2014 Service Catalogue en Compliance Microbiology

7/24/2019 2014 Service Catalogue en Compliance Microbiology

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Service Catalogue 2014Prices valid from April 2014

Robert-Perthel-Str. 49-!0"#9 $%l&

'el.( )49-*0+221-9!"4!"-0

,a.( )49-*0+221-9!"4!"-2!e-mail( i&focomplia&ce-microbiolog/.de

.complia&ce-microbiolog/.com



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Complia&ce Advice a&d Services i& icrobiolog/ mb3

Co&te&t

Service Catalogue 2014 .................................................................... 1

About us ............................................................................................ 4

our Co&tacts ................................................................................... 5

6aborator/ services ........................................................................... "

7iological 8&dicators ......................................................................... "

Determination of resistance in the BIER-Vessel ....................................................................................... 7

Determination of resistance in dry heat ................................................................................................... 9

CFR-Part 11 documentation of rocess data ............................................................................................ 9

sore susensions ............................................................................................................................... 1!

"dditional offers for D-Value determinations ......................................................................................... 1!

#anufacture and Certification of customer secific Bio Indicators ........................................................... 11

$ur%eillance of sterilisers throu&h 'ioindicators ...................................................................................... 11

Chemical i&dicators ........................................................................ 12

icrobiological 9ami&atio& of Pharmaceutical Products accordi&gPh. 9ur. ........................................................................................... 1#

(ater for Pharmaceutical Puroses) Determination of the *otal Via'le Count +ith #em'rane filtration ..... 1,

#icro'iolo&ical Eamination of on $terile Products /Ph. Eur 0..10 2 .................................................... 13

*otal %ia'le aero'ic count .................................................................................................................... 13

#icro'iolo&ical Eamination of on $terile Products /Ph. Eur 0..1,2 ..................................................... 13

Com'ined Eamination of on $terile Products /accordin& to Ph. Eur. 4.1.32 ........................................... 14



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$uita'ility of the *otal Via'le Count #ethod in the resence of the roduct /Ph. Eur.0..10 2 ................... 1

$uita'ility testin&5 *est for secified microor&anisms ............................................................................. 1

/Ph. Eur. 0..1,2 ................................................................................................................................. 1

Efficacy of "ntimicro'ial Preser%ation /Ph. Eur. 4.1.,2 ............................................................................ 17

Validation of the method for Determination of the *otal Via'le Count ..................................................... 17

Bacterial Endotoin *est /6"6-*est Ph. Eur. 0..132 .............................................................................. 18

En%ironmental monitorin& .................................................................................................................... 18

#icro'iolo&ical Eamination of harmaceutical roduction and adacent areas......................................... 19

:ualification of culture media ............................................................................................................... 19

"dditional reorts ................................................................................................................................ 19

:alidatio& studies ........................................................................... 20

Alloa&ce for i&dividual studies a&d eami&atio&s i& thelaborator/ ....................................................................................... 20

icrobiological Compete&ce ........................................................... 21

e&eral terms a&d co&ditio&s ......................................................... 25



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About usService co&cept

(ith the foundation of Comliance "d%iceand $er%ices in #icro'iolo&y ;m'< inColo&ne ;ermany in 1999 our mission+as to cometently suort enterrises+ith their micro'iolo&ical ro'lems andencounter those +ith ractical solutions.=ur &oal is to ro%ide our customers +itha ser%ice that not only contains of aclassical micro'iolo&ical la'oratoryser%ice 'ut also micro'iolo&ical consultin&ser%ices. *hus +e offer an aroach of a+hole ser%ice > from the de%eloment ofa concet throu&h the eecution ofeeriments in the la'oratory.

(e may hel you +ith the realisation ofeeriments that ha%e 'een de%eloed+ithin a consultin& roect. *his may result in indi%idual roect lans tailored to your needs. =n the otherhand results of la'oratory roects may re?uire rofessional eerience to dra+ the ri&ht conclusions. "sall of our roects are scientifically suer%ised 'y Dr. @laus <a'erer +e can assure that +e osses thenecessary eertise to suort you +ith your ro'lems as +ell.=ur customers can 'e sure to recei%e a comlete $er%ice from one source and a%oid comlicated and

indirect communication and coordination from the 'e&innin&. (e ro%ide you +ith ersonal ad%ice and aflei'le la'oratory-ser%ice at all times.

;or<i&g areas

Besides the standardised testin& accorin& to Ph. Eur. +e +erea'le to 'uild u &reat eertise in the field of D-Valuedeterminations and Biolo&ical Indicators. *here are fe+ otherla'oratories that can match our eeriences in this area. Forthese eeriments +e re&ularly use our BIER-Vessel /Biolo&icalIndicator E%aluation Resistometer2 articularly for tests +ith

sore rearations on different surfaces and the recertification ofBiolo&ical Indicators.

"dditionally +e may ro%ide suort also for %ery secial andcomle ro'lems +ithin the area of ?uality assurance. *hiscontains the lannin& and eecution of a %ariety of eerimentsfor eamle roduct secific endotoin deletion studies orcontainer closure studies.

E%en indi%idual roects +ith the concetion of mechanicalde%ices to match certain eeriment re?uirements ha%e 'eenrealiAed in the ast. If you need suort +ith indi%idual solutions

for your micro'iolo&ical ro'lems come and sea to us.



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icrobiological Compete&ce

;ood ad%ice is the com'ination of ractical eerience and state-of-the art no+-ho+.

"ll ser%ices ro%ided for our clients are technically re%ie+ed 'y Dr. @laus <a'erer. <e com'ines more than,! years of ractical eerience in the harmaceutical industry +ith rofound no+-ho+ in the sector ofmicro'iolo&ical ?uality assurance in harmaceutical roduct manufacturin&. <e is one of the 'est reco&niAedsecialists in his area of eertise +orld+ide. *hrou&hout his rofessional career he has suortednumerous comanies +ith a &reat %ariety of micro'iolo&ical challen&in& roects includin& the lannin& ofsteriliAation rocesses and elimination of errors +ithin such rocesses.*his hi&hly secific eertise hels us to ro%ide hi&h %alue +ith consultin& lannin& and eecutin& ourmicro'iolo&ical ser%ices. <is ad%ice in secific ?uestions remains eclusi%ely a%aila'le for our clients. =ur&oal is to deli%er hi&h-?uality results to customers and our eerience assures that +e reach it.

If you +ould lie to learn more a'out Dr. <a'erer and his rofessional eerience you are ro%ided +ithmore detailed information startin& at a&e 21.

=ualit/ ma&ageme&t s/stem

=ur mission is to ro%ide our customers +ith hi&h ?ualitati%e ser%ices to their satisfaction. =ur ?ualitymana&ement system ensures to fulfill this re?uirement. *o&ether +ith our &reat flei'ility and the closecooeration to our customers +e ro%ide con%enient solutions for our customers ro'lems.

=ur la'oratory is insected 'y our re&ulatory authorities in comliance +ith 3 "#; /;erman harmaceutical le&islation2



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o /ou have further >uestio&s about complia&ce or our services?

our Co&tacts

r. habil. $laus 3aberer $arl-3ei&@ Schhlei&

#ana&in& Director#icro'iolo&ical issues consultancy

#ana&in& DirectorCommercial Issues

3ildegard 3aag Christopher Schhlei&

<ead of la'oratory "ccountin& Controllin&

'el.( )49-*0+221-9!"4!"-0,a.( )49-*0+221-9!"4!"-2!

e-mail( i&focomplia&ce-microbiolog/.de

$tatus5 Fe'ruary 0!13



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6aborator/ services

6aborator/ services

B&fortu&atel/ e ca& &ot provide /ou ith prices i& the P, :ersio& of this catalogue. D& /ourdema&d e ill se&d /ou a paper versio& i&cludi&g prices or provide /ou ith a& i&dividual

>uotatio& upo& re>uest.

7iological 8&dicators

For the determination of the resistance of 'iolo&ical indicators in dry heat or in the BIER-Vessel +e +illesta'lish an indi%idual ?uotation uon your re?uest.

etermi&atio& of resista&ce i& the 789R-:essel

*he D-Value determinations /determination of resistance2 of sore rearations are 'ein& erformed in ourResistometer /BIER-Vessel2 for steam steriliAation rocesses. Furthermore +e are a'le to determine +hetheryour 'iolo&ical indicator is alica'le for your steriliAation rocess or not. =ur BIER-Vessel matches there?uirements of ""#I and I$= 111,8-,.

(e are also a'le to esta'lish ne+ models for secific ro'lems in close cooeration to our customers.

-:alue calculatio&

*he calculation of the D-Value can 'e erformed throu&h t+o different methods5

1. $tatistical method) ,E-method /G ,raction Ee&ati%e2

0. &umeratio& method

For recertifications of 'ioindicators +e recommend to choose the method that the manufacturer indicates inthe certificate for the articular 'ioindicator or sore susension

=n your demand +e can also record the rocess data accordin& to the re?uirements of CFR Part 11 andro%ide you +ith a &rahic erformance on the recorded data.



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6aborator/ services

Corroboratio& of -value for 'iolo&ical indicators /e.&. aer stris amoules2 in theBIER-Vessel 'y use of the ,E-#ethod /u to 7 inacti%ation times of ma. ,! minutes +ith1! relicates each run2 includin& initial %ia'le sore count

Prices upo&re>uest

Corroboratio& of -value for 'iolo&ical indicators /e.&. aer stris amoules2 in theBIER-Vessel 'y use of the &umeratio& #ethod /u to 4 inacti%ation times of ma. ,!minutes +ith , relicates each run2 includin& initial %ia'le sore count

Corroboratio& of -value for sore susensions in the BIER-Vessel 'y use of the ,E-#ethod /u to 7 inacti%ation times of ma. ,! minutes +ith 1! relicates each run2

includin& rearation of relicates and initial %ia'le sore count

Corroboratio& of Survival G $ill-time in the BIER-Vessel includin& initial %ia'le sorecount

etermi&atio& of -value for sore susensions o& surfaces in the BIER-Vessel 'yuse of the ,E-ethod /u to 7 inacti%ation times at 101 HC of ma. ,! minutes +ith 1!relicates each run2 includin& rearation of relicates and initial %ia'le sore count

etermi&atio& of -value for sore susensions i& product in the BIER-Vessel 'y use

of the ,E-ethod /u to 7 inacti%ation times at 101HC of ma. ,! minutes +ith 1!relicates each run2 includin& rearation of relicates and initial %ia'le sore count&ro+th control of roduct dilution/Please note5 *he D101HC-%alue for sore susensions ro%ided 'y Comliance has already'een corro'orated.2

etermi&atio& of @-value /D-%alue determination for a sore rearation in roduct at, different temeratures2 in the BIER-Vessel includin& rearation of relicates and initial%ia'le sore count



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6aborator/ services

etermi&atio& of resista&ce i& dr/ heat

Corroboratio& of -value for biological i&dicators /aer stris2 in dry heat 'y useof the ,E-ethod /u to 7 inacti%ation times of ma. ,! minutes +ith 1! relicates eachrun2 includin& initial %ia'le sore count.

Prices upo&re>uest etermi&atio& of -value of spore preparatio&s /e.&. in roduct2 at %arious

temeratures in dry heat 'y use of the ,E-ethod /u to 7 inacti%ation times of ma.,! minutes +ith 1! relicates each run2 includin& rearation of relicates and initial%ia'le sore count

C,R-Part 11 docume&tatio& of process data

C,R Part 11 complia&t docume&tatio& of rocess data at %arious ositions 'y use ofthe @aye Validator /CD2

Prices upo&re>uest C,R Part 11 complia&t docume&tatio& of rocess data at %arious ositions 'y use of

the @aye Validator /CD and &rahic erformance2

0

500

1000

1500

2000

2500

0 0 : 0 1

0 1 : 0 1

0 2 : 0 1

0 3 : 0 1

0 4 : 0 1

0 5 : 0 1

0 6 : 0 1

0 7 : 0 1

0 8 : 0 1

0 9 : 0 1

1 0 : 0 1

1 1 : 0 1

1 2 : 0 1

1 3 : 0 1

1 4 : 0 1

1 5 : 0 1

1 6 : 0 1

Time (min)

P

r e s s u r e ( m b a r )

0

50

100

150

200

250

T em p er a t ur e ( °

C )

mbar

Temp in °C

fi&5 *emerature- and ressure conditions in the BIER Vessel) defined and reroduca'le eosition-conditions



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6aborator/ services

spore suspe&sio&s

Provisio& of a i&depe&de&tl/ certified spore suspe&sio& of ;. stearothermohilus "*CC 794, +ith a sore titer of 1 E8ml sufficient for 1-0 D-%alue determinations/minimum ?uantity 0ml2

Prices upo&re>uest

,urther spore suspe&sio& ca& be provided upo& re>uest

Additio&al offers for -:alue determi&atio&s

Sporulatio& of isolates ro%ided 'y the customer incl. microscoic control of urity

and initial %ia'le sore count

Prices upo&re>uest

8de&tificatio& of aero'ic sore-formin& 'acteria 'y means of "PI-$ystem

E%aluation of colony morholo&y and urity

roth Promotio& 'est inoculation of the testmicroor&anism /e.&. ;.stearothermohilus2 in the roduct dilution /*$BJsamle2

Subculturi&g on C"$=-"&ar if a roduct leads to a tur'idity of the media 'y themself

and a %isual e%aluation of &ro+th in the enrichment isnt ossi'le /e.&. for emulsions orsusenions2

8&activatio& of antimicro'ial in&redients +ith e.&. filtration

7la&< H Coo&e/-stud/ for roducts +ith a stron& antimicro'ial acti%ity

etermi&atio& of a spore populatio& sore susension ro%ided 'y the client/+ithout Determination of ResistanceD-Value Determination2

ote5 For roducts +ith antimicro'ial acti%ities testin& rocedures ha%e to 'e a&reed on.



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6aborator/ services

a&ufacture a&d Certificatio& of customer specific 7io 8&dicators

8&oculated product filled i& Ampoules incl. Pro%ision of a indeendently certifiedsore susension of e.&. ;- stearothermohilus "*CC 794, +ith a sore titer of 1 E8ml-value determi&atio& of the sore rearation initial sore count &ro+th control ofroduct dilution

P r i c e s u p o & r e > u e s t I 0 e 0 i l l e s t a b l i s

h a & o f f e r a d a p t e d t o / o u r

i & d i v i d u a l & e e d s

8&oculated stoppers or caps incl. Pro%ision of a indeendently certified soresusension of e.&. ;- stearothermohilus "*CC 794, +ith a sore titer of 1 E8ml -value determi&atio& of the sore rearation initial sore count &ro+th control ofroduct dilution

8&oculated primar/ pac<age incl. Pro%ision of a indeendently certified soresusension of e.&. ;- stearothermohilus "*CC 794, +ith a sore titer of 1 E8ml -value determi&atio& of the sore rearation initial sore count &ro+th control ofroduct dilution

Dther surfaces incl. Pro%ision of a indeendently certified sore susension of e.&. ;-stearothermohilus "*CC 794, +ith a sore titer of 1 E8ml -value determi&atio&of the sore rearation initial sore count &ro+th control of roduct dilution

Stabilit/ test of customer specific 7io 8&dicators incl. $tora&e under secifiedconditions determination of the %ia'le sore count after 1 and , month stora&e timeCorro'oration of D-%alue at the end of the stora&e time +ith one eosition time in theF-Ran&e

Surveilla&ce of sterilisers through bioi&dicators

Pro%ision of 10 certified spore strips additionally 1 stri as ositi%e control disensin&in nutrient media and incu'ation documentation of results

Kon re?uest

*he re?uired num'er of sore stris deends on the siAe of the dry heat steriliAer. 1! sore stris are

sufficient for a medium-siAed steriliAer.

Please contact us for assistin& you to %erify the re?uested count of Bioindicators for your $teriliserL



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6aborator/ services

Chemical i&dicators

Chemical Indicators are 'ein& used for daily controls as +ell as for the %alidation of

steriliAation rocesses.

Different tyes of steriliAation demand the use of adated articular Chemical Indicators.

Various roducts are 'ein& offered at the maret.

Chemical Indicators are classified accordin& to DI E I$= 1113!-1.

(e are a'le to %erify if the Chemical Indicator used lies +ithin accordance to 8SD

11140 classification usin& either our BIER-Vessel or our Dry <eat $teriliAer.

(e may %erify the follo+in& classes of Chemical Indicators5

• class 1/rocess indicators2

• class , /sin&le %aria'le indicators2

• class 3 /multi%aria'le indicators) on the 'asis of I$=2

• class 4 /steam inte&ratin& indicators) on the 'asis of I$=2

Prices upo&re>uest



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6aborator/ services

icrobiological ami&atio& ofPharmaceutical Products accordi&g Ph.

ur.

;ater for Pharmaceutical PurposesI etermi&atio& of the'otal :iable Cou&t ith embra&e filtratio&

"?ua urificata /urified +ater2

1 samle /filtration of 1!!ml2

Prices upo&re>uest

0-3 samles in one test /er samle2

M 4 samles in one test /er samle2

"mount of +ater needed er test5

"?ua %alde urificata /hi&h urified +ater2

1 samle /filtration of 1 ml and 0!!ml Pro'e2

Prices upo&

re>uest




"?ua ad iniecta'ilia /(ater for inection(FI2

1 samle /filtration of 1 ml and 0!!ml Pro'e2

Prices upo&re>uest






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6aborator/ services

icrobiological 9ami&atio& of Eo& Sterile Products

*Ph. 9ur 2.5.12 +

'otal viable aerobic cou&t

*otal "ero'ic #icro'ial Count /*"#C2 and *otal Com'ined Neast and #ould Count/*N#C2

Prices upo&re>uest

#em'rane filtration each dilution additional

Pour late method additional

Customer secific tests

ecessary "mount of roduct er test5 #in. 1! & or ml

alica'le to all roducts +hich can 'e rendered filtera'le into a suita'le solution

icrobiological 9ami&atio& of Eo& Sterile Products*Ph. 9ur 2.5.1#+

Detection of secific microor&anisms

Bile-tolerant &ram-ne&ati%e 'acteria E. coli Ps. aeru&inosa $. aureus er &erm

Prices upo&re>uest

$almonella

Clostridia

Bile-tolerant &ram-ne&ati%e 'acteria /?uantitati%2

Candida al'icans

ecessary "mount of roduct er test ,! & or ml



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6aborator/ services

Combi&ed 9ami&atio& of Eo& Sterile Products *accordi&g toPh. 9ur. !.1.4+

Dralia /"e?uous and non-ae?uous rearations2 *"#C *N#C and secifiedmicroor&anisms /E. coli2

Prices upo&re>uest

Dralia %e&eta'le or mineral ori&in for +hich antimicro'ial re-treatment is not feasi'leand +ith aro%al of %ia'le count of ra+ material of M 1! , cfu er & or ml

*"#C *N#C and secified microor&anisms /E. coli 'ile-tolerant &ram-ne&ati%e 'acteria$. aureus and $almonella2

Rectalia

*"#C and *N#C

Preparatio&s for topical use5 for oral muclosa /oromucosal2 &in&i%al /&in&i%al2dermis /cutan2 nose /nasal2 and ear /auricular2

*"#C *N#C and secified microor&anisms /$. aureus J Ps. aeru&inosa2

Prearation for %a&inal use

*"#C *N#C and secified microor&anism /$. aureus J Ps. aeru&inosa J C. al'icans2

3erbal medici&al products /of +hole reduced or o+dered her'al dru&s25

... to +hich 'oilin& +ater is added 'efore use

*otal %ia'le count and secified or&anism /E. coli /?uant.22Prices upo&re>uest

... to +hich 'oilin& +ater is not added 'efore use

*otal %ia'le count and secified or&anism /'ile-tolerant &ram-ne&ati%es 'acteria /?uant.2E. coli J $almonella 2

re?uired amount of roduct,! & or ml

Note: The suitability of the method must be proved for each product by validation according (Ph.Eur 5.1.4).



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6aborator/ services

Suitabilit/ of the 'otal :iable Cou&t ethod i& the prese&ceof the product *Ph. 9ur.2.5.12 +

#ethod suita'ility %alidation > er test or&anism) surface sread

Prices upo&re>uest

#ethod suita'ility %alidation surface sread /*"#C +ith 4 test or&anisms2

#ethod suita'ility %alidation surface sread /*"#CJ*N#C +ith 7 test or&anisms2

re?uired amount of roduct er test or&anism5 0! & or ml

Suitabilit/ testi&g( 'est for specified microorga&isms*Ph. 9ur. 2.5.1#+

#ethod suita'ility %alidation > er test or&anism) surface sread

Prices upo&re>uest

Dralia /"?ueous and non-a?ueous rearations2 secified microor&anisms /E. coli2

Dralia %e&eta'le or mineral ori&in for +hich antimicro'ial re-treatment is not feasi'leand +ith aro%al of %ia'le count of ra+ material of M 1! , cfu er & or ml secifiedmicroor&anisms /E. coli 'ile-tolerant &ram-ne&ati%e 'acteria7 $. aureus and $almonella2

Preparatio&s for topical use5 for oral mucosal /oromucosal2 &in&i%al /&in&i%al2dermis /cutan2 nose /nasal2 and ear /auricular2 secified microor&anisms /$. aureus JPs. aeru&inosa2

Preparatio& for vagi&al use secified microor&anisms5/$. aureus J Ps. aeru&inosa JC. al'icans2

3erbal medici&al products /of +hole reduced or o+dered her'al dru&s2O

...to +hich 'oilin& +ater is added before use secified or&anism /E. coli /?uant.22Prices upo&

re>uest ...to +hich 'oilin& +ater is &ot added before use secified or&anism /'ile-tolerant&ram-ne&ati%es 'acteria /?uant.2 E. coli J $almonella 2

"mount of roduct needed er test or&anism5 0! & or ml

Eote( In case the roduct has antimicro'ial roerties dilution filtration or addition of aninacti%atin& a&ent is needed and the suita'ility of the method needs to 'e demonstrated in themethod %alidation. If no inacti%atin& method is no+n and a suita'le method has to 'ede%eloed the amount of samle needed +ill 'e corresondin&ly hi&her. *he additional cost +ill'e calculated 'ased on a roect lan reared 'y Comliance and a&reed 'y the client.



1"

6aborator/ services

9fficac/ of A&timicrobial Preservatio& *Ph. 9ur. !.1.#+

Determination 'y surface sread method

Determination of Inoculum er test or&anism accordin& to Ph.Eur. 0..10 'y surfacesread method

Prices upo&re>uest

ach test orga&ism a&d evaluatio& time /for roducts +here etensi%e samlerearation is not re?uired2

Pare&teralGophthalmic rearations /3 'acteria testin& times2

'opical rearations /3 'acteria 4 testin& times2

Dral preparatio&s /4 'acteria , testin& times2 incl. test of secific contaminatin&microor&anism

additional cost mem'rane filtration each dilution

additional cost our late method

Customer secific tests

Benti&te #en&e fQr die DurchfQhrun& einer PrQfun&5 14! & o. ml

'A+. 'ei PrQfun& im End'ehltnis5 4 #uster

alica'le to all roducts +hich can 'e rendered filtera'le in a suita'le solutionuon re?uest

:alidatio& of the method for etermi&atio& of the 'otal:iable Cou&t

Each test or&anismKon

re?uest

Re?uired amount for %alidation5 14! & o. ml

If tested in the ori&inal roduct container 4 #uster



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6aborator/ services

7acterial 9&dotoi& 'est *6A6-'est Ph. 9ur. 2.5.14+

6imit value 'est *el-Clot-ethod A+

1 samle

Prices upo&re>uest

$amle eamination of one 'atch/, samles5 'e&in middle end20-3 samles in one test /er samle2M 4 samles in one test /er samle2

Validation of the test for 'acterial endotoin /er 'atch2

Semi->ua&titative 'est *el-Clot-ethod 7+1 samle

Prices upo&re>uest



If the ser%ice you desire is not listed 'elo+ feel free to contact us for a customiAed ?uote.

9&viro&me&tal mo&itori&g

Co&tact plates Sedime&tatio& plates active air samples

1 samle

Prices upo&re>uest



/samlin& erformed 'y customer2



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6aborator/ services

icrobiological 9ami&atio& of pharmaceutical productio&a&d adJace&t areas

$ecific e%aluations on occasion /e.&. failure in%esti&ations2 or durin& %alidation of themanufacturin& rocesses

Prices upo&re>uest

Determination and characteriAation of 'io'urden of ra+ materials intermediates andfinished roducts

E%aluation of #edia Fills

*rend analysis and interretation of en%ironmental data includin& identification data

Biochemical Identification of microor&anisms /"PI-$ystem2

=ualificatio& of culture media

ami&atio& of Eutritivit/ a&d Selectivit/ accordi&g Ph. ur.

er media and test or&anismPrices upo&re>uest

:ualification +ith additional test or&anisms and or secial nutrient media

Additio&al reports

Etra char&e for interim reort Accordi&gadditio&aleffort

$u'se?uent translation of a reort

==$-Reort



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6aborator/ services

:alidatio& studies

=ne of our core cometences is to de%elo indi%idual roects and studies for our customers.*hese studies are tailored to our customers secific needs and +ishes and the corresondin&roect-lans are al+ays reared in close cooeration.

*he follo+in& list contains a 'rief o%er%ie+ of different study-tyes that +e are a'le to erform. Ifthe study you are looin& for is not listed simly contact us to e%aluate the feasi'ility of thedesired study.

• De%eloment and %alidation of otimiAed steriliAation rocedures

• simulations of secific deletion methods

• ?ualification of dry-heat and steam steriliAation

• rocess secific testin& and characteriAation of 'iolo&ical indicators

• micro'iolo&ical %alidation of +ater systems

• %alidation of disinfection methods

• Container Closure Inte&rity *est

• endotoin deletion studies e.&. +ithin a heat-tunnel %alidation

Alloa&ce for i&dividual studies a&deami&atio&s i& the laborator/

3ourl/ rates

Biolo&ical-*echnical "ssistantPrices upo&re>uest

<ead of la'oratory



21

icrobiologcal Compete&ce

icrobiological Compete&ce

Curriculum :itae r. rer. &at. habil. $laus3aberer#ana&in& Director #icro'iolo&ist

Studies

19>197, $tudies of Biolo&y and Biochemistry at theKni%ersities of *Q'in&en and @ln ;ermany

197, Ph.D. in hysiolo&ical chemistry from Kni%ersity of@ln ;ermany Biochemistry /6iids2 of Cell#em'ranes

1973-1981 Postdoctoral studies in micro'iolo&y at the Kni%ersity of Rochester K$" andat the Kni%ersity of Klm ;ermany

Biolo&y of #ycolasmas and #ycolasma Viruses) #ethods5

• Biochemisty of nucleic acids

• Electron Microskopy

• Characterization of host cells, viruses and proteins

• Biology and biochemistry of virus replication

198, "ssociate Professor in #icro'iolo&y /Kni%ersity of Klm2

14 years of annual courses to under&raduate students in micro'iolo&ical analyticsand ?uality assurance

Professio&al Career

1981-1980 Proect #ana&er at IP<"R-Institut fQr @linische Pharmaolo&ie <henirchen;ermany

198,-198 <ead of #icro'iolo&ical :uality Control at <ofmann-6a Roche-"; ;renAach;ermany

198-1999 <ead of #icro'iolo&ical :uality Control at <oechst "; and later Director of#icro'iolo&y ;lo'al :uality =erations at <oechst #arion Roussel in Franfurt;ermany.

seit 1999 #ana&in& Director of Comliance "d%ice and $er%ices in #icro'iolo&y ;m'< atColo&ne his o+n consultant comany +ith micro'iolo&ical la'oratory ser%ice.



22


Professio&al eperie&es

cli&ical pharmacolog/

• Project management of immune pharmacologic clinical studies of Phase 1 and Phase 2

• Planning and equipping of a microbiological laboratory for clinical studies according GLPand GCP guidelines

icrobiological =ualit/ Co&trol a&d =ualit/ Assura&ce

• Head of microbiological QC/QA department for more than 10 years;

• Planning and development of microbiological QA/QC procedures for pharmaceuticaldevelopmental products;

• Validation of sterilization procedures and aseptic procedures;

• Environmental monitoring and control of plants for production of sterile pharmaceuticalsunder GMP conditions;

• Pharmacopoeial methods for microbiological quality control under GMP conditions;

• Setting of microbiological standards and guidelines in a globally operating pharmaceuticalcompany;

• International auditing practice for many years;

• Training in microbiological techniques, methods, practices and their validation worldwide;

• Officially recognized Qualified Person under German drug law.

Professio&al 'rai&i&g

• Numerous public presentations in collaboration with professional training organizations(Publication list upon request);

• Regular appearance as speaker, panelist or chairman in international congresses



2#


Represe&tatio& of professio&al committees

198 - resent "ssociated ;erman eert for Euroean Pharmacooeia5 Eert ;rou 1#icro'iolo&y. Eert in %arious ad hoc +orin& arties and Euroean dele&ate forinternational harmoniAation of micro'iolo&ical methods

1987 - 1990 #em'er of the micro'iolo&ical +orin& arty of "PV /"r'eits&emeinschaftPharmaAeutischer Verfahrenstechni2

1987 - 1990 DI I$=5 #em'er of the standardiAation committees for steam steriliAation andmem'rane filtration in DI"#ed

1993 - 0!11 #em'er of the ;erman #irror Committee for CE5 0!35

#ethods of $teriliAation

1993 - 0!11

1998-0!!9

#em'er of the +orin& &rou I$= *C 198(; 9 "setic Processin&

Chairman of the &rou

$ince 1994 PD" #em'er of %arious tas forces

1997-1999 Chairman of the tas force Parametric release

0!!!-0!!4 #em'er of PD" +orin& &rou5 Validation of $team $terilisation

0!!,-0!!3 #em'er of the P:RI +orin& &rou /'y in%itation2 for discussion of secific

?uestions of FD" in course of re%ision of the FD"-Draft /0!!02 for "seticProcessin& of Pharmaceuticals

0!!4- 0!10 PD" #em'er of $cientific "d%isory Board



24

Certificatio&



2!

Certificatio&



25

e&eral terms a&d co&ditio&s


1. Co&tractual co&ditio&s

1.1 *he contractual relations are defined 'y the

ser%ice catalo&ue of C=#P6I"CE "d%ice and$er%ices in #icro'iolo&y ;m'< /hereinafterreferred to as SComlianceT2 the secifiedcustomer ?uote and the terms and conditions setforth hereunder. "lternati%e arran&ements areonly %alid in +ritin&. Ecet for the follo+in&&eneral terms and conditions the le&al re&ulationsaly eclusi%ely.

1.0 $er%ices +hich are not art of the ser%icecatalo&ue e.&. method de%eloment secialeert reorts certificates in other lan&ua&es than;erman are su'ect to indeendent contracts and

rice arran&ements.

1., "ll orders re?uire +ritten form. =rders sent 'y faor e-mail fulfil such form re?uirement.

1.3 In the e%ent that Comliance is not reared toaccet an order Comliance +ill inform the clienthereof +ithout unnecessary delay.

1.4 *he confirmation of order 'y Comliance shalldetermine the scoe of the ser%ices to 'e ro%ided'y Comliance here under /the U$er%icesU2. *heorder shall constitute a 'indin& a&reement oncethe confirmation of order has reached the client.

*he order confirmation cannot 'e amended ormodified +ithout rior +ritten aro%al 'yComliance. #odifications or amendments of thescoe of the ser%ices re?uire +ritten form.

1. Costs for the rearation of roect lans as artof offer rearations ha%e to 'e aid 'y the cliente%en if the order does not materialiAe as a reasonof the clients decision.

1.7 Comliance shall ee secret all the clients no+-ho+ disclosed to Comliance +ithin the contet ofthe order.

1.8 (ith re&ard to otential sulementaryerformance /o. 7.12 the client shall store retainsamles.

2. Additio&al epe&diture

0.1 If additional studies +hich +ere not redicta'le atthe time of the confirmation of order are re?uiredin certain cases to o'tain or %erify results therocedure shall 'e su'ect to the accetance 'ythe client. "ny costs resultin& from such additionalstudies shall 'e 'orn 'y the client.

0.0 If additional studies are necessary +ithin theframe of the tests to &uarantee a roer

conduction of the $er%ices +hich results in a ne+ricin& Comliance shall 'e entitled to ause theiroerations until an a&reement +ith re&ards tosuch additional costs has 'een reached 'et+eenthe arties.

0., In case a ne+ rice arran&ement cannot 'ereached the order shall 'e considered terminated.In this e%ent the client shall 'ear the costs of theactual attainment. Eenses for ==$ clarificationha%e to 'e aid 'y the client unless the reason is aresult of the erformance of the $er%ices 'yComliance.

#. 'erms of pa/me&tGdue date

,.1 In%oices are due strictly net +ithin ,! days afterthe date or the receit of the in%oice on +hichdate funds ha%e to 'e credited to the account of

Comliance. "lternati%e terms of ayment need to'e a&reed in +ritin&.

,.0 For the rocessin& of rush-orders and secialorders for +hich definite handlin& times ha%e'een a&reed and +arranted surchar&es for there?uired additional effort aly.

,., Comliance may demand ad%ance ayments of uto 4!W of the contract %alue. Comliance mayalso demand art ayments for already erformedarts of the $er%ices.

,.3 "dditional transort cost resultin& from the usa&e

of a courier comany +ithin the frame of an order+ill 'e char&ed to the client.

,.4 =ffer rices are eclusi%e of V"*) final ricesinclude V"* at the rate of taation %alid on theday of conclusion of the contract.

,. In%oices to the client must 'e ?ueried in +ritin&+ithin ,! days after the date and receit of suchin%oice other+ise the in%oice shall 'e deemedacceted.

,.7 Che?ues are acceted for ayment on account oferformance only. *he accetance is carried out

'y itemiAed 'ill for collection and discount fees.

,.8 In the e%ent of late ayments the Client shall ayto Comliance interest of 3 ercenta&e ointsa'o%e the then %alid discount rate of the DeutscheBundes'an +ithout further reminder. *heassertion of further dama&es due to late aymentsis reser%ed. Furthermore the Client shall refundany collection costs incurred 'y Comliance as aresult of any such late ayment.

,.9 "rrears or su'stantial loss of financial standin& ofthe Client entitle Comliance su'ect to further

ri&hts to re?uest reayment cash or other



2"


collaterals from the client for further sulies orser%ices. In such e%ent Comliance shall ha%e theri&ht to +ithdra+ from eistin& a&reements andthe client shall not 'e entitled to dama&es as aresult of such +ithdra+al.

,.1! In an e%ent as descri'ed in Clause ,.9a'o%e Comliance shall ha%e the ri&ht to demandimmediate ayment for all outstandin& de'ts.

,.11 In the e%ent of material or le&al defectsretentions of ayments shall 'e limited to suchamounts as the client may 'y la+ and 'y thisa&reement deduct from the total urchase ricefor reason of such defects. " more etensi%eretention is ecluded.

4. Drder performa&ce

3.1 Comliance taes resonsi'ility for theerformance of the tests accordin& to methods/test rocedures2 no+n 'y and a&reed uon +iththe Client +hich are 'ased on the current state ofthe art such as customer methods methodstaen from literature harmacooeia =ECD E;DI- E and I$= standard. Comliance does nottae resonsi'ility for the methods themsel%es.Knless these methods +ere either de%eloed 'yComliance or adated and %alidated for thee?uiment of Comliance. *he client ays all costsfor these de%eloments adatations or%alidations. =ther+ise the client 'ears the

resonsi'ility for the methods used.

3.0 If a no+n test rocedure is not a%aila'le aroect lan is de%eloed and arran&ed +ith theclient.

3., Comliance is not 'ound to store samles so thatthe client is o'li&ed and 'ound to chec the resultsro%ided 'y Comliance immediately and notifydefects +ithout delay.

3.3 *he client 'ears the cost of any a&reed stora&e ofsamles for a eriod lon&er than the in%esti&ationeriod.

!. eliver/ time

4.1 "&reed deli%ery times shall not commence rior tothe clarification of all technical ?uestions and thecomletion of the contractually fied articiationof the client. "ny a&reed deli%ery dates shall 'eostoned for such time eriods durin& +hich the$er%ice can not 'e erformed due to non-comleted articiation of the client.

4.0 In the e%ent that roect lannin& is art of the$er%ices or a contract is concluded 'ased on alan de%eloed 'y Comliance the deli%ery time

starts +ith the accetance of the lan 'y theclient.

4., *he deli%ery time starts a ne+ if anysulementary modifications of Comliancesser%ices are arran&ed.

4.3 In case of an interrution of the oerations atComliance or our suliers +hich is due to forcemaeure the arran&ed deli%ery times shall 'eetended 'y the time of such interrution. *hesame alies to any 'usiness disrution 'y non-imuta'le measurements of industrial conflicts.Be&innin& and end of the industrial action shall 'ecommunicated +ithout delay. *he a&reed deli%erydates shall 'e ostoned accordin&ly.

4.4 *he client may only +ithdra+ from the a&reementdue to failure to comly +ith a deli%ery eriod or

deli%ery date if an ade?uate additional eriod forerformance or cure has 'een set out 'efore hand'y the client and Comliance is resonsi'le for thetrans&ression of the deli%ery eriod or the deli%erytime and the additional eriod. *he limitation ofthe ri&ht for +ithdra+al does not aly ifComliance seriously and definiti%ely refuses theser%ices or if there are secial circumstances+hich +hen the interests of 'oth arties are+ei&hed ustify immediate +ithdra+al. *heade?uate additional eriod for erformance orcure in terms of this clause shall 'e at least ,

+ees from the receit 'y Comliance of +rittennotification thereof.

5. Ris< assumptio&

.1 (ith the accetance of the order Comliance shall'ear the ris of aroriate handlin& of samlesafter their receit 'y Comliance. If the samlesare not suita'le for the $er%ices due to reasons for+hich Comliance is not resonsi'le /e.&. climaticinfluences or other dama&es durin& transortimroer shiment 'y the client +ron& samleidentification non-o'ser%ance of rele%ant safetyre&ulations2 Comliance shall inform the client+ithout delay and the client shall remedy suchdeficiencies. Comliance is entitled to char&e theclient for erformed ser%ices 'ased on actualeffort /includin& costs for return consi&nmentsdisosal e.&. of toic carcino&enic su'stancesdru&s etc.2 if the unsuita'ility of the deli%ery +asnot or not yet detecta'le uon ser%ice ro%ision.

.0 (ith re&ards to shiments sent %ia a couriercomany the ris asses to the client +ith thetransfer of the shiment to the courier comanythus relie%in& Comliance of any further lia'ility

for any ris of delay loss or deterioration.




". ;arra&t/ G 6iabilit/

7.1 Comliances +arranties are limited to the $er%ices+hich are fied in +ritin& in the order. $uch+arranties are limited to the rectification ofdefects or faults in an ade?uate eriod ro%ided

that the client has notified Comliance of suchdefect or fault in +ritin& +ithin 1 month after thereceit of the test results eert reort etc. In thiscase Comliance can chose to cure the defect orto reeat the ser%ice as secified in the order at itso+n costs. For this urose the client shall ro%ideretain samles /see o. 1.72 free of char&e. Ifrectification is not erformed on time orinsufficient the client is entitled to a ricereduction of u to 04W of the order %alue. "llother clients claims for dama&es are ecludedsa%e for the lia'ility for inury to life 'ody or

health or dama&es caused 'y &rossly ne&li&ent orintentional acts 'y Comliance.

7.0 Comliance offers a +arranty for a eriod of oneyear. *he eriod of +arranty starts +ith thetransfer of the shiment to the courier ser%ice.

7., If the $er%ices reresent a art in another ser%icero%ided 'y the client to a third arty the clientshall arran&e an identical lia'ility a&reement +ithsuch third arty /his customer2. *he clientindemnifies Comliance a&ainst any claims 'y suchthird arty resultin& from failure to arran&e such

lia'ility a&reement +ith the third arty.7.3 *he re&ulations of the Product 6ia'ility "ct remain

unaffected.

7.4 Comliance is lia'le for delay and imossi'ility incases of &ross ne&li&ence or intention 'yComliance or one of its reresentati%es orassi&nees accordin& to the le&al re&ulations.Comliances lia'ility in cases of &ross ne&li&enceis limited to the dama&e forseea'le and tyical tothe contract. Comensation for further lia'ilitiesfor imossi'ility and delay of ser%ice is limited to1!W of the ser%ices %alue. Further claims a&ainstComliance - includin& 'ut not limited to cases oftrans&ression of the date for ser%ice deli%ery set'y Comliance - are ecluded.

F. Cop/right

8.1 Results of tests erformed on 'ehalf of the clientare the eclusi%e roerty of the client. *heu'lication or reroduction of our resultscertificates study and eert reorts as +ell asresentations for maretin& uroses and theirusa&e in etracts for any other alication aresu'ect to the rior +ritten aro%al 'y

Comliance. *his also alies in all cases in +hich

the document is mared +ith the name of anemloyee of Comliance.

9. cess of samples

9.1 If Comliance recei%es more samles than

necessary for the erformance of the tests theremainder shall 'e stored for 0 months and shall'e a%aila'le for follo+-u eamination. *hesamles shall 'e stored accordin& to the clientssecifications /c. 3.32.

10. Prohibitio& of assig&me&t

1!.1 *he client may assi&n to a third arty hisclaim for eecution of due ser%ices only +ith rior+ritten aro%al 'y Comliance.

1!.0 *he assi&nment of outstandin& de'tsa&aint Coomliance to any third arty re?uires

Comliances rior +ritten aro%al.

11. Place of performa&ce a&d Jurisdictio& GPartial i&validit/

11.1 *he lace of erformance of all claimsunder this a&reement is Colo&ne /@ln2 ;ermany.*he courts of Colo&ne /@ln2 ;ermany shall ha%esole urisdiction.

11.0 *he la+s of the Federal Reu'lic of;ermany aly eclusi%ely to this a&reement.

11., $hould any indi%idual ro%ision of this

a&reement 'e or 'ecome in%alid the %alidity ofthe remainin& conditions shall not 'e affected.Instead of ineffecti%e ro%isions %alid ro%isions+hich most closely aroimate those desired 'ythe arties shall come into force resecti%ely.

11.3 Comliance +ould lie to oint out thatclients data is electronically sa%ed and rocessed.

In the e%ent of any disute the ;erman %ersion ofthese &eneral terms and conditions shall re%ail.

Status( 04.01.2010

Documents

2014 Service Catalogue en Compliance Microbiology