1.0 OBJECTIVETo describe the procedure for operation and monitoring of performance of dynamic pass box.
2.0 SCOPEThis SOP is applicable for operation and monitoring of performance of dynamic pass box.
3.0 RESPONSIBILITYMicrobiologist - Quality Control
4.0 ACCOUNTABILITYManager - Quality Control
5.1 Operation5.1.1 Clean the dynamic pass box with 70% IPA and wipe with lint free cloths and record the same in cleaning record of dynamic pass box.
5.1.2 Switch on the main power supply of dynamic pass box.
5.1.3 Switch on the motor blower, visible light and UV light.
5.1.4 After 30 min record the pressure differential of magnehelic gauge in mm of water column in the pressure differential record of dynamic pass box.
5.1.5 Switch off the UV light after completion of work and record the burning time of UV light in burning time record.
5.1.6 Check the working hours of the UV light by its auto recorder. Total burning hours should not be greater than 3000 hours.
5.1.7 If working hours is more than 3000, replace the UV light by new one.
5.1.8 Motor blower and UV light is continuously switched on until the material is there in pass box except for media (in case of media switch off UV light).
5.1.9 Switched off the UV light of garment cabinet 15 minutes before opening the door of pass box or before replacing material.
5.1.10 After replacing the material from pass box close the door of pass box and switch on the UV light.
5.1.11 If any drop in pressure differential of magnehelic gauge of dynamic pass box is observed during operation, then inform to maintenance personnel for pre-filter cleaning and maintenance department maintains record of the same.
5.2 Monitoring Performance5.2.1 Prepare the plates of soybean casein digest agar as per the SOP of media preparation for microbial bio burden evaluation.
5.2.2 Pre-incubate the plates before exposure at 30°C to 35°C for 24 hours.
5.2.3 Ensure that the dynamic pass box is ON for minimum 30 minutes before exposing the plates.
5.2.4 Expose these plates for 30 minutes at rest on five different location of the garment cabinet as shown in the schematic diagram.
5.2.5 After exposure, plates are incubated at 30°C to 35°C for 48-72 hours to get the no. of bacterial colonies & further same plate incubate at 20 to 25°C for 48-72 hours to get fungal count.
5.2.6 Keep negative control plate without exposure and positive control plate by exposing the plate in the outside environment.
5.2.7 Maintain monitoring performance record.
5.2.8 Frequency: Performance of dynamic pass box will be performed in every fortnight.
5.2.9 Acceptance criteria: Less than 1 cfu/plate. Positive control should show growth and negative control should not show any growth.
6.0 ABBREVIATIONS6.1 SOP - Standard Operating Procedure
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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