Environmental Monitoring of Primary Engineering Controls
Taylorville, Illinois
Policy Name:
Environmental Monitoring of Primary Engineering Controls
MM.05.01.07 The hospital safely prepares medications.
USP (797) Pharmaceutical Compounding – Sterile Preparations
Primary Engineering Control (PEC): A device or room that provides an ISO 5 environment for
the exposure of critical sites when compounding CSPs. At TMH, the PEC consists of a positivepressure Compounding Aseptic Isolator unit located within a limited access anteroom (IV Room).
The PEC is set up to provide a sterile air wash (First Air = Air exiting the HEPA filter in a
unidirectional, uninterrupted air stream that is essentially particle free) in order to
aseptically access the critical sites when transferring sterile drugs and fluids. A Critical Site is a
location that includes any component or fluid pathway surface (vial septa, bag injection
port, etc) that is exposed to air, moisture or touch contamination during the sterile
compounding process.
A PEC in good working order, combined with proper aseptic manipulations of critical sites on
commercially sterilized drugs and fluids, should provide CSPs of acceptable quality for routine
patient care.
A Quality Assurance Program is in place at TMH to monitor the effectiveness of the PEC
provided environment. The QA program will monitor for effective:
CAI Performance Certification
CAI Airflow Pressure Monitoring
PEC Air Sampling Plan
Media-Fill Challenges
CAI Interior Glove Fingertip Sampling
CAI Interior Surface Sampling
CAI Disinfection and Decontamination
PEC (IV Room) Disinfection and Decontamination
1. CAI Performance Certification: TMH will contract with a qualified individual to certify the
functional performance of the CAI at least every 6 months. That person will be trained vs.
the Certification Guide for Sterile Compounding Facilities. Any findings from the certification
process that is outside of the normal operating parameters of the CAI will have immediate
actions taken to correct the deficiency.
2. CAI Airflow Pressure Monitoring: The CAI at TMH has a “Photohelic” pressure monitor
located on the upper face of the machine. This gauge continuously monitors the air pressure
leaving the HEPA filter. The Lower Control Limit (LCL) is currently set per manufacturer’s
recommendations at 0.06 PSIG. The Upper Control Limit (UCL) is set at 0.44 PSIG. There is
also a Low-Pressure Alarm Light and a High-Pressure Alarm Light located on either side of
the photohelic pressure gauge. These lights will activate whenever the LCL or UCL have
been breached. The lights have written recommendations for action to solve the pressure
Environmental Monitoring of Primary Engineering Controls
problem written on the label below the light. The pharmacy staff will document the operating
pressure daily at the beginning of the CSP shift. Documentation will occur on the PEC
Environmental Monitoring Log (PECLog). Action will be taken by the pharmacy in
response to any breach of the LCL or UCL or upon activation of either alarm lights.
Documentation of these actions will occur on the PECLog.
3. PEC Air Sampling Plan: TMH monitors for airborne viable particles WITHIN the CAI. When
functioning properly, the CAI will maintain ISO 5 air quality within the compounding area and
antechamber regardless of the outside air quality. Air quality OUTSIDE of the CAI will be
controlled by cleaning, disinfecting and decontamination procedures, but not routinely tested
for viable particles. Air sampling will be performed twice annually (and more frequently if
other environmental monitors suggest) in conjunction with the CAI Performance Certification
testing. The results of the tests will be documented in the PEClog. Any result exceeding an
upper control limit shall be acted upon and re-tested until control is regained. Actions will be
documented on the air sampling log.
4. Media-Fill Challenges: TMH will require each person responsible for the compounding of
sterile products within a CAI to complete a media-fill challenge successfully. This test will be
performed successfully at the time of hire, at least annually after hire and upon a failure of
any of the other environmental monitoring functions which would suggest a break in
technique. The media-fill challenge will consist of a commercially-prepared kit with written
procedures for the completion of the tests. The resultant cultures will be incubated per
procedures and monitored and documented by the Pharmacy Manager. The media-fill test
procedure will be visually monitored by the Pharmacy Manager (or designee) and will
constitute a verification of the personnel’s aseptic technique abilities. Any failure of the
challenge will cause the test to be redone until a satisfactory result is obtained. The
documents from these testing procedures will be filed with the employee’s annual
performance evaluation papers.
5. CAI Interior Glove Fingertip Sampling: TMH will perform periodic (at least 2x/year) interior
glove fingertip sampling tests to ensure the sterility of the interior environment remains within
intended limits. This test will consist of a culture of the right first and fourth fingers and the left
second and third fingers. The cultures will be placed on a commercially-prepared tryptic soy
agar plate designed for that purpose. The culture will be inoculated on the disk as follows:
right 1 to the upper left quadrant, right 4 to the upper left quadrant, left 2 to the lower left
quadrant and left 3 to lower right quadrant (as plate is facing the tester). The testing will be
carried out on gloves AFTER a standard disinfecting process has been performed. ANY
subsequent growth will be considered a test failure (no growth considered a “pass”). A test
failure will require a change of gloves and a re-challenge. Consecutive sampling failures will
require a review of systems and an action plan.
6. CAI Interior Surface Sampling: TMH will perform periodic (at least 2x/year) CAI interior
surface sampling to ensure that the environment is being adequately disinfected and
decontaminated. The procedure will consist of 3 cultures of the interior CAI surface using
commercially-prepared tryptic soy agar plates. The plates will be inoculated as follows: #1
plate = upper left CAI surface, #2 = center middle CAI surface, #3 = lower right CAI surface
(as seen from tester). The testing shall be completed immediately after a proper disinfecting
of the CAI via procedure. ANY growth on any plate shall be considered a CAI test failure. The
surface shall be disinfected again and re-tested. Consecutive testing failures will require a
system review and action plan. Any growth noted will be sent to the TMH lab to attempt to
identify/classify the organism. Any results of that classification will be noted on the final test
report. All actions and results from the testing shall be noted on the sampling report and filed
per procedure.
Environmental Monitoring of Primary Engineering Controls
7. CAI Routine Disinfection Process: The interior surface of the CAI, interior gloves/sleeves and
the interior antechamber surface shall be disinfected periodically. The procedure is required
to be performed a.) at the beginning of the compounding day b.) periodically throughout the
compounding process c.) immediately after any breach of CAI containment and d.) after any
spill within the CAI environment. The daily disinfection procedures are documented on the
PECLog, with subsequent disinfections considered part of the routine daily operations and do
not require documentation.
8. CAI Routine Decontamination Process: The interior surface of the CAI, interior
gloves/sleeves and the interior antechamber surface shall be decontaminated periodically.
The CAI will be decontaminated 3 times weekly on Mondays, Wednesdays, and Fridays. The
decontamination of the surfaces will be performed using a commercially-prepared product
designed for CAI decontamination (Maxima RTU Aseptic Enclosures). The product is a
quaternary disinfectant with staphylocidal, pseudomonacidal, virucidal, fungicidal and
mildewcidal properties. Decontamination efforts will be documented via the PEC log.
9. PEC Disinfection and Decontamination: The walls, floors, countertops, shelving units and
other items allowed in the IV-Room shall be disinfected and decontaminated periodically by
the pharmacy staff. This shall be done weekly (usually a Wednesday, but flexible as staffing
allows) and documented via the PEC log. The decontamination of the surfaces will be
performed using a commercially-prepared product designed for CAI decontamination
(Maxima RTU Aseptic Enclosures). The product is a quaternary disinfectant with
staphylocidal, psudomonacidal, virucidal, fungicidal and mildewcidal properties. Disinfection
and decontamination efforts will also be performed in response to a spill or other event
thought to potentially compromise the environmental integrity.
USP-NF General Chapter <797> Pharmaceutical Compounding – Sterile Preparations
Aseptic Enclosures – Operating and Maintenance Instructions
Don Schaeffer
Manager, Pharmacy
February 2013
November 2013

Environmental Monitoring of Primary Engineering Controls