To avoid airborn contamination in material during sampling.
This procedure is applicable during sampling of raw material in sampling booth installed in raw material store.
3.1 Doing : Technical Assistant
3.2 Checking : Executive/Manager
Head of the Department
5.1.1 It is important and most essential to avoid any air born contamination in the material during sampling.
5.1.2 To sample the raw material under “Clean environment” the sampling booths are designed in which fresh air is initially sucked through core filter then 5 micron filter, before passing through HEPA filter to reduce the load on HEPA filter.
5.1.3 Core filter and 5 micron filter are cleanable and require cleaning it periodically as and when required.
5.1.4 The recommended manometer reading is between 7 to 15 mm of water.
5.1.5 If reading goes more than 15, it indicates chocking of HEPA filter and needs replacement of HEPA filter.
5.1.6 Whenever replacement of HEPA filter takes place, the system is to be validated w.r.t. PAO test.
5.1.7 If reading goes down ,it indicates chocking of prefilter which requires cleaning. Inform engineering department for cleaning of prefilter.
5.2 Operation of sampling booths
5.2.1 Switch ‘ON’ the mains.
5.2.2 Switch ‘ON’ the light.
5.2.3 Start blower at slow speed one hour before the sampling.
5.3 Note the reading of differential pressure daily.
5.4 Always open material for sampling when system is ‘ON’
5.5 Sample the material as per raw material sampling SOP.
5.6 Don’t take sampling device outside of booth, but collect in closed container in booth itself, to avoid any spillage outside the booth.
5.7 After sampling every raw material, note the manometer reading.
5.8 Use clean sampling device for different material.
5.9 Close the poly bag/ containers of sampled material under laminar flow unit, before taking it out.
5.10 Put ‘OFF’ the system after use.
6.1 HEPA = High Efficiency Particulate Air
6.2 PSIG = Pound per Square Inch Gauze
6.3 DOP = Di Octyl Pthalate
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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