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

Doc. No.
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02-D-110-A4
REVISION:
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__________________________________________________________________
Sigma Aldrich Israel Ltd

New API Production Facility
LUDAN Project No. 134457

FWSTERIL Contract no. 1.BJ.3631A
Mobile CIP System

PG-3801
Data Sheet
02-D-110-A4-P4 PG-3801 CIP System
Doc. No.:
02-D-110-A4
REVISION:
P4
PAGE
2 OF
7
_____________________________________________________________________
APPROVAL PAGE
Author:
Approved by:
Approved by:
Approved by:
Approved by:
Approved by:
Approved by:
Name
Giorgio Urbano
Giuseppe Abbate
Moshe Avron
Yoel Ben-Tolila
Avi Katz
Yael Asscher
Theo Ackermann
Function
FW Process Leader
FW Project Manager
LUD Project Engineer
LUD Project Manager
SAI Proj. Eng.
SAI Project Manager
SAI Q.A
Signature
REVISION HISTORY
Revision No
P0
Date
07/04/2006
Description
P1
02/08/2006
2nd issue
P2
01/09/2006
3rd issue
P3
17/09/2007
P4
31/11/2008
4th issue
UPDATE
1st issue
Date
Doc. No.:
02-D-110-A4
REVISION:
P4
PAGE
3 OF
7
____________________________________________________________________
ATTACHED DOCUMENTS
Number
Revision
Description
02-D-003-FLL
02-D-058-A1
P4
P4
Fluid List
P&ID
PROCESS SPECIFICATION FOR

MOBILE CIP SYSTEM
CLIENT:
PROJECT:
CONTRACT No:
SERVICE:
Date
Author
Reviewer
P3

CIP System
P0
P1
P2
P3
07-04-06
02-08-06
01-09-06
17-09-07
FDN
FDN
FDN
CC
GU
GU
GU
GU
UNIT:
ITEMS:
P&ID's:
No. REQD.:
38
PG-3801
02-D-058-A1
1
DOCUMENT No.:
FW PROCESS SPEC. No.:
02-D-110-A4
3631 1396J_01
SCOPE
Scope of this specification is to give the minimum requirements for the design, supply, install, start up and validate the mobile CIP System skids
for 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 REQUIREMENTS
Vendor 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 rules
In case of non-compliance with EU GMP rules or FDA regulations, the Vendor shall have to take all required corrective
actions 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 requirements
concerning 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-ATEX
Pressure Vessel are according ASME VIII div.1
Piping 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 < 135C; top of the tank and areas close to sampling valve are Zone 1.
Solvent utilized are:
Ethanol
Ethyl Acetate
Dichloromethane
ATEX IIA
IIA
D
< 300C
< 450C
Class I
according to NFPA
INSTALLATION
The equipment will be installed in pharmaceutical area, hence all external finishes must be realized to minimize
retention 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.
CERTIFICATES
Vendor will issue PED certificates
FAT included
SAT to be quoted separately on a man-daily basis
IQ, OQ protocol (blank) to be quoted separately
IQ, OQ protocol execution to be quoted separately on a man-daily basis
EU 98/37 CE marking
GUARANTEES
The 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.
5 of 8

MOBILE CIP SYSTEM
38
UNIT:
PG-3801
ITEMS:
02-D-058-A1
P&ID's:
CIP System
1
No. REQD.:
P0
P1
P2
P3
07-04-06
02-08-06
01-09-06
17-09-07
Date
FDN
FDN
FDN
CC
DOCUMENT No.:
02-D-110-A4
Author
GU
GU
GU
GU
3631 1396J_01
Reviewer
DESCRIPTION OF THE SUPPLY
The mobile Cleaning Packages prepare, hold and distribute the solutions needed to clean the process equipment.
The package will be provided with:
CLIENT:
PROJECT:
CONTRACT No:
SERVICE:
- a detergent mobile vessel for concentrated acid or soap detergent

- a detergent mobile vessel for concentrated base or NaClO
-1 Delivery pump
- Heat Exchanger
- 2 detergent pump
- Fluid filter
- wheels in white Teflon
- Instrumentation
- PLC
- Piping, valves, fittings
- Spare parts
- Documentation
- Electrical switchboard and transformers
GENERAL FEATURES
FOR THE SKIDS
Pharmaceutical standard
yes
Location
Layout
Piping layout
indoor
not applicable
Skid frame material
SS AISI 304
Installed power
by Vendor
Electr.area classification
Electrical protection
Weight
not applicable
IP 55
by Vendor
Mechanical code / stamp

Stamp
Material in contact with
cleaning fluids
PED, categ. IV, module G

CE marking
AISI 316L,ferrite content < 0.5%
Finishing
Ra < 0.5 m
Ra <1.2 m
PTFE
internal
external
Gaskets
Piping
Insulation
Welding
Electrical
Automation / Instrumentation
Test(s)
TANK
ITEM
Type
Volume
nominal/geometr.
Dimensions
Design pressure
Design temperature
Operating pressure
Operating temperature
Nozzles
Spray-ball(s)
Vent filter
Type
Weight (empty/filled)
6 of 8

MOBILE CIP SYSTEM
CLIENT:
PROJECT:
CONTRACT No:
SERVICE:
Date
Author
Reviewer

CIP System
P0
P1
P2
P3
07-04-06
02-08-06
01-09-06
17-09-07
FDN
FDN
FDN
CC
GU
GU
GU
GU
DELIVERY PUMP
UNIT:
ITEMS:
P&ID's:
No. REQD.:
38
PG-3801
02-D-058-A1
1
DOCUMENT No.:
02-D-110-A4
3631 1396J_01
RECIRCULATING PUMP
Head
P-3801
centrifugal, sanitary
open impeller self-drainable
to distribute CIP to all users
operating max 6 m3/h
design 8 m3/h
operating 5 bar
Head
NPSH
req'd/availab.
Manufacturer / Model
Rotation speed
Nozzles
inlet/outlet
vent/drain
Efficiency
Seal
by Vendor
/
0.7 bar(a)
60C
by Vendor
variable (VFD shall be included)
DN 50
/
by Vendor
by Vendor
/
by Vendor
by Vendor
by Vendor
NPSH
req'd/availab.
Rotation speed
Nozzles
inlet/outlet
vent/drain
Efficiency
Seal
Power inst. / absorbed
by Vendor
ITEM
Type
Service
Flow rate
Not Required
ITEM
Type
Service
Flow rate
DETERGENT # 1 PUMP
/
/
DETERGENT # 2 PUMP
Related to
Type
P-3802
Dosing, diaphragm
Related to
Type
P-3803
Dosing, diaphragm
Service
Flow rate
to dose acid detergents

200 l/h
Service
Flow rate
to dose caustic detergents

200 l/h
Head
1.5 bar (Vendor to confirm)
Head
1.5 bar (Vendor to confirm)
NPSH
req'd/availab.
Rotation speed
Nozzles
inlet/outlet
vent/drain
Efficiency
Seal
by Vendor
ambient
by Vendor
N/A
by Vendor
N/A
N/A
NPSH
req'd/availab.
Rotation speed
Nozzles
inlet/outlet
vent/drain
Efficiency
Seal
by Vendor
ambient
by Vendor
N/A
by Vendor
N/A
N/A
>7m
/
/
by Vendor
-
by Vendor
ACCESSORIES
Fluid filter
in-line, 0.22 m, PTFE

housing SS AISI 316L
30 Nm3/h (compr. air @ 7 barg)
ITEM
Control board
F-3801
pressure drop
max 0.1 bar
>7m
/
/
by Vendor
-
by Vendor
HEAT-EXCHANGER
SERVICE
to heat chemical solutions and to adjust the
temperature of the fluid to be distributed
(note 1)
Duty: as a minimum 10 KW
ITEM
E-3801
Type
Electrical heat-exchanger Shell & Tubes

sanitary double tube sheet
by Vendor
by Vendor
by Vendor
Power board
Heat-transfer surface
Overall dimensions
Weight
NOTES:
1) The heat exchanger shall be designed as able to heat up the CIP fluid from 15 C to 60 C
in less than 15 minutes (to be guaranteed by Vendor)
7 of 8

MOBILE CIP SYSTEM
CLIENT:
PROJECT:
CONTRACT No:
SERVICE:
Date
Author
Reviewer

CIP System
P0
P1
P2
P3
07-04-06
02-08-06
01-09-06
17-09-07
FDN
FDN
FDN
CC
GU
GU
GU
GU
CONTROL UNIT
TYPE
SOFTWARE DEVELOP.
PLC Siemens serie S7/Allen

Bradley or approved equivalent
software specification and
development by vendor according to
specification.
"Automation Physical, Procedural
and Process model" ISA S88 and
Automation S88 Description 02-I005-APP
Ethernet (for FUTURE connection

with PAS)
ACQUIRING DATA SYST. PLC
INTEGRATION
OPERAT. INTERFACE
UNIT:
ITEMS:
P&ID's:
No. REQD.:
38
PG-3801
02-D-058-A1
1
DOCUMENT No.:
FW PROCESS SPECIFICATION No
ELECTRICAL
FEED (V/Ph/Hz)
POWER (kW)
02-D-110-A4
3631 1396J_01
400 / 3 / 50 3PH + N + G
installed
by vendor
absorbed
by vendor
PROTECTION CLASS
ATEX / IP 55
DESIGN CODE
CLASSIFICATION
NOTE:
CE /CENELEC EN60079-10
MCC supplied by Vendor
frequency converter supplied by Vendor
1 Local Panel (HMI or SCADA )
vendor std + local paper recorder

hardwired general alarm
signal to AMS (free contact)
CONN. TO OTHER EQUIPMENTS
CONNECTION TO AMS
8 of 8

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

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Sigma Aldrich Israel Ltd

LUDAN Project No. 134457

Mobile CIP System