The primary engineering control or PEC (hood) is to be cleaned daily. The most common PECs used are laminar airflow workbenches (LAFWs), compounding aseptic isolators (CAIs), biological safety cabinets (BSCs), and compounding aseptic containment isolators (CACIs). … The PEC is first cleaned with a germicidal detergent.
What does PEC stand for in compounding?
Compounding Aseptic Containment Isolator (CACI) Clean Area or Clean Zone. C-PEC (Primary Engineering Control)
What is ISO Class 5 Pec?
To certify the PEC as an ISO Class 5 environment the certifier will perform a nonviable particle count of particles 0.5 micron or larger. To certify as ISO Class 5 the PEC will not have more than 3520 particles per cubic meter of air. … The ante chambers in CAIs and CACIs are particle tested.
What is a PEC hood?
Pharmacies use primary engineering controls (PEC) or hoods to provide ISO 5 classified environments in which to compound all non-immediate or non-emergency preparations.
What ISO Class is the PEC room?
The C-PEC is placed in an ISO Class 7 buffer room that has fixed walls, a HEPA-filtered supply air, a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas, and a minimum of 30 air changes per hour (ACPH).
When should an ISO Class 5 Pec and work surface be cleaned?
According to USP <797>, ISO 5 PECs should be wiped down with 70% IPA before and after each use, and at least every 30 minutes when ongoing compounding activities are being performed. You may also read,
What does ISO stand for in sterile compounding?
| ACPH | Air Changes Per Hour |
|---|---|
| IPA | Isopropyl Alcohol |
| ISO | International Organization of Standardization |
| NIST | National Institute for Standards and Technology |
| USP | United States Pharmacopeia |
Check the answer of
How often should PECs be cleaned and disinfected?
The PEC shall also be disinfected with sterile 70% isopropyl alcohol between compounding activities and every 30 minutes while compounding. It shall also be disinfected with sterile 70% isopropyl alcohol after spills or surface contamination when compounding. Sterile water may be used first if needed.
How often do IV hoods need to be certified?
A facility must certify any new PEC and continue to certify the PEC every 6 months. A PEC must also be certified when it is moved or altered, when there are identified problems with end products or staff technique and in response to issues with compounded preparations such as patient infections. Read:
What is the difference between an ante and buffer area?
An anteroom between a primary room and corridor ensures a safe airflow buffer zone between the controlled pressurized space and an unclean area. The two spaces are separated by a completely walled area with a door. However, in some applications an ante area without walls or a door can achieve the same effect.
What is a Class 7 cleanroom?
An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot.
What is a Class 8 clean room?
ISO 8 cleanrooms, also known as Class 100,000 cleanrooms, can be modular or soft-walled and have a maximum particle count
What does ISO stand for in clean rooms?
The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1.
How often must ISO Class 5 compounding areas be cleaned?
Daily Cleaning of ISO 5 Laminar Airflow Work Bench, Biological Safety Cabinets and other PEC (Primary Engineering Controls) Minimum Cleaning Frequency: Beginning of each shift, before each batch, every 30 minutes while compounding, as spills occur, when surface contamination is suspected.
Which area in the pharmacy must have an air quality of ISO class of 5 or better?
The area should also limit personnel activities and traffic, and avoid materials that are extraneous to sterile. The pharmacy in those settings must place ISO Class 5 PEC in a restricted access buffer area with an ISO Class 7 environment if low-, medium-, or high-risk level aseptic compounding is to be performed.
