02-d-110-a4-p4 pg-3801 cip system

Doc. No.: 02-D-110-A4REVISION: P4PAGE 1 OF 7__________________________________________________________________

Sigma Aldrich Israel Ltd

New API Production Facility

LUDAN Project No. 134457FWSTERIL Contract no. 1.BJ.3631A

Mobile CIP SystemPG-3801

Data Sheet

02-D-110-A4-P4 PG-3801 CIP System

Doc. No.: 02-D-110-A4REVISION: P4PAGE 2 OF 7_____________________________________________________________________APPROVAL PAGE

Name Function DateAuthor: Giorgio Urbano FW Process LeaderApproved by: Giuseppe Abbate FW Project ManagerApproved by: Moshe Avron LUD Project EngineerApproved by: Yoel Ben-Tolila LUD Project ManagerApproved by: Avi Katz SAI Proj. Eng.Approved by: Yael Asscher SAI Project ManagerApproved by: Theo Ackermann SAI Q.A

REVISION HISTORY

Revision No Date DescriptionP0 07/04/2006 1st issueP1 02/08/2006 2nd issueP2 01/09/2006 3rd issueP3 17/09/2007 4th issueP4 31/11/2008 UPDATE

Signature


Doc. No.: 02-D-110-A4REVISION: P4PAGE 3 OF 7____________________________________________________________________ATTACHED DOCUMENTS

P4 P&ID

Revision Description

P402-D-003-FLL Fluid List

Number

02-D-058-A1


CLIENT: UNIT:PROJECT: ITEMS:CONTRACT No: P&ID's:SERVICE: No. REQD.:

DateAuthorReviewer

SCOPEScope of this specification is to give the minimum requirements for the design, supply, install, start up and validate the mobile CIP System skidsfor the pharmaceutical plant of SIGMA ALDRICH ISRAEL located in Jerusalem (Israel).The skids will be installed in a class "ISO 8 at rest" area.

TECHNICAL REQUIREMENTSVendor must consider as essential conditions that:- design, construction, materials of construction, components of supply shall be in accordance with the latest US and

European pharmaceutical standards, as well as recommendations of ISPE Baseline - the equipment will be part of a system that must be fully validated to be in compliance with FDA codes and

European GMP rulesIn case of non-compliance with EU GMP rules or FDA regulations, the Vendor shall have to take all required correctiveactions until the supply would meet the above requirements.

Weldings shall be inspected and shall be complete with documentation for validation.

Materials employed for pressure parts shall be certified by 3.1.B EN 10204 certificates.

Equipment must be designed, constructed and tested according to current European and Israelian Law requirementsconcerning mechanical safety.Vendor shall comply with standards, codes and specifications of qualified Israel and international Institutions (EN, DIN,IEC, etc.; see in particular PED, DIN 24255 and IEC 34 norms).Compliance with the listed codes and standards is Vendor responsibility.Instruments and safety devices will be supplied calibrated by Vendor (with calibration certificate)

The equipment will be cleanable, drainable, easy access for maintenance and inspection.The equipment will be designed and built according to EU standards: 97/23/CE-PED, 98/37/CE (DM) and 94/9/CE-ATEXPressure Vessel are according ASME VIII div.1Piping will be designed and built according to BPE-2005 and the attached piping specification.

ATEX (PRELIMINARY INFORMATION)The equipment will not be internally classified (N2 blanketing) (to be confirmed after risk analysis)ATEX external classification is: II 3 G-D IIB < 135°C; top of the tank and areas close to sampling valve are Zone 1.

Solvent utilized are: Ethanol ATEX IIA < 300°CEthyl Acetate IIA < 450°CDichloromethane D Class I according to NFPA

INSTALLATIONThe equipment will be installed in pharmaceutical area, hence all external finishes must be realized to minimizeretention of dust / microbial growth, and shall minimize disruption of air flow

DOCUMENTATION:Vendor will supply a full set of documents (4 copies), in English. Documents supplied will be described in the budget quotation.

CERTIFICATESVendor will issue PED certificatesFAT includedSAT to be quoted separately on a man-daily basisIQ, OQ protocol (blank) to be quoted separatelyIQ, OQ protocol execution to be quoted separately on a man-daily basisEU 98/37 CE marking

GUARANTEESThe equipment is fully drainable; all nozzle are at minimum length.The equipment performs according to this specification and other figures, if any.Noise level is less than 65 dB(A) , measured at 1 meter all around the installed equipment.

DOCUMENT No.: 02-D-110-A43631 1396J_01FW PROCESS SPEC. No.:GU GU

PROCESS SPECIFICATION FORMOBILE CIP SYSTEM

Sigma Aldrich Israel Ltd 38New API Production Facility PG-3801 FWSTERIL Contract no. 1.BJ.3631A 02-D-058-A1CIP System 1

P0 P1 P2 P3

FDN CC07-04-06 02-08-06 01-09-06 17-09-07

GU GUFDN FDN

P3

02-D-110-A4-P4 PG-3801 CIP System 5 of 8


DateAuthorReviewer

- PLC- Piping, valves, fittings- Spare parts- Documentation

Pharmaceutical standard Mechanical code / stampStamp

Location Material in contact withLayout cleaning fluidsPiping layout

Finishing internalSkid frame material external

GasketsInstalled power Piping

InsulationElectr.area classification WeldingElectrical protection ElectricalWeight Automation / Instrumentation

Test(s)

ITEM Design pressureType Design temperatureVolume nominal/geometr. Operating pressureDimensions Operating temperature

Nozzles

Spray-ball(s)

Vent filter Weight (empty/filled)Type

- a detergent mobile vessel for concentrated base or NaClO

- wheels in white Teflon

indoor AISI 316L,ferrite content < 0.5%

yes

DOCUMENT No.: 02-D-110-A4

Ra < 0.5 μm

FOR THE SKIDS

- Heat Exchanger- 2 detergent pump

by Vendor

Ra <1.2 μmPTFE

- a detergent mobile vessel for concentrated acid or soap detergent - Instrumentation

-1 Delivery pump

not applicable

SS AISI 304

/

not applicableIP 55by Vendor

PED, categ. IV, module GCE marking

- Fluid filter - Electrical switchboard and transformers

FDN FDN FDN CC07-04-06 02-08-06 01-09-06 17-09-07

CIP System 1P0 P1 P2 P3

New API Production Facility PG-3801 FWSTERIL Contract no. 1.BJ.3631A 02-D-058-A1


Sigma Aldrich Israel Ltd 38

GU GU GU GUDESCRIPTION OF THE SUPPLY

The mobile Cleaning Packages prepare, hold and distribute the solutions needed to clean the process equipment.

3631 1396J_01FW PROCESS SPEC. No.:

GENERAL FEATURES

The package will be provided with:

TANK



DateAuthorReviewer

ITEM ITEMType Type

Service ServiceFlow rate Flow rate

Head Head

NPSH req'd/availab. NPSH req'd/availab.Operating temperature Operating temperatureManufacturer / Model Manufacturer / ModelRotation speed Rotation speedNozzles inlet/outlet Nozzles inlet/outlet

vent/drain vent/drainEfficiency EfficiencySeal Seal

Power inst. / absorbed Power inst. / absorbed

Type Type

Service ServiceFlow rate Flow rate

Head Head

NPSH req'd/availab. NPSH req'd/availab.Operating temperature Operating temperatureManufacturer / Model Manufacturer / ModelRotation speed Rotation speedNozzles inlet/outlet Nozzles inlet/outlet

vent/drain vent/drainEfficiency EfficiencySeal Seal

Power inst. / absorbed Power inst. / absorbed

Fluid filter SERVICE

(note 1)ITEMControl board

ITEMpressure drop

TypePower board

Heat-transfer surfaceOverall dimensionsWeight

NOTES:

to heat chemical solutions and to adjust the

max 0.1 bar

Duty: as a minimum 10 KW

temperature of the fluid to be distributedhousing SS AISI 316L

-

1) The heat exchanger shall be designed as able to heat up the CIP fluid from 15 °C to 60 °Cin less than 15 minutes (to be guaranteed by Vendor)

by Vendor

ACCESSORIES

by Vendorsanitary double tube sheet

N / A

Electrical heat-exchanger Shell & Tubes

by VendorN / A

/ by Vendor

E-3801

/ -


Related to P-3803

P-3801 Not Required

DETERGENT # 2 PUMP

by Vendor

HEAT-EXCHANGER

in-line, 0.22 μm, PTFE

by Vendor

N / A N / A

30 Nm3/h (compr. air @ 7 barg)

F-3801

N / A

/

P-3802

DETERGENT # 1 PUMP

by VendorN / Aby Vendor

- / -

1.5 bar (Vendor to confirm)

by Vendor by Vendor

by Vendor

ambient ambientby Vendorby Vendor / > 7 m / > 7 m

1.5 bar (Vendor to confirm)

200 l/h 200 l/hto dose acid detergents to dose caustic detergents

Dosing, diaphragm Dosing, diaphragmRelated to

by Vendor

/by Vendor / by Vendorby Vendorby Vendor

/60°Cby Vendorvariable (VFD shall be included)

DN 50 / by Vendor

operating 5 bar

by Vendor / 0.7 bar(a)

3631 1396J_01FW PROCESS SPEC. No.:

/

to distribute CIP to all usersoperating max 6 m3/hdesign 8 m3/h

GURECIRCULATING PUMP


Sigma Aldrich Israel Ltd 38New API Production Facility PG-3801 FWSTERIL Contract no. 1.BJ.3631A 02-D-058-A1CIP System 1

P0 P1 P2 P307-04-06 02-08-06 01-09-06 17-09-07

FDN FDN FDN CCGU GU

DELIVERY PUMP

centrifugal, sanitaryopen impeller self-drainable

GU



DateAuthorReviewer

TYPE FEED (V/Ph/Hz) 400 / 3 / 50 3PH + N + GBradley or approved equivalent POWER (kW) installed by vendor

SOFTWARE DEVELOP. absorbed by vendor

PROTECTION CLASS ATEX / IP 55

INTEGRATION DESIGN CODE CE /CENELEC EN60079-10CLASSIFICATION

ACQUIRING DATA SYST. NOTE: MCC supplied by Vendorfrequency converter supplied by Vendor

OPERAT. INTERFACE

CONNECTION TO AMS hardwired general alarm

CONN. TO OTHER EQUIPMENTS


PLC Siemens serie S7/Allen

PLC

software specification and development by vendor according to specification."Automation Physical, Procedural and Process model" ISA S88 and Automation S88 Description 02-I-005-APPEthernet (for FUTURE connection with PAS)

vendor std + local paper recorder

signal to AMS (free contact)

1 Local Panel (HMI or SCADA )

New API Production Facility PG-3801FWSTERIL Contract no. 1.BJ.3631A 02-D-058-A1


Sigma Aldrich Israel Ltd 38

CIP System 1P0 P1 P2 P3

02-08-06 01-09-06 17-09-0707-04-06FDN FDN CCFDN

GU GUCONTROL UNIT

GU GUELECTRICAL

3631 1396J_01FW PROCESS SPECIFICATION No
