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: ________