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Twincubator Use and Maintenance: Document Type: SOP

This SOP describes the setup, operation, and maintenance of the TwinCubator hybridization block used for molecular diagnostic assays like MTBDRplus and MTBDR CM. The TwinCubator allows controlled heating and shaking of DNA strips during hybridization. Staff are responsible for following this SOP. Cleaning and maintenance procedures are described to properly care for the TwinCubator. Records of cleaning, maintenance, and repairs must be documented.

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felix bazan
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681 views

Twincubator Use and Maintenance: Document Type: SOP

This SOP describes the setup, operation, and maintenance of the TwinCubator hybridization block used for molecular diagnostic assays like MTBDRplus and MTBDR CM. The TwinCubator allows controlled heating and shaking of DNA strips during hybridization. Staff are responsible for following this SOP. Cleaning and maintenance procedures are described to properly care for the TwinCubator. Records of cleaning, maintenance, and repairs must be documented.

Uploaded by

felix bazan
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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533558065

Document type: SOP

Document code: TB 07-15


TWINCUBATOR USE AND
MAINTENANCE
Confidentiality: none

TABLE OF CONTENTS
1. PURPOSE...................................................................................................................... 2
2. SCOPE .......................................................................................................................... 2
3. RESPONSIBILITIES ...................................................................................................... 2
4. CROSS-REFERENCES ................................................................................................. 2
5. PROCEDURES .............................................................................................................. 2
5.1. Set-up ................................................................................................................................ 2
5.2. Operation ........................................................................................................................... 3
5.2.1 Running an existing program ............................................................................................... 3
5.2.2 Editing programs .................................................................................................................. 3
5.3. Maintenance ...................................................................................................................... 3
5.3.1 Cleaning .................................................................................................................................. 3
5.3.2 Servicing ................................................................................................................................. 3
6. REFERENCES ............................................................................................................... 4
7. CHANGE HISTORY ....................................................................................................... 4

This SOP template has been developed by FIND for adaption and use in TB laboratories
Release date: ddMMMyy Page 1 of 4
Twincubator_TB 07-15_V1.0

1. PURPOSE

This SOP describes the using and maintenance of the TwinCubator with hybridization block at the
________________TB Laboratory. The TwinCubator (Hain Lifescience) is intended for use with DNA
strips corresponding to reverse hybridization assays and was designed for molecular diagnostic
assays developed by Hain Lifescience (MTBDRplus and MTBDR CM).

2. SCOPE

This SOP relates to all procedures involving Line Probe Assays (LPA) performed in the
__________________TB Laboratory. The TwinCubator is situated in the Post-Amplification room and
must not be used in the other laboratories.

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 General Procedures (TB 02) and Molecular Methods (TB 06).

5. PROCEDURES

5.1. Set-up

 TwinCubator, installed after checking compatibility of voltage supply.


 Ensure adequate ventilation by placing TwinCubator at least 25 cm away from adjacent
instruments or walls.
 Ensure that TwinCubator is placed on a firm and flat surface.
 Perform initial test run at maximal speed to ensure that unit does not move during shaking
process.

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Twincubator_TB 07-15_V1.0

5.2. Operation

5.2.1 Running an existing program


For more details:

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


Location:

 TwinCubator can store a maximum of 9 programs, each containing up to 20 steps.


 After turning unit on, use arrow keys to switch between program and step numbers.
 Select desired program with +/- key.
 Running program may be paused with left arrow key. Temperature will be maintained at current
setting but shaking will be paused. Shaking may be restarted with right arrow key.
 Advance from one program step to the next by pressing right arrow once. Start selected program
step by pressing the right arrow once more.
 A tone signals the end of an incubation step; shaking and heating will be continued until right
arrow is pressed once.

5.2.2 Editing programs


 To edit programs, turn instrument on with power switch while holding down ‘Prog’ key for short
time.
 Select program and step to be edited with arrow and +/- keys.
 Individual set temperatures, times, shaking frequencies, and step models are selected with arrow
keys and desired values adjusted with +/- key.

5.3. Maintenance

 If any liquid (sample or reagent) enters wells of hybridization block, wells must be immediately
cleaned with mild soap solution followed by distilled or de-mineralized water.
 The plexi-glass lid should be regularly wiped during operation to remove condensation
accumulating over time.
 Plastic trays used for hybridization reactions may be reused a few times following rinse with
distilled water.

5.3.1 Cleaning
 Clean TwinCubator on a weekly basis using 1% bleach solution followed by water.
 Prior to cleaning TwinCubator, power must be switched off and power cable removed.
 Frame of unit may be cleaned with slightly moist cloth or ethanol. Avoid aggressive cleaning
agents.
 Record cleaning in the Laboratory Cleaning and Maintenance Logbook.

Use: Laboratory Cleaning and Maintenance Logbook_form.xls


Location:

5.3.2 Servicing
In the event of failure of the unit, an Equipment Failure Report must be completed and the service
representatives must be called out.
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Twincubator_TB 07-15_V1.0

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

Use: Equipment Failure Report_form.doc


Equipment Failure Notice_form.doc
Location:

 Unit should only be opened by approved expert.


 Prior to shipping for servicing and repairs, TwinCubator should be cleaned and decontaminated.
 Case should be cleaned with precision wipe soaked in 70% ethanol.
 Wells of hybridization block should be cleaned with 1.5% bleach solution.
 Completed and signed decontamination protocol must be included in the shipment to the
manufacturer.
 Plexi-glass lid is the only element that may be exchanged in event of defect; push lid up and
sideways until unhinged out of the spring bearing.
 New lid can be inserted ‘last in first out.’

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

Use: Equipment Maintenance File_form.doc


Location:

6. REFERENCES

Reference Manual: TwinCubator, Hain Lifescience.

7. CHANGE HISTORY

New version # Old version # No. of Description of changes Source of


/ date / date changes change request

Page 4 of 4

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