Settle AIr Plate Technique

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

Issue

Air Settling plates Technique S

Title :

Issue Date

06-032008

Valid : from Review : Date

10-032008 06-032009

Destination .Copy No 1 2

Reference: -

ules and Guidance for pharmaceutical

manufacturers.and.distributors,2002.(Specifi

ation).

No .of copies 1 1

Copy owner Quality Control Manager Head of Microbiology Department

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).

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)

Code: QU-04-0023 -INS

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- 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-040007-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.

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•

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:

Copy No:(

-

Date and Time of sampling.

-

Department name.

-

Location/room name

-

Product name – Batch N.o.

-

Name of sampler.

)

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Code: QU-04-0023 -INS

•

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Record samples in the log book of environmental monitoring samples receipt (QU04-0001-REC) and the log book of environmental monitoring results (QU-04-0006REC).

-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-04-0008CRF). Send

the original to the QA Department, a

directorate and keep another

copy to the production

copy in the Microbiology department.

•

Record the results which exceed the action limit on the Deviation log book (QU-040016-REC) and issue a non conformity report (QU-04-0018-crf) to the Quality Assurance Department for necessary actions.

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Code: QU-04-0023 -INS 6.4- Frequency and specifications:

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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 roomgranulation roomblendingroom1-blending room2tablet compression roomcapsule filling room-coating

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Amendment list

Edited by Change Made .Item No .Page No Change Date .Serial No

( Copy No:( )

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