and MidiCaps - Sartoriusmicrosite.sartorius.com/fileadmin/Image_Archive/micro... · · 2007-05-10and MidiCaps | 3 1. ... 4.1 Sterilizing Grade Filtration Capability 7 4.2 Particle

Comparability Studyfor Filter Capsules ofthe Existing Design and MidiCaps

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1. Introduction 4

2. Performed Tests 5

3. Test Desriptions 6

4. Test Results 74.1 Sterilizing Grade Filtration Capability 74.2 Particle Release 84.3 Extractable Substances according to

the current USP 94.4 Extractables Profile Analysis 154.5 Biocompatibility 174.6 Flow Rate Performance 184.7 Total Throughput Performance 274.8 Mechanical and Thermal Stability 294.9 Endotoxin Testing 31

5. Summary 32

Table of Contents

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The use of disposable filter capsulesin pharmaceutical and biopharma-ceutical production has increasedsignificantly in the last years.Meanwhile filter capsules are anintegral part of many productionprocesses. The extended use of filtercapsules in bio-pharmaceuticalmanufacturing added new require-ments onto these filter capsules.Therefore Sartorius AG has decidedto introduce a new capsule designfor its existing filter units into themarket.

This new capsule design focuses ondesign improvements of the capsulehousing, offering multiple advan-tages for users in biopharmaceuticalproduction, while the filterelements inside the capsulehousings remain completelyunchanged compared to theexisting capsule design. Of course,the polypropylene material of thecapsule housing itself, remainsunchanged compared to theexisting capsule design.

The new capsule design will beimplemented for all filter capsuleproduct lines starting with 500 cm2

(Size 7) up to 4.500 cm2 (Size 0)filtration area of Sartorius AG,which includes the followingproduct lines:

– Sartopore® 2 (544…)

– Sartopore® 2 Gamma Capsules(544.G…)

– Sartobran® P (523…)

– Sartolon® (510…)

– Sartofluor® (518…)

– Sartoclean® CA|GF (560…|562…)

– Sartopure® PP2|GF2 (557…|559-…)

To allow all current users of theexisting Sartorius capsule design tobenefit in an optimal way of theadvantages combined with theimplementation of the new design,we have conducted a compre-hensive comparability studybetween the two capsule designs.The comparability study focuses onall application relevant chemical,physical and mechanical propertiesof both capsule designs and allowsfor fast track implementation of thenew design into all processescurrently using the existing design.

The comparability study wasperformed in the way thatSartopore® 2 0.2 µm rated capsulesof the new design were used asmodel to compare all relevant datawith Sartopore® 2 capsules 0.2 µmrated of the existing capsule designin order to demonstrate compara-bility.

As result out of this comprehensivecomparability study it can be statedthat the change from the existingcapsule design to the new capsuledesign for each product line isclassified as a minor change (AnualReport). The test results demon-strate full comparability betweenthe filter capsules of the existingand the new capsule design.

Of course a comprehensivevalidation of each individualproduct line of the new capsuledesign will be performed bySartorius AG and all validation datawill be summarized in respectiveValidation Guides for each productline.

1. Introduction

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2. Performed Tests

The tests performed within thiscomparability study for the newcapsule design were in detail:

A.) Sterilizing Grade FiltrationCapability

B.) Particle Release Test

C.) Extractable Substances according tothe current USP

D.) Extractables Profile Testing

E.) Biocompatibility Testing

F.) Flow Rate Performance

G.) Total Throughput Performance

H.) Mechanical and Thermal Stability

I.) Endotoxin Testing

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Sterilizing grade filtration capabilitywas tested with autoclaved capsulesaccording to HIMA and ASTM F 838-83 guidelines usingBrevundimonas diminuta aschallenging organism.

The tests for particle release andextractable substances areperformed in dynamic extractionmode after defined flush volumesof 1, 2.5, 5 and 10 liters as thismethodology represents best actualfiltration conditions. The filterstested have been autoclaved priorto testing.

The extractables profile testing andthe biocompatibility testing weredone by two different qualified,independent laboratories, each onespecialized in the respectivedisciplines.

The testing for flow rate, totalthroughput, thermal andmechanical stability was done withcapsules according to SartoriusStandard Operating Procedures.

The Endotoxin testing was doneaccording to the current USPstandard stated under the section“Sterile Water for Injection”.

3. Test Descriptions

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4. Test Results

4.1 Sterilizing Grade FiltrationCapabilityThe basic filter elements incorpo-rated into the existing and the newcapsule design are completelyidentical and have been validatedfor sterilizing grade filtrationcapability during the productvalidation of each sterilizing gradefilter product line of the existingcapsule design.

Besides the filter element itself, thewelding of the filter element intothe capsule housing and the struc-tural integrity of the capsulehousing itself can have an influenceon the sterilizing grade filtrationcapability of sterilizing grade filtercapsules. Therefore the sterilizinggrade filtration capability of thenew capsule design and theassociated manufacturingtechnology has been validated usingSartopore® 2 sterilizing grade filtercapsules of the new capsule design.Sartopore® 2 filter capsules of thenew design from numerous lotswere tested according to theBacterial Challenge Test in accor-dance with the HIMA Document No. 3, Vol. 4 (April 1982) “Microbio-logical Evaluation of Filters forSterilizing Liquids”|ASTM F 838-83Guideline and DIN 58356, Part 1.

ConclusionIntegral sterilizing grade filtercapsules of the new capsule designprovide sterile filtrates whenchallenged with > 1 ƒ 107

Brevundimonas diminuta. Theresults demonstrate that theintegrity and bacterial retentiveproperties of sterilizing grade filtercapsules are not affected whenchanging from the existing to thenew capsule design.

The basic filter elements for eachproduct line and filter size ofintegrity testable filter capsulesremain completely unchanged whenchanging from the existing to thenew capsule design. Therefore theintegrity test parameters forintegrity testable filter capsules ofthe new capsule design remaincompletely unchanged compared tothe integrity testing parameters ofthe existing capsule design for eachproduct line and filter size. This isalso valid for product specificintegrity test data determinedduring product specific validationstudies.

The integrity testing parameters forrespective filters can be found inthe corresponding directions for use

The following table summarizes theBC-Test results with Brevundimonasdiminuta of numerous integralSartopore® 2 sterilizing grade filtercapsules of the new capsule designfrom 3 different production lots:

Lot.-No. Bioburden Bacterial Challenge Test after autoclaving[CFU/cm2]

402243 > 1 ƒ 107 passed

402343 > 1 ƒ 107 passed

414243 > 1 ƒ 107 passed

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4.2 Particle ReleaseIn general the particle release fromfilters should be minimized. Forparenteral solutions, therequirements are defined in the USPMonographs, which set maximumlimits for particle content based ondefined particle sizes. The particlerelease for filter capsules of theexisting and the new capsule designwas measured, using Sartopore® 2capsules of the existing and thenew design after autoclaving.

The following tables list the testresults for the existing and the newcapsule design.

Particle Particle Particle Particle Particle Limits LimitsSize per ml per ml per ml per ml according according[µm] after 1 l after 2.5 l after 5 l after 10 l to B.P. to USP

flush flush flush flush

< 2 72 199 122 128

2-5 12 37 28 33 500

5-10 3 8 6 8 80

10-15 0 0 1 1

15-20 0 0 0 0 25

20-25 0 0 0 0

25-50 0 0 0 0 3

> 50 0 0 0 0 0 0

Particle Particle Particle Particle Particle Limits LimitsSize per ml per ml per ml per ml according according[µm] after 1 l after 2.5 l after 5 l after 10 l to B.P. to USP

flush flush flush flush

< 2 17 5 7 7

2-5 8 3 3 2 500

5-10 2 2 1 0 80

10-15 0 1 0 0

15-20 0 0 0 0 25

20-25 0 0 0 0

25-50 0 0 0 0 3

> 50 0 0 0 0 0 0

ConclusionThe tables above show that forcapsules of the existing as well as ofthe new design the requirements ofthe current USP and BP for particlerelease are met in the very first literof rinse volume. Accordinglycapsule filters of both designs donot have to be rinsed prior to beingable to produce a filtrate thatconforms with the current USP andBP for particle content. Thereby fullcomparability of the existing andthe new capsule design with regardto particle release has been

Existing Capsule Design

New Capsule Design

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ConclusionFilter capsules of the existing andthe new design produced filtratesafter autoclaving that, whenmeasured, were below the require-ments set by the current USP Limitsfor Oxidizable Substances for“Sterile Water for Injection”.Thereby full comparability betweenthe existing and the new capsuledesign with regard to release ofoxidizable substances has beendemonstrated.

4.3 Extractable Substances accordingto the current USPThe determination of extractablesubstances serves to establish theminimum required rinse volume inorder to use filter capsules of theexisting and the new design to filtersolutions where no addition ofextractable substances are required.As a limit, the current USP require-ments for “Sterile Water forInjection” are used. The samples offiltrates, of Sartopore® 2 capsules ofthe existing and the new design aretaken for analysis of OxidizableSubstances, pH and ConductivityChanges, Chloride, Sulfate andAmmonia.

Determination of Oxidizable Substances in the Filtrate


Lot.-No. Non-Volatile Non-Volatile Non-Volatile Non-Volatile Residue after Residue after Residue after Residue after1 l rinse 2.5 l rinse 5 l rinse 10 l rinse volume volume volume volume

935241 passed passed passed passed



New Capsule Design





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Determination of pH Values andConductivity of the FiltrateThe following limits were used inconjunction with USP for “PurifiedWater” and the filters were testedin the pH range of 5 to 7. Therelationship between the pH valueand the maximum allowableconductivity for Water for Injectionaccording to the USP is:

pH Value Maximum Allowable Conductivity [µS/cm]

5 4.7

5.1 4.1

5.2 3.6

5.3 3.3

5.4 3.0

5.5 2.8

5.6 2.6

5.7 2.5

5.8-6.1 2.4

6.2 2.5

6.3 2.6

6.4 2.8

6.5 3.1

6.6 3.4

6.7 3.8

6.8 4.3

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A. Results for pH Values

Blank: 5.8


935241 5.8 5.7 5.7 5.75

935341 5.8 5.8 5.8 5.8

935441 5.8 5.8 5.85 5.85

NoteDue to the interrelationshipbetween the pH value determi-nation and the measurement of theconductivity, results for both testsmust be viewed together.

B. Results for Conductivity

Blank: 0.7


935241 0.7 0.7 0.7 0.7

935341 0.65 0.7 0.7 0.7

935441 0.65 0.7 0.7 0.7

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New Capsule Design

A. Results for pH Values

Blank: 5.95


402243 6.0 6.0 6.0 6.0

402343 5.9 6.0 6.0 6.0

414243 5.95 5.95 6.0 6.0

NoteDue to the interrelationshipbetween the pH value determi-nation and the measurement of theconductivity, results for both testsmust be viewed together.

ConclusionBoth parameters, pH and pHdependent conductivity of thefiltrate, when filtering with capsulesof the new and the existing capsuledesign are well below the limitrequirements of the current USP.Thereby full comparability betweenthe existing and the new capsuledesign with regard to conductivityand pH-shift has been demonstrated.

B. Results for Conductivity

Blank: 0.7


402243 0.7 0.7 0.7 0.7

402343 0.75 0.7 0.7 0.7

414243 0.7 0.7 0.7 0.7

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Determination of Chloride, Sulfate and Ammonia in the Filtrate


Chloride





Sulfate





Ammonia





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New Capsule Design

Chloride





Sulfate





Ammonia





ConclusionFilter capsules of the existing andthe new capsule design producedfiltrates were below the require-ments set by the current USP Limitsfor Chloride, Sulfate and Ammoniafor “Sterile Water for Injection”.Thereby full comparability of theexisting and the new capsule designhas been demonstrated with regardto Chloride, Sulfate and Ammoniarelease.

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4.4 Extractables Profile AnalysisThe current USP and European Ph.describe overall limits for contami-nants in different solvents andliquids such as Water for Injection,etc. For the general evaluation andquantification of the contaminants,methods for the determination ofthe non-volatile residue (NVR), totalorganic content (TOC) as well aspH-conductivity determination aregiven among other testing methods.

For the explicit analysis of theindividual extractables or leachablesfrom polymeric devices orcompounds and their chemicalstructure, no analytical method isdescribed from a pharmaceuticalpoint of view. This is due to thebroad range of polymericcompounds and the various solventsused in the downstream processing,resulting a large variety of theoreti-cally potential extractables from thepolymers. Such extractables can bedegradation products of the basepolymer or its monomers, stabi-lizers, processing and protectiveadditives, lubricants or surfacemodifying agents. As long as thepolymer is compatible with theapplied solvent, the extractableslevels are well below the detectionlimits of the individual analyticalmethodologies.

To evaluated extractables andcompare polymers or devices withrespect to the individualextractables profile it is necessaryto use a worst case scenarioapproach, where extractables aregenerated on purpose by usingextreme extraction conditions. Inthe following, such an approachwas used to compare theextractables profile of the capsulehousings of the existing and thenew capsule design.

As the identical base polymer isused in both designs, differences inthe extractables profile could onlybe based on differences of toolingor device processing’s. Even this ishighly theoretic and has a very lowprobability, the following analysiswas performed to verify the compa-rability of the extractable profile ofthe design formats under worst caseextraction conditions.

Materials and Methods For both housings of the existingand the new capsule design,identical procedures for extractionwere used. The capsule housingmaterials of both designs wereextracted in 1 l of WFI for 24 hoursat 70 °C and in 1 l of Ethanol (HPLCgrade) for 24 hours at 50 °C. Bothextracts were analysed directly viaRP-HPLC with UV detection with apeak identification using FT-IR andHead Space GC-MS. Furthermore100 ml of the extracts were driedand the solid residue analysed byFT-IR. The sensitivity of themethodologies are in the range ofppm.

To provide a detailed analysis of theextractables under worst caseconditions in the lower ppb range,100 ml of the extracts wereconcentrated by the factor of 40 to 100 (depending on thesolvent) via RP solid phaseextraction. The eluates of the RPsolid phase were analysed using theidentical methods described above.

The scope of the combination of themethodologies is to provide acomprehensive extractables profileon the potential extractables suchas high and low MW, volatile andnon-volatile, stable and unstablecompounds in the low ppb to thehigh ppm range under worst caseconditions.

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Results

The following extractables could be identified under the selected worst case conditions.

Existing Capsule Design New Capsule Design

4-Ethyl-benzylmethanol 4-Ethyl-benzylmethanol

Diethylhexylphthalat Diethylhexylphthalat

2,4-bis(1,1-dimethylethyl)phenol 2,4-bis(1,1-dimethylethyl)phenol

Irgafos 168 Irgafos 168

Dibutylphthalat Dibutylphthalat

Irganox 1010 Irganox 1010

ConclusionIn general, all extractables could bedetermined only in the concen-trated samples, thereby having onlya concentration in the lower ppbrange. The identified extractablesare degradation products of thebase polymer Polypropylene, UV-stabilizers, antioxidants andprocessing additives which aretypical for polypropylene used inpharmaceutical applications and donot have toxicological relevance inthe found concentrations.

As demonstrated with this investi-gation, the extractables profiles ofthe existing and the new capsuledesign is identical. This result couldbe expected, for the base polymersare identical and the differenttoolings in the capsule processingdo not have an impact on theextractables of the capsule itself.The comparability of the existingand the new capsule design withregard to their extractables profilesis thereby given.

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4.5 BiocompatibilityThese tests are to determine that allcomponents used in themanufacture of filter capsules ofthe existing and the new design arebiosafe and meet or exceed therequirements for the current USPClass VI-121 °C Plastic Tests.

Sartopore® 2 filter capsules of thenew and the existing design weresupplied to an independent testingfacility for evaluation under therequirements of the current USPClass VI Plasitcs Tests, including thefollowing test:

– Intracutaneous Test– Systemic injection Test– Implantation Test (7 days)

Test ResultSartopore® 2 filter capsules of thenew and the existing design passedthe Biocompatibility Test accordingto the current USP. All materialsused for construction of these filterelements meet or exceed therequirements of the USP Class VI-121 °C Plastics Tests. Thereby thecomparability of the existing andthe new capsule design with regardto Biocompatibility has beendemonstrated.

Certificates are available on request.

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4.6 Flow Rate Performance The tests for flow rate wereperformed in order to demonstratethat the flow rate performance ofthe filter capsules of the newdesign is at least as good as theflow rate performance of the filtercapsules of the existing design. Thiswill assure that the filtration timein a current applications will remainwithin defined worst case param-eters when changing from theexisting to the new capsule design.The tests were performed usingSartopore® 2 0.2 µm rated capsulesof the existing and the new capsuledesign of each filter size andconnector combination according toSartorius Standard Operating Proce-dures.

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Lot.-No. Flow Rate Flow Rate Flow Rate Flow Rate at 0.1 bar dp at 0.5 bar dp at 1 bar dp at 2 bar dp[l/h] [l/h] [l/h] [l/h]

004281 390 1.740 3.240 5.520

Existing Capsule Design with 11/2 inch Tri-Clamp inlet andoutlet connector

Flow Rate for filter element size 0(4.500 cm2 filtration area)


403043 440 2.100 3.840 7.020

New Capsule Design with 11/2 inch Tri-Clamp inlet andoutlet connector



311343 280 860 1.390 1.650

Existing Capsule Design with 11/2 inch Tri-Clamp inlet and hosebarb outlet connector



403243 290 940 1.470 2.210

New Capsule Design with 11/2 inch Tri-Clamp inlet and hosebarb outlet connector


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360603 230 670 1.050 1.580

Existing Capsule Design with hosebarb inlet and outlet connector



403143 240 740 1.110 1.630

New Capsule Design with hosebarb inlet and outlet connector


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343603 180 910 1.740 3.240




402243 190 1.020 1.950 3.480




311343 174 660 1.089 1.360




402243 180 708 1.150 1.830



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360603 140 510 850 1.350




402343 144 560 900 1.380



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402603 120 600 1.200 2.100




402843 132 630 1.200 2.220




402243 120 520 900 1.500

New Capsule Design with 11/2inch Tri-Clamp inlet and hosebarb outlet connector



205253 102 430 780 1.380



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363203 108 420 720 1.140




402943 108 432 740 1.200



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402303 50 240 460 780


Flow Rate for filter element size 7(500 cm2 filtration area)


402443 60 300 630 1.080




256003 50 200 450 720




402643 70 300 540 960



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415703 50 270 420 690




402343 70 300 540 960



ConclusionFilter capsules of the new designshow at least the same flow rateperformance than filter capsules ofthe existing design. Especially forfilter elements with higher effectivefiltration area (2.000 cm2 and 4.500 cm2) at higher differentialpressure the capsules of the newdesign show higher flow rates thancapsules of the existing design dueto the design optimization of theconnectors of the capsules housing.As a result, the filtration time in acurrent application will be identicalor lower when changing from thenew to the existing design. Therebyfull comparability between theexisting and the new capsule designwith regard to flow rate has beendemonstrated.

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4.7 Total Throughput Performance The tests for total throughputperformance were performed inorder to demonstrate that the totalthroughput performance of thefilter capsules of the new design isat least as good as the flow rateperformance of the filter capsulesof the existing design. This assures,that the filter sizing used for anapplication can remain unchangedwhen changing to the new capsulesdesign from the existing design. Thetests were performed usingSartopore® 2 0.2 µm rated capsulesof the existing and the new capsuledesign according to SartoriusStandard Operating Procedures.

Lot.-No. Total Throughput at 95% blockage[kg]

41.5

Existing Capsule Design TotalThroughput for filter element size 0 (4.500 cm2 filtration area)


42.0

New Capsule Design TotalThroughput for filter element size 0 (4.500 cm2 filtration area)


935541 26.2



402243 26.6



935641 15.3



402843 15.7


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935941 6.4

Existing Capsule Design TotalThroughput for filter element size 7 (500 cm2 filtration area)


402443 6.9

New Capsule Design TotalThroughput for filter element size 7 (500 cm2 filtration area)

ConclusionThe filter elements incorporatedinto the existing filter capsuledesign and into the new filtercapsule design are completelyidentical. The total throughputperformance of these filterelements is unaffected by thedifferent capsules designs. For allcurrent applications using theexisting capsule design the filtersizing can remain completelyunchanged when changing to thenew capsule design. Thereby fullcomparability between the existingand the new capsule design withregard to total throughputperformance has been demon-strated.

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4.8 Mechanical and Thermal Stability

Determination of max. allowabledifferential pressureSartopore® 2 0.2 µm rated filtercapsules of 3 different productionlots of the existing and the newcapsule design were sterilized byautoclaving and subsequentlypressurized with an inlet pressure of6 bar|87 psi with pressurized air for24 hours with outlet closed.

After 24 hours capsules leakage wasdetermined using the automaticintegrity test device Sartocheck 4 tocheck for leakages at 6 bar. Anysignificant pressure decrease duringthis test would lead to a non passedstatement.

ConclusionFilter capsules of the existing andthe new capsule design retain theirstructural filter integrity after auto-claving when pressurized with 6 bar|87 psi for 24 hours. In orderto guarantee a high degree of safetyduring use the max. allowed differ-ential pressure for the new capsuledesign was set at 5 bar|72.5 psi incomparison to 4 bar|58 psi for theold capsule design.

Lot.-No. Test Pressure Integrity Test[bar|psi]

935241 6|87 passed

935341 6|87 passed

935441 6|87 passed


Lot.-No. Test Pressure Integrity Test[bar|psi]

402243 6|87 passed

402343 6|87 passed

414243 6|87 passed

New Capsule Design

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Burst Pressure determinationIn order to determine the burstpressure of filter capsules of theexisting and the new design,Sartopore® 2 capsules 0.2 µm rated,from 3 different production lotswere sterilized by autoclaving andsubsequently pressurized with airuntil a crack of the capsule housingoccurred.

Burst Pressure determinationafter thermal stressIn order to verify that filter capsulesof the new capsule design canwithstand multiple autoclavingcycles, Sartopore® 2 0.2 µm ratedfrom 3 different production lotswere sterilized 25 times byautoclaving and subsequentlypressurized with air until a crack ofthe capsule housing occurred.

ConclusionThe test results verify that filtercapsules of the new capsule designare unaffected by multipleautoclaving cycles at 134 °C for 20 minutes. Thereby full compara-bility between the existing and thenew capsule design has beendemonstrated.

ConclusionThe test results verify that filtercapsules of the existing and thenew capsule design do withstandcomparable physical stress. Therebyfull comparability between theexisting and the new capsule designwith regard to mechanical stabilityhas been demonstrated.

Lot.-No. Determined burst pressure after 1 autoclaving cycle[bar|psi]

935241 > 10|145

935341 > 10|145

935441 > 10|145


Lot.-No. Determined burst pressure after 1 autoclaving cycle[bar|psi]

402243 > 10|145

402343 > 10|145

414243 > 10|145

New Capsule Design

Lot.-No. Determined burst pressure after 25 autoclaving cycles[bar|psi]

402243 > 10|145

402343 > 10|145

414243 > 10|145

New Capsule Design

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4.9 Endotoxin TestingSartopore® 2 capsules of 3 differentlots of the existing and the newcapsule design have been testedthat the effluent produced by thesecapsules contains less than 0.18 EU/ml.

ConclusionThe test results verify that capsulesof the existing and the new capsuledesign comply with the limits of thecurrent USP for endotoxin release.Therefore comparability for the newand the existing capsule design isgiven with regard to endotoxinrelease. Thereby full comparabilitybetween the existing and the newcapsules design with regard tocontent of endotoxins has beendemonstrated.

Lot-No. LAL Test Result

935241 passed

935341 passed

935441 passed


Lot-No. LAL Test Result

402243 passed

402343 passed

414243 passed

New Capsule Design

32 |

The new capsule design incorpo-rates the identical filter elementscompared to the existing capsuledesign for each product line ofcapsules manufactured by Sartorius AG. Furthermore the basepolymer for manufacturing capsuleshousings of the existing and thenew capsule design remainscompletely unchanged.

The implementation of the newcapsule design into processes usingthe existing capsule design willallow for significant improvementson process safety and ease ofoperation. This comparability studybetween the existing and the newcapsule design was performed todemonstrate full comparabilitybetween both designs, to allow afast implementation of the newcapsule design in all processcurrently using the existing design.

Thereby Sartopore® 2 capsules 0.2 µm rated of the existing and thenew design were used to compareall application relevant specifica-tions of the new and the existingcapsule design in order to demon-strate full comparability betweenboth designs. This study serves as amodel for implementation of thenew capsule design for all capsuleproduct lines of Sartorius AG.

The results of the tests reported inthis document give documentedevidence that there is full compara-bility between filter capsules of theexisting and the new capsuledesign. As a result of this study thechange from the existing to thenew capsule design for Sartoriusfilter capsules has been classified asminor change.

5. Summary

Specifications subject to change withoutnotice. Printed in Germany on paperbleached without any use of chlorine · GPublication No.: SPK5750-e04121Order No.: 85030-521-67

Sartorius AGWeender Landstrasse 94–10837075 Goettingen, GermanyPhone +49.551.308.0Fax +49.551.308.3289www.sartorius.com

Sartorius BBI Systems GmbHSchwarzenberger Weg 73–7934212 Melsungen, GermanyPhone +49.5661.71.3400Fax +49.5661.71.3702www.sartorius-bbi-systems.com

Sartorius North America Inc.131 Heartland Blvd.Edgewood, New York 11717, USAPhone +1.631.254.4249Toll-Free +1.800.3687178Fax +1.631.254.4253

Sartorius BBI Systems Inc.2800 Baglyos CircleBethlehem, PA 18020, USAPhone +1.610.866.4800Fax +1.610.866.4890

Sartorius Ltd.Longmead Business ParkBlenheim Road, EpsomSurrey, KT19 9 QQ, U.K.Phone +44.1372.737159Fax +44.1372.726171

Sartorius S.A.4, rue Emile Baudot91127 Palaiseau Cedex, FrancePhone +33.1.6919.2100Fax +33.1.6920.0922

Sartorius S.p.A.Via dell’Antella, 76/A50011 Antella (FI), ItalyPhone +39.055.63.40.41Fax +39.055.63.40.526

Sartorius, S.A.C/Isabel Colbrand 10–12Planta 4, Oficina 121Polígono Industrial de Fuencarral28050 Madrid, SpainPhone +34.91.3586091Fax +34.91.3588804

Sartorius Technologies N.V.Luchthavenlaan 1–31800 Vilvoorde, BelgiumPhone +32.2.756.0670Fax +32.2.756.0681

Sartorius K.K.KY Building, 8–17Kitashinagawa 1-chomeShinagawa-kuTokyo 140-0001, JapanPhone +81.3.3740.5407Fax +81.3.3740.5406

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and MidiCaps - Sartoriusmicrosite.sartorius.com/fileadmin/Image_Archive/micro... · · 2007-05-10and MidiCaps | 3 1. ... 4.1 Sterilizing Grade Filtration Capability 7 4.2 Particle