Gea_std Single Use Cip Sys_cipd

Standard Single Use

CIP Systemand

Integration

Leading Technologies. Individual Solutions.

There are three importantelements to consider in thedesign and implementation ofany CIP System; the CIP Skid,the equipment & systems to becleaned and the CIP supply &return lines.

The CIP Skid controls thecleaning (“T.A.C.T.”) parametersof Temperature, Action(velocity/pressure), Chemicalconcentration and Time ofexposure. It can be configuredwith many different options as required by the owner toachieve the desired cleaningresults.

Knowledge and Experience Required

More of a challenge is thedesign considerations of theequipment & systems to becleaned. In recent years theindustry has given moreattention to this and importantguidelines have been publishedby ASME-BPE, ISPE, etc. Andwhile these guideline havemade large strides addressing

the mechanical aspects, it is not mandatory (or sometimespossible!) for equipmentsuppliers to follow them. Thus it requires knowledge and experience in identifyingpotential CIP issues relating to equipment geometry anddeveloping a tactical CIPapproach to the process system.

There are several integrationtechniques for connecting theCIP skid with the targetedprocesses to be cleaned with theCIP supply & return circuits.Perhaps the most known is the use of flow-plates so that“make-break” circuits can beestablished, thus giving theowner a safe operation with a degree of flexibility albeit a manual operation. In moreadvanced operations, the use of matrix piping technology is used which employs mix-proof valves that allow the CIPsupply & return to be totally“hardpiped” and automated,thus maximize the efficiency of the CIP operation.

GEA Liquid Processing takescomplete responsibility for all aspects of the CIP System.

Our Process Engineers will audit your process forcleanability. Our CIP Systemskids are completely designed,engineered, fabricated,automated and tested in ourworkshop. We can furtherintegrate the CIP System Skid into your operating plantutilizing the latest integrationtechniques.

We assign a qualified ProcessEngineer to your project tofacilitate discussions regardingsite-specific requirements,integration concerns and final FAT/SAT protocols. Thisvertically integrated projectapproach has the benefit of: • Seamless communications

between disciplines• Eliminates budget variances

that would result from havingmultiple contracts

• Enhances the “speed tomarket” of the overall project

CIP SKID“T.A.C.T”

ControllableParameters

PROCESS EQUIPMENT AND SYSTEMS• Equipment geometry• Hygienic design of system• Tactical selection of CIP devices

Non-controllable elements, as they are set in thedesign and construction phase

Elements of a CIP System:

CIP Supply

CIP Return

CIP System In today’s pharmaceutical and biologic manufacturing,cleaning the process equipment and systems is crucial to the overall success of the enterprise. For larger productionand bulk facilities, cleaning is accomplished by acentralized CIP system and is considered a critical utility.

Recommended flow rates for cleaning verticalcylindrical vessels having dished heads

Vessel ID Flow rate

ft mm gpm lpm

1.5 457 12 to 14 45 to 53

2 610 16 to 19 60 to 72

3 914 24 to 28 90 to 106

4 1219 31 to 38 117 to 144

5 1524 39 to 47 148 to 178

Flow Rates to achieve 5 f/s (1.5 m/s)

SANITARY TUBE SIZE

OD ID Flow rate

inch mm inch mm gpm lpm

0.5 12.7 0.37 9.4 1.7 6.5

0.75 19.1 0.625 15.9 4.8 18

1.0 25.4 0.875 22.2 9.4 35

1.5 38.1 1.375 34.9 24.0 90

2.0 50.8 1.85 47.0 42.8 162

3.0 76.2 2.875 73.0 102.0 386

ASME-BPE 2005 Table SD-4 ASME-BPE 2005 Table SD-5

Control System Integration

One of the keys to success is the correct integration of the controlsystem to the process design and the CIP elements. In manycases, the CIP flow path will share process devices such asvalves, pumps, agitators etc. which will need to be energized in sequential fashion to ensure that cleaning will take place.

Furthermore, CIP programs are set-up to allow configuration of the controllable parameters by authorized operators, thus allowing the system to be easily optimized duringcommissioning or during the life cycle of the process. The result is a secure CIP system that will be repeatable and reliable in operation!

GEA Liquid Processing is staffed with knowledgeable ControlEngineers that are experienced with GAMP guidelines and can deliver complete, seamless control systems or provide the required interface with existing control systems.

Matrix PipingIntegration of aCIP System

Manual Flow PlateConfiguration Automatic

Matrix Piping

Action

Chemicals

Time

Temperature

Controllable CIP Parameters:T.A.C.T.

CIP tank

Secondary dedicated water tank

CIP return pump with low pointdrain valve

Chemical addition system(s)

Tank insulation

Air blow

CIP supply pressure transmitter

CIP supply temperature transmitter

CIP supply flow transmitter

Steam supply condensate drip leg

Heat exchanger drain

CIP return temperaturetransmitter

CIP return flow switch

CIP return conductivitytransmitter

Portable

Explosion Proof (Class I / Div 1,2)

Options

GEA’s single use CIP System Skid can be configured with the following options to meet your specific needs.

For detailed technical support, call us at 410-997-8700. Our engineers will assist you with the final CIP systemskid configuration required to deliver specified CIP solutions and discuss plant integration options.

2

1

3

4

5

6

7

8

9

10

11

12

13

14

15

16

4

13 1214

8

7

9

3 CIP RETURN PUMP

CIP RETURN

CIP SUPPLY

STEAM

CONDENSATE

10

11

HEATEXCHANGER

PLANT AIR

CIPSUPPLYPUMP

CHEM2

CHEM1

6

PRO

CESS

AIR

5 5DEDICATED

WATERTANK

2

CIPTANK

1

PROCESS WATER

USP WATER

CT FS TE TT

TT TE

PT

FE FT

PI

LT LT

4

Technical Data Typical Utility Requirements

Steam . . . . . . . . . . . .1000 lb/hr at 35 psi.Process water . . . . . .30-60 gpmElectrical . . . . . . . . . .120 VAC, 20 Amp for control cabinet. . . . . . . . . . . . . . . . . . .460V, 3 phase 60 Hz for the MCCAir . . . . . . . . . . . . . .90 psi (30CFH for airblow)*Specific flow data and utility requirements will be altered to suit individual process requirements.

Dimensional Information

Standard Documentation Package

• Pipe and Instrument Diagram (P&ID)• Dimensional drawings• Complete set of electrical drawings• Functional Design Specification (FDS)• Software Design Specification (SDS)• I/O list• Set of software applications• Maintenance manuals and spare parts

list for all components• Welding & inspection documentation• Material certificates and surface finish

reports for all process components

One-tank systemA = Height: 8’B = Width: 6’C = Length: 9’Dry weight: 4200 lbs

Two-tank systemA = Height: 8’B = Width: 6’C = Length: 13’

Dry weight: 6800 lbs

cGMP Process Solutions

for the Pharmaceutical and Biotech Industries

GEA Liquid Processing is a world leader in providing

technically advanced cGMP process solutions for liquid

processes. Utilizing good engineering practices and GAMP

compliant automation, our knowledgeable sta� delivers

completely integrated and reliable hygienic liquid process

systems that meet the most stringent regulations.

Columbia, MD

Hudson, WI

GEA Process Engineering Inc.9165 Rumsey Road • Columbia, MD 21045 • Tel: 410-997-8700 • Fax: 410-997-50211600 O'Keefe Road • Hudson, WI 54016 • Tel: 715-386-9371 • Fax: 715-386-9376E-mail: [email protected] • Website: www.niroinc.com