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SOP on Procedure for viable air monitoring in pharmaceutical company

SOP on Procedure for viable air monitoring in pharmaceutical company

  • OBJECTIVE
  • To lay down a procedure for environmental monitoring of air.
  • SCOPE
  • This SOP shall provide the procedure for monitoring the viable air borne count.
  • RESPONSIBILITY
  • Quality Control Executive / Officer.
  • ACCOUNTABILITY
  • Head Quality Assurance.
  • PROCEDURE
  • The microbial environmental conditions shall be monitored by Settle plate method or air sampling at the locations mentioned in annexure I.
  • In case the active air sampler is out of order then settle plate method can be used as alternative for monitoring the microbiological quality of air.
  • PRE START UP:
  • Prepare required quantity of Soyabean Casein Digest Agar media (SCDA).
  • Aseptically prepare media plates by adding about 20 to 25 ml of the medium into sterile petri plates of 90 x 15 mm size and allow to solidify under LAF.
  • Store the prepare media plates in sterile stainless steel containers at a temperature of
  • 22.5°C  ± 2.5°C.
  • For monitoring carry the stainless steel containers with plates into the area where it is to be monitored.
  • Mark the plates appropriately with the date of sampling, location number, and the method used prior to sampling.
  • Sterilize the stainless steel aspirating head of the air sampler prior to use by autoclaving.
  • Active Air Sampling:
  • Analyze the microbial quality of air by sampling 100 litres of air at each of the locations mentioned in annexure I, using Active air sampler)
  • Carry the pre-incubated SCDA plates and sterile SS head in a SS container to the sampling location.
  • At the sampling location remove the lid of the plate and place the plate in the sterile SS head of the air sampler,  Assemble the SS head on the main body of the air sampler.
  • Operate the air sampler.
  • After the completion of sampling remove the plate from the SS head, cover with the lid and replace the plate in the SS container.
  • Carry the container to the Microbiology laboratory and incubate the media plates at  30-35°C for 5 days.
  • After completion of incubation, count the number of colonies on each plate and record the results as number of CFU/m³ using the below given formula: X = Pr x 1000 / V
  • Where:
  • V  = Volume of sampled air
  • r   = Colony Forming Units counted on 90 mm plates
  • Pr = Probable count obtained by positive hole correction
  • X  = Colony Forming Units per m3 of air
  • Record the results
  • Based on the frequency of air sampling i.e. weekly, monthly, once and once in three months, record the results.
Active air sampling

(CFU/ml)

Settle Plate Method

(CFU/ml)

Bacteria Fungus Bacteria Fungus
Alert limit (For location to be sampled weekly) 100 10 20 02
Alert limit (For location to be sampled monthly, once in

2 month and once in 3 months)

160 16 20 02
 Action Limit (For location to be sampled weekly) 160 16 50 05
Action limit (For location to be sampled monthly, once in

2 month and once in 3 months)

250 25 50 05
  • In case any of the result crosses the alert limit, inform Head QC/QA, followed by Head Production & Engg.
  • If the results crosses the alert limits on second day, then inform Head QC/QA followed by Head Production & Engg. and sanitize the area if required.
  • If the counts exceed the action limits on second consecutive day showing an upward trend, then inform Head QC/QA,  followed by Head Production &  Engineering, stop the activities and sanitize the area.
  • Forms and Records (Annexures)
  • Report Of Viable Air Monitoring – Annexure I
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

ANNEXURE I

Report Of Viable Air Monitoring

Date of sampling:

Date of final observation:

A.R.No.:

Area Plate Code Observations (CFU/Plate)
Settling  Plate Air Sampling
Corridor I 1
2
Corridor II 3
Corridor III 4
5
Corridor IV 6
7
Corridor V 8
9
Corridor VI 10
Corridor VII 11
Corridor VIII 12
13
Corridor IX 14
Secondary Change Room 15
16
Packing Cubicle I 17
Packing Cubicle II 18
Packing Cubicle III 19
Packing Cubicle IV 20
Packing Cubicle V 21
Packing Cubicle VI 22
Clean Utensil (Coating) 23
Drying Room( Coating) 24
Wash Room (Coating) 25
Uncleaned Utensil (Coating) 26
Office 27
Coating II 28
Solution Making Coating II 29
Coating I 30
Solution Making Coating I 31
Coated Tablet Quarantine 32
Uncleaned Utensil 33
Wash Room 34
Drying Room 35
Clean Utensil 36
Granulation
Near FBD 37
Near OGB 38
Near RMG 39
Paste Making 40
Granulation
Near FBP 41
Near OGB 42
Near RMG 43
Paste Making 44  
Granulation
Near FBP 45
Near OGB 46
Near RMG 47
Paste Making 48
Blending 49
Spare Parts Room I 50
Spare Parts Room II 51
Granule Quarantine 52
Compression Cubicle 1 53
Compression Cubicle 2 54
Compression Cubicle 3 55
Compression Cubicle 4 56
Coated Tablet Quarantine 57
Tablet Quarantine 58
Ready For Packing 59
Leak Test Room 60
Recoverable Rejects 61
Primary Packing Material Day Store 62
Scrap Removal Air Lock-I 63
Scrap Removal air Lock-II 64
Spare Parts Room (Capsule) 65
Enginnering Office 66  
Filled Capsule Quarantine 67
IPQC 68
Die Punch Room 69
Capsule Filling I 70
Capsule Filling II 71
Office 72
House Keeping 73
Wash Room (Dispensing) 74
Active Raw Material Dispensing I 75
Active Raw Material Dispensing II 76
Excipient Dispensing I 77
Excipient Dispensing II 78
Raw Material Dispensing Room 79
Raw Material Day Store(After Dispensing) 80
Clean Container Store 81
Cold Room 82
Raw Material Store
Near Entry Door 83
In Front Of Sampling Room 84
Near Exit Door 85
Air Lock I (Sampling Room) 86
Air Lock II (Sampling Room) 87
Air Lock III (Sampling Room) 88
Sampling Room 89
RLAF I (Sampling Room) 90
RLAF II (Sampling Room) 91
A/C Raw Material Store I 92
A/C Raw Material Store II 93
Under Test Area 94
Approved Area 95
Man Air Lock 96
Staging Material 97
Rejected Material Store 98
Material Exit 99
Finished Goods Store
Near Entry Door 100
Near Exit Door 101
Blister Foil Room 102
Carton Coding 103
Secondary Packing Material Store 104
Packing Hall
Near Packing Line 2 105
Near Packing Line 4 106
Near Packing Line 6 107
Packing Material Store 108

 

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