Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:
iv.
Faecal streptococci:
Using direct inoculation of 1 mL into TSB, if there is turbid-
ity, transfer into azide dextrose broth or azide blood agar and identify using the
API and/or automated identification system.
8.3.8 g
eneral
ii.
inStruction
for
w
ater
a
nalySiS
Analyze the sample as fast as possible. In case of a probable delay, keep it in a refrigerator for a
maximum of 2 h. Never incubate or keep the sample at room temperature.
An appropriate level of control may be maintained by using data trending techniques and limit-
ing specific contraindicated microorganisms.
8.3.9 i
identification
of
m
icroBial
ii.
SolateS
• For general purposes: Colony morphology, gram staining, or microscopic morphology as
a routine may be sufficient.
• Pheno-typical isolates from puriied water can be characterized. Biochemical testing, such as
oxidase test, urease test, catalase test, citrate test, coagulase test, and indole test and commercial
test kits such as API tests and reagents may be used for conformation of some unique isolates.
Identification of isolates from critical sampling points such as water used for preparation and
areas immediate to these critical sampling points such as water used for clean in place (CIP)
should take precedence over identification of microorganisms from noncritical sampling points.
• Isolates from WFI can be identiied to species level (if possible) using API tests/automated
identification system. This pertains to the detection of any isolate obtained from a sample
that breaches either the alert or action level.
• Mold does not carry “special” status relative to bacteria. Any signiicant shifts in type or
number require action—regardless of mold vs. bacteria.
Note:
The organism recovered from production environments may be highly stressed due to
physical factors, contact with chemicals, and thermal stress. It may be difficult to obtain typi-
cal biochemical reactions with these isolates. The databases for commercial test kits and ID
systems are often designed for clinical isolates and may be incomplete with regard to indus-
trial isolates. Thus, interpretation of such microbial data requires experienced judgment.
• Identiication methods should be veriied, and ready-to-use kits should be made available
for their intended purpose. The methods used for identification of isolates should be veri-
fied using indicator microorganisms.
• The information gathered by an identiication program can also be useful in the investiga-
tion of the source of contamination, especially when the action levels are exceeded.
8.3.10
r
eSult
1.
Result validity:
The result can be invalid if
a.
Either negative control or positive control was unacceptable
b.
The used media or reagent is unacceptable
c.
Unusual events during sampling
d.
The sample subjected to factor changing its original content such as extent transporta-
tion time, incubate at high temperature or improper handling
i. Carry out a laboratory technical investigation and retest the testing reagents
ii. Repeat the test with more restrict sampling and testing conditions
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