This document provides guidelines for pharmaceutical staff on proper procedures for preparing, storing, and monitoring sterile products in the pharmacy in order to prevent contamination, including following aseptic technique and using engineering controls like laminar airflow hoods when compounding intravenous medications, as well as procedures for quality control monitoring, storage and specific considerations for multidose vials. Adherence to these guidelines is important to avoid patient morbidity and mortality that can result from contaminated pharmaceuticals.

1. ١
KING KHALID HOSPITAL
INFECTION PREVENTION
AND
CONTROL MANUAL
PHARMACY
Dr. Nahla Abdel Kader, MD, PhD.
Infection Control Consultant, MOH
Infection Control CBAHI Surveyor
Infection Prevention Control Director
KKH.

2. ٢
DEFINITION
To provide clear guidelines for pharmaceutical staff on the
correct procedures for preparation, storage and monitoring of
sterile products compounded in the pharmacy and to prevent
contamination of sterile products prepared in the pharmacy
COMMENTS
Patient morbidity and mortality can result from contaminated
pharmaceuticals items.
Sterile pharmaceutical products can become contaminated via:
1. Intrinsic contamination, which occurs during the manufacturing
process.
2. Extrinsic contamination, which occurs subsequent to
manufacturing; during the admixture process or while the infusate
is in use

3. ٣
PROCEDURE
A. Aseptic Technique:
1. Failure to utilize aseptic technique can result in
contamination of pharmaceuticals, and has been associated
with epidemics.
2. Remove any hand/wrist jewelry and scrub nails, hands and
forearms with an antimicrobial soap before handling sterile
products.
3. Do not eat, drink or smoke in the preparation area.
4. Avoid touch contamination of sterile supplies.
5. Wear a gown, facemask, shoe covers, hair covers, and
where applicable a cover for facial hair upon entering the
preparation area .
6. Personnel engaged in compounding intravenous (IV)
admixtures should wear sterile gloves. Gloves should be
removed when exiting the preparation area. Gloves
personnel should not answer the phone.
7. Procedures should be developed to validate the aseptic
technique for each person preparing sterile products, and
repeated at periodic intervals

4. ٤
Next… PROCEDURE
B. Engineering Controls:
Process: All sterile products should be prepared in a class 100
environment, no greater than 100 particles per square foot,
which can be achieved with the use of a certified vertical or
horizontal laminar airflow hood.
Use of the Laminar Airflow Hood (LAFH)
1. Operate the LAFH continuously. Before processing sterile
products therein, it should be in operation for a period of
time long enough to purge room air from the work area ( at
least 30 minutes or as per manufacturers’
recommendations).
2. Do not disrupt the air flow between the HEPA filter and any
sterile objects to avoid contamination.
3. Complete all work at least 6 inches inside the LAFH.

5. ٥
Next… PROCEDURE
4. Disinfect the work surfaces and all accessible interior
surfaces of the hood with a hospital approved disinfectant
before begining work.
5. Clean the exterior surfaces of the hood daily with a hospital
approved disinfectant.
6. Inspect the containers of the ingredients used to compound
the sterile product for defects, product integrity and the
expiration date noted.
7. Do not use defective products or expired products.
8. Defective products should be reported to the Ministry of
Health using the Drug Quality Report.
9. Disinfect the entire surface of all ampoules, vials and
containers with 70% Isopropyl Alcohol before entry into the
LAFH and allow to air dry.
10. Handle all ampoules, vials, needles and syringes in such a
way as to maintain asepsis and avoid unnecessary
turbulence within the LAFH.
11. Ensure annual certification of the LAFH, or more
frequently as needed and maintain certification records

6. ٦
Next… PROCEDURE
C. The Sterile Product Preparation Area:
1. Should be functionally separate from other areas.
2. Should have a controlled air flow under positive
pressure that should not be disrupted by air ducts, vents
or excess traffic that could produce air currents
introducing contaminants.
3. Should be free of particle shedding materials such as
cardboard boxes, or powdered gloves. Such materials
should not be stored in any area surrounding the hood.
4. Should not have carpets, drapes and other particulate –
shedding materials in the preparation area.
5. Should be with minimal personnel traffic and confined to
those persons directly engaged in IV admixture
procedures, or their supervision

7. ٧
Next… PROCEDURE
D. Quality Control Monitoring:
1. Examine the final sterile product for any leaks, cracks,
turbidity or particulate matter.
2. Label all admixed parental fluids to include the following
information:
a. Patient Name
b. Medical record number, patient location.
c. Solution and ingredient names, and concentrations
d. The administration regimen names, and concentrations
e. The expiration date and time
f. Storage requirements
g. Identification of the responsible pharmacist by badge
number
h. Appropriate additional labelling, for example any
precautionary measures that need to be taken.
i. Device specific instructions
j. Any additional information in accordance with local
regulations or requirements

8. ٨
Next… PROCEDURE
E. Storage:
The pharmacy is responsible for the appropriate storage of
pharmaceuticals throughout the institution. The following
applies to parenteral admixtures:
1. Store admix parenterals according to the manufacturers’
recommendations.
2. Remove expired medication from patient care areas and
correctly dispose.
3. Store admixed parenterals in the refrigerator for up to 1
week providing refridgeration begins immediately after
preparation and is continuous. The stability of admixed
ingredients may dictate a shorter or longer refridgeration
period.
4. Follow manufacturers’ recommendations

9. ٩
Next… PROCEDURE
F. Pharmacy Responsibilites Involving Antimicrobial
Control:
Concerns about antimicrobial resistance causing
increased morbidity, mortality and healthcare costs
have led to recommendations to control antimicrobial
use.
1. Establish a system to control and monitor
antimicrobial usage.
2. Participate in the development of programs for
formulary and antimicrobial control.
3. Collaborate with physicians regarding patient
specific recommendations for antimicrobial use

10. ١٠
Next… PROCEDURE
G. Multidose Vials (MDV’s):
1. MDVs should be used and stored according to
manufacturers’ instructions.
2. MDVs should be labeled with the opening date.
3. MDVs should be discarded when:
a. Empty
b. The expiration date is reached
c. Suspected or visible contamination of the vial
4. The rubber stopper of MDVs should be wiped with Isopropyl
Alcohol 70%, and allowed to air dry before needle insertion.
a. Avoid touch contamination of the MDV.
5. MDVs should be accessed with a sterile needle each time and
the needle removed on completion.
a. The needle should not be left as permanent access, as it
will provide a portal of entry for micro-organisms

11. ١١