Code: QU-04-0023 -INS Issue

No./Amn.No:(1/0
Title : Air Settling
S plates Technique

Issue Date 06-03- Valid 10-03-

2008 : from 2008
Review 06-03-
: Date 2009

Destination

.Copy No No .of Copy owner

copies
1 1 Quality Control Manager
2 1 Head of Microbiology Department
Reference: -

ules and Guidance for pharmaceutical

manufacturers.and.distributors,2002.(Specifi

ation).
Code QU-04-0023-INS Issue No./Amn.No:(1/0

-Purpose:
To inspect the cleaningness of working environment in different plant locations using
settling plates (Passive air sampling).

2- Scope:
2-1- LFH (Microbiology Department)
2-2- Weighing booth - Raw material sampling booth.
2-3- Microbiology laboratory
2-4- Solid manufacturing areas:
) RM stagnant room-oven drier room-fluid bed dryer room-granulation room-
lendingroom1-blending room2-tablet compression room- capsule filling room-coating
oom-blistering room-sorting room-central packaging room.).
2-5- Dispensing room.

3- Definitions and Abbreviations: None.

3-1- Settle Plate Method-

The principle behind this method is that the bacteria carrying particles are allowed to
ettle onto the medium for a given period of time and incubated at the required
emperature. A count of colonies formed shows the number of settled bacteria containing
articles.

- Responsibility:
4-1- Microbiologist in Microbiology Department

- Reference:
-1- Rules and Guidance for pharmaceutical manufacturers and distributors, 2002.

Specification).
-2- Checklist of settling plates (QU-04-0003-FRM) (Sampling locations).

-3- SOP No. (QU-04-0038-SOP) (Identification of pathogens).

Copy No:( ) Page No.:( 2 / 14

Code: QU-04-0023 -INS Issue No./Amn.No:(1/0

- Procedure:

-1- Preparation of sedimentation plates (settle plates).

• Pour approximately 25 ml of sterile nutrient agar or trypton soy agar into sterile
Petridis (90mm in diameter), allow to solidify.
• Incubate the plates, inverted, for 24 hours at 30-35°C to verify their sterility.
• Label the base of plates (the part containing the media) with the label No(QU-04-
0007-LBL) provided with the name of the department, location No., date, time,
previous (in case of rest) or current (in case of operation) product name, batch No.
and name of sampler.
-2- Sampling.
• Transfer the plates into the area/room where you want to test the cleaningness of
working environment.
• Wear the provided gloves.
• Place plates at table/stand height if possible or another appropriate position.(Work
surfaces must be disinfected before and after use).
• Raise the lids of plates to expose the surface of the medium, rest the lid on the
very edge of the plate so that the entire agar surface is completely exposed, take
care not to put fingers on plates.
Copy No:( ) Page No.:( 3 / 14

Code QU-04-0023-INS Issue No./Amn.No:(1/0

• Leave plates exposed for four hours at all locations.

• Refer to the checklist of settling plates (QU-04-0003-FRM)to find out the sampling
locations of plates. Record the date and time(exposure time) of the collected
samples in the same checklist.
• After exposure: replace lids of plates, and carefully place them back in a
protective bag to avoid breakage before returning to the microbiology lab.
 • Relocate the plates to the microbiology department with the following
information:
- Date and Time of sampling.
- Department name.
- Location/room name
- Product name – Batch N.o.
- Name of sampler.

Copy No:( ) Page No.:( 4 /14

Code: QU-04-0023 -INS Issue No./Amn.No:(1/0

• Record samples in the log book of environmental monitoring samples receipt (QU-
04-0001-REC) and the log book of environmental monitoring results (QU-04-0006-
REC).
-3- Incubation and detection of pathogens:
• Incubate the plates at 30-35°C for 48 hours, Count the developed colonies using
the colony counter and record the average results
in the results’ log book (QU-04-0006-REC).

• Wash out the surface of the plates using 5 ml sterile saline solution

• Refer to SOP No. (QU-04-0038-SOP) to test the previously obtained culture for the
presence of Pseudomonas aeruginosa, Staphylococcus aureus and Candida
albicans, Record the results in
the results' log book (QU-04-0006-REC) . and certificate of analysis (QU-04-0008-
CRF). Send the original to the QA Department, a copy to the production
directorate and keep another copy in the Microbiology department.
 • Record the results which exceed the action limit on the Deviation log book (QU-04-
0016-REC) and issue a non conformity report (QU-04-0018-crf) to the Quality
Assurance Department for necessary actions.

Copy No:( ) Page No.:( 5 / 14

Code: QU-04-0023 -INS Issue No./Amn.No:(1/0

6.4- Frequency and specifications:

 Location
Caution

(average count)

(cfu/plate/4h)
Action

(average count)

(cfu/plate/4h)
Frequency

LFH (Microbiology Department)

------
> 1 cfu/4 h

Weighing booth
> 40 cfu/4 h
> 50 cfu/4 h

Raw material sampling booth

(Microbiology laboratory)
> 40cfu/4 h
> 50 cfu/4 h

Solid manufacturing areas:

RM stagnant room-oven dryier
room-fluid bed dryer room-
granulation room-
blendingroom1-blending room2-
tablet compression room-
capsule filling room-coating
Copy No:( ) Page No.:( 6 / 14

(Code: QU-04-0023 -INS Issue No./Amn.No:( 1/0

Amendment list
 Edited by
Change Made
.Item No
.Page No
Change Date
.Serial No
( Copy No:( ) Page No.:(14 /14