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Sunday, June 29, 2008

Clean Room Hoods & Other Facilities - maintenance and monitoring

Cleanliness of the clean room hoods must be maintained. We must have maintenance and cleaning schedule of the clean room hoods in daily, weekly and monthly basis. Regular environmental cleaning, monitoring and maintenance must be occurred to provide sterility and safety for patients receiving medications as well as the health care team who preparing the medications. Below are some ideas how to clean Laminar Airflow Hood (vertical and horizontal airflow hood) and other exercise of cleaning practice in clean room area.

Cleaning of Clean Room Hoods (Laminar Airflow Hoods; vertical and horizontal)

You can do cleaning of Laminar Airflow Hoods once a week or whenever spill occurs by using Conclikt cleaner. If possible, remove the pan and the vent covers. Use spray bottle to apply Conflikt cleaner to remove pieces as well as inside the hood. Wait for approximately 12 minutes to allow surfaces to soak. Wipe surfaces starting from back of the hood. The direction of wiping is from side to side towards the front opening of the hood. Use lint free gauze pads when wiping.

For any glass surfaces of clean room hoods, use water to avoid hazing of the glass. You also need to use isopropyl to apply to all surfaces. Wipe the surfaces from back to front of the hood and wiping from side to side in broad strokes. Allow surfaces for air dry without wiping. Depend on the pan and vent covers condition, you also required to replace it if needed.

Clean once a shift with isopropyl alcohol. Apply isopropyl alcohol to all surfaces. Wipe from back to front of hood wiping from side to side in broad strokes. Allow surfaces to air dry without wiping.

Cleanroom Maintenance: Trash, Waste and Cleaning of Surfaces

Collection and removal of trash, biohazard waste and cleaning of non-sterile surfaces are part of immediate maintenance in clean room area. The following events will occur on a scheduled basis and will be documented in the log adjacent to the clean room area.

You should put in daily schedule to clear and empty waste and replace liners. Cleanse laminar airflow hood and cleaning of non-sterile environment surfaces also in daily scheduled.

For weekly basis cleaning are removing biohazardodous waste, replace liner and/or receptacle. Cleaning of countertops, stool tops and other equipment (i.e pump) should be done in daily basis. Floor moping should be done twice a week, but subject to floor conditions. For cleaning of the walls, windows and doors is in monthly basis. Other exercise is doing monthly are cleaning and sanitize the bins.

Facilities Monitoring: Refrigerator, Freezer and Room Temperature Monitoring For those equipment that monitored by MadgeTech®: Temperature data will be downloaded monthly. The data must be printed and saved in proper file location. Each unit will be regulated for every six (6) months. For the units equipped with an audible alarm system will be tested once every 30 days to ensure proper function.

Corrective Action for Units Displaying Temperatures Outside of Range Designated:

1. For units with remote monitoring, an alarm will notify Facilities Management at OHSU if and when the temperature has gone out of predetermined range. Research Pharmacy Services personnel will be notified immediately via paging system or telephone.

2. In cases of an audible, non-remote monitored system, valuation of the unit will be made. Every effort will be made to find out the cause of alarm prior to movement of stock as outlined below.

3. In the event that the system is not functioning and it is suspected or confirmed that the unit is non-operational, immediately transfer all products to a similar, working, monitored unit in the department. Submit an inventory list to the broken unit that includes date and time the items were moved, a complete list and quantity of the items moved, and the location of the new storage space. Inform the RPS Pharmacist in Charge of the unit failure and inventory transfer.

4. Within 48-hour (2 working days) observation period will occur in case of unit malfunction. The temperature and conditions of the unit will be observed prior to return of inventory into the unit.

In any and all cases, the monitoring firm and study team will be notified in writing regarding the alarm, the cause and the status of study inventory.

Facilities Maintenance: Refrigerator and Freezer Maintenance, Calibration and Cleaning

1. Units equipped with an audible alarm system will be tested once every 30 days to ensure proper function.

2. The following USP temperature ranges will be maintained

Room Temperature - 20°C -25°C
Refrigerator - 2°C -8°C
-20 Freezer - -20°C - -10°C
-70C Freezer - ≤-70°C

The above exercise and practice to maintain the clean room hoods, maintain and monitor other facilities in the clean room area should be done in regular basis to ensure the clean environment in the work place.