1.0 OBJECTIVETo describe a procedure for operation of air sampler “HIMEDIA”.
2.0 SCOPEThis SOP applicable for operation of air sampler “HIMEDIA”.
3.0 RESPONSIBILITYMicrobiologist - Quality Control
4.0 ACCOUNTABILITYManager - Quality Control
Air is aspirated at a fixed speed for variable time through a cover, which has been machined with a series of small holes of a special design. The resulting laminar air flow is directed onto the agar surface of a “contact plate” containing medium consistent with the microbiological examination to be performed. When the pre-set sampling cycle is completed, the plate is removed and incubated. The organisms are then visible to the naked eyes and can be counted for an assessment of the level of contamination.
Fertility test of Media: Perform the growth promotion test of each lot of media, used for environment monitoring as per SOP.
5.2 Operation of Air Sampler:
5.2.1 Use Tryptone Soya Agar media plates for environmental monitoring.
5.2.2 Incubate all media filled plates for 48 hrs at 30-35°C before use.
5.2.3 Installation of Media plate in air sampler.
5.2.4 Unlock and remove micro perforated sieve from the tester.
5.2.5 Remove the cover from the sieve and autoclave the sieve for 20 min at 121°C or as per validated cycle.
5.2.6 Sanitize the external surface of the tester with 70% IPA v/v.
5.2.7 Position the media plates into the re-used area of the tester head. Retain the media plate in position by holding on to it. Lock the micro perforated sieve into position.
5.2.8 Push the ON/OFF switch button. Previously selected air sample value appears on display.
5.2.9 Press SET key. SPE, display on the screen with previous speed setting whether low-medium-high.
5.2.10 To set speed, press stop key on each press of stop key speed will change from low-medium-high-low.
5.2.11 To save speed press set key as desired speed setting.
5.2.12 Now the display will show previous set on time with first digit blinking. Use the start key to shift between digit on each press of start key the blinking digit will shift from 1,2,3 etc.
5.2.13 Use the stop key to set the ON time value on each press of stop key the blinking digit will increment from 0-9-0.
5.2.14 To save ON time press set key when the desired time is on display.
5.2.15 Time and speed has to set such a way so that it will suck 1000 lts of air.
5.2.16 To turn ON the fan at desired speed for the displayed ON time, Press start key for second time.
5.2.17 Delay time will be display on the screen i.e. 5 second. After delay time the fan will be turned ON as set for desired time.
5.2.18 The ON time will decrease on the display and show on every second.
5.2.19 When On time will change zero fan will be turned OFF and buzzer will be turned ON for some time.
5.2.20 To turn off the fan in middle of the ON time, Press STOP key.
5.3 Remote Control Operation
5.3.1 Press ON key.
5.3.2 Preset ON time and fan speed led will be displayed. To turn ON the fan at displayed speed press the START key.
5.3.3 The ON time will be decremented and show on the display of zero On time and beep or buzzer will indicated completion of sampling.
5.3.4 To STOP fan in middle of ON time, Press the STOP key.
6.1 SOP - Standard Operating Procedure
6.2 IPA - Isopropyl Alcohol
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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