2. PRIMARY ENGINEERING CONTROLS (PECS)
PEC is a device or a room that provides an ISO class 5 environment for
compounding CSPs (compounded sterile preparations).
PEC relies on high-efficiency particle air (HEPA) filter (which is ≥ 99.99%
efficient in removing particles as small as 0.3 microns in size).
Types NESH
1. Laminar Airflow Workbench
2. Biological Safety Cabinets
3. Compounding Aseptic
Isolators
4. Compounding Aseptic
Containment Isolators
1. Compounding Aseptic
Isolators
- Microsphere IsoTech (vertical
airflow)
3. THE ARCHITECTURE
USP <797> NESH
1. Buffer area (“cleanroom”) – area
where a PEC is located and
where activities such as
preparation, compounding, and
staging CSPs occur (must meet
or exceed ISO 7).
2. Ante area – space for
handwashing, garbing and
product decontamination (must
meet or exceed ISO 8).
The installation of Microsphere
creates a special compounding
environment.
Our IV room is a combination of
buffer area and ante area (not
separation of 2 areas into 2 different
rooms).
It is not recommended but is
acceptable in accordance with USP
<797> , yet still might not be in
compliance with the upcoming
<800>.
4. IV ROOM DEVICES
Types NESH
1. Pharmacy Compounding
Devices
2. Automated Compounding
Devices
3. Repeater Pump
4. Robotic Systems
Pharmacy Compounding
Device – Microsphere
ISO 5.
5. CLEANING AND DISINFECTING - FREQUENCY
USP <797> (minimum
frequency)
NESH
1. ISO 5 PEC
• beginning of each shift
• before each batch
• every 30 minutes when
compounding
• after spills
• when surface contamination is
known or suspended
2. Counters and easily cleanable
work surface – DAILY
3. Floors – DAILY
4. Walls – MONTHLY
5. Ceilings – MONTHLY
6. Storage shelving - MONTHLY
1. ISO 5 PEC (Microsphere) – in
compliance.
2. Counters and easily cleanable
work surface – in compliance.
3. Floors – in compliance.
4. Walls – N/A
5. Ceilings – N/A
6. Storage shelving - in
compliance.
6. CLEANING AND DISINFECTING - STEPS
USP <797> NESH
1. Cleaning with a germicidal
detergent and water will
remove visible solids or soiling
before disinfecting.
2. Cleaning with a germicidal
detergent will leave a residue
that need to be removed from
work surfaces by sterile 70%
alcohol.
3. Disinfecting removes microbial
contamination.
4. Cleaning should be done from
the cleanest area to dirtiest
area.
5. Great care must be exercised
to avoid getting the HEPA filters
wet during cleaning.
Follow the steps and compliance.
1. Germicidal = CaviCide and
Sporicide (used alternatively
weekly – by the end of the
week)
2. 70% alcohol (spray and wipes)
– use for daily cleaning.
3. Cleaning of Microsphere ISO 5
– follow manufacturer’s
recommendation (left to right
and top to bottom and use of
wipers)
7. ENVIRONMENTAL MONITORING
USP <797> NESH
1. Temperature
2. Surface sampling
3. Pressure and velocity
4. Particles
5. Viable Monitoring
1. Temperature: Recorded daily –
in compliance.
2. Others: N/A
9. AMPULS, SINGLE-DOSE AND MULTIPLE-DOSE
CONTAINERS
USP <797> Classification NESH
1. Single dose-containers – intended
for one use (include bags, bottles,
syringes, ampules and vials) and
may not be saved or used at anytime
during the compounding process and
5microns filter straws or needles
must be used when withdrawing
contents from ampules.
2. Pharmacy bulk packages
3. Multiple-dose vials – may be
reused or saved up to manufacturer’s
recommend BUD or max of 28 days
for reuse or saved and must be noted
if intended to reuse.
1. Single dose-containers: In
compliance.
2. Pharmacy bulk packages: N/A
3. Multiple-dose vials: Never reuse
or save.
10. PERSONNEL RESPONSIBILITIES
USP <797> Requirements NESH
1. Hygiene and Garbing
• Before entering compounding area, all personnel must remove
personal outer garments, all cosmetics and jewelry. No nail polish
and natural nails should be kept trimmed and neat.
• Garbing procedures:
o Shoe covers hair covers face mask.
o Hand wash: remove debris from under fingernails using
running warm water and a nail cleaner wash hands
then forearms to the elbows with soap and water for at
least 30s dry hands and forearms using an electronic
hand dryer or lint-free disposable towels.
o Non-shedding gowns waterless alcohol scrub
powder-free gloves and disinfect the gloves with 70%
alcohol.
2. Compounding Procedures
• Periodically disinfecting gloves with 70% alcohol
• The gowns can be reused during the workshift only and must be
hung inside-out. Shoes, hair cover and mask cannot be reused.
• All hand hygiene and garbing must be followed upon returning to
compounding area.
3. Cytotoxic and other hazardous agents (OSHA
requirements)
4. Specialty Preparations
5. Compounding Competency
• Low and medium risk operations: training and competency
assessments are required initially upon hiring or transferring to
compounding responsibilities.
• And periodically every 12 months for all staffs involved.
• Includes: Media-fill testing and glove fingertip testing.
1. Hygiene and Garbing – in
compliance.
2. Compounding Procedures – in
compliance.
3. Cytotoxic and other hazardous
agents – N/A.
4. Specialty Preparations – N/A.
5. Compounding competency – in
compliance .
11. PACKAGING AND LABELING
USP <797> Requirements NESH
All risk level CSP should contain at least
the following information:
1. All solution, drug and ingredient
names, amounts, strengths and
concentrations, and the total volume
of CSP.
2. BUD and time.
3. Appropriate auxiliary labeling.
4. Any storage requirements, if CSP will
not be immediately administered.
5. Device-specific instruction (if
applicable).
6. Identification of individual
responsible for checking CSP (e.g.
pharmacist initial).
In compliance.
Note: BUD is only for 12 hours.
12. STANDARD OPERATIONAL PROCEDURES (SOPS)
USP <797> NESH
• Lists and recommends SOPs and
should be reviewed to guide the
pharmacy department in
developing, writing and
implementing SOPs.
• SOPs are part of a good quality
assurance program within the
pharmacy.
• Cleaning and garbing procedures
that are updated every year.
• Quality Assurance Program is
online and all staffs involved are
required to review every year.
13. PHARMACY PERSONNEL RESPONSIBILITIES
PHARMACISTS PHARMACY TECHNICIANS
• Follow NESH’s SOPs:
1. Inspection and Verification of
CSPs including checking correct
ingredients, quantity and quality,
labels, BUDs, calculations.
2. Preparation of immediate-use
CSPs.
3. Competency: Media-fill Test &
Gloved Fingertip Sampling
(annually).
• Regularly update with current USP
and IV compounding
regulations/requirements.
• Oversee all the compounding
activities.
• Assigned pharmacist(s) should
also be responsible for IV training
of new technicians.
• Follow NESH’s SOPs:
1. Gowning and Garbing.
2. Maintaining and Cleaning IV room.
3. Compounding techniques
(including review of calculations).
4. Temperature control.
5. Competency: Media-fill Test &
Gloved Fingertip Sampling
(annually).
Laminar Airflow Workbench functions in a similar manner as Compounding Aseptic Isolator, but the difference is CAI is a closed system and the compounding area does not interact with airflow.
For horizontal airflow never allow anything to pass behind a sterile object
For vertical airflow (Microsphere IsoTech) never allow anything to pass above a sterile object
For non-hazardous compound LAFW and/or CAI
For hazardous compound BSC and CACI
Buffer area: water sources, sinks or floor drains are not permitted in the buffer area or not immediately adjacent to.
Requirement for buffer area: air supply: HEPA filtration (room), room pressurization, perforated plate or swirl air diffuser if necessary.
ACD = accurately combine drugs and solutions into single delivery container and most commonly used for TPNs
