Cleaning, Disinfecting, Deactivation, and Sporicidal Application
Sterile Non-Hazardous and Hazardous Compounded Products

 

Purpose/ Applicability:  The purpose of this standard operating procedure is to document a procedure for daily and monthly cleaning and disinfecting of the cleanroom in the compounding pharmacy.

 

Scope: Applicable to cleaning of the anteroom, nonhazardous sterile compounding room, and hazardous sterile compounding room.

 

 

Definition(s):

 

USP: United States Pharmacopeia

 

Cleaning: To make free from direct, organic matter, salts. First step of any disinfection process.

Cleaning Agent: An agent for removal of product residues that may inactivate sanitizing agents or harbor microorganisms.

Deactivation: Treatment with another chemical, heat, ultraviolet light, or other agent to create a less hazardous agent or surface.

Decontamination: Removal or neutralization of a contaminant. This can be microbiological or chemical.

Disinfection: Using specialized cleansing techniques and/or agents on inanimate objects that destroy or prevent growth of microorganisms capable of infection.

 

Sanitizing Agent: An agent that reduces a number of all forms of microbial life including fungi, viruses, and bacteria.

Sporicidal Agent: An agent that destroys bacterial and fungal spores when used with appropriate concentration and contact time.

 

Equipment:

Cleaning agents / Disinfectants: Sterile isopropyl alcohol, Lysol

Sporicidal: Peridox

Lint free wipes or cleaning wand

Mops, clean mop heads, buckets

 

Procedure:

Background

 

• Daily and monthly cleaning is completed by a technician.
  • Daily cleaning occurs in the morning, prior to the preparation of any sterile products
  • Monthly cleaning occurs on the last Thursday of every month
• Cleaning is logged on a daily basis by the technician who completes the process
• Separate, dedicated instruments should be used for ISO 7 (buffer and ante room) and ISO 5 (hood).
  • Instruments should be labeled appropriately so they do not move between rooms
• Choose low shedding, sterile materials (i.e. wipes, mop heads)

 

 

Selection: Select cleaning and disinfection agents based on compatibilities and effectiveness. Selection and use of disinfectants must be guided by microbial activity, inactivation by organic matter, residue, corrosiveness, shelf life and safety of personnel.

• • Inactivation of the most common microorganisms (bacteria) occurs with a contact time of
    ≤ 1 minute.
  • After disinfectant has been sprayed or wiped, it must be allowed to dry before compounding can resume.
    • *NOTE*: Nothing should be sprayed in the hood
      
      

Techniques: Clean “difficult to clean” areas first. Wiping moves from the cleanest area to the dirtiest, most critical to least critical (top to bottom, back to front). Use a clean wipe with every section of the PEC to avoid re-depositing contaminants. Wipe in straight lines with overlapping strokes to avoid gaps. Never wipe in a circular motion.

• • When mopping, use the Pull-Lift cleaning technique:
    • 1. Lift mop, place on surface, pull it towards you.
    • 2. Lift mop again, place down at start of first stroke, overlapping approximately 10-20%. Pull toward you.
    • 3. Repeat.
      
      

Cleaning & Disinfecting PEC: Remove all items on the surface of the PEC and use sterile alcohol saturated wipes, rather than spraying. *Never spray in the hood.* Use cleaning agent (germicidal detergent diluted with sterile water), then disinfect with sterile 70% isopropyl alcohol. Disinfect all surfaces in the PEC with sterile isopropyl alcohol: at the beginning and end of each work shift, between each drug batch, every 30 minutes during continuous compounding, and after a spill or when surface contamination is suspected.

 

 

Cleaning / Disinfecting (log on pg 5/6)

 

• Don cleanroom garb (including hazardous garb when cleaning the hazardous room)
• Clean hood with alcohol and cleaning wand or lint free wipes
  • Top to bottom, back to front
    • IV stand in non-hazardous (or any other equipment inside the hood) with alcohol
• Wipe inside and outside of the pass-through with alcohol and lint free wipes
• Wipe all work surfaces and equipment outside the hood with alcohol and lint free wipes
• Mop floors working from the back of the rooms toward the door
  • Solution of 125ml Lysol per 2 liters of water
  • Use mop handle for the specified area
  • Use one bucket of solution and mop head per area

 

Daily Cleaning Processes – General

• ISO Class 5 PEC: Use Germicidal detergent (Lysol) diluted with sterile water, then use sterile 70% isopropyl alcohol.
• Horizontal surfaces: germicidal detergent diluted with sterile water.
• Floors (pass-through floor): germicidal detergent diluted with sterile water.

 

 

Sporicidal (log on pg 6)

 

• 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 or mop with Lysol solution

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Daily Cleaning/Disinfecting Log

Please date and initial each task when complete

 

Date	Equipment and all interior surfaces of the PEC	Pass -through	Work Surfaces outside the PEC	Floors