ISO Classification Location Flashcards
What types of locations are there based on international organization for standardizations (ISO)
- Ante area / Ante room
- Buffer area / Clean room
- Laminar airflow hood (LAFH)
The ante area / ante room location is based on what type of air quality?
ISO class 8
The clean area / clean room location is based on what type of air quality?
ISO class 7
The laminar airflow hood (LAFH) location is based on what type of air quality?
ISO class 5
What are the five levels of risks associated with compounded sterile products?
1) Immediate-use category
2) Low-risk level
3) low-risk level with < 12 hour beyond-use date (BUD)
4) Medium-risk level
5) High-risk level
What type of risk level association is defined within preparing compounding sterile products for emergency situations where low-risk compounding procedures would lead to an unreasonable delay in therapy, when preparing to use aseptic technique that take less than an hour to compound the formulation and administered in a non-sanitized room that has a BUD of 1 hour (refrigeration or room temperature)?
Immediate-use category
What type of risk level association is defined within preparing compounded sterile products by using aseptic technique in a sanitized room with simple admixtures (up to 3 ingredients added with 2 entries into the infusion bag) that use closed system transfer methods that has BUDs of 48 hours (room temperature), 14 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?
Low-risk level
What type of risk level association is defined within preparing compounded sterile products in a ISO Class 5 LAFH of a non-sanitized room with simple admixtures (up to 3 ingredients added with 2 entries into the infusion bag) that use closed system transfer methods with sterile ingredients, and must be administered with 12 hours of preparation, and has a BUD of 12 hours (refrigeration of room temperature)?
Low-risk level with < 12 hour BUD
What type of risk level association is defined within preparing compounded sterile products by aseptic technique in a sanitized room with complex manipulations (several ingredients and entries into the bag) or extensive amount of time required to compound (e.g. TPNs and batch compounded preparations) formulations that are used over several days with sterile ingredients that have a BUDs of 30 hours (room temperature), 9 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?
Medium-risk level
What type of risk level association is defined within preparing compounded sterile products in a sanitized room by using non-sterile ingredients (e.g. bulk powders), or using compounding method that involves open system transfers with a improper garb, and has BUDs of 24 hours (room temperature), 3 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?
High-risk level
What are the highlights of aseptic technique?
- Allow LAFH to run 30 minutes before compounding if not in continuous use
- Clean the LAFH with 70% isopropyl alcohol (wipe from top to bottom and back to front; clean all surfaces inside the hood except the screen housing the HEPA filter)
- Remove items from their packaging before placing them inside the hood
- Perform sterile manipulations at least 6 inches inside the outer edge of the hood
- Do not place any objects between the HEPA filter and work area
- Swab surfaces with 70% isopropyl alcohol prior to puncturing (e.g. rubber stopper on a vial)
- Do not block or disrupt the flow of air over the critical sites with hands/fingers when manipulating the objects inside the hood
What type of opening method creates an opening pathway between the sterile product contents in a vial container and a syringe needle that to obtain the sterile product contents from the vial container, and commonly known as the rubber stopper?
Critical site
Sterile alcohol swabs are soaked in what type of alcohol?
70% isopropyl alcohol
What type of container must be used for the disposal of needles?
Red sharps container
What is the purpose of of laminar airflow hood (LAFH)?
Creating an environment with very low concentration of particles and microorganisms so that formulations are safe and human infusion can be prepared
Note: LAFH can also be abbreviated as LAFW (laminar airflow workbench)
How many air filters is a LAFH equipped with?
2 air filters (1 regular filter and HEPA filter)
What type of strainer removes 99.97% of particles from the air that are 0.3 microns (micrometers) or larger?
High Efficiency Particulate Air (HEPA) filter
How frequently should a HEPA filter be wiped or sprayed with alcohol?
Never (can cause damage to the filter membrane)
The LAFH must be turned on and left running for how many minutes prior to use?
30 minutes
Besides running the LAFH for 30 minutes, what else must be done prior to using it?
Cleaning the LAFH with 70% isopropyl alcohol
How frequently should a LAFH be cleaned with alcohol when is constant use?
Every 30 minutes
To assure that filtered air reaches the critical site, pharmacy technicians must work at least how many inches inside the LAFH?
6 inches
In a LAFH, pharmacy technicians want to avoid placing their hands or other objects behind the materials they’re working with in-order to prevent?
Airflow obstruction
What type of hood should be used for compounding chemotherapy?
Biological safety cabinet
