This Blister Packing Machine URS is provided to aid the user through the important components, variables and options necessary to procure a functional Blister Line that meet the user’s needs in the most cost effective method possible.
The URS is then provided to the supplier to provide a price quote for purchase of the Blister Packing Machine including the design and manufacturing of the equipment.
SCOPE:This document will provide the user requirement for a Blister Packing Machine. These requirements define the business needs of the user, clearly and precisely identify what the user requires the system to do, and states any constraints, regulatory and documentation requirements associated with the design fabrication and supply of a Blister Packing Machine. The purpose of Blister Machine is to blistering ampoules / ampoules & vials
The section shall consist of flow scheme:
Validation Plan:
The machine will undergo the qualification and validation activities stated below. All qualification and validation protocols and reports, according to the subchapters below, need to be formally approved by QA, Production & Engineering. The equipment supplier or vendor has specific responsibilities as outlined by the Validation Plant and this URS.
Figure: Validation Approach
Scope of Work:
One complete equipment according to this specification.
FAT in the manufacturer’s factory
Installation, Start-up and SAT at The ACME Laboratories Ltd.
Spare Parts
Documentation
Qualification including protocols and execution
ENVIRONMENT & OPERATION:
Layout
The Blister packaging machine shall be installed in the secondary packing area. Room Height is 2.7 m
Physical condition and room classifications:
Room temperature packing area is 22 ± 20 C, relative humidity 50% ± 5
Utilities
Requirement of utilities to be specified by the supplier and must be supplied at the time of quotation.
Normal Operation
The Blister packaging machine shall blistering as per requirement.
Quality requirements
The output of the Blister packaging machine (Alu-Alu, Alu-PVC, Alu-PVDC) shall be airtight (leak proof), and easy to handle in secondary packaging area.
The packaging characteristics (numbers & placement pattern of ampoules per blisters) have to be possible to modify by changing the process parameters and required change parts.
Blistering of different products (ampoules of different sizes & shape) will be done in the same machine. The downtime for the line clearance has to be minimized (batch changeover time)
The blisters produced shall be free of empty pockets. If so the same shall be detected by suitable mechanism in the machine.
Capacity
The blister packing machine shall be able to produce at a rate of minimum 60 blisters/min with combi pack.
The foils can be Alu-Alu; Alu-PVC or Alu-PVDC
Data sheet for vial for 10 ml / 15 ml tubular vial.
The product loss in the blistering section shall be less than 0.1%.
The ampoule output temperature from the machine shall be less than 30-350 Centigrade.
Preliminaries
The incoming ampoules which need to be blister packed, will be of different weights, sizes & shapes.
Process / Operation
The ampoules, which are in trays, shall be loaded into the inlet chute of blister packaging machine manually.
The films will be un-winded from the reel lock & made to pass through the heating plate followed by forming (as per the desired pattern the blister) to form grooves, where the ampoules shall be placed.
The ampoule in inlet chute shall pass through orientor & retainer (auto feeding device), which shall arrange to retain the ampoules in the preset pattern, before being placed in the formed blisters.
The ampoules shall be placed in the grooves of the blisters, followed by sealing by lid ding foil from blister pack.
The entire web of blister packs shall be coded. (Batch No., mfg date & exp date etc.)
The indexing & trimming mechanism then cuts each blister from the web, followed by trimming of the blister edges.
The misfiled mechanism shall check cach blister for preset number & placement arrangement of ampoules. In case of deviation the misfiled mechanism shall divert the path of such blister to rejects.
The discharge from the blister packaging machine shall be fed to an inclined conveyor to suit the inlet conveyor of secondary packaging machine, if the discharge is at a lower level.
The cut roll is controlled in a separate spool, which will later be removed, from the machine.
There shall be continuous blowers to take away the heat from the forming area.
Effluent/Drainage
The chilled water will be circulated for cooling of heating mechanism in the forming tool.
Quality Control
Checking of blisters for empty pockets
Cleaning / Sanitation / Sterilization
The blister packaging machine shall be designed with an accent on cleanliness & easy accessibility to all parts to ensure easy maintenance and cleaning for changeover.
The equipment shall be easily accessible for manual cleaning of the outside surfaces.
The IPC bins/blister hopper shall be removable and manually cleaned in a separate washing room.
Instrumentation
All doors and hatches giving an access to moving parts shall be equipped with safety switches, which stops the machine immediately and activates an alarm.
At least the following measurements shall be measured automatically online, continuously shown on HMI and printed on process printer:
Aluminium/PVC/PVDC foils left over roll feedback both for blister foil & lidding foil.
Auto data storage on power failure
Chilled water inlet & outlet temperature.
Date, day, time operator name, batch no. details
Diagnosis record.
Digital rate indicator (units/minutes).
Inlet pressure and supply of compressed air.
Inlet pressure and supply of nitrogen gas.
Job / run selector.
Level of ampoules in the hopper
User & ID password dialogue
Product counter (reset table)
Production record printout
Recipe/ ingredients numbers fed to the machine for a particular batch
Reject Counter
Run indicator light.
peed adjustment
Temperature setting of the forming tool
Coding setting details like batch number date of mfg, lot no., exp date etc.
Necessary Programme
Suitable programming tool from Siemens or Allen Bradley for PLC program and for HMI application.
Total number of recipes (different placement arrangement, no. of tracks) to be stored in the control system memory at least 20
Control System and Automation
The machine shall be equipped with a PLC, an operator panel and a removable remote mobile hand panel used for machine settings.
The PLC controls the process and acquires data from it. Via HMI the operator is able to feed parameters and control commands for PLC. HMI visualises the functioning of the equipment to operator.
The system shall be able to log data from the process and operator actions.
The system has ability to manage several user levels, ID’s and passwords.
The system must have a local stop capability that shuts the system down in an orderly manner.
The PLC-unit shall be equipped with sequence programs for starting and stopping the entire machine, for controlling the normal operation.
All text signs on control knobs; switches, operator panel etc. shall be in English language.
Utility Failure
The control system shall work such that a utility failure does not break the process/system or cause hazardous situations.
PLC and HMI programs must retain on electric power failure. System recovery after power failure must be possible.
The stored data must retain on electric power failure.
When reconnected after an electric power failure, the system must not start automatically any control actions without operator input.
Emergency Stop
Emergency stop must stop the complete machine immediately in a safe way.
Emergency stop buttons must be positioned on both sides of the tunnel & in the technical area so that operator can reach the stop from all sides of the machine.
Restart after operator shall perform emergency stop from the HMI in an easy and safe way.
All operator settings shall be unchanged and restored after an emergency stop.
Error Handling
If a hardware failure occurs, the complete machine must stop immediately in a safe way.
Alarms
Error messages on HMI shall be in plain text with fault code.
All alarms shall be indicated by a light column & audible signal.
All alarms shall be continuously printed on paper.
TECHNICAL SPECIFICATIONS
Material and surface finish of parts in contact with the product
All contact parts shall be made of stainless steel AISI 304 or compatible.
Surface finish of chamber, trays etc. in the chamber shall be Ra < 0.5 after electro polishing.
The contact surface finish shall be electro polish.
All contact parts rather that stainless steel should be food grade material.
Material and surface finish of parts not in contact with the product
SS AISI 304 or equivalent shall be used in surface that are not in contact with the product.
Material and surface finish of outer surface
All material used in the equipment shall be of durable type.
The outer surface finish shall be of easily cleaning type.
Outer surface finish of stainless materials in classified rooms shall be mirror polished, if not otherwise stated.
Non-metallic materials
Elastomers in direct contact with the product after treatment shall be according to FDA Code 21 CFR 177.
Hoses, gaskets, diaphragms and O-rings in direct contact with the product shall be PTFF and/or EPDM, Kalrez or silicon.
Oil in instruments in direct contact with the product shall be according to FDA Code 21 CFR 177.
All non-metallic materials used in the equipment shall be of durable type and must withstand cleaning with ethanol 70% and detergents.
Hoses in contact with the product or clean utilities shall be food grade quality, anti-static.
Insulation Material
Insulation of the equipment should be cGMP norms and specified by the supplier.
Material of the signs and name plates
All materials used in the equipment shall be of durable type and must withstand cleaning with 70 % ethanol and detergents.
The signs and name plates shall be made of stainless steel AISI 304 or compatible with at least the following information: Item number of the equipment given by the purchaser, manufacturer’s type; size and serial number, manufacturing year, material, other information requested by the authorities.
Demand of Construction
General
Working height of the Units shall be 1000 mm above the floor and variable at ± 25 mm. If more, a suitable service platform has to be provided for the equipment.
The Units shall be equipped with anti-static parts in contact with the product.
All the machines should rest on levelling screws provided with pads to enable proper levelling of the machine on the production floor.
Blister Packaging Machine:
The blister packaging machine shall be equipped with auto feeding device.
The machine shall be equipped with misfeed device to divert the path of those blisters, which are not filled/packed as per the preset condition.
The machine shall be equipped with safety guards for avoiding human injury.
The blistering machine shall be equipped with coding embossing /jet-printing provision as per requirement.
The machine shall be equipped with perforation device for cutting / providing perforations across the blister web as per requirement.
The machine shall be equipped with inclined conveyor at the end of the machine to convey the blisters to the secondary packing section.
The blister machine shall be designed for easy manual cleaning & material movement & better validation.
The unit must belong to standard GMP design.
The unit shall be designed for fail-safe condition.
Pipes & Hoses
Utilities are provided according to installation drawings.
Pipe and hose connections in contact with the product shall be TC or other hygienic type.
The liquids from the system if any shall be led to drain.
The drain piping shall be equipped with an air gap, no less than 50 mm.
Hygiene Design
The equipment shall be easily accessible for cleaning.
The floor under/around the equipment shall be easily accessible for cleaning.
Cleaning Outer surface of the Equipment
All parts which face the clean room environment must be made of durable type and withstand cleaning with
ethanol and detergents. The outer surface shall be easy to clean, without grooves and pockets to reduce risk of contamination.
Insulation
All hot surfaces must be insulated or protected by suitable means.
Supplier to specify heat emission of the water pre-treatment system during max. operating temperature.
Identification of Equipment
The name plate shall have at least the following information: Item number of the equipment given by the purchaser, manufacturer’s type; size and serial number, manufacturing year; material etc.
Separate pieces of equipment like motors, gear boxes, instruments, valves, etc. shall be supplied with equipment name plate according to supplier standards approved by client.
The equipment item numbers have to be used in all documentation of this purchase.
Noise Level
Noise level of the equipment shall be as low as possible, and must not exceed 75 dB (A) measured at operator working places.
The variation level of the equipment shall fulfill the requirements according to ISO 10816.
Dispatch
Before packing and dispatch the water treatment system must be well cleaned inside as well as outside and dried.
Before packing and dispatch connections – like TC connections – shall be sealed.
Calibration
All transmitting instruments shall be calibrated upon delivery including traceable calibration protocol.
All transmitting instruments shall be recalibrated in place after installation.
The supplier shall deliver basic data for issuing an SOP for recalibration.
Programmable Control Systems
Suitable PLC from Siemens, Allen Bradley, Omron.
The circle time of the PLC program must be 100 ms.
Profibus DP is preferred if field bus is used.
PLC must have 10% spare I/O of each type (DI, DO, AI, AO) after SAT.
PLC must have 30% free memory space after SAT.
Demands of instrumentation
The valves in the system shall be controlled either with pneumatic actuators or manually.
Valves that are controlled with actuators shall have safety position spring close/spring open.
The actuators of the open/closed valves shall work with compressed air in the pressure interval 5-7 bar, g.
Critical valves shall be equipped with position-indicators.
Position-indicators shall be inductive of type PNP.
The instrument enclosure materials shall be made of durable type and must withstand cleaning with 70 % ethanol and detergents.
The instrument cabling materials, including cables, racks, clamps, and other components shall be made of durable type and must withstand cleaning with 70% ethanol and detergents.
Measurement inaccuracy including repeatability and hysteresis must be within +/- 10% of the range.
Minimum protection class of equipment is IP54.
All wiring installation shall be marked in both ends as well as on the connection plinths.
There shall be enough cable to allow calibration of instruments “ in place”.
Demands of the control equipment
System components shall be suitable for this application. Industrial components of high quality shall be preferred.
System must be equipped with Ethernet communication card in order to in the future transfer relevant data (e.g. statuses, measurements and alarms) to higher level systems (e.g. SCADA and Data Server).
Transfer protocol of the Ethernet is TCP/IP. Transfer rate is > 100 Mbits/s.
The machine will be equipped with a PLC unit.
The machine shall be equipped with a process printer. The printouts shall be archive-persistent.
The program structure must be modular and well defined. Graphical representation shall be preferred. Attention shall be paid to readability of program code.
Alarms and critical process parameters shall continuously be printed on the system printer during processing.
Preferred operator panel is graphical colour panel of type Siemens FAT/IQ Simatic or Omron.
HMI graphics and text design must be clear and unambiguous for FAT operator.
Screen update time must be less than 3 seconds.
System must have at least 3 different access levels.
Level 1 – Operator’s Access:
input of operator’s password (on a local level)
Input of verifying operator’s password (on a local level)
Equipment operation.
To allow viewing and reset of all equipment alarms.
To allow viewing of all equipment set points (including alarms).
View and reset product counters.
Level 2 – Maintenance Access:
Cycling and checking of line system and subsystems
Level 3 – Supervisor Access, Level 1 Access +
To allow changing of all equipment set points (including alarms)
To allow the system clock
The PLC shall be locked when the operator key is not inserted in the machine.
Users must be automatically logged out after a configurable time period of inactivity.
There must be possibility to step through sequences manually (user will correct access level)
Latest alarm must be displayed on alarm list in HMI screen.
The alarm massage must include at least tag name, time and date, explanation of alarm.
There must be a possibility to define Lo, Lolo and Hi, High alarm limits for measurements.
HMI must have a alarm page which shown all alarms.
There must be a configurable time delay and hysteresis for measurements alarm limits to avoid oscillating alarms.
Minimum length of password is 8 characters and maximum validity period is 60 days (shall be configurable parameters).
Control Cabinets:
The control cabinet shall contains all electrical and control components including main switch and fuses, breakers and contactors for all motors, relays and timers, step down transformers for single phase and control voltage.
The control cabinet is placed next to the machine.
The surface of the control cabinets shall be as the rest of the machine
There shall be 20% reserve space for the future expansion for apparatus cables after installation is completed.
Cabinet shall be equipped with lighting and 230 VAC outlets for service. They shall be disconnected by the main supply disconnect device. Floor cabinet shall be provided with a base.
potential free contacts for possibility to export signals, alarms. testing shall be performed on all analogue and digital inputs and outputs to prove that:
The whole loop from the HMI to the object works
The HMI has the correct tag numbers for each object
Relevant alarms are printed on the HMI.
Marking:
All equipment in the control system shall be marked so they can be identified.
Program and wiring diagrams must use the same tag names for instruments as in the functional specification.
MAINTENANCE & SPARE PARTS
Maintenance
The machine shall be built with intention for quick and easy access for service and maintenance.
The supplier shall provide customer an adequate training for operation and maintenance of the control system.
The supplier shall propose a maintenance agreement.
Spare Parts
Spare parts, recommended for two years of normal operation.
Special tools necessary for service and maintenance shall be stated as a separate post in the quotation
The supplier shall provide a list of recommended spare parts of the control system.
LEGISLATION & STANDARDS
The equipment shall be built, certified in accordance with all applicable EU directives, The equipment shall be validated and used in accordance with cGMP requirements for medical device / pharmaceuticals.
General Laws and Directives:
The supplier shall comply with and work in accordance to an established and documented QMS.
The supplier’s QMS shall be certified to a recognised quality standard e.g. ISO 9001, cGMP or QSR
The equipment shall fulfil the requirements of the EU Pressure Equipment Directive (PED)
The unit shall fulfil the “ EC declaration of conformity for machinery, Directive 98/37/EC, Annex ll A” and be provided with a CE-label.
Regulation of The Bangladesh Work Environment Authority.
Noise level measurements shall be carried out according to ISO 3746.
Electro-Technical Standards
The supplier shall comply with the standard EN 60204-1 Machine safety, Electric equipment of machines.
Vibrations according to ISO 10816.
Equipment shall also meet 73/23/EEC Low Voltage Directive and 89/336/EEC EMC Directive.
All electrical equipment and installations will be in accordance with European standard (IEC).
Laws and Standards Concerning Preparation of Pharmaceuticals Device
The blister packaging machine shall fulfil all cGMP, PIC/S, EU and FDA requirements for pharmaceutical manufacturing.
GAMP 4, Guide for Validation of Automated Systems (ISPE), should be followed.
The automation system shall fulfil 21 CFR Part 11.
Regulations and Requirements
The supplier develops, manufactures and delivers the equipment and the associated documentation and service according to these URS.
ASPL shall be entitled to inspect and audit the suppliers QMS and the facilities, if desired, prior to any business agreements.
The supplier takes full responsibility for the function of the machine.
QUALIFICATION
Documentation of Machine Test:The tests consist of functional checks and the respective documentation during the first start-up the equipment
The following tests must be performed: the movements, settings, monitoring, control connections, motor connections and the motor functions, the specifications and setting of the pneumatics, hydraulics, cooling, the safety functions including alarm displays, the operating panel displays with setting functions, the tightness of the hydraulic, pneumatic and vacuum systems
The checks of the aseptic systems are an important part of the machine test.
The documentation includes: the functional test of aseptic program, including valve positions the pressure of the system the calibration of the temperature probes for the registration of the sterilisation temperature and the calibration of the measuring instruments. filter test protocols (only for machines with the “in-line Test”)
ASR particle test
ASR over-pressure test sterilisation temperatures for all temperature probes of the system cleaning and passivation of the system (passivation regulations and protocol)
The supplier shall provide a written proposal with in 02 weeks of receipt of this document at the factory site.
Supplier will prepare the DQ (Design Qualification) and get approval from authorized man of the clint in advance.
Supplier shall provide the following documents, at the time of the offer submission and inspection visit/acceptance trials, all in English language.
Equipment completeness and compliance to the specifications and design
Process flow chart
P&I diagram
Equipment Operational compliance
Proper IQ, OQ, PQ protocol & execution report.
Detailed piping layout- Isometric with all components, with slops indication in accordance with the premises in consideration. Necessary of ensure correct hook up points (no dead leg). Details of supporting device / systems.
All Mechanical Plans “As built Drawings”
All Electrical Plans “As built Drawings”
Instruction Layout-equipments, pipes, cable trays, tanks, valves etc.
Copies or samples of any checklists used to record tests and checks.
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:
Proposed issue dates of documents
Approval dates of documents
Key activities
The critical path
The following manuals / drawings to be provided by vender – (Soft & Hard Copies)
Installation Manual
Operational Manual
Service Manual (Including trouble shooting and maintenance)
Routine maintenance schedule and change parts
PLC ladder diagram
Wiring diagram
Equipment layout diagram
Control Panel Board Electrical Assembly drawing & others necessary.
Complete spare lists.
Operator interface instruction manual with screen printed Flow chart.
Hardware design specification, technical documentation and manuals, input/ output list, software source code (backup on memory card), operation interface program (back up on memory card) for computerized control system,
Technical Documents
List and specification of all equipments, valves & components, pipe fittings, Electrical & pneumatic, Instruments & PLC controlling.
Pressure vessel pressure hold procedure & test report.
Passivation & cleaning procedure and report for pressure vessels & sanitary pipes.
Manufacturer data sheets & technical documentation of all valves & components.
Sanitary piping pressure holds procedure & test report.
Electrical, instrumental & pneumatic component list & specification, schemes with cross reference.
Manufacturer data sheets & technical documents for Electrical, instrumental & pneumatic component.
The supplier shall deliver basic data for issuing an SOP for recalibration of measuring instruments.
Safety instructions & Training documents, user’s manuals for all components.
The offer must include the process description, flow chart, elevation drawing of equipment dimensions for space
needed for installation, machine size dimensions, total time required for job complete, preliminary P&ID, list of project and quality documents.
Certificates
Material certificates for all metallic parts in contact with product.
Material certificates/statements for all non-metallic parts/gaskets in contact with product
Certificates and/or measurement protocols for surface finish for all metallic parts in contact with product.
Declaration of conformity/CE certificate
Cleaning certificates.
Noise levels certificate/measuring protocol.
Calibration certificates with validity date & signature of measuring apparatus (like pressure sensors / transmitters, Temperature sensors / transmitters, Flow sensors / transmitters, Hardness & Conductivity sensors / transmitters etc)
Training certificate.
Certificate of archive-proof printout.
Surface roughness certificate
Pressure vessel certificate by official authority.
Welding documentation
Welder certificates, for hygienic piping.
Welding logbook (welding data, visual inspection).
Welding identification maps.
X-ray test logbook on 10 % of welds.
Borescope test logbook on 50% of welds & Videos.
Passivation certificate.
Welding procedure specification for sanitary pipes.
Welding Isometric drawings.
Welding Machine general set up & daily set up reports.
Welding Master sample Quality control reports.
SUFFICIENT SAMPLES OF WELDED MATERIALS FOR TESTS & PRESERVE
The supplier shall specify and agree with ASPL the quantities of materials and components required for his own tests and for acceptance trials as agreed and confirmed prior to ordering, together with delivery date required and method of packaging within one month of placement of the order.
ASPL shall undertake to supply free of charge the materials/components requested by the supplier for tests and trials by the date specified.
Suppliers will carry the materials by own cost.
RESPONSIBILITIES
Supplier’s Responsibilities
Supplier is fully responsible for supply, installation and commissioning of the plant and loop system.
Vender / supplier must follow the GMP and should comply with USP 34.
Supplier will prepare the DQ and get approval from client in an advance.
All materials of construction must comply with GMP requirements for materials of contact and be certified.
All certificates should be handed over to client
The acceptance / signature of ASPL on any document provided by vender/ supplier shall not withdraw the responsibility of vender/ supplier regarding the achievement of the performance criteria defined here.
Vender will nominate a project manager and pass his resume to client for information.
Supplier will provide specification of utilities required for installation & operation of system within two weeks from received of L/C or PO.
Supplier shall be responsible for any damages to existing facility caused by supplier people and be compensated thereof as appropriate to client.
Tracking any change after DQ, through a change control procedure to be approved by client.
The supplier guarantees that all calculations, plans, estimates and other documents shall comply with the standards of the trade.
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.
Critical Instruments for machine qualifications checking to be provided by the machine manufacturer.
Provide a list of user in Bangladesh of the quoted machine.
ASPL’s Responsibilities
Provide Argon gas for welding, chemicals for passivation and managing wastes disposal.
Shipping to Chittagong Seaport
Custom Clearance
Transport of equipment from Chittagong to factory site at Dhamrai.
Unloading, temporary storage, movement into position.
Provision of suitably qualified maintenance personnel for attendance at FAT and training by supplier, both at supplier’s work on site.
Provision of suitably qualified and experience tradesmen to conduct installation under supplier’s supervision.
Civil work, associated with installation.
Arrangement to make available necessary utilities (electricity, compressed air, steam, chilled water, potable water)
FACTORY ACCEPTANCE TEST
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 ASPL 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.
FAT protocol to be prepared by vendor, which will be approved by ASPL. Protocol to executed jointly by vendor and ASPL representative.
The Factory Acceptance Test protocol shall be submitted to the user for review and approval prior to execution.
During this visit the equipment will be inspected and examined for its compliance with this specification; and appropriate tests performed:- e.g.
Provide documents of Design qualification
Wherever possible a complete production run at normal operating rate for a period of not less than 3 hours duration.
Regeneration, sanitation including cleaning, dismantling and reassembly of pumps and valves, etc.Inspection of plant’s mechanical, pneumatic & electrical components to correct hydraulic & electrical installation, marking and check Compliance with documentation.
Inspection of the factory certificates and calibration certificates and the welding documentations.
Determination of compliance with agreed specification an / or regulations.
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 dispatched to the
SITE.
For any revisit by ASPL as a result of a failure at Inspection visit and/or Acceptance Trials; the costs including travel and hotel shall be at the supplier’s expense.
ASPL specialized pharmaceuticals limited reserves its rights for sending representatives to vendor workshops, in order to Audit vendor documentation tracking system, follow up, any time during the progress of works.
SITE ACCEPTANCE TEST (SAT), COMMISSIONING, VALIDATION AND TRAINING OF OWNER’S PERSONNEL
The supplier shall quote separately for the provision of competent English speaking, Commissioning Engineer (or
Engineers) on site to:
Supervise the installation of the equipment.
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.
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).
The training of client’s maintenance personnel:
The supplier should comply with the following validation requirements as appropriate:
Demonstrate compliance with the Specification.
Visual inspection of the systems for leaks.
Verification of the performance data of the individual system flow rates, pressures, water quality, temperature control.
All DQ, IQ, OQ & PQ documents has to comply the cGMP standards.
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-6 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 client).
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.
All Qualification protocol (IQ,OQ & PQ) should be prepared by vendor which will be approved by client
IQ & OQ should be executed by vendor which will be sign off by vendor & client.
Vendor shall be released the project only after the full satisfaction of the customer when all performance criteria are achieved satisfactorily.
PQ protocol should be executed by client including the analysis of WFI sample.
ASPL May be engaged 3rd party for the checking of performance according to agreed specification compliance with
CGMP requirements.
The supplier would be required to undertake the validation tests and record all data in the prepared protocols on site, witnessed by ASPL’s representative.
It will be the supplier’s 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 supplier’s expense.
Manuals & Maintenance Instructions:
Operator Manual / Installation and assembly instructions for all devices
User’s manuals for all components
Trouble shooting guide / Maintenance Manual
Safety Instructions
Training Documents
DOCUMENTATION STANDARDS
All certificates must be dated and signed.
Calibration certificates for testing instruments shall show the period of validity.
All checklists must have a signature and date by each item. (A tick or cross is not sufficient).
Acceptable limits must be indicated for each design parameter.
Full explanations must follow any results that deviate from design parameters.
Any alterations or corrections to the documents should be initialed and dated.
Correction fluid should not be used. Corrections must be made by deleting with a single line and signed and dated.
A statement shall be incorporated into the documentation, which details the qualification and position of every signatory.
Drawings must be annotated to show that they have been checked.
The position (Job title) and affiliation (company) of all persons signing protocols must be shown.
All documents should be on English.
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). ASPL will not be responsible for any costs associated with storage due to the supplier’s
failure to comply with the Schedule of Key Dates.
It will remain the supplier’s responsibility to adequately protect equipment under his supply whilst in transportation, off loading and final positioning up to and including installation and commissioning.
CHANGE CONTROL
The changes in documents are as followed and manage as per approved change control policy.
