carr powerfuge technology - celldcelld.com/documents-pdf/carr powerfuge machine overview.pdf ·...

CARR Powerfuge

Technology

CARRCARR®® PowerfugePowerfuge®®

• Powerful liquid/solids separations (20.000 x g)

P6Pilot P12 P18

• Scalable Solutions

– up to 1.700 L/h

• Automated solids recovery

• TrueClean™ design

– enabling CIP/SIP Validation

ApplicationsApplications

• Biotechnology

– E. Coli Cells

– Cell Lysates

– Inclusion Bodies

– Protein Precipitates

– Yeast Processing

• Pharmaceuticals

– Final Dosage Formation

• Specialty Chemicals

– Inkjet Ink, Photo resist, Silica

– Difficult, high-valued separations

DriveAssembly

ScraperScraper

Bearing Bearing HousingHousing

SwinglockSwinglock

Bowl CaseBowl Case

BowlBowl

CentrateCentrateCaseCase

LowerLowerCaseCase

Separation Bowl

CIP-Sprayball

Gate to

Release the Solids

Solids Scraper

Spindle

Product Feed

Centrate Outlet

Process FlowProcess Flow

1. 1. Feed introduced into Feed introduced into Feed Cone.Feed Cone.


1. 1. 1. Feed introduced into Feed introduced into Feed introduced into Feed Cone.Feed Cone.Feed Cone.

2. 2. Feed then enters Bowl Feed then enters Bowl up to holes in Bafflesup to holes in Baffles..



2. 2. 2. Feed then enters Bowl Feed then enters Bowl Feed then enters Bowl up to holes in Baffles.up to holes in Baffles.up to holes in Baffles.

3. 3. Feed fills Bowl up to Feed fills Bowl up to Bowl Lip.Bowl Lip.




3. 3. 3. Feed fills Bowl up to Feed fills Bowl up to Feed fills Bowl up to the Bowl Lip.the Bowl Lip.the Bowl Lip.

4. 4. Feed decants from Feed decants from Bowl Lip into plenumBowl Lip into plenum..Pool Surface




3. 3. 3. Feed fills Bowl up to the Feed fills Bowl up to the Feed fills Bowl up to the Bowl Lip.Bowl Lip.Bowl Lip.

4. 4. 4. Feed decants from Bowl Feed decants from Bowl Feed decants from Bowl Lip into plenum.Lip into plenum.Lip into plenum.

5. 5. Centrate accumulates in Centrate accumulates in plenum and flows out plenum and flows out from Centrate Port.from Centrate Port.

Pool Surface




3. 3. 3. Feed fills Bowl up to the Feed fills Bowl up to the Feed fills Bowl up to the Bowl Lip.Bowl Lip.Bowl Lip.

4. 4. 4. Feed decants from Bowl Feed decants from Bowl Feed decants from Bowl Lip into plenum.Lip into plenum.Lip into plenum.

5. 5. 5. Centrate accumulates in Centrate accumulates in Centrate accumulates in plenum and flows out plenum and flows out plenum and flows out from Centrate Port.from Centrate Port.from Centrate Port.

6. 6. Solids separate and Solids separate and pack against Bowl wall.pack against Bowl wall.

Pool Surface

Automated Solids RemovalAutomated Solids Removal

• Continuously feed bowl until

solids capacity is reached

• Decelerate to complete stop,

drain bowl

• Engage scraper drive at low

RPM, scraper arm advances

into cake, discharging solids

into chute

• Initiate next feeding cycle or

proceed to CIP/SIP operations

Powerfuge PilotPowerfuge Pilot

Specifications:

• Maximum G-Force 20.000 x g

• Maximum Speed 15.325 rpm

• Maximum Flow Rate 1 L/min

• Operating temperature 2-40ºC

• Jacketed Bowl Case (cooling)

• Pellet capacity of 1 L

• Bowl Volume 1,1L

Powerfuge PilotPowerfuge Pilot

Powerfuge P6Powerfuge P6

Specifications:

• Force – 20.000xg

• Total bowl volume 1,1 Liters

• Sediment volume 1,0 Liters

• Flow rate capacity up to 60 L/h

• 316L Stainless Steel Case

• Titanium Bowl

• USP Class VI Elastomers

• 1,5 horsepower 230V/50 Hz/20A


Specifications:

• Force – 20.000xg

• Total bowl volume 9,0 Liters

• Sediment volume 8,0 Liters

• Flow rate capacity up to 500 L/h


• Titanium Bowl


• 10 horsepower 400V/50Hz/45A


Specifications:

• Force – 20.000xg

• Total bowl volume 36 Liters

• Sediment volume 32 Liters

• Flow rate capacity up to 1.700 L/h


• Titanium Bowl


• 30 horsepower 400V/50Hz/70A

Major AssembliesMajor Assemblies

DriveAssembly

ScraperScraper

Bearing Bearing HousingHousing

SwinglockSwinglock

Bowl CaseBowl Case

BowlBowl

CentrateCentrateCaseCase

LowerLowerCaseCase

cGMP CompliancecGMP Compliance

• True CleanTM Design

– Sanitary Design

– CIP

– SIP

• Automation

– Processing, Solids Removal, CIP/SIP

• Closed System Processing

• cGMP Documentation

True True CleanCleanTMTM Design Design -- CIPCIP

• Requires Sanitary Design

– All process wetted components

• 100% CIP Access

• Reproducible CIP Process

• Verification

– Swab tests consistent with other process steps

CIP Design PhilosophyCIP Design Philosophy

• Zone cleaning

• Short, high pressure bursts

• 100% coverage

• Typical 4-step cycle

• Fully automatic

CIP Wash ZonesCIP Wash Zones

Solids chute wash zone (reslurry

vessel or CIP cap)

Swinglock wash zone

Upper bearing

wash zone

Bowl casewash zone

Bowl/scraperwash zone

Feed pathwash zone

Lower case wash zone

CIP Validation CIP Validation -- RiboflavinRiboflavin

Test

• Dextrose/Riboflavin surface coverage

• Ambient water cycle

• Disassemble and view under black light

Acceptance

• No visible fluorescence

CIP Validation CIP Validation -- SwabSwab

Test

• Yeast, riboflavin process organics

• Run process

• Perform auto CIP cycle

• Repeat fluorescence inspection

• Swab 12 areas for TOC analysis

Acceptance

• All 12 swabs were below acceptable TOC limits

Customer ValidationCustomer Validation

“The TOC analysis of the samples shows that the centrifuge was very clean after both cleaning cycles. […] The centrifuge has been shown to be cleanable with the CIP cycles defined above and CIP 310 detergent. It is concluded that the final cycle parameters can easily be defined and validated.”

– Fortune 100 biopharmaceutical

company

SIP Design PhilosophySIP Design Philosophy

• Single point steam connection to header

• Steam to flow through all areas of machine

including auxiliary piping

• Steam/condensate outlets at all low points

and at all outer boundaries

– Ported valve assemblies

• Steam flow and sterilization temperature

throughout the entire system

SIP ValidationSIP Validation

• SIP Process is Validated

• (12) RTD’s placed throughout

system and ancillaries

• Steam injected into system

• Temperatures recorded on a Kaye

digistrip at 1 minute intervals

SIP Validation ResultsSIP Validation Results

0

20

40

60

80

100

120

140

160

0 10 20 30 40 50 60

Time (minutes)

RT

D T

em

pera

ture

(C

)RTD1

RTD2

RTD3

RTD4

RTD5

RTD6

RTD7

RTD8

RTD9

RTD10

RTD11

RTD12

LETHAL

cGMP DocumentationcGMP Documentation

Material Traceability• Material certificates and test reports

• Weld reports and inspection reports

In-Coming Materials

• Vendor qualification and auditing

• 100% inspection of fabricated and critical components

Documentation

• Documentation of System Configuration

• Complete documentation control & file management

• Engineering change order and customer approval process

• Final test report and procedures

• Operating manuals and engineering drawings

CARR Powerfuge CARR Powerfuge -- SummarySummary

• More Separating Force

– 20.000 x G for better performance, yield

– Superior liquid clarity

– Drier cakes

– Sub-micron clarification or classification

• Automated Processing

– No operator exposure

• Scalable Solutions

– Up to 1.700 LPH

• cGMP Compliance

– TrueClean™ design

– Enabling CIP/SIP validation

∑

Unmatched VersatilityUnmatched Versatility

Powerfuge

Disc Stack

Centrifuge

Tube Bowl

Centrifuge

Filtering

Centrifuge

Filter

Systems

High separating force

(20,000 G’s) b b

Ultra dry solids – easily

recovered b Possible

Submicron clarification b b b b

Auto solids discharge b b b Possible

Ease of maintenance b b

Sealed for safety/purity b b b b

No media disposal b b b

carr powerfuge technology - celldcelld.com/documents-pdf/carr powerfuge machine overview.pdf ·...

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