Hand Hygiene and Garbing
Gloves touching the floor
Moving trash cans and removing the liners.
This is the percentage HEPA Filters remove particles.
99.97%
Pressure qualifications per facility
Positive Pressure Rooms: Ante and non-Haz- required minimum +0.020 (we record to the 3rd decimal).
Negative Pressure Rooms (Hazardous Rooms)- Required minimum pressure of -0.010 to -0.030- (we record to the 3rd decimal).
SCA's do not have pressure requirements.
What is the difference between decontamination and disinfection.
Decontamination- inactivating, neutralizing, or removing hazardous drugs on surfaces usually by chemical means.
Disinfection inhibiting or destroying microorganisms, eliminates any possible contaminants and sterilizes surfaces.
The process to follow for power interruptions/ differentials in pressure in a negative pressure room NOT within designated limits.
stop compounding and lower the BSC shield. exit cleanroom. Notify leadership. check doors and pass throughs make sure they are closed- no exhausts are blocked. call facilities management if pressures are not within limits in 2 alarm cycles.
The tradition amount of time for changing gloves and gowns in the hazardous compounding room.
Gloves: Every 30 mins or sooner if compromised (soiled)
Gown: every 4 hours or sooner if compromised (soiled)
Define non-viable particles and viable particles
Non-viable Particles: does NOT contain a living microorganism but acts as a form of transportation for viable particles.
Viable Particles: Particles that contain one or more living microorganisms (bacteria or fungi).
These are the required air changes that are needed per room to maintain cleanliness.
Minimum 30 ACPH in buffer rooms and ISO7 and anterooms. Up to 15 ACPH may be provided by the LAFW and no less than 15 must be provided as fresh HEPA air from the rooms HVAC system.
Recommended 20 ACPH in ISO8 Anterooms
These are our 4 typical cleaning agents
TB1 3300 / PREempt Plus- 1 min dwell time
Peridox RTU- Sporicidal- 3 min dwell
ISO alcohol - dwell time is until it is completely dry.
The process of power interruptions/differentials in pressure for positive pressure rooms that are NOT within limits.
Check all doors and pass throughs are closed completely, check returns/exhausts are not blocked. notify leadership. Call facilities management if pressures do not return within 2 alarm cycles.
This is the proper procedure for exiting the cleanroom, you may utilize 2 different methods and must avoid certain actions.
You may either discard all garb on the dirty side of the anteroom prior to exiting or just outside the anteroom but no garb should be worn in the pharmacy area. Avoid donning and doffing in the anteroom at the same time.
We take these measures to prevent exposure to hazardous medications during compounding
Do not fill patient-specific Level 1 Hazardous Medication syringe preparations more than three-fourths full.
Do not expel air from syringes.
Use of close system transfer devices whenever possible.
This is the control that staff has for the compounding area.
Control all access to the clean room.
Restricting access as needed to maintain the appropriate environment for sterile products compounding.
Responsible for people entering the clean room IE EVS and facilities.
Restricting peoples access who have not done proper hand hygiene and garbing
Any supplies/equipment that has not been properly sanitized prior to entry- ladders etc.
This is the correct order of cleaning the Laminar Flow Hood
Ceiling, Diffuser, IV bar, hooks, hook rest, walls, equipment, and work surface. - wipe top to bottom/ back to font using a side-to-side motion.
The process to follow when power is restored for positive pressure room within their designated limits. including process for if power is lost to the PEC(s).
Positive: If it is less than one hour- no further action is need. After one hour- if the PEC maintained power, compounding may continue for CSP category 1 only. Once back in range, terminal clean with sporicidal. resume normal compounding after.
If you have lost power to the PEC- You can only make immediate use preps.
outer garb, shoe covers, outer gloves. Dispose in hazardous waste container prior to exiting the hazardous compounding area.
The process of how air circulates through the BSC (Biological Safety Cabinet).
A vertical flow PEC.
Air enters the main chamber from the room and will pass through the HEPA filter giving vertical, negative airflow.
Air circulates through the chamber and HEPA filter and then is sent out into the environment; no air is recirculated across the work surface.
This is the classification of the PEC (Primary Engineering Control)
ISO 5 as it is where we compound and the critical sites are exposed so it is the cleanest.
Routine Disinfection of the BSC has the following order and frequency.
Diffuser (ceiling), back, sides, shield, equipment, and work surface.
The process for the negative pressure room after power has been restored- remaining negative what to do if it alarms and when it doesn't alarm and process for when it is neutral or positive.
Does not alarm-Remains negative less than one hour but outside designated limits: decontaminate BSC and resume compounding. Greater than 1 hour- Decontaminate the PEC and resume compounding.
Does alarm - terminal clean negative pressure room with sporicidal agent and resume compounding.
Same is applicable for neutral to positive EXCEPT- you clean the adjacent positive pressure room with sporicidal agent.
Process of checking gowns prior to putting it on.
1. Check expiration date
2. make sure bag is not torn or punctured and has not been otherwise compromised.
3. If sterile gowns are stored outside the anteroom, thoroughly wipe the gown package down with sterile alcohol prior to entry.
This process is how the air circulates through the LAFW (Laminar Airflow Workbench).
Pre-filter- air travels through intake pre-filter to remove the large particles of contaminates.
Air is then directed through the HEPA Filter
Air then crosses the DCA (direct compounding area) in a horizontal direction and exits the PEC.
It operates continuously. if turned off, allow 30 minutes to run BEFORE prepping CSPs.
These are the specific surface requirements for IV rooms
Smooth and flush mounted
Sealed or Caulked
Non-shedding
Easy to clean and resistant to damage from cleaning agents
Free from cracks and crevices.
This is the disinfection frequency daily.
Beginning and end of each compounding session- when we go to lunch or leave to go to another side included. Every 30 minutes horizontal surfaces only.
This is the process you use for construction or renovation of cleanroom areas
After it has been completed, you must clean until there is no visible dirt. Once that is done, perform terminal cleaning 3 times non-sporicidal, sporicidal, and second application of sporicidal. resume compounding when the room passes viable and non-viable sampling.