KAN-TN-LP 02 Issue Number : 3
April 2016
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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
a. The following information shall be available from the manufacturer or producer
commercial or noncommercial bodies supplying media to third parties: - Name of the medium, individual components and any supplements and, if
possible, their product codes; - Technical data sheet, e.g. formulation, intended use, filling quantity if
applicable references; - Safety andor hazard data where needed;
- Batch number;
KAN-TN-LP 02 Issue Number : 3
April 2016
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11 - Target pH of the complete medium;
- Storage information and expiry date; - Assigned shelf-life;
- Quality control certificate showing test organisms used and results of performance testing with criteria of acceptance.
b. Laboratory shall have sufficient appropriate quantities of reagents media commercial kits available to carry out the volume of work following the required
test methods. c. Raw materials dehydrated formulations and individual constituents should be
stored under appropriate conditions, e.g. cool, dry and dark. d. All containers, especially those for dehydrated media, should be sealed tightly.
e. Dehydrated media that are caked or cracked or show a color change should not be used.
f. Shelf life of prepared media under defined storage conditions shall be determined and verified.
g. Stored reagents, reference materials and supplies shall be under the appropriate conditions and in a secure manner to ensure the separation of incompatible
materials. h. Solutions of reagent, standard and any other such as mobile phase properly
labeled with solution name, concentration, date of preparation, expiration date, and identity of person who prepared.
i. Disposed of reagents and standards solutions appropriately followed to National and or local regulation
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
12 j. Laboratory shall have documented verification or comparison of standards andor
reference materials before use and the protocol when non-conforming results are encountered.
k. Distilled or de-ionized water systems are monitored for conductivity, bacterial content, and total chlorine periodically. Heavy metals analysis, water quality test
and use test are performed annually on the water systems. l. Microbiology media preparation and sterilization areas are separated from work
areas to prevent contamination of clean media. m. Laboratories shall ensure that all reagents including stock solutions, media,
diluents, and other suspending fluids are adequately labeled to indicate, as appropriate, identity, concentration, storage conditions, preparation date, and
validated expiry date and or recommended storage periods.
7. REFERENCE MATERIAL AND REFERENCE CULTURE
