Microbiological Monitoring
Scope-
This standard specifies recommendations for microbiological monitoring
of environment used for the preparation of cytotoxic drugs.
Objectives-
The objectives of this standard is to standardise microbiological
monitoring methods of environment used for cytotoxic preparation
so as to ensure that end-product consistently result in sterile
products of acceptable quality.
Referenced documents-
The following articles were referred to in this guideline.
| • |
ASHP Technical assistance
bulletin on quality assurance for pharmacy-prepared sterile
product. Am J Hosp Pharm 1993; 50: 2386-98 |
• |
ASHP Technical assistance bulletin
on handling of cytotoxic and
hazardous drugs. Am J Hosp Pharm 1990; 47: 1033-49 |
| • |
SHPA Guidelines for the safe handling
of cytotoxic drugs in Pharmacy
Departments. Aust J Hosp Pharm 1990; 20(5): 391-4 |
| • |
OSHA Work-practice guidelines for personnel
dealing with cytotoxic
(antineoplastic) drugs. Am J Hosp Pharm 1986; 43: 1193-1204 |
| • |
National Coordinating Committee on
Large Volume Parenterals.
Recommended guidelines for quality assurance in hospital
centralised intravenous admixture services. Am J Hosp Pharm
1980; 37:645-655 |
| • |
Michael J Akers, Glenn E Wright, Kimberly
A Carlson. Sterility testing of antimicrobial-containing
injectable solutions prepared in the pharmacy. Am J Hosp
Pharm 1991:48:2414-8 |
| • |
Laura A Cornish, Patricia A Montgomery.
Pharmacy. In: Russell N Olmsted, ed. APIC Infection Control
and Applied Epidemiology: Principles and Practice. St Louis:
Mosby, 1996 |
Definitions-
For the purpose of this standard, the definitions below apply.
LAFC refers to laminar airflow cabinet (This can be an isolator
or biological safety cabinet)
Personnel
Personnel must be trained and validated in aseptic dispensing
techniques and have a knowledge of microbiology, particulate contamination,
pharmaceutical calculations and incompatibilities.
Before working with sterile products, personnel should read the
appropriate policies and procedures and sign to verify their understanding.
No make-up or jewellery is allowed in the clean room.
Personnel with infectious diseases, such as respiratory tract
infections, that might result in contamination of products should
not be allowed into the clean room or prepare sterile products.
Personnel must change into sterile, non-shedding jumpsuits, hair
covers and shoe covers. Mask and sterile gloves must also be worn
before entering the clean room.
Environmental control and monitoring
The level of environmental control achieved is evaluated by measuring
the viable particles in the environment.
The count reported as colony forming unit (cfu) per cubic metre
is a
measure of microbial contamination of the environment at the time
and under the conditions of sampling.
If air sampler is used, air sampling of the LAFC is carried out
using an air sampler set for sampling 320 litres for 8 minutes
or its equivalent.
Air sampling is carried out at least once a month with increased
frequencies if problems are detected. It must also be carried
out within 2 weeks of any certification done on the LAFCs.
Each sampling exercise must be carried out using two types of
agar strips/plates:
a. Agar strip/plate which is TSA-Agar for total count and
b. Agar strip/plate which is Rose-Bengal-Agar for yeast and mould.
The air sampling is to be carried out in different locations within
the LAFCs. Two sampling are to be done in each site. In between
sampling, the rotor blades of the sampler are disinfected with
alcohol swabs.
A pair of sterile gloves is to be worn during sampling.
After sampling, the agar strips/plates are to be sent for incubation.
The incubation conditions for the agar strips/plates are:
a. For the TSA-agar strip/plate it must be incubated at 30°C
to 35°C for
48 hours,
b. For the Rose-Bengal-agar strip/plate it must be incubated at
28°C
to30°C for 120 hours.
The colonies are then counted and expressed as cfu per cubic metre.
A maximum of 1 cfu per cubic metre is permitted for samples taken
in the LAFCs.
If the counts for any of the LAFCs are >1 cfu per cubic metre,
NO sterile preparations are to be done in that LAFC until the
LAFC has passed the air sampling exercise. Remedial actions must
be carried out and the cause of the contamination traced and rectified.
The air sampling must be carried out until such time that the
result of the exercise is not more than 1 cfu per cubic metre.
The details of each air sampling exercise must be documented.
The following information is to be included in the documentation:
a) Date of air sampling exercise
b) Person/s conducting air sampling exercise
c) Sampling locations
d) Sampling volume
e) Time when sampling exercise commenced and completed
f) Results
g) Remarks
