Cleanroom Out of Specification SOP

Background

Per USP 800, there are requirements for cleanroom use that specify that the relative humidity be no higher than 60% and that air temperature be below 68°F. USP 800 sets expectations for the safe handling of HDs in pharmacy settings and includes tight pressure requirements and high air change volumes as well as comfortable temperatures and a specific ceiling on relative humidity.

Chemotherapy and other hazardous drugs will still be prepared in the cleanroom, as outlined in the policy below, as the cleanroom is set up to have the appropriate air changes per hour, negative pressure, and has a regularly examined HEPA filter.

Policy

In the case that the cleanroom(s) is/are out of appropriate range as monitored by appropriate sensors, the following must be adhered to :

• Non-hazardous room
  • Only products that can be prepared are those for immediate use
    • NO batching may be completed during this time
  • Vials that are brought into the cleanroom during this time must be disposed of immediately after use as they are considered single use when the temperature and humidity are out of range
    • They cannot be returned to the Medication Dispensary shelves for later use
• Hazardous room
  • Only products that can be prepared are those for immediate use
  • Vials that are utilized to draw up medication in the cleanroom during this time must all be disposed of immediately after use as they are considered single use only when the temperature and humidity are out of range

• As soon as the temperature / humidity is back in range, a deep clean must be completed following the monthly cleaning/disinfecting log (below, pg 4).
  • No batch products can be made UNTIL 2 hours after the deep clean has been completed. Any immediate use products prepared during this time must have their drug vial treated as single use.
  • No hazardous drugs can be stored (MDV) for further use UNTIL 2 hours after the deep clean has been completed. Any drugs used in this time must be treated as single use.

Monthly Cleaning (Cleaning, Disinfecting, Deactivation, Sporicidal 797 SOP)

Sporicidal (see below)

• Don cleanroom garb
  • Hazardous garb when cleaning the hazardous room
  • Use respirator with 3M Particulate P100 Filter attached when cleaning under the hazardous hood work surface and while using sporicidal.
• Apply sporicidal using the wipes to the following surfaces. (must stay wet for 10 minutes)
  • Work surfaces and under the hazardous hood work surface
    • IV stand in non-hazardous
  • Equipment outside of the hood
  • Pass-throughs, inside and out
  • Work surfaces outside of the hood
  • Storage shelves and bins
  • Doors and door frames

• Mop the following surfaces with sporicidal solution (use mop handle for the specified area)
  • Use 1 ounce (30ml) Sporicidal solution per gallon of water.
  • Use one bucket of sporicidal solution and mop head for all 3 areas to clean walls, floors, ceiling

• • • Non-Hazardous Room
    • Hazardous Room
    • Anteroom
• Once the contact time of the Sporicidal specified by the manufacturer is achieved. Clean all areas previously disinfected with sporicidal with the appropriate cleaner (Sterile alcohol) and lint free wipes
  • Note : Sporicidal is also detergent (no need to follow with Lysol)

Monthly Cleaning Processes – General

1. Empty trash and supply bins
2. Ceiling, walls/windows, pass-throughs, surfaces, outside of PEC, all portion of carts, supply bins, doors, handles, vents
3. ISO Class 5 PEC
4. Restock supply cart
5. Refrigerator, freezers, incubators
6. Floors

HD Specific Cleaning Processes

• Must clean under the hood work surface once a month -
  • Wear respirator with 3M Particulate P100 Filter attached when completing these processes.