Microcentrifuge_TB 07-16_V1.0.doc

TABLE OF CONTENTS

1. PURPOSE 2

2. SCOPE 2

3. RESPONSIBILITIES 2

4. CROSS-REFERENCES 2

5. PROCEDURES 2

5.1. General Safety 2

5.2. Centrifugation 3

5.3. Quality control 3

5.4. Maintenance 4

5.4.1. Cleaning 4

5.4.2. Servicing 4

6. REFERENCES 4

7. CHANGE HISTORY 5

1.  PURPOSE

This operating procedure describes the use and maintenance of the microcentrifuge. Optimal operation of the microcentrifuge is achieved through regular servicing and preventive maintenance.

A centrifuge is intended to separate particles in a liquid by sedimentation. Dense particles sediment first, followed by lighter particles. In a TB laboratory, centrifuges are used for the sedimentation of tubercle bacilli and their concentration within liquefied sputa or body fluids (usually urine).

The microcentrifuge is primarily used within the ______TB Laboratory during DNA extraction procedures from decontaminated and heat-killed sputum specimens or clinical isolates.

2.  SCOPE

This SOP covers procedures involving centrifugation in the ______TB Laboratory.

3.  RESPONSIBILITIES

All staff members working in the ______TB Laboratory are responsible for the implementation of this operating procedure. All users of this procedure who do not understand it or are unable to carry it out as described are responsible for seeking advice from their supervisor.

4.  CROSS-REFERENCES

See: / Document Matrix_TB 01-01_V1.0.doc
Location:

Refer to SOPs listed under 07-01 (General Procedures), 07-02 (Specimen Handling) and test-specific SOPs.

5.  PROCEDURES

5.1. General Safety

·  Centrifuge should be installed on a good stable base.

·  Before using the centrifuge check the rotor for firm placement.

·  Centrifuge must not be knocked or moved during operation.

·  In case of fault or emergency release, never touch the rotor before it has stopped turning.

·  Only the rotors and accessories approved by the manufacturer for this device may be used.

·  The centrifuge must not be operated with highly corrosive substances which could impair the mechanical integrity of rotors, hangers and accessories.

·  Rotors, suspensions and accessories that possess any traces of corrosion or mechanical damage or if their term of use has expired may not be used any longer (see Section 5.4).

·  Do not overload rotor. Overloading can result in destruction and severe damage to the centrifuge.

·  Preventive maintenance procedures for the centrifuge must be carried out according to Section 5.4

·  The microcentrifuge should be operated using personal protective equipment at all times (gloves, gown, mask).

5.2. Centrifugation

·  Load the rotor with specimens in cryovials symmetrically. If you centrifuge odd number of cryovials use a cryovial with an appropriate amount of water for balance. Failure to do so may lead to detrimental wear to the motor and drive system.

·  The cryovials must be tightly capped.

·  Check the inside of the centrifuge and the rotor to ensure that everything is dry. If there is any sign of corrosion, discontinue use until the corroded part has been repaired by a qualified service technician.

·  An Equipment Failure Notice must be placed on the centrifuge indicating that work is prohibited.

·  An Equipment Failure Report must be issued.

Use: / Equipment Failure Notice_form.doc
Equipment Failure Report_form.doc
Location:

·  Close the rotor lid firmly by turning manually clockwise by hand.

·  Close the centrifuge lid.

·  Set up needed parameters (see User Manual).

·  For DNA extraction procedure for line probe assays, the microcentrifuge is run at 10,000 g.

·  A 15 minute cycle is used for initial sedimentation of the decontaminated specimen.

·  A five minute cycle is used following heat kill and ultrasonication.

·  Refer to the Genotype MTBDRplus for MDR-TB Screening procedure.

See: / Genotype MTBDRplus_TB 06-01_V1.0.doc
Location:

·  Press the “START” key in the control panel.

·  Lid cannot be opened during the run.

·  If a preset run time is used, as soon as the set speed reaches zero, the centrifuge lid opens automatically.

·  Centrifuge may be manually stopped at any time by pressing the “STOP” key. At this point, the remaining run time is displayed.

·  Loosen the rotor lid and check for any spills.

·  Remove the cryovials.

·  Replace the rotor lid and close the centrifuge lid.

5.3. Quality control

·  Sediments and supernatants should be visible after centrifugation.

·  The centrifuge should not be used if the interior is hot, if unusual vibrations or noises occur, or if deterioration (corrosion of parts) is detected. A qualified service technician should be contacted.

·  An Equipment Failure Notice must be placed on the centrifuge indicating that work is prohibited.

·  An Equipment Failure Report must be issued (see above for location).

5.4. Maintenance

5.4.1. Cleaning

Clean centrifuge according to the Laboratory Cleaning and Maintenance procedure.

See: / Lab Cleaning and Maintenance_TB 02-05_V1.0.doc
Location:

·  Record cleaning in the Laboratory Cleaning and Maintenance Logbook

Use: / Laboratory Cleaning and Maintenance Logbook_form.xls
Location:

5.4.2. Servicing

·  Users are NOT to make any repairs. Service must be done by a qualified service technician. The service technician must ensure that the unit operates safely and properly. This would include checking the centrifuge brushes, timer, speed and electrical leaks.

·  The equipment must be serviced annually.

·  Records of the service must be kept in the Equipment Maintenance File which is lodged in the ______TB Laboratory Office.

Records of the service must be kept in the Equipment Maintenance File

Use: / Equipment Maintenance File_form.doc
Location:

6.  REFERENCES

World Health Organization. Maintenance and repair of laboratory, diagnostic imaging and hospital equipment. Geneva: WHO; 1994.

World Health Organization. Manual of basic techniques for a health laboratory. 2nd ed. Geneva: WHO; 2003.

World Health Organization. Regional Office for the Eastern Mediterranean. Basics of quality assurance for intermediate and peripheral laboratories. 2nd ed. Cairo; 2002.

7.  CHANGE HISTORY

New version # / date / Old version # / date / No. of changes / Description of changes / Source of change request

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