SOP on Monitoring of Compressed air and Nitrogen for Microbial analysis

0
374

1.0 Objective:

1.1 To lay down the procedure for monitoring of Compressed air and nitrogen for microbial purity.

2.0 Scope:

2.1 This SOP is applicable for monitoring of compressed air and nitrogen for microbial purity at pharmaceutical formulation plant.

3.0 Responsibility:

3.1 Chemist or above of Microbiology Laboratory.

3.2 Head – Microbiology Section.

4.0 Accountability:

4.1 Head – Quality Control.

5.1 Procedure:

5.1.1 Monitor Compressed air and Nitrogen using M-Air-T Isolator System as per respective SOP (SOP on Operation, Calibration, Cleaning and Maintenance of M Air T Isolator Air Sampler).

5.1.2 Take the M-Air-T Isolator Air sampler to the respective sampling location.

5.1.3 Disinfect the sieve plates and sampling head of M-Air-T Air sampler with 70% IPA before and after sampling.

5.1.4 Clean the outer surfaces of M-Air-T Air sampler with a lint free cloth soaked in disinfectant solution.

5.1.5 Carry out the sampling by pressing the start Key on the control Keypad.

5.1.6 After sampling of 1000 litres of compressed air, close the plate and remove it from the sampling head.

5.1.7 Label the plate with location name, date of sampling and initial of the person responsible for the activity.

5.1.8 Bring the plates to Microbiology Laboratory and incubate for 72 Hours at 200C-250C and observe the plates for fungal growth, followed by 48 hours at 300C-350C to observe the plates for bacterial growth.

5.1.9 After the incubation period, observe the plates and record the details in the format as per annexure -I and annexure-II for Sterile area and non Sterile area respectively.

5.1.10 Refer to the table-1 for the sampling locations of compressed air in non sterile area and table-2 for the sampling locations of compressed air in sterile area and table 3 for sampling locations of nitrogen in sterile and non sterile area.

Table 1

  S.

No.

Equipment

 

Equipment I.D. No.

 

Location Compressed Air ID. No
1. Dry Air Receiver
2. Roll Compactor
3. Semi Automatic-9 Capsule Filling Machine
4. Automatic Filling -90T Capsule Filling Machine
5. Strip Packing Machine

 

6. Alu-Alu Packing Machine

 

7. Blister Packing Machine

 

8. Rapid Mixer Granulator

 

9. Tablet Compression Machine
10. Bottle Air-jet cleaning Machine
11. Dry Syrup Filling and Sealing Machine
12. Auto coater

 

13. Fluid Bed Dryer
14. Rapid Mixer Granulator
15. Fluid Bed Dryer
16. Auto coater

 

Table 2

  S.

No.

Equipment

 

Equipment I.D. No.

 

Location Compressed Air ID. No
1 Vial Filling Machine

                                              

  Table 3

  S.

No.

Equipment

 

Location I.D. No.

 

1 Nitrogen Gas Receiver
2 Vial Filling M/C

 

5.11 Sampling shall be done on daily basis if there is filling in sterile areas and once in a month for Non sterile (Oral) and utility blocks.

5.12 Acceptance limit: < 1.0 cfu per plate.

6.0 List of Annexure / Formats:

S.

No.

Format Title Format

Number

Annexure

Number

No. of Pages
01 Report of Viable monitoring of compressed gasses-Sterile area
02 Report of Viable monitoring of compressed gasses-Non sterile Area

 

7.0 References (if any):

7.1 Not applicable

8.0 Reason for Revision:

8.1 Not applicable due to new version.

9.0 Abbreviations:

9.1 SOP : Standard operating procedure

9.2 No. : Number

9.3 QC : Quality Control

9.4 QA : Quality Assurance

Annexure-I

Report of Viable Particle Monitoring for Compressed air and nitrogen in sterile Area

Facility Sterile Product Manufacturing Areas Sterile Filling Area
Medium Used Microbiological Ref No.
Medium Lot No. Sampler I.D.
Tested on Volume/Location 1000 Liters
Reported on

                  

Incubation
Temperature Period Incubator I.D. No.
20-25oC From:                 To:  
30-35oC From:                 To:  

 

Area Sampling Point Total Viable Count (cfu/Plate)
TVMC After 72 Hrs TVMC After further

48 hrs

Total Viable Microbial Count
Vial Filling Room CG-27
Vial Filling Room NG-01
Observation Done by
Date of Observation

 

Legend: TVMC: Total Viable Microbial Count

Acceptable Level: < 1 cfu/Plate

Result: The compressed air monitored for viable counts by air sampler is within/Not within the acceptable levels

 

 

 

Performed By/Date: ______________     Checked By/Date: _____________

Annexure-II

Report of Viable Particle Monitoring for Compressed air

Facility Non Sterile Product Manufacturing Areas Generation Point & Manufacturing Area
Medium Used Microbiological Ref No.
Medium Lot No. Sampler I.D.
Tested on Volume/Location
Reported on

                  

Incubation
Temperature Period Incubator I.D. No.
20-25oC From:                 To:  
30-35oC From:                 To:  
Area Sampling Point Total Viable Count (cfu/Plate)
TVMC After 72 Hrs TVMC After further

48 hrs

Total Viable Microbial Count
Dry Air Receiver
Roll Compactor
SA-9
AF -90T
Strip Packing   m/c
Alu-Alu  Machine
Blister        Packing m/c
RMG

 

Compression Machine
Bottle Air-jet cleaning m/c

 

Dry Syrup Filling m/c
Auto coater
FBD
RMG (PD Lab)
FBD (PD Lab)
Auto coater (PD Lab)
Nitrogen Gas Receiver
Observation Done by
Date of Observation

 

Legend: TVMC: Total Viable Microbial Count

 

Acceptable Level: < 1 cfu/Plate

 

Result: The compressed air monitored for viable counts by air sampler is within/Not within the acceptable levels

 

 

Performed By/Date: _______                   Checked By/Date: ________

LEAVE A REPLY

Please enter your comment!
Please enter your name here