Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

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Content
1. 2. 3. Scope Definitions and abbreviations Personnel qualifications #!$ %edical fitness #!& 'ducation and training Procedure (!$ Principle (!& Samples (!# ')uipment and materials (!( Reagents and solutions (!* "etailed instructions for use (!+ Recording and reporting (!, -ualit. control (!/ Safet. precautions !elated documents

4.

"nne# 1. $nspissator lo%boo& "nne# 2. 'aintenance lo%boo&

Compiled b. 3ame "ate Signature Laborator. area:

'0amined b.

1ppro2ed b.

Replaced Code:

3e4 2ersion Code:

3o of copies:

Reason for c5ange:

Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

Code: ersion: no! "ate: of release Page: 2 of 6

1.

Scope

65is SOP describes t5e optimal operation of an inspissator t5roug5 regular ser2icing and pre2enti2e maintenance! 65e SOP must be adapted for different t.pes of inspissator t.pes according to t5e manufacturer7s instructions!

2.
8C: 31:

Definitions and abbreviations

degrees Celsius not applicable

3.

Personnel qualifications

3.1 Medical fitness

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3.2 Education and training 'ducation and training must be gi2en on t5e follo4ing topics: 5.giene re)uirements9 4earing and use of protecti2e e)uipment and clot5ing9

pre2ention of incidents and steps to be ta:en b. 4or:ers in t5e case of incidents (bio5a;ard incidents< c5emical< electrical and fire 5a;ards)9 good laborator. practice9 organi;ation of 4or: flo49 use of e)uipment (operation< identification of malfunctions< maintenance)! 65e training s5all be: gi2en before a staff member ta:es up 5is/5er post9 strictl. super2ised9 adapted to ta:e account of ne4 or c5anged conditions9 and repeated periodicall.< preferabl. e2er. .ear!

4.

Procedure

4.1 Principle 65e inspissator (coagulator) is intended for batc5 production of egg=based culture medium (L>4enstein?@ensen< Oga4a and ot5er modified egg=based media) 4it5 or 4it5out t5e addition of drugs! 12ailable inspissators differ in si;e and in t5e t.pe of 5eater: some :eep t5e temperature 5omogeneous and stable b. means of a 4ater= bat5 and ot5ers b. forced air circulation! 4.2 Samples

Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

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31 4.3 Equipment and materials Inspissator< properl. maintained and installed according to t5e manufacturerAs manual (specific to eac5 inspissator)! Calibrated t5ermometer 6imer Remo2able tube rac:s 4it5 appropriate tubes or bottles for culture 65ermoresistant glo2es 4.4 Reagents and solutions "istilled 4ater< obtained from ion=e0c5ange s.stems t5at do not use salt bac:=flus5ing to regenerate t5e ion=e0c5ange cartridge (sodium ions are 2er. corrosi2e to t5e stainless steel tan:)! 4.5 Detailed instructions for use 4.5.1 Check before use Replace inspissator 4ater 4it5 fres5 distilled 4ater once a 4ee: to pre2ent corrosion of t5e stainless steel tan:! 'nsure t5at t5e element is submerged belo4 t5e 4ater le2el at all times< to pre2ent o2er5eating and damage of t5e element! 4.5.2 Loading the inspissator Heat t5e inspissator to /B 8C! Place t5e bottles/tubes in a slanted position in t5e inspissator! Co2er 4it5 a blan:et< if recommended b. t5e manufacturer! Coagulate t5e medium for (* minutes at /B?/* 8C! (65e medium 5as been prepared asepticall. and t5is 5eating is t5erefore designed to solidif. t5e medium< not to sterili;e it!) 65e )ualit. of egg=based media deteriorates if coagulation is performed at too 5ig5 a temperature or for too long! Heating for a second or t5ird time 5as a detrimental effect! C5ec: t5e )ualit. of t5e medium once cooled (see section (!, belo4)! 4.5.3 Cleaning Clean t5e inspissator 4it5 a damp clot5 after disconnecting t5e inspissator from t5e electricit. suppl.! 12oid t5e use of sol2ents for cleaning! Clean t5e immersed parts using proprietar. 5eating element cleaners! Note Follow the manufacturers instructions carefull ! as these cleaners ma be to"ic. 4.! Recording and reporting

Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

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Record data in t5e logboo: after preparation of eac5 batc5 of medium! Record details of t5e loading and operation of t5e inspissator in t5e inspissator logboo: (1nne0 $)! Incidents< accidents and/or mec5anical problems must also be recorded (1nne0 &)! 4." #ualit$ control isuall. c5ec: t5e )ualit. of t5e medium once it 5as cooled! It s5ould not be li)uid< and s5ould not release large 2olumes of 4ater! "iscolouration of t5e coagulated medium ma. be due to e0cessi2e 5eating! 65e appearance of small 5oles or bubbles on t5e surface of t5e medium also indicates fault. coagulation procedures< especiall. 45ere t5e medium is in contact 4it5 t5e glass (internal 4all of t5e tube)! If t5e medium is li)uid or disintegrates easil.< t5e inspissation temperature mig5t 5a2e been too lo4! 65is can be detected b. tapping (on t5e 5and) one or t4o tubes randoml. c5osen from t5e inspissated batc5! Poor )ualit. media s5ould be discarded! #terilit check 1fter inspissation< t5e 45ole media batc5 s5ould be incubated at #*?#, 8C for &( 5ours and tubes c5ec:ed for t5e appearance of contamination! 1lternati2el.< a randoml. selected sample of tubes is incubated at #*?#, 8C for &(?(/ 5ours! 65e batc5 is used onl. after a negati2e test result (2erif.ing t5e absence of contamination)! 4.% Safet$ precautions Use thermoresistant glo$es to protect from 5eat! Ce careful of steam 45en opening t5e inspissator! Dor ser2ice or repairs< onl. t5e control unit ? not t5e tan: or bridge plate ? is remo2ed! Ser2ice and repair s5ould be performed b. a )ualified ser2ice tec5nician! Refer to t5e manufacturerAs manual for safe 5andling of t5e inspissator!

!elated documents

%anufacturerAs manual< specific to eac5 inspissator

Laborator ser$ices in tuberculosis control. %art &&&' Culture! Eene2a< Forld Healt5 Organi;ation< $GG/ (FHO/6C/G/!&*/)!

Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

Code: ersion: no! "ate: of release Page : of 6

"nne# 1. $nspissator lo%boo&

Date (ime )perator *olume of load +no. of vials,tubes'edium type L. L./pyr )%a0a L. $12 L. !$3 L. 4'5 L. S'

Institution Laboratory name Location Head/Responsible person

Standard Operating Procedure (SOP) Use and maintenance of an inspissator

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"nne# 2. 'aintenance lo%boo&

$(4' $D41($3$C"($)1 Crand name: %odel/t.pe: Serial no! 6el: 6el:

')uipment: I3SPISS16OR Purc5ase date: Location 4it5in laborator.: Farrant. e0pir. date: %anufacturer: 1ddress:! Contact person: 6ec5nical ser2ice representati2e:

P4!$)D$C$(67 "ate %aintenance operation Operator

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3"$L8!4 4*41(S Correcti2e action ta:en

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