Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:
8.3.5.18
Water treatment Penicillin and cephalosporin Plants
sampling Point description
activity
frequency
a
Feed water
Once/3 months
After sand filter I
Once/3 months
After sand filter II
Once/3 months
Once/3 months
After 5 µ cartridge
After RO
Once/3 months
RO tank
Once/3 months
After deionizer
Once monthly
After UV lamp
Once monthly
Supply water
Once monthly
Return water
Once monthly
a
It is appropriate to increase or decrease sampling based on the performance. The time and date can be deter-
mined according to the activity.
8.3.6 g
eneral
i
inStructionS
for
w
ater
S
amPle
m
aniPulation
• Deliver the sample to the laboratory as fast as possible, and the maximum time is 2 h after
that the sample will be unacceptable to microbiological analysis.
• Maintain the quality of the sample through the transport to the laboratory, especially the
neck of the bottle must not be mishandled.
8.3.7 m
icro
c
ount
m
ethodology
c
onSideration
• The method selected must be capable of isolating the numbers and types of organisms that
have been estimated significant relative to the system control and product impact for each
individual system. The recommended method is the membrane filtration method, whereas
pour plate and the most probable number may be used as per requirements.
• Culture approaches for each type of water are further deined by the type of medium used
in combination that should be selected according to the monitoring needs presented by a
specific water system as well as its ability to recover microorganisms that could have a
detrimental effect on the product or the process.
Cultivation on low-nutrient media and incubation at 20-25°C for 5-7 days (recommended). The
applied approach can be documented and validated.
1.
Media growth promotion:
Media are able to support growth when inoculated with less than
100 colony-forming units (CFU) of the challenge organisms as per STM MC 000. The media
are capable of supporting growth of indicator microorganisms and of environmental isolates
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