area & liquid filling area as per location lay out.
3. After completion of exposure time close the plate by plating the lid on the plate and carry to    microbiology laboratory in a closed box to avoid any contamination.

5.4.8    Incubate the media plate (s) along with one unexposed plate (Negative control) of the same media   lot at 30°C – 35°C for 48-72 hrs. for bacterial count and at 20°C – 25°C for 5 days for fungal count.

1. After completion the incubation period count the number of CFU present on the plate.
2. Negative control (Unexposed Plate) should not have any growth.

      5.4.11   Record the results of ‘O’area  and Liquid filling area .

   5.5     Surface Monitoring:

5.5.1       Pre requisite :                            `

• Soyabean Casein digest Agar Media. 
• 55 mm dia contact plate.                                                                                                                                                                                                                                                                    

1. Prepare the Media plate as per respective SOP  or use prepared contact plate.
2. Carry the media plates to the area to be sample in a closed container (moped by using                                                                                                                                                                                                                                                                                                                                                                          

             70% IPA) to avoid any accidental contamination and write the following details on the plate. 

1. Select at least two  location for surface monitoring  in ‘O’ area & liquid filling area, one at floor near the drain & one at wall near the equipment, as per surface monitoring location lay out.
2. Aseptically place the plate, touch and press the contact plate (55 mm dia ) on to the surface  to be sampled.
3. Decontaminate  the sampled surface with stérile 70 % IPA after sampling.
4. After sampling close the plate and carry to microbiology laboratory in a closed box to avoid any contamination.
5. Incubate the contact plate along with one unexposed plate (Negative control) of the same media lot for bacteria at 30°C – 35°C for 48-72 hrs. After completion of the incubation period count the number of colonies present on the plate.
6. Negative control (Unexposed Plate) should not have any growth.

   5.5. 10 Record the results of ‘O’area  and Liquid filling area .   

   5.6      Non viable particle count: 

   5.6.1    Pre requisite :

             Laser Particle Counter.        

1. Carry the Laser particle counter to the area to be sample.
2. Collect the Sample near the critical operation / machine at working hight in‘O’area and Liquid filling area as per sampling location lay out .
3. Operate the laser particle counter as per SOP.
4. Draw 1ft3 air sample per location.

   5.6.5    After completion of sampling attach the print out generated by laser particle counter. 

   5.6.6     Record the results of ‘O’area  and Liquid filling area .

    5.7     If the results exceed the alert level, allow the manufacturing activities of the area and follow the below procedure. 

1. Investigate the matter by reviewing the data available & verify the accuracy of test procedure, sampling procedure & analyst training. If any discrepancies found invalid the results & re confirm.
2. Simultaneously inform to QA / Production/ Engg. Dept. to investigate the root cause by reviewing the data available of operation, calibration, performance verification, maintenance, cleaning of HVAC and sanitization of area to take appropriate corrective and preventive actions, if required.

5.8     If the results exceed the action level, stop the manufacturing activities of the area and follow the below procedure.  

1. Investigate the matter by reviewing the data available & verify the accuracy of test procedure, Sampling procedure & analyst training. If any discrepancies found invalid the results & re confirm.

     5.8.2     Simultaneously inform to QA / Production/ Engg. Dept. to investigate the root cause by reviewing     the data of operation, calibration, performance verification, maintenance, cleaning of HVAC and sanitization of area to take appropriate corrective and preventive actions as required.

1. Identify the colonies present on the plate based on colony characteristics, if any new colony other than routine micro flora observed, isolate and identify the organism as per respective  SOP   to establish the routine micro flora  information data as per  respective SOP

         5.9     Trending of results:

   5.9.1   Prepare point wise trends of results on 6 monthly/yearly basis for the count observed in the form of graph and chart.

Swab Analysis

Like Contact plates, in this method, the samples are collected from the locations on the gown that are most susceptible to contamination. After sampling, the swab is then transferred to a medium containing growth medium and incubated for the required time.

The growth of the organisms in the form of colony-forming units is then observed in these all-incubated plates.

The Limits

There are standard limits for microbial growth observed in each grade of clean room environment.

About the Author

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"A seasoned professional with a Master's in Chemistry, the author brings more than two decades of expertise in Quality Control, Analytical Method Validation, and advanced QMS investigation. Their experience is globally validated by successful management of major regulatory audits, including those conducted by the US, EU, Brazil, and Russian authorities."

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