Cleanroom Out of Specification SOP

Purpose/ Applicability: To provide a guideline for the procedure to utilize when the cleanroom temperature or humidity is out of range and sterile products require preparation.

Scope:

This applies to the non-hazardous and hazardous rooms in the Medication Dispensary cleanroom when the temperature is >68° Fahrenheit and >60% humidity. There is not a lower limit that is specified for either temperature or humidity.  

Definition(s):

  • USP : United States Pharmacopeia
  • HDs : Hazardous Drugs
  • SOP : Standard Operating Procedure
  • ISO : International Standards Organization

Equipment:

  • C-PEC : Primary engineering control (hood)
  • C-SEC : Secondary engineering control (room)

Procedure:

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.

 

Site

Minimum Frequency of Cleaning

ISO Class 5 Primary Engineering Control (LAWF, BSC, CAI, CACI)

At the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected

Isolator

Clean the isolator (pass-through) during daily cleaning.

Work surfaces outside the PEC (in buffer area and/or segregated compounding area)

Daily

Floors

Daily

Walls

Monthly

Ceilings

Monthly

Storage shelving

Monthly

Example: 

“Deep Clean” Cleaning/Disinfecting (Sporicidal) Log

Please date and initial each task when complete

Date

All PEC surfaces and the area underneath the tray

Pass -through

Work Surfaces and equipment outside the PEC

Floors

Walls, doors and door frames

Ceilings

Storage shelving and bins

Furniture, Refrigerator, Waste Receptacles, Beakers, etc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Last Updated: 7/13/2023



KeywordsPharmacy, dispensary, cleanroom, humidity, specification, USP fungal, growth, compromise, limit, BSC, Equashield, Chemo   Doc ID124738
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-03-10 14:39 CDTUpdated2023-07-14 14:14 CDT
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
CleanURLhttps://answers.uillinois.edu/illinois.vetmedvth/cleanroom-humidity-out-of-specification
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