Aseptic Techniques and CSPs 2022

Compounding Sterile Preparations

and Aseptic Technique
USP 797 Training Program
Part - 4 (Cleaning, Disinfection and PPE)

Dr. Desouky F. Fayed, B.Sc.Ph, MSc., Pharm D, FCCS

Cleaning and Disinfecting the Compounding Area

• Cleaning is different from disinfection.
• Cleaning is indicated when heavy spills occurs.
• Use sterile water for injection or irrigation for cleaning and low-
shedding wipes.
• Then disinfect with 70% isopropyl alcohol. WHY 70%?
• Allow alcohol to dry before compounding begins. WHY?
• All cleaning materials e.g., wipes, sponges, and mops, shall be non-
shedding composed of synthetic microfibers
• Cleaning materials are dedicated for use in buffer and ante-area.
• Cleaning material shall not be removed from the area except for
disposal.

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Syringes, needles and tubing remain in their individual packaging and are only
opened in ISO Class 5 area.

Cleaning and Disinfecting the Compounding Area

• Remove vials and ampoules from
cartons/boxes.
• Disinfect the surface with 70%
isopropyl alcohol spray.
• Disinfect the neck of ampoule or the
rubber port of a vial with alcohol
swab.
• Do not use alcohol wetted gauze
pads or other particle generating
material to disinfect the sterile entry
points.
• Do not take shipping or external
cartons into the buffer or clean area.

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Aseptic Techniques and CSPs 2022

All supplies and drug components are disinfected with an appropriate cleaning
agent prior to being moved into the ISO Class 5 compounding area.

Personnel Cleaning and Garbing

• Squamous cells are shed from human body at daily rate of 106 per
hour. Those are laden with microorganisms.
• Persons with rash, sunburn, weeping sores, conjunctivitis, active
respiratory infection, wearing cosmetics shall be excluded form
working in ISO Class 5 and ISO Class 7.
• Remove personal outer garments, cosmetics, jewelry, piercings,
artificial nails or extenders.
• Natural nails must be neat and trimmed.

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Aseptic Techniques and CSPs 2022

• Mops floors, using the

mop labeled “floors”.
Clean Room Clean Room
• Starting at the wall
opposite the room entry
Clean Room

Clean Room
door.
• Mops floor surface in
even strokes (one
direction) toward the Clean Room
operator.
• Moves carts as needed to
clean entire floor surface. Clean Room

• In the ante-area, cleans

sink and all contact
surfaces; cleans floor Clean Room
with a disinfectant
solution. 7

Deep Clean Microfiber Damp Mop

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Room Cleaning Order

1. Ceiling 1. Top to Bottom

2. Walls 2. Inside-out (Back to front)
3. Floor 3. Side to Side use long-axis
4. In one direction

1. Buffer area (1st) …….. ISO Class 7

2. Ante-Room (2nd) ……. ISO Class 8

1. Ceiling ‫السقف‬

3. Wall 3. Wall
‫جدار‬ 2. Wall ‫جدار‬
‫جدار‬

4. Floor ‫اﻷرضية‬

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Aseptic Techniques and CSPs 2022

1. Ceiling ‫السقف‬

3. Wall
‫جدار‬ 3. Wall
2. Wall ‫جدار‬ ‫جدار‬

4. Floor ‫اﻷرضية‬

Use Germicidal Detergent

(Disinfectant)
• An agent that frees from infection, usually a chemical agent but
sometimes a physical one, and that destroys disease-causing
pathogens or other harmful microorganisms but may not kill
bacterial and fungal spores. It refers to substances applied to
inanimate objects.

• Cleans buffer area chairs, the interior and exterior

of trash bins, and storage bins using disinfectant
solution soaked lint free wipe.

• Documents all cleaning activities as to who performed

such activities with date and time noted

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Floors in the buffer area, ante area, or segregated compounding area are cleaned
daily with the designated cleaning agent after compounding has been completed
and this activity is documented. Even strokes (one direction) towards the operator.

• Cleans all buffer area carts by

removing contents and using
germicidal detergent soaked lint-
free wipe.
• Cleans all carts starting with the
top shelf and top of post,
working down to wheels.
• Cleans the under side of shelves
in a similar manner.
• Uses a new wipe for each cart.
Allows to dry.
• Wipes carts with sterile 70% IPA
wetted lint-free wipe to remove
any disinfectant residue.
• Use new wipe as needed.

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• Cleans buffer area:

 Chairs
 the interior & exterior of trash bins
 Storage bins
 Using disinfectant solution soaked
lint-free wipe.

Cleaning materials that are reused (mop handles, mop heads, etc.) are labeled
according to their location of use AND policies and procedures have been developed
regarding maintenance of the reusable items so that repeated use does not increase the
bio-burden of the controlled environments.

• All staff who perform

cleaning (whether
compounding personnel or
housekeeping support
personnel) are trained in:
 Cleaning and disinfecting
 Hand hygiene and
 Garbing
• Staff competency is verified
initially on an ongoing basis
as per written policies.

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How Often Do you Clean Your LAFH?

The critical areas inside the

ISO Class 5 environments are
cleaned and disinfected at:

1. the beginning of each

work shift.
2. between batches.
3. every 30 minutes during
continuous compounding.
4. when there are spills.
5. In the event of or
suspicion of procedural
breach. Only Pharmacy staff are allowed to do so.

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LAFH Cleaning & Disinfection

• Disinfect all flat surfaces of the hood with 70 % isopropyl alcohol and dry with a lint
free paper towels, to minimize air turbulence.

• Begin cleaning the hood using long side to side motions on the top surface, start from
the back of the hood and work toward the front.
• The sides of the hood are cleaned using back to front motions again working from the
top to the bottom of each side.
• The surface of the hood is cleaned using side-to-side motions; start from back of the
hood and work toward the front.
• Upon the completion of cleaning, the pharmacist/assistant who performed the
preparation will initial the cleaning log sheet in the column corresponding to the data
and shift on which the cleaning was accomplished.

Vertical LAFH

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Horizontal LAFH
Cleaning and Disinfection Schedule
More Frequent than Daily
ISO Class 5 and work surfaces:
(with 70% IPA)
• Beginning of day/shift
• Prior to each batch
• Every 30 minutes
• When visibly soiled
• As spills occur
• Suspect contamination
Empty trash as needed
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Daily
ISO Class 5 (with germicidal
detergent then 70% IPA)
Floors - start from furthest location
in clean room out thru ante-room
(include pass-through floor).
Easily cleanable horizontal surfaces
in ante and clean rooms.
Empty trash
Re-stock daily supply
2022
Monthly
ISO Class 5 (with germicidal
detergent then 70% IPA)
Ceiling, walls, pass-through,
Floors - start from furthest location
in clean room out thru ante-room
(include pass-through floor).
Every surface: outside LAFH, all
carts (top, bottom, wheels, etc.),
Supply bins, doors, handles, vents.
Empty trash
Re-stock daily supply
Clean refrigerators, freezers, etc.
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Minimum Frequency of Cleaning and Disinfecting

Compounding Area
Site Minimum Frequency
ISO Class 5 - At the beginning of each shift
- Before each batch
- Every 30 minutes
- After spills
- When surface contamination is known or suspected.
Counters & work surfaces Daily
(ISO Class 7 and 8)
Floors Daily
Walls Monthly
Ceilings Monthly
Storage shelving Monthly
Refrigerators/Freezers Monthly

Personal Protective Equipment (PPE)

Order of Donning

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Personnel Cleaning and Garbing

• Don PPE in the order from dirtiest to cleanest.
1. Shoe covers
2. Head and facial hair cover
3. Face mask
4. Eye shield (hazardous, irritants, etc.)
5. Hand cleaning (nail cleaning) with disinfectant liquid soap and water.
6. Drying with lint-free disposable towels or air dryer.
7. Don non-shedding disposable gown.
8. Antiseptic hand cleaning with alcohol gel.
9. Wear sterile powder-free gloves.
10. Disinfect contaminated gloves with 70% IPA.

Hand Hygiene

• USP Chapter <797> harmonized with CDC (Centers for disease Control
and infection) Guidelines for Hand Hygiene

• Hand washing is defined as the vigorous, brief (30 seconds) rubbing

together of all surfaces of lathered hands, followed by rinsing under a
stream of water.

• Hand washing suspends microorganisms and

mechanically removes them by rinsing with water.
The fundamental principle of hand washing is
removal, not killing.

• Single most important way to reduce the risks of transmitting germs.

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Hand hygiene is paramount to safety, as this agar imprint of an unwashed hand

shows

Hand Washing
• Hand washing is the first essential
step in aseptic technique.

• Remove all jewelry and scrub

hands and arm to wrist.
• Duration: 30 seconds.
• Use the infection control-
approved anti microbial soap.
• Use circular motion, do not scrub
using up and down motions.

• Pat dry with a lint free paper

towels to avoid leaving particles.

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Personnel Cleaning and Garbing

• Hair net
• Beard cover
• Face mask
• Gown
– Nonsterile
• Gloves
– Sterile
• Shoe covers

Personnel Cleansing and Garbing

• Inside the clean area, cleanse hands and arms with alcohol-based surgical
hand scrub with persistent activity

• After hands and arms are dry, don sterile powder-free gloves compatible
with sterile 70% IPA

• Repeatedly apply sterile 70% IPA to contact areas of gloves whenever non-
sterile surfaces are touched (e.g. vials, counter tops, carts)

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Gloved hands are cleaned with sterile 70% IPA prior to entering/re-entering an
ISO Class 5 area as well as regularly after touching non sterile objects.

• Disinfect the neck of ampoule or the

rubber port of a vial with alcohol swab.

• Allow 3 strokes in the same direction

• Allow it to dry.

• Do not use alcohol wetted gauze pads or

other particle generating material to
disinfect the sterile entry points.

• Do not disinfect a contaminated needle.

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Personnel Cleaning and Garbing

• Remove gown before leaving the compounding area during the shift to be re-
used later. Fold it inside out.
• Shoe covers, hair and facial hair covers, face masks and gloves shall be replaced
with new ones before re-entering the compounding area and proper hand
hygiene shall be performed.

END

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