I.

V INFUSION
SOLUTION
PRODUCTION LINE
1. GENERAL DESCRIPTION OF THE PROJECT
2. PRODUCTS & CAPACITIES
3. PRELIMINARIES
4. CIVIL WORKS BY CUSTOMER
5. BUILDING WORKS BY CUSTOMER
6. INTERIOR WORKS
7. SANITARY WORKS
8. AIR CONDITIONING & MECHANICAL
VENTILATION
9. ELECTRICAL EQUIPMENT
10. WAREHOUSE EQUIPMENT
11. PROCESS EQUIPMENT
12. PROJECT & CONSTRUCTION
MANAGEMENT
13. BASIC DESIGN
14. DETAIL DESIGN PHASE
15. CONTRACT DOCUMENTATION PHASE
16. QUALIFICATION & VALIDATION
17. TRAINING
18. PRODUCT LICENSING
19. PROJECT EXECUTION
20. COMMUNICATION & SOFTWARE
21. PROJECT TEAM ORGANISATION
22. PROJECT SCHEDULE
23. PRE-CONDITIONS
24. SCHEDULE OF TOTAL COSTS
25. COMMERCIAL TERMS AND CONDITIONS
26. ATTACHMENT 1: DESCRIPTION OF PLÜMAT
FORM FILL SEAL LINE
27. ATTACHMENT 2: PROPESED PLANT
LAYOUT
28. ATTACHMENT 3: SITE MASTERPLAN
1. GENERAL DESCRIPTION OF THE
PROJECT
 Basic- and Detail Engineering
 Supply, installation and commissioning of
Equipment
 Qualification (VMP, DQ, IQ and OQ)
 Site supervision
 Training of personnel
 LVP Product licences
On a turnkey basis, for the whole project as
described in this file.
The facility will consist of :
 production areas where sterile products
will be produced,
 areas for process utility service
generation and distribution,
 as well as facilities for storage of raw
materials and packaging materials and
finished products.

The facility will be designed in order to:

 provide maximum containment of the
products,
 avoid cross-contamination of products,
improve efficiency and yield
 and to give maximum flexibility for
further extensions.

 The energy and utility area will include

the equipment for the process utilities
 e.g. purified water, WFI, pure steam,
plant steam, compressed air, and chiller.
 The electrical rooms for transformer, low
voltage distribution, high voltage
distribution and emergency power
supply will also be located in the energy
and utility building. The adjacent area is
provided for the installation of cooling
towers.

1.2 Assumptions for the preparation of the

study
  All architectural works are performed by the
local contractors
 No emergency power generator
 Supply of all services inside of the site the
building
 Local seismic requirement does not affect the
design of equipment.
 Raw material for testing and commissioning is
provided by the ‫الشركة المنفذة‬.

2. PRODUCTS & CAPACITIES

Large Volume Parenteral:
The plant shall serve for the production of
infusion solutions in form of bags, processed on
Form-Fill-Seal Technology with Pluemat Port &
Tube System.

Annual Capacity approx. 10 Mio bags per year

Size of bags 500 ml
Haemodialysis Solution:
The plant shall serve for the production
Haemodialysis solutions as 35X and 40X
concentrate in 5 l canisters.
Annual Capacity approx. 150.000 canisters per year Size of
canister 5 liter

3. PRELIMINARIES
Preparation of the site infrastructure at
the site to be provided by the ‫مالك المشروع‬

building contractor:
 Temporary roads
 Site safety and health program
 Temporary site security program
 Temporary drainage
 Temporary electrical supply
Temporary water supply
 Temporary enclosing fence and gate
 Temporary telephone connections.
 Temporary site facilities for site
management and qualification team -
mobile container
 Temporary site facilities for toilets and
showers for staff
  Removal of all temporary site installation
and equipment after completion of the
work.

CIVIL WORKS BY ‫مالك المشروع‬

1) Electrical supply
Power supply cable from the public grid to the
utility area inside site Lightning Protection and
Earthing System
 2) Water supply
Water pipe work from the facility mains to
connection point inside site. Total water
consumption: app. 13 m³/h
3) Waste Water and Sewage
Waste Water pipe work from the facility
system to connection point outside site the
building

4) Drinking Water Supply

Water storage tank for water supply. The water
quality must confirm to WHO-standard for
drinking water.
5) External lighting
It is necessary to install an exterior lightning to
illuminate all ways and places in the factory area,
around the new building. The lightning fittings will
 be fixed on columns. The complete exterior
lighting system includes all cables, distribution
cabinets and needful assembly/installation work.

6) Paved Roads, Security Fence & Gate

Fence and gates
Roads incl. approaches to the various facilities of the
plant and connection to the public road system
acc. to local requirements and regulations. Dotted
roads in drawing are not paved but with crushed
stone (gravel)
Parking facilities for cars and trucks.
7) Landscaping
Cow grass mixed with tropical trees
 5. BUILDING WORKS BY ‫مالك المشروع‬

 Production Administration and

Warehouse Building
 Earthworks
 Foundation in reinforced concrete Load
bearing structure
 Steel structure
 Roof and wall cladding: heat insulated
sandwich panels.

 Bottom slab in reinforced concrete (max.

load 2 t/M2 for production building), floor
preparation for production area to the
required standards
 Doors & Windows acc. local standard
 Docking bays including sliding gate
 6. INTERIOR WORKS by ‫الشركة المنفذة‬
 Production
 Partition Wall with glazing (Clean Room
Walls), surface of partition washable,
resistant to disinfectants, no source for
emission of particles, e.g. special
coating.
 Suspended walkable ceilings in
production area with illumination (Clean
Room Ceilings)
 Flooring (Clean Room Flooring), surface
of floor in production area washable,
resistant to disinfectants, no source for
emission of particles, e.g. special epoxy
coating resistant to material handling
equipment.
 Clean Room Doors & Windows incl.
airlocks etc.
 Warehouse / Quarantine Store
Flooring smooth surface of floor in production
area, washable, resistant to disinfectants, no
source for emission of particles, e.g. special
coating resistant to material handling
equipment. Painting Work
 SANITARY WORKS
Waste Water and Sewage System by
‫الشركة المنفذة‬
Three independent systems for:
 Rain water
 Waste water (e. g. toilets, showers)
 Process waste water to be installed in the
ground. The process waste water does not
require any special treatment or purification.
Temperature of process waste water may reach
90°C (short-term load); Process waste water
drain points are located in production area
  The disposal of above mentioned rain water
and sewage must comply with the local
requirements.
 Floor outlets in stainless steel, GMP-type for
cleanrooms, connected to the waste water
system

Sanitary System by ‫الشركة المنفذة‬

Potable water pipework from the tie in point of the
energy and utility building to various
points of consumption, if necessary instantaneous
water heater as decentralised units (e.g. for
showers).
All necessary accessories such as sinks, urinals,
shower equipment etc.
Connection of the above mentioned equipment and
floor outlets to the sewage system. Stainless steel
sinks for personal lockers in the production area.

8. AIR CONDITIONING & MECHANICAL

VENTILATION BY
 ‫الشركة المنفذة‬

 Air Conditioning
Air conditioning systems are provided for the
production and related rooms, with requirements
according to the thermal and hygienic conditions.

 Production Building
Air Conditioning systems with fresh air and
recirculated air, to condition the process
areas, including filters EU6 and EU9, sound
attenuators, chilled water coils and fan, duct-
system of galvanised steel, grilles and diffusers for
supply air with HEPA filters (for
cleanroom classes D: EU14); incl. control system
and necessary equipment, cabling as well as
switchboard cabinet.

 Warehouse
Air Conditioning system with fresh air and
recirculated air to condition the storage area,
including filters EU6, sound attenuators, chilled
water coils and fan, duct-system of galvanised
steel, grilles and diffusers for supply air incl.
control system and necessary equipment,
cabling as well as switchboard cabinet.

 Additional Services
Automated building service control system.
Chilled water system for air conditioning system incl.
air cooled chillers, insulated pipework ( see Process
Utilities )
  Mechanical Ventilation
 Production Building
 Locker rooms, Toilets

9. ELECTRICAL EQUIPMENT BY
‫الشركة المنفذة‬
 Transformer Substation
The packaged transformer substation with a
capacity of app. 2 mW will be connected to the main
low voltage cabinet by means of power-cables.
  Main Low Voltage Cabinet
The main low voltage cabinet will be built as a
type-tested low voltage switch gear and
control-gear assembly, according to the German
standard DIN/VDE 0660. The main low voltage
cabinet is assembled to include two main
breakers for the power supply of the
transformers, power rail, and power switchgear
for all connected process-machines.

 Secondary Distribution Cabinets

All assembled power outlet sockets and other
electric power loads are to be connected to separate
secondary distribution cabinets.
Furthermore, all circuits for complete illumination of
the buildings are to be connected to separate
distribution cabinets.
The secondary distribution cabinet is a
steel-enclosure for partial type-tested
distribution-switchgear combination (PTSK) DIN
VDE 0660, part 500, as single distributor. Inside the
distributor are circuit breaker, over-voltage
protection, fuses etc.
  Wiring System and Interior Lighting
All distribution cabinets have to be connected to the
main low voltage cabinet by means of wiring cables.
The wiring cables are running on cable-trays fixed on
walls or roof. The completed building is to have
power sockets and lightning in all rooms. The
luminance in the process plant and all offices shall
be 500 lx. In other areas 300 lx.
  Safety Lighting
The buildings will be equipped with safety
lightning to indicate emergency exits, in case of
power supply failure. The safety lightning system
will be build according to German standard VDE
0108. The safety illumination is battery operating.
  Telephone System

The building will be equipped with a telephone

system. The telephone system includes 20
telephones, one telephone-centre and the complete
telephone wiring. The package

 Wiring for Computer System

Wiring network for approx. 5 PC stations located
in the production plant and warehouse office.
Server, Computers and Software to be provided
by ‫مالك المشروع‬
.

 CCTV System
The building will be equipped with a CCTV system.
The system includes 12 cameras, one central control
station with one recorder and the complete wiring.
10. WAREHOUSE EQUIPMENT BY
‫الشركة المنفذة‬
For the storage of raw material, packaging material
and quarantine storage, a warehouse for approx.
2000 pallet places is considered.
Appropriate equipment for the operation of the
warehouse is provided. Finished goods shall be
transferred to quarantine store directly after
production.

 Pallet warehouse
Capacity: approx. 2000 pallet places
 Design of the shelves:
Storage of Europol pallets length x width x height
-1.200 mm x 800 mm x 1.600 mm Excess ends of
100 mm each in length and width is considered
Max. load of each pallet: 750 kg
Ram protection on all critical corners of the shelving
Marking of the rack bays and rack places with
ID-Number and section number. Material of shelf:
steel, painted or galvanised

 Material Handling Equipment and

Accessories
 2 Reach fork lift truck
Load: max 1000kg
Width of aisle: 2.7 m
Lifting height: max. 9 m
 Special free lift height of truck with retracted
lifting unit: approx. 2 m Each truck with 2
batteries to facilitate changing, Including
battery charger, Operation time each cycle:10 h
  2 Pallet lift
For transport between production and storage
Load: 1.000 kg:
Width of aisle about 3.000 mm
Each truck with 2 batteries to facilitate changing,
Operation time each cycle: 10 h
  5 nos. Hand pallet truck

For transport inside the production area

Material: stainless steel

Load: 1000kg

 20 nos. stainless steel pallets for

transportation of raw materials in production
area
11. PROCESS EQUIPMENT
Water Treatment and Distillation
 Highly Brackish Water (HBW) RO plant
capacity: 6.5 m³/h
 Potable water Tank: 5 m³
 Purified Water plant capacity: 2.5 m³/h
 1 purified water tank 10 m³, stainless steel
 1 multi-stage distillation unit capacity: 1.5 m³/h
 WFI tank 12 m³, stainless steel
 1 pure steam generator capacity: 500 kg/h
 set of accessories e.g. pump station, incl.
pipework loops in stainless steel for purified
water, WFI and pure steam, valves, fittings,
instruments, heat exchanger, insulation,
cabling, control panel
  IV Solutions production:
Raw material weighing for IV solutions
 1 Floor scale
 3 Table scales in different ranges
 1 set of accessories e.g. LF-unit, weighing
terminal, label printer, writing desk

 Solution Preparation and Dispensing

 2 solution preparation tanks 6 m³, stainless
steel with agitator
 service platform for two prep. tanks, stainless
steel
 set of accessories for solution preparation e.g.
filter group for pre- and sterile filtration,
 pipework in stainless steel, insulation, valves,
fittings, flow meters, instruments, cabling,
control panel
 set of vacuum conveyor system for high
quantity raw materials

 Bag Forming, Filling and Sealing

  Form Fill Seal Machine, Type Plümat FFS 3000
for 500 ml Bags: Output: Up to 2500 bags per
hour Including:
- Welding device for 500ml bags, twin port
- set of printing cliché assembled on base plate
- Hot foil printing, one colour
- Laminar Flow unit
- CIP/SIP system
- External printer
- Spare part package for 1 year of operation
For a detailed description of the FFS machine see
attachment 1.

Sterilisation, Inspection and Packaging

 high pressure autoclave acc. the hot water
spraying process double sterilisation chamber
in stainless steel incl. 2 sliding doors for total 7
carts, incl. all necessary pipes, circulating
pump, heat exchanger, SPS control incl.
Fo-value calculator and printer capacity:
approx. 6000/batch bags at 500 ml
 7 autoclave carts, stainless steel, with 9 trays
each, plus 63 additional trays

 set of accessories for sterilisation area like

stainless steel rails for the carts, piping,
insulations, valves, instruments incl. 1
validation printer
 pressing belt device for testing the tightness
of the bags frame in stainless steel
 2 visual inspection stations, illuminated for
checking bag surface, closure and bag
contents
 1 overwrapping machine for wrapping the
sterilized and inspected bags with a PE film

 1 bag conveyor system to connect all

inspection and packaging stations
 manual packaging station, consisting of
stainless steel tables, 1 gravity roller conveyor
 and 2 tape dispersers for closing the cardboard
boxes

 IV Haemodialysis Concentrate
Production:
 Raw material weighing for HDC
production
 1 Floor scale
  1 Table scale
 1 set of accessories e.g. LF-unit, weighing
terminal, label printer, writing desk

Solution Preparation and Dispensing

 1 solution preparation tank 6 m³, stainless steel
with agitator
 service platform for preparation tank, stainless
steel
 set of accessories for solution preparation e.g.
filter group for filtration, pipework in stainless
 steel, insulation, valves, fittings, flow meters,
instruments, cabling, control panel
 set of vacuum conveyor system for high
quantity raw materials

 Container filling and closing

1 Bench mounted semi-automatic single head liquid
filler, type PLÜMATEX-F 014-1 CF
suitable to fill canisters or other containers. Filling
nozzle is sleeplessly adjustable by a
vertical spindle adjustment. A mechanical container
centring device ensures proper positioning under the
filling nozzle.
Hand switch operation initiates fill cycle.
Based on a calculated total processing time of 20sec
/ 5l canister by an operator the output is indicated
with approx. 180 canisters / hour. The filling time will
be app. 6 hours for a single batch of 5000 litres.
The annual target production of 150.000 units can be
produced in app. 150 days.
  IPC Laboratory
 1 set of equipment for chemical laboratory
consisting of analysis scale, precision
o balance, Polari meter, ph.-meter, drying
cabinet, incineration oven, flame photometer,
water bath, spectroscope and various small
equipment and glass ware
1 set of equipment for bacteriological
laboratory consisting of LF-bench, refrigerator,
breeding board, microscope, laboratory scale,
ph.-meter, steam kettle, steam steriliser, hot
air steriliser,
air sampler, magnifier and various small
equipment and glass ware 1 set of small
equipment and glass ware for LAL-Test
(endotoxins) like reaction tubes, multiblock
with heater, test tube racks, laboratory mixer,
test tubes and pipettes etc. 1 set of laboratory
furniture
 Utilities
 1 steam boiler plant capacity: 6 to/h, 8 bar (g)
consisting of boiler with fuel oil burner, feed
water tank incl. degassing, support
constructions, internal pipework, pipework for
steam/condensate to connect all consumers,
insulation, filter, pumps, water softening
plant, dosing station for chemicals, water test
cabinet, switch panel, gas connection,
steel plate chimney.

 Fuel oil storage tanks are to be provided by the

‫مالك المشروع‬
 1 compressed air system capacity: 10 m³/min, 8
bar (g) oil free and dry consisting of 2
compressors, stainless steel buffer tank 5 m³,
air-dryer (-40°C), filters, internal pipework and
pipework to consumers in stainless steel,
valves instruments, switch panel.
 1 cooling/cold water system to supply cooling
energy to process plant and HVAC, consisting
of 3 air cooled chillers total approx. 1500 kW,
internal pipework, pipework to connect all

consumers, insulation, pumps, filter, dosing unit

for chemicals, control panel etc.
 1 cooling tower, 170 m³/h incl. internal
pipework, pipework to connect all consumers,
 insulation, pumps, filter, dosing unit for
chemicals, control panel etc.

 Miscellaneous
 set of furniture for personnel air locks in the
production area, consisting of wardrobes,
benches, containers for dirty cleanrooms
 clothes, stainless steel sinks, dispenser for
disinfectants etc.
 set of furniture for workshop in the spare part
area, consisting of wardrobes, benches,
tools for maintenance etc.

 Spare Parts
 set of spare part which is selected in
accordance with our experience to be
sufficient for one year of plant operation.
The spare parts will mainly be delivered
together with the respective machinery in
 order to be available when the plant is
started up. A detailed spare part list will be
elaborated as part of the plant
documentation.

12. PROJECT & CONSTRUCTION

MANAGEMENT
The services provided under this category are:
a) Providing total project management services
from the inception to completion of the entire
project, including preparation of project briefs,
appointing and co-ordination of
consultants, subcontractor and ‫الشركة المنفذة‬,
b) preparation of various levels of project
schedules for planning and implementation
and monitoring all the activities and
elements relative to the agreed target, preparing
reports and their submission to ‫ مالك المشروع‬and
accepting the complete work on behalf of the ‫مالك‬
‫المشروع‬.
c) Providing full time resident site personal for
constant inspection of the works.
d) Providing the full service required for
construction management in serving as the
overall co-ordinator where separate contracts are
awarded
e) Providing the project management for the
following services:
I. Building Services
II. Process Media
III. Clean Room
IV. Process and related services
13. BASIC DESIGN
a) The services provided under this category are:
b) Taking the ‫’مالك المشروع‬s instructions and
analysing the project brief.
c) Preparing preliminary conceptual sketch
proposals to interpret the project brief.
d) Developing the preliminary conceptual
proposals into sketch design to a stage
sufficient to enable an application is made
for planning approval or approval in
principle to comply with the relevant by laws.
e) Where applicable, preparing and submitting
the drawings and other necessary drawings
and documents to the relevant authorities for
either town planning approval or approval in
principle together with the local architect
provided by the ‫مالك المشروع‬
Providing the basic design for the following services:
 Architectural services by ‫’مالك المشروع‬s architect
Building Services
 Process Media
Clean Room
 Process and related services
14. DETAIL DESIGN PHASE
The services provided under this category are:
a) Upon approval of the proposals by either
the relevant authority or the (‫)مالك المشروع‬
Management, developing the schematic
design drawings to a stage to enable to
commence the detail design work.
b) Updating the project planning and
implementation schedule and submitting the
same to ‫ مالك المشروع‬for approval.
Providing the Design Development Phase for
the following services:
 Architectural services by )‫(مالك المشروع‬
 Building Services
 Process Media
 Clean Room
 Process and related services
15. CONTRACT DOCUMENTATION PHASE

The services provided under this category are:

a) Upon approval by ‫ مالك المشروع‬of design
development and the planning and
implementation schedule, preparing and finalising
the detailed drawings and other documents
necessary to the stage of completion.
Providing the Contract Documentation Phase
for the following services:
 Building Services
 Process Media
 Clean Room
 Process and related services

16. QUALIFICATION & VALIDATION

The first step of all qualification / validation
activities is the creation of the validation
Master-Plan. It specifies all qualification and
validation activities to ensure the production
of pharmaceutical products according to
accepted international standards e.g. FDA-
standard. The following steps of qualification for
each plant are the risk analysis (RA), the
installation qualification (IQ), the operational
qualification (OQ) and for some equipment

the performance qualification (PQ). The validation

activities cleaning validation (CV) and the process
validation (PV) are also described in the validation
Master-Plan.
Included in the risk analysis, the IQ and OQ is the
factory acceptance test (FAT) at the site ‫الشركة المنفذذة‬
and the site acceptance test (SAT) at the site. ‫مالذك‬
‫المشروع‬

Description of the activities:

By ‫الشركة المنفذة‬:
Validation Master Plan (VMP) Risk Analyses (RA)
Qualification protocols (IQ, OQ, PQ)
Factory and site acceptance test (FAT, SAT)
After the equipment will be installed at the facility
and the SAT is completed, the qualification (IQ,
OQ, PQ) will be executed by the ‫ مالك المشروع‬together
with the licenser.
All site activities will be carried out by ‫’مالك المشروع‬s
validation team. The final qualification reports will be
generated by ‫ مالك المشروع‬and will be reviewed by
‫الشركة المنفذة‬.

By the ‫ مالك المشروع‬under supervision of ‫الشركة‬

‫المنفذة‬
Qualification executions on site (IQ, OQ, PQ)
17. TRAINING
Training will be performed by ‫ الشذذركة المنفذذذة‬and
equipment vendor’s specialists during FAT at
vendor’s site and during installation and start-up.
For this purpose ‫ مالذذك المشذذروع‬will nominate his
personnel (not more than 5 operators and
capable of speaking English) in time and is
responsible for the uninterrupted presence
during the training.

18. PRODUCT LICENSING

‫ الشركة المنفذة‬must offer certified licenses for standard
electrolyte infusion solutions and parenteral
nutrition solution according to the following list:
 Aqua ad injectable 500ml
Electrolyte Solutions:
 Isotonic Sodium chloride-solution 0,9% 500ml
 Ringer-Lactate-Solution 500ml
 Ringer- Solution 500ml
 Deltajonin 500ml
 Deltajonin G5 500ml
 Deltajonin OP 500ml
 Deltajonin OPG 500ml
 Deltajonin HG 5 500ml
 Deltajonin BG 500ml
 Deltajonin päd I N 500ml
 Deltajonin päd II N 500ml
 Deltajonin päd OP G5 500ml
 Parenteral Nutrition:
 Glucose- Solution 5% 500ml
 Glucose- Solution 10% 500ml
 Glucose- Solution 20% 500ml
  Glucose- Solution 40% 500ml

All of these products can be produced on the

offered equipment.

Licensing of products includes the following services:

• Product files for registration at authorities
• Complete Manufacturing Instructions
• Performance qualification (PQ) support
Licensing should be included in the project lump
sum. A proposal can be elaborated after detailed
discussion of ‫ مالك المشروع‬final product requirements.
19. PROJECT EXECUTION
‫ الشركة المنفذة‬will execute the project according to the
‫ الشركة المنفذة‬Quality Standard Manual and the
Project Schedule in.
All steps of the phases will be documented, filed
and submitted to ‫ مالك المشروع‬after finalizing the
engineering phases to ensure that all activities
comply with the cGMP Guidelines of the EU.
All requirements of local building codes shall be
covered by the local architect. Standards and
regulations of technical equipment and systems
will follow the current cGMP Standards.
The Conceptual Design including, the
Status-Quo Analysis, Production Process
Documentation and Development of Lay-Out
Variants will be the basis for the commencement
of the future Engineering Phases.
The meetings shall take place at ‫’مالك المشروع‬s place
or in China. (The ‫ الشركة المنفذة‬project
manager and ‫ الشركة المنفذة‬engineers from process
departments will attend the meetings.)
During the project meetings the status of the project
will be documented concerning the activities, e.g.
executed engineering works and time schedule,
in order to meet the defined project scope.
20. COMMUNICATION & SOFTWARE
The communication of the partners will be
performed via mail, telephone, e-mail and
facsimile. Exchange of information and
documents should be made via e-mail as much as
possible. The following devices are available for
data storage:
The parties agree that the ruling language for all
activities is English. The provided documentation
and other written documents is English.
‫ مالك المشروع‬provides all documents related to the
process and all User Requirements (UR) in
English.
21. PROJECT TEAM ORGANISATION
We expect the team where all members are
experienced in pharmaceutical plant projects.
22. PROJECT SCHEDULE
The minimum project time will be approximately 18
months.
This may differ depending on ordering date,
building construction time and delivery time of
main equipment.
A detailed project schedule shall be created in the
first engineering phase.
23. PRE-CONDITIONS
‫ مالك المشروع‬management must fulfil the following
pre-conditions:
 Appoint an engineering project manager. The
engineering project manager should have the
necessary competence, time and ability to
make decisions on behalf of the
management related to the project
 Appoint a validation project manager. The
validation project manager should have the
necessary competence, time and ability to
make decisions on behalf of the Management
related to the project
 Work on and answer ‫ الشركة المنفذة‬questions
which only concern the ‫مالك المشروع‬
Management within at least five working days
 Carry out and distribute corrected circulars
within five working days
 To be responsible for, or to delegate, requests
for possibly required additional assistance.
 Supply documents such as

 Plans including existing and

bordering building shells
 Other, e.g. existing plans and studies

 Provide national regulations (English

version) as fare as required
Exclusions
 Site Surveying Work
 Topographical Plans and Site/Soil Reports
 Architectural works
 Building Works
 To pay any fees to authorities
24. SCHEDULE OF TOTAL COSTS
‫ الشركة المنفذة‬should offer the project on a turnkey lump
sum basis for The total sum relates to the following
subtotals:
25. COMMERCIAL TERMS AND
CONDITIONS
Warranty and Liability
‫ الشركة المنفذة‬will carry out the works and is liable for the
following:
• ‫ الشركة المنفذة‬will carry out their work with due care
and attention complying with technical
regulations in accordance with the present state of
the art, as well as the guidelines based on the
information given to them by the ‫مالك المشروع‬.
 The work will be carried out according to
schedule, as long as the work is not delayed
through no fault.
 Neutral and independent work using available
experience
 All information, data and documents and the
results of the study will be held in the
strictest confidence.
 ‫ الشركة المنفذة‬can be held liable for damage due to
mishandling by their staff. This liability is limited
to direct damage and for any indirect damages
The guarantee is valid for a period of 12
months from date of Acceptance.
26. ATTACHMENT 1: DESCRIPTION OF
PLÜMAT FORM FILL SEAL LINE
PLUEMAT Form Fill Seal Line FFS 3000
Application:
The FFS-line is a fully automatic linear single lane
system suitable for the sterile bag making, filling
and sealing of e.g. IV bags under pharmaceutical
requirements.
Processed material for bag making is double wound
PP-multilayer flat film. The film is caught by several
grippers and passed through the machine.
Separate Modules fulfill the requirements for
printing, bag making, filling and sealing. At the end
of the process the filled and sealed bags are carried
out on a conveyor belt.
Two bags are produced in each station per cycle.
  Double wound Pluemat FFS machine
Polyolefin film
The frame is a welded stainless-steel construction,
subdivided in the bag maker and bag filling section.
The control cabinets, integrated with the control
panel, are mounted directly at the machine frame.
The installed safety guards made off Polycarbonate
meet the workers-safety-rules and guarantee an
optical overview as well as easy accessibility of the
individual stations.
All cables, valve terminals and drive units are stored
in one closed cable-canal. By this way the filling and
drive unit area is separated to meet the
pharmaceutical requirements.
The frame is mounted on foots with thread, so that
the machine can be align in horizontal line without
any problems.
The machines are designed for use in the
Pharmaceutical process and are in compliance with
CE standards.
All machines meet the requirements of the cGMP
and WHO regulations.
Main common features:
Machine output: up to 2500bph / up to 500ml bags
Bag volumes: mainly 100, 250, 500, 1000ml (others
on request) Sealing method: SFC port system
Processed film: Polyolefin film, double wound
PP-multilayer flat film Sterilization temp.: 121°C
CIP/SIP: included
Printing: machine is equipped with hot foil printing
device
Time of operation: Start - Stop - Start procedure at
any time Power supply: Lowest Power supply
requirements
Operation: One operator permanently, second
temporary
Bag format exchange: less than one hour, by the
operator Flexibility: Highest flexibility regarding
- Various bag volumes
- Bag designs
- Machine output
- Time of operation
- Exchange tools for bag layout
- Processing of different pharmaceutical fluids
Options:
- welding devices as exchange parts to go for
different bag volumes
- Special bag welding devices as exchange parts to
go for special bag design, such as double chamber
bags, triple chamber bags
- exchange parts to go for single port bags or
double port bags
- Printing clichés made from brass
Simplicity in operation, maintenance and machine
adaptation:

Simple exchange parts increase the machine

flexibility regarding various applications
enormously. The exchange of such machine parts
is simplest. This work can be done by customer’s
staff easily. It requires less time and no special or
heavy tools.
Major technical machine data FFS 3000

Output: up to 2500 bags per hour Filling product: IV

fluid
Filling temperature: max. 55°C
Filling accuracy: at 500 ml +/- 0,7 %; at 1000 ml +/-
0,5 %
Sterilization: the filling system is in-line sterilisable
up to 121 °C, CIP/SIP device is included.
Power feed: 230/400 V, 50 Hz
Power requirement: approx. 16 KW (excl. LF)
Power consumption: approx. 6 KW (excl. LF)
Laminar Flow: approx. 3 KW
Cooling water: Approx. 100l/h, 15 - 20° C
Compressed air feed: 6 bar, free of oil and dry
Assembling structure: Pipe connections and valves
shall be of sterile products, be easily dismounted
and cleaned, compare to cGMP requirements.
Sealing points (gaskets), lubricating point,
pneumatic parts shall be of good sealing, and no
leakage of oil, gas and water.
Piping, pipe connections, flexible hose connections
and valves connections point shall be of no dead
points. For the installation points such as control
loop, electric parts, sensors and lubricating points
and easy-to-wear parts, there shall be enough space
for the convenience of service and maintenance.
Material: All product contact steel parts are made of
stainless steel 1.4404/1.4571. All other product
contact parts such as flexible hoses and gaskets are
not be toxic, do not have any chemical reaction with
the solutions, can stand sterilization temperature of
125° C, do not give out particles, be wear resisting,
anti-aging and not be deformed.
Gaskets are made off Silicon, Teflon and EPDM. All
other parts are made of stainless steel 1.43014. The
pipe connections meet the requirements of DIN
11850 and the sterile screws the requirements of
DIN 11861/1 Operators: 1 permanent, second
operator temporarily
Accessories: laser printer for online process
documentation included
Machine documentation: instruction and operations
documentation in English in paper form / DVD
Description of the bag and the bag components:

Bag design: Twin- or single port bags with SFC port

system*
*The machine has to be equipped with exchange
parts to manufacture both bag types.
Bag design: e.g. 90-2389 (500ml)
Bag sizes: from 50 up to 5000ml
Bag material: Polyolefin double wound multi-layer
flat film
Bag printing: Hot Foil printing, one colour optionally
multi-colour printing Welding method: Contact heat
welding
PLÜMAT SFC-Port system
The Pluemat FFS line is going for single/double port
bags, processed sealing system is the SFC port
system. This sealing system is especially developed
for pharmaceutical applications and would
increase the total bag costs extremely.
The SFC-Port consist of three individual parts, these
are port, stopper and cap.
27. ATTACHMENT 2: PROPESED PLANT
LAYOUT

ATTACHMENT 3: SITE MASTERPLAN