1.0 OBJECTIVETo describe the procedure for operation and monitoring of performance of garment cabinet.
2.0 SCOPEThis SOP is applicable for operation and monitoring of performance of garment cabinet.
3.0 RESPONSIBILITYMicrobiologist - Quality Control
4.0 ACCOUNTABILITYManager - Quality Control
5.1 Operation5.1.1 Clean the UV garment cabinet with 70% IPA and wipe with lint free cloths and record the same in cleaning record of garment cabinet.
5.1.2 Switch on the main power supply of garment cabinet.
5.1.3 Switch ON the motor blower, visible light and UV light.
5.1.4 After 30 minutes (from the time of switching ON the instrument) record the pressure differential of magnehelic gauge in mm of water column in the pressure differential record of garment cabinet.
5.1.5 Switch off the UV light after completion of work and record the burning time of UV light in burning time record of UV light of garment cabinet.
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 are continuously switched on until the sterilized dresses are kept inside the garment cabinet.
5.1.9 Switched off the UV light of garment cabinet 5 minutes of using the sterilized dresses.
5.1.10 After wearing the sterilized dress close the door of garment cabinet and switch on the UV light.
5.1.11 After completion of analysis, put off the used dresses in used garment container.
5.1.12 On next day before putting the sterilized dresses in garment cabinet, clean the garment cabinet with 70% IPA and wipe with lint free cloths and put the sterilized dresses on stainless steel.hanger and close the door of garment cabinet and switch on the motor blower and UV light.
5.1.13 If any drop in pressure differential of magnehelic gauge of garment cabinet 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 preparation of media 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 garment cabinet is switched on for minimum 30 minutes before exposing the plates.
5.2.4 Expose these plates for 30 minutes at rest period 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 garment cabinet will be performed in every fortnightly.
5.2.9 Acceptance criteria : Less than 1cfu/plate. Positive control should show growth and negative control should be negative.
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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