KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
7 ii. Work instructions for disinfection sterilization and disposal of bio hazardous
material iii. Work instructions for glassware cleaning
iv. Work instructions for equipment instruction manuals v. Work instructions for computer software related data entry and approval.
5. EQUIPMENT AND MEASUREMENT TRACEABILITY
a. Laboratory shall have:
i. Procedure specifies the schedule and requirements for maintenance, performance, calibration, and verification of laboratory testing equipment that
meet the criteria of the maintenance and calibration parameters needed to achieve the accuracy of instruments used for analytical testing.
ii. Equipment records containing description of the instrument, critical accessories and software, manufacturers name, type identification and serial number;
Laboratory number; installation qualification IQ and operational qualification OQ records obtained from the installer or manufacturer; and other related
material such as instrument service and repair, warranty information, service contract conditions and specifications.
iii. Laboratory shall have operating instructions for each instrument, including starting and shutting down the instrument.
iv. pH meter at least available two buffer to cover the range of pH needed in the tests methods for determination of pH standards, buffers available within their
expiry dates. v. Probes of pH meter maintained with cap on andor in buffer solution or distilled
water. vi. Safety cabinet shall have documented protocol and record of decontamination.
vii. Program established to check regularly the rate of airflow and particle count in the Biohazard hoods or laminar flow cabinets.
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
8 b.
The effectiveness of the autoclave operation shall checked monthly with a biological indicator.
c. Thermometers and or thermocouples used for checking temperature of
incubators, water baths refrigerators, and freezers calibrated against a reference thermometer by calibration laboratory and traceable to a national standard.
d. Automatic Pipettes is there an initial verification of volume delivered checked.
e. Are there regular checks to ensure that the equipment is performing within the
specifications. f.
Hygrometer shall calibrated by calibration laboratory and traceable to a national standard, when humidity is influence to the outcome of the test.
g. Equipment that is not operating properly is clearly marked to show that it is out
of service. h.
When an instrument is discovered to be improperly operating, it is tagged and taken out of service. Equipment is not returned to service until performance
checks and verification have been performed and documented. i.
Each instrument has an established schedule specifying performance checks, including the testing frequency and acceptable performance specifications. These
performance checks ensure the instrument is operating properly and consistently prior to analysis.
j. All instruments required for the routine test in microbiology field are available: i.
Bunsen burners or other flame source functioning properly, ii.
Colony counter for pour plate and spread plate method functioning properly,
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
9 iii.
Incubators functioning properly, maintained within the specified temperature range, temperatures monitored and recorded and spatial variability in
incubators checked periodically, iv.
Water baths functioning properly, maintained within the specified temperature range; temperatures monitored and recorded periodically,
v. Working thermometers are traceable to national standards,
vi. Microscopes covered with dust cover when not in use,
vii. Optical surfaces of microscopes cleaned after each use,
viii. Autoclave is functioning properly, monthly test of autoclave performance using a spore strip or spore suspension, capable of demonstrating a 6 log
kill of Bacillus stearothermophilus, ix.
Laminar air flow, check performance and check with sterility plates also airflow monitoring,
x. Sterilizing ovens, check stability and uniformity of temperature and Monitor
temperature, xi.
Regularly scheduled maintenance program for each piece of equipment, where appropriate and records of service where service was required,
xii. Distilled water that producing in-house and or purchasing from external
supplier and used to make media or reagents in microbiology tests shall check the conductivity periodically,
xiii. If total heavy metal may influenced the results of tests method for specific microbiology test, distilled water that producing in-house and or purchasing
from external supplier and used to make media or reagents in microbiology tests shall be check the total heavy metal periodically.
k. Laboratory shall have arrangement for avoidance of cross-contamination arising from equipment, such as:
i. Disposable equipment should be clean and sterile when appropriate;
ii. Re-used glassware should be properly cleaned and sterilized when
appropriate; iii. Laboratories should have a separate autoclave for decontamination.
However, one autoclave is acceptable provided that adequate precautions
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
10 are taken to separate decontamination and sterilization loads, and a
documented cleaning programmed is in place to address both the internal and external environment of the autoclave.
l. Laboratories should carry out initial verification of volumetric equipment such as
automatic dispensers, dispenserdiluters, mechanical hand pipettes and disposable pipettes and then make regular checks to ensure that the equipment
is performing within the required specification. m. Verification should not be necessary for glassware which has been certified to a
specific tolerance. n. Equipment should be checked for the accuracy of the delivered volume against
the set volume for several different settings in the case of variable volume instruments and the precision of the repeat deliveries should be measured.
o. Where centrifuges are used in test procedures, an assessment should be made of the criticality of the centrifugal force. Where it is critical, the centrifuge will
require calibration. p.
Conductivity meters, oxygen meters, pH meters and other similar instruments should be verified regularly or before each use.
6. REAGENTS AND CULTURE MEDIA
