Saturday, October 18, 2008


To provide a procedure for operation of Air sampler
2.0 SCOPE :
The procedure covers the relevant method for the operation of the slit Air sampler
Preparation of Agar media strip:
Media composition and preparation refer SOP No. QC/MB/04/1.3. Under aseptic conditions (LAF) pour the media using sterilized pipettes into the pre-sterilized empty strips. Allow the media to solidify and then put back the strips into their respective wrappers. Incubate the strips for 24 hour & check for free from contamination.
For Bacteria use Soyabean Casein digest Agar Strips
For fungi use Sabouraud Chloroamphenicol Agar Strips
Carry the air sampler and prepared media strips to the respective departments.
Follow the gowning procedure as required by the respective department to avoid additional contamination.
Disinfect the hands with 70% v/v IPA wear the sterile surgical gloves.
4.1 Fix the sterilized impeller cup and the impeller to the stainless steel tubular handle.
4.2 Insert the prepared media strips in the slot provided in the impeller cup carefully
( without touching the media ) such that the agar surface faces the impeller
4.3 Connect the thin cord from the supply out point of the charger to the socket at the base of the impeller unit handle
4.4 Put on the charger by sliding the button to ON position at the back of the charger.
4.5 Press the ON button
4.6 Set the timer for 5 mins by pressing the UP and DOWN buttons
4.7 Hold the impeller handle and sample the air near the supply grill of each department by pressing the reset button. The green LED glows as the impeller starts
4.8 After the time lapse, the impeller stops, the buzzer beep indicates the completion of time cycle
4.9 Hold the strips by its tab carefully and pull out the strip. Replace the strip in its original wrapper. So that the agar surface faces away from the sliding lid. Seal the wrapper using adhesive tape.
4.10 Mark on the wrapper as desired sampling point, date, and batch number of the media. Incubate at 30° to 35°C for 72 hours ( bacteria) and at 20° to 25°C for 120 hour (fungi)
4.11 After use put off the charger and replace the parts in the case provided

4.12 Colony count : At the end of the incubation period carryout the microbial count visually.
The colonies detected per unit volume of air can be calculated:
cfu / litre = Colonies on agar strip / 40 x Sampling time
[ 1 min corresponds to 40 ltrs air separation volume]

cfu/m3 = (Colonies on agar strip /Sampling time in min) X 25

cfu/ft3 = Colonies on agar strip x 0.708 /Sampling time in minutes

4.13 Record the findings in the respective log sheet cfu/m3 as of air.
Bacterial Count:
Standard Limit : NMT 490 cfu/1000 lts of air.
Action : NMT 350 cfu/1000 lts of air.
Alert : NMT 250 cfu/1000 lts of air.
Fungal Count:
Standard Limit : NMT 10 cfu/1000 lts of air.
Action Limit : NMT 8 cfu/1000 lts of air.
Alert Limit : NMT 5 cfu/1000 lts of air.
Trends to be plotted with action and alert limits are defined.
Identify the organism based on the colony morphology and Gram’s staining.
Frequency : Once in 3 months in all critical areas.
(Critical areas are Dispensing area, Manufacturing area, Filling area, Granulation area, Compression area, Coating area )
Report Format :
1.Liquid orals.
3.Dry syrup.
5. Stores.

4.14 Action to be taken :
If the observed count exceeds alert limit immediately informed to QA department, and maintenance department. The frequency of sampling should be increased until the count should be less than alert limit.
If the count exceeds the action limit, immediately informed to QA department, and maintenance department . All the activities should be stopped immediately in the respective area and the area should be sanitized till the bioburden is below the alert limit. The frequency of sampling should be increased until the count should be less than alert limit.
Action plan count exceeding standard limit
During routine monitoring if the environment count exceeds standard
limit(in any one strip or more) the following actions are to be taken.
QA department, Production department and maintenance department should be informed.
Inform manufacturing department to stop activity in that particular area.
Increase the frequency of monitoring, investigate the cause and carry out the fumigation
Monitor the environment count till the bioload level comes below alert level.
Recheck the bioload of all products, which were manufactured during the last two checks drawing extra samples in order to evaluate the effect on product.
Thorough investigation must be carried out for the route cause of increase in Bioload.
Destruction of strips: After use the exposed strips should be destructed by autoclaving at 121°C for 20 min at 15lbs.

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