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Type of Construction - State of the Art GMP Materials: S.S. AISI 316/316L Cleaning Interchangeability Format or Product change Effectiveness of Seals Heat Insulation 450C No Asbestos Electrical Requirement


Noise level < 75 dB(A) Machinery Safety & Guarding of dangerous parts Appropriate National Standards E.g. B.S. TUV, ASME, ISPESL. Supply of pressure reducing valves


SERVICES Characteristics of services on site Consumption (to be specified by Supplier with Quotation) Main Physical Data Changes to Services or Main Physical Data PLANS, DOCUMENTS AND O & M MANUALS CUSTOMERS RESPONSIBILITIES TRIAL SAMPLES Supplier to request quantities to be sent INSPECTION VISIT/ACCEPTANCE TRIALS Acceptance trials at Supplier's works INSTALLATION COMMISSIONING AND VALIDATION ON SITE & PERSONNEL TRAINING EXPORT PACKAGING, DELIVERY FOB, INSURANCE AND PROTECTION.

ARTICLE 5: ARTICLE 6: ARTICLE 7: ARTICLE 8: ARTICLE 9: ARTICLE 10: ARTICLE 11 Name Prepared by Checked by Checked

Designation Executive, Engineering Manager, Maintenance Sr. Manager,

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Signature & Date

Tridip Bhattacharjee Mazibur Rahman Mizanur Rahman

SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. by Reviewed by Approved by Production Sr. Manager, Maintenance General Manager, Factory

A.K.M Khairul Alam Jiban Kumar Ghosh


Compression of Pharmaceutical powders or granules into tablets at variable speed The machine will complete of - Auto loading system - Dedusting equipment - Dust collector etc. - Magnesium spray system - All connecting pipes and accessories - Tool box with necessary tools. - Supplier shall include the machinery dimension & layout of the quoted machine considering safety cover opening. The equipment defined in this specification shall confirm to: - The current state of the art GMP - European machine agency (EMA) and FDA regulations and guidelines, as may be applied to this type of equipment.

1.2. Machine Functions

1.2.1. Product: Tablets of different shapes (Round, Caplet, Oblong, Oval) and sizes ranging from 6 to 25 mm in diameter for round tablet and from 10/5 mm to 25/10 mm for Caplet tablet. Sl o. 01 02 n Name product Calbo 500 Calbo D Caplet Caplet 19 X 1459 of the Shape Size Weight RPM Output Tablet/hr . 9.2 mg 19 X 1461

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03 04 05 06 07 Cotrim DS
Calboplex Contilex Filwel Gold Filwel silver

Caplet Caplet Caplet Caplet Caplet

9.2 19 X 9.2 19 X 9.2 19 X 9.2 19 X 9.2 19 X 9.2

mg 1100 mg 1800 mg 900 mg 1450 mg 1450 mg

Supplier will fill up the above table (RPM & Output Tablet hr.) 1.2.2. Capacity: Normal working capacity of the machine should be 300000 (Three lacs) tablets / hour. 1.2.3. Design & Tooling: Double sided, D-type tooling 1.2.4. Auto loading system: Auto loading equipment is to be set for loading the powder / granules from storage drum/container to Machine Hopper. Autoloader will be On/OFF according to product level of hopper. 1.2.5. Hopper arrangement: Hopper arrangement will allow connection of lay-flat tube to the hopper, ensuring proper feeding of materials to feed frame. Level sensor required in hopper to control feed from IBC above. Level sensor will be integrated with existing control panel. Inside the hopper there should be looking glass for monitoring powder level. Surface finishes of hopper will be Internal: 0.38 to 0.51 micron Ra and External: 0.51 to 0.64 micron Ra. 1.2.6. Compaction force: Machine to be equipped with 100 KN (Maximum) pre-compression facility and main compaction force will be 100 KN (maximum)
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1.2.7. Essential Feature: Upper punch guides to be fitted with keyways for shaped punches. Dust control connections from tabletting machine and deduster to central dust extraction system. -Toughened glass hinged viewing panels. -Automatic lubrication where required. -Variable speed rotary paddle granule feeder. 1.2.8. Dedusting equipment Dedusting / polishing equipment to be set for polishing the final product. Its speed must be synchronised with basis machine speed. 1.2.9. Dust collector etc. Dust collector is to be used for collecting extra dust form the different points of the machine. Machine should have provision to control suction pressure to control dust. 1.2.11. All connecting pipes and accessories Other accessories to be used for connecting the machine as usable. 1.2.12. Tool Box Tool box to be supplied with necessary tools for maintenance the machine. 1.3. Option: Supplier should quote separate price for each option. - Auto loading system - Tablet deduster: -Tablet deduster machines, - Automatic weight controlling unit. - Safe feature with alarm system - Touch screen / operator interface including product parameter setting and monitoring system - Upper punch pressure (Pre & main pressure) monitoring system (upper punch pressure guide display system) - Dust collector - Automatic lubricating system with alarm. - Hard chrome plating for die table
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- A set of tools to assist with change part removal and replacement - Anti vibrating mounting - Additional lower cam to adjust depth of die fill - Compaction force monitoring and controlling system - Feedback to adjust depth of die fill lower cam to control tablet weight - Upper & lower punch tightness detector - Ejection force indicator - Pre & main pressure control from touch screen. - Automatic sampling system - Automatic gate to drive out of specification tablets - Parts in contact with the product should SS 316 L and other will be SS

304. Surface mounted adjacent to working area should be constructed in SS construction and complete covering of the machine top is required for ensuring safety and protection.
1.5. Wear and Tear Spare Parts

The supplier shall include a budget quotation for wear and tear spare parts and electrical and electronic spares for two years normal (single shift) operation. placement. Like autoloader filter (qty: 10 pc), all type of silicon gasket (Qty: 05 each), oil seal, scraper (Qty: 02 set), good quality upper & lower punch Dust seal (2 sets), proximity sensor, V belt etc along with other spares as recommended by the supplier. 1.6. Room dimension: Room dimension of Tablet compression is 6800 mm (L) X 5400 mm (W) X 2850 mm (H)
1.7 Documentation (In English)

List to be itemised with unit prices, after order

- Instruction manual for installation, start up, operation, maintenance, format changeover, calibration, troubleshooting; - All mechanical, electrical, pneumatic, hydraulic, lubrication plans, complete parts list with parts assembly drawing. - Logic diagram for control system/software - Manual/catalogue of all standard components, - Test Certificate of main Components,
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. - List of MOC of all product contact parts, Certificate of MOC for product contact parts, - Calibration certificate for critical measuring/monitoring instruments - SOP (Standard Operating Procedure), Design Qualification (DQ), Installation Qualification (IQ) & Operational Qualification (OQ).
Note: Except IQ/OQ, all other documents should be 02 set (01 set original & 01 set copy. Where appropriate soft copies of documents to be provided. Also check article no. 5.0 Plans & Documents for instruction on documentation. 1. 8 Customer Reference A customers list for similar model of equipment supplied (especially in Bangladesh) to be included in the offer. 1. 9 URS Revision History

RV 00 Revision No.

11-11-2011 Date

Preliminary Description


The Equipment defined in this specification shall conform to: The current state of the art GMP WHO & cGMP regulations and guidelines, as may be applied to this type of equipment.

Thus, the supplier shall in the design and construction of the equipment, be obliged to separate the purely technical parts (motors, etc.) from the purely pharmaceutical parts in direct contact with the product, so far as is practicable. Stainless steel must be welded under inert gas (argon or nitrogen) and the welds treated by pickling and passivation, to prevent any subsequent corrosion. All welds to be crack and crevice free. Internal welds and welds likely to be in contact with the product shall be ground smooth and flush. All other welds to be ground smooth. All welds shall be polished to the same standard as the surrounding areas. Stainless steel fabrication areas should be totally segregated from any areas where carbon steel machining, grinding or similar operations are carried out.
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All parts of the equipment in contact with the product shall be stainless steel, SS316L and polished or, as otherwise requested in the User Requirement Specification [URS] (Article 1) of this Specification, or other materials compliant with FDA Regulations 21 CFR 311.65, e.g. PTFE, silicone or viton rubber. Surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive, so as to adversely affect product quality. Product contact surfaces shall have a surface better than Ra 0.5 micron. All product contact lubricants shall be food grade. With the exclusion of certain ancillary items in the technical area, the use of materials requiring painting to resist corrosion shall be avoided.



The design and construction of the equipment shall be such that sharp angles and corners and other parts, not easily accessible for cleaning are avoided. 2.4 Interchangeability (In the case of several machines of the same type). As a general rule, all equipment and machines of the same type shall be identical, unless otherwise specified. All mechanical, electrical and electronic parts, and accessories including spares, should be capable of being fitted to any of the machines of the same type, without any sort of adaption. An exception to this is where matched sets are vital to the balancing of specific items of rotating equipment. 2.5 Format or Product Change

In order to reduce the time taken for a format or product change, the supplier shall make every effort to standardise the types of fixing for the change parts required for each format. All the change-parts relative to a particular format shall be engraved with the same reference, to aid identification.The facility to change format parts with the use of tools and positive location of change parts is preferred wherever practical. 2.6 Effectiveness of Seals

For normal operation with the services defined in Article 4, there must be no escape of product, water or other fluid. In the case where some loss is inherent in the normal functioning of the equipment, this loss should be contained in such a way as to prevent
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. the escape of product etc. onto the walls and floors of the production area. 2.7 Heat Insulation

During normal operation, no external part of the equipment should reach a temperature in excess of 550C. Where parts are likely to attain a temperature in excess of 550C, they should be insulated with mineral or chemical insulating materials and clad. For those parts in the pharmaceutical zone, this cladding shall be in stainless steel (AISI 304). Note: No asbestos, in any form, shall be permitted for any purpose. 2.8 Electrical Requirements

All wiring shall be carried out in accordance with the latest edition of CENELEC/IEC Regulations. All electrical equipment located in process areas should be rated to IP55 (dust proof and protected against water jets) unless specified otherwise in User Requirement Specification and terminations within the machine made in sealed junction boxes. Electrical equipment located in non-process technical (plant) areas should be rated to IP41 minimum. All equipment should be fitted with an hours run meter and should be designed to interface with the whole line to include emergency stop buttons. Control devices 4 to 20 mA for analogue signals. 24Vdc for digital. PLC preference is Siemens. ARTICLE 3: SUPPLIER'S RESPONSIBILITIES The supplier guarantees that all calculations, plans, estimates and other documents shall comply with the standards of the trade. Examinations and signature by the CUSTOMER of any document prepared by the supplier shall not on any account exempt the supplier, even in part, from responsibility. The supplier guarantees that the equipment supplied shall conform to the standards of the trade, the relevant Manufacturing Standard including Safety Standards, and the requirements of legislative or regulatory provisions applicable. In particular:-

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The noise levels at the work place for each machine, operating at maximum speed must be below 75 dB(A) at operator work position, or 1 metre from machine. The supplier shall state noise levels during normal operation of the equipment. 3.2 Machinery Safety & Guarding of Dangerous Parts

The machine guarding shall satisfy the requirements of BS 5304 (1988) or equivalent national standard. Guards shall be fitted so that machine will not run with an interlocked guard open. The supplier shall ensure that the equipment is designed as a minimum, where applicable, in accordance with the following: ISO/TR 12100 : general principles for ISO 15534 : Parts 1 & 2 1992 Safety of Machinery (Basic concepts,

design), Parts 1 & 2 2000 Ergonomic Design for the Safety of Machinery, 1999 Safety of Machinery Safety related parts Parts 1: General principles for design ISO 13850 : 1996 Safety Principles of Design ISO 13852 : prevent danger ISO 13853 : danger of Machinery Emergency Stop

ISO 13849-1 : of control systems

1996 Safety of Machinery Safety distances to zones being reached by the upper limbs 1998 Safety of Machinery Safe distances to prevent zones being reached by the lower limbs

ISO 13854 : 1996 Safety of Machinery Minimum gaps to avoid crushing of parts of the human body ISO14119 : associated with 1998 Safety of Machinery Interlocking devices guards Principles for design and selection

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Equipment shall be tested and certificated by the National Inspection Authority of the country of origin, eg. B.S. 5500, TUV, ASME, ISPESL.. In addition, SQUARES Insurers may carry out any tests deemed necessary at the suppliers works. 3.4 Pressure Reducing Valves

The supplier shall include with his quotation any Pressure Reducing Valves (e.g. for steam and compressed air), that he considers necessary. ARTICLE 4: SERVICES Supplier must complete and return this page and following page with quotation. Copy this page as necessary in cases of multiple equipment offered. Failure to comply with this requirement may render the quotation invalid. Information to be supplied by the supplier at the time of Quotation. 4.1 Characteristics Of Services On Site Max (peak) Mean __________ _______ __________

Consumption Electricity 400V (10%) 3-phase 4-wire N & Earth 50Hz

Electricity 220V (10%) Single-phase 50 Hz _______ Compressed Air (Instrument) 6 bar Compressed Air (Product Contact) 6 bar Main Physical Data Maximum size installed (mm) any additional access Lx __________


4.2 -




H (mm)

Note of _______________ -

requirements _________

Maximum weight installed (kg)

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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. H 4.3 Is foot-print provided with quotation Yes/No Changes to Services or Main Physical Data Minimum size of access openings for transfer/positioning (mm) Lx Wx

Changes in any of the information shown in Section 4.1 and 4.2 above shall be advised immediately to SQUARE in writing by letter (as well as by confirmation drawing). This applies to all suppliers during the quotation period, and to the successful supplier through the contract period. ARTICLE 5: PLANS & DOCUMENTS

5.1. Documentation in English 5.1.1. Certificate of material of construction (MOC) 5.1.2. Calibration certificate 5.1.3. Design qualification (D.Q.) 5.1.4. Format for FAT / I.Q. / O.Q. documentations 5.1.4. Catalogue of used equipment / instruments 5.1.5. Documentation of sound level (not more than 75 dB) 5.1.6. Operation, Maintenance, & parts manual containing the following Mechanical assembly diagram Electrical schematic & wiring diagram Pneumatic schematic diagram PLC ladder diagram Hydraulic schematic diagram Procedure of operation & maintenance Procedure of trouble shooting using hard ware & software Transportation, Installation and Start up procedure Schematic diagram of lubrication system Instruction of cleaning etc. SOP (Standard operating procedure) Preventive maintenance schedule Instruction of change over


Within two weeks, at the latest, of placement of the order, the supplier shall issue a detailed programme for the supply of the equipment, which will include all of the dates agreed before order placement. Programme to detail the equipment supply and the following: a) b) c) Proposed issue dates of documents Approval dates of documents Key activities
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Within four weeks, at the latest, of placement of the order, the supplier shall furnish P & IDs and plans and drawings of the equipment showing front elevation, side elevation and plan view (footprint). The plans should show:Overall dimensions which shall identify any skids, etc. Position and types of connection for all services including any remote service requirements. Confirmed characteristics and consumption of all services (Complete and return copy of Article 4). Fixing points of the equipment for unloading and for into position. The weight of each item of equipment. Access requirements around the equipment for Operation, cleaning, maintenance.

moving -

Copies or samples of any check lists or documentation used to record tests and checks normally conducted at installation and commissioning, i.e. installation and commissioning method statements. Copies or samples of any checklists or documentation used to record tests and checks normally conducted at pre-delivery inspection (PDI) Factory Acceptance Tests (FAT).


The supplier shall provide, at the time of the inspection visit/acceptance trials 3 copies of the following documents, all in English language (professionally/technically translated, if necessary). Suppliers own documentation of the following: a) Equipment completeness and compliance to the specifications and design b) Equipment operational compliance All Mechanical Plans As built Drawings All Electrical Plans As built Drawings Instruction Manual for installation, start up, operation, preventive maintenance, format change over, calibration, fault finding and rectification. Approved, amended or modified installation and commissioning methods statements.
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. Approved, amended or modified validation documentation for Installation Qualification (IQ) and Operational Qualification (OQ) (Refer Article 10). Equipment Details:a) b) c) d) e) f) g) h) i) j) k) l) Manufacturer's name Model No./frame size Serial No. Drawing No.(s) Date of manufacture Test certificates and statutory documentation Performance curves for pumps, fans, etc. Technical Information: This shall include technical specifications and design duties Suppliers' spares lists for 2 years operation Lubrication schedule Preventive maintenance schedule List of all instruments

The supplier should note that where a packaged unit is offered, the information under a) - l) for component parts for each sub-supplier will be required. ARTICLE 6: DEFINITION OF SQUARES RESPONSIBILITIES 6.1. Shipping to Chittagong seaport. 6.2. 6.3. 6.4. 6.5. Customs Clearance. Transport of equipment from Chittagong to factory site at Pabna. Unloading, temporary storage, movement into position. Provision of suitably qualified maintenance personnel for attendance at FAT (Article 8) and training by supplier, both at suppliers works and on-site (Article 10). Provision of suitably qualified and experienced tradesmen to conduct installation under suppliers supervision (Article 9). Civil Work, associated with installation.

6.6. 6.7.

ARTICLE 7: SAMPLES OF MATERIALS & COMPONENTS FOR TESTS The supplier shall specify and agree with SQUARE the quantities of materials and components required for his own tests and for acceptance trials as agreed and confirmed prior to ordering, together
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. with delivery date required and method of packaging within one month of placement of the order. SQUARE shall undertake to supply free of charge the materials/components requested by the supplier for tests and trials by the date specified. ARTICLE 8: INSPECTION VISIT/ACCEPTANCE TRIALS In certain selected cases, a pre-inspection visit shall be conducted by SQUARE to check on progress and to perform preliminary checks and inspections and review documentation. The nature and extent of Inspection Visit and any Acceptance Trials shall be agreed with supplier before order placement. This shall be conducted on the premises of the supplier or nominated company in the presence of the representative(s) of SQUARE at a date fixed by mutual agreement. The supplier is asked to give at least 4 weeks advance notice, when he is ready for such visit/trials. During this visit the equipment will be inspected and examined for its compliance with this specification; and appropriate tests performed:e.g. Wherever possible a complete production run at normal operating rate for a period of not less than 2 hours duration using materials supplied (Article 7). Product change-over including cleaning, reassembly of pumps and valves, etc. dismantling and

The Acceptance Trials shall be considered to be satisfactory if the overall levels of performance of output and quality specified in User Requirement Specification - specific requirements, are achieved. Only after satisfactory Inspection (and Acceptance Trials) the equipment may be packed and despatched to the SITE. For any revisit by SQUARE as a result of a failure at Inspection visit and/or Acceptance Trials; the costs including travel and hotel shall be at the suppliers expense. ARTICLE 9: INSTALLATION The supplier shall include in his quotation, as a separate optional price, for supervision of mechanical, electrical and pneumatic installation of all his equipment, including remote items. The supplier is to list and describe the extent and termination of mechanical and electrical requirements which he regards as "by others", in order to clarify the
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. responsibilities of all parties concerned. Similarly any Builders Work or Drainage requirements must be clearly identified. Services by others may be assumed to be valved/isolated within 3 metres of the equipment.




The supplier shall quote separately for the provision of a competent English speaking, Commissioning Engineer (or Engineers) on site to:10.1 Supervise the installation of the equipment (Refer Article 9). 10.2 Check equipment installation, perform the start-up of the equipment and the commissioning to agreed commissioning method statements including the calibration of critical instruments, gauges etc. For commissioning, the quotation should be on a fixed lump sum basis with rates for man-day working, and an indication of on site programme. 10.3 Supervise Site Acceptance Tests (SAT) at site and rectify any problems. (The supplier will be asked to provide examples of commissioning documentation at the Technical/Commercial Meeting prior to order placement). 10.4 The training of client's maintenance personnel: at suppliers works at SQUAREs site in Pabna.

For training, the quotation should be on a man training day basis, with an indication of the number of days of training normally required. A training programme, to be approved by SQUARE shall be required. 10.5 The supplier shall quote separately for the following Validation (Qualification) Services. 10.5.1 Provision of detailed DQ, IQ and OQ Protocols for SQUARE approval prior to practical qualification.
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Note: The supplier should comply with validation requirements as appropriate: -

Demonstrate compliance with the Specification. Provide documentation showing that computer software has been developed according to agreed protocols to comply with Good Automated Manufacturing Practice (GAMP), in particular to comply with the document GAMP-3 or the latest current version, prepared by the GAMP forum. Provide drawings for Design Qualification at agreed dates Record all changes and advise the client of any changes made. Allow inspection during construction and testing (if required by SQUARE ). Advise the client of their test procedures. Ensure the item operates to specification. Provide documented proof of testing. Provide accurate as built drawings at agreed dates. Provide start-up, operating and maintenance instructions at agreed dates. Provide certificates of calibration for gauges and sensors and Materials Compliance Certificates when requested. Provide certificates of calibration for all testing equipment at agreed dates.

Installation Qualification (IQ) is the formal, documented inspection of the installation to verify all installation specifications have been met and that the equipment conforms to the specification. IQ Protocols should include, but not be confined to: i) ii) iii) iv) v) vi) vii) viii) ix) x) Description of item and function. Objectives of IQ and scope. Record and verification of components and documentation availability check. Verification of as built drawings and installation. Verification of services and connections. Certificates of compliance for product contact materials. Pressure test certificates (where appropriate). Certificates of all Ex-rated components (where appropriate). Test equipment used and date of calibration. Calibration of all critical instruments.
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. xi) Conclusions including a clear statement on whether the item has been successfully qualified or not.

Operational Qualification demonstrates according to a formal protocol that the equipment will operate as intended throughout all anticipated operating ranges. OQ Protocols should include:i) ii) iii) iv) v) vi) vii) Description of item and function. Objectives of OQ and scope. References to manuals, guidelines etc. required to carry out OQ. Test equipment used and date of calibration. Test objectives, methods and acceptance criteria. Test results. Conclusions including a clear statement on whether the item has been successfully qualified or not.

The supplier would be required to undertake the validation tests and record all data in the prepared protocols on site, witnessed by SQUAREs representative. It will be the suppliers responsibility to ensure the equipment conforms to the test procedures, and if a failure occurs, make such modifications as may be necessary and re-test the equipment to prove the equipment meets the requirements, at the suppliers expense. 10.6 10.6.1 Documentation Standards All certificates must be dated and signed.

10.6.2 Calibration certificates for testing instruments shall show the period of validity. 10.6.3 All checklists must have a signature and date by each item. (A tick or cross is not sufficient). 10.6.4 Acceptable limits must be indicated for each design parameter. 10.6.5 Full explanations must follow any results that deviate from design parameters. 10.6.6 Any alterations or corrections to the documents should be initialled and dated. Correction fluid should not be used.
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SQUARE PHARMACEUTICALS LTD SALGARIA, PABNA. URS OF ROTARY TABLET PRESS MACHINE. Corrections must be made by deleting with a single line and signed and dated. 10.6.7 A statement shall be incorporated into the documentation which details the qualification and position of every signatory. 10.6.8 Drawings must be annotated to show that they have been checked. 10.6.9 The position (Job title) and affiliation (company) of all persons signing protocols must be shown. ARTICLE 11: EXPORT PACKAGING, DELIVERY FOB, INSURANCE AND PROTECTION The supplier will be fully responsible for all arrangements and costs of transport, insurance, taxes and duties required to deliver the equipment to nearest seaport as required in performance of the Work under the order, i.e. a Free on Board (FOB). SQUARE will not be responsible for any costs associated with storage due to the suppliers failure to comply with the Schedule of Key Dates. It will remain the suppliers responsibility to adequately protect equipment under his supply whilst in transportation, off loading, and final positioning up to and including installation and commissioning.

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