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Eli Lilly and Company

Technical Specifications Revision 0.2

Technical Specifications

B103 Commercialization Launch Filling FacilitySyringe Filling Line

Revision: 0.2

Revision date: 27 July 2009


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Revision History

Revision Date Changes

0.2 DRAFT

Any difference between this document and any previous document must be resolved in favor of the current version.

This document contains confidential material of the company to be used exclusively by Eli Lilly & Co., its associated

companies and contract personnel.

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Prepared by:

Justin Svec B103 Senior Process Engineer

Printed Name Title Signature Date

Your signature indicates the user requirements were accurately developed for this system and are in compliance with Eli Lilly andCompany procedures.

Review and Approval

Reviewed by:

Justin Farrell Engineering. Consultant, ETC



Lyle Fait

B103 Senior Process

Automation Engineer



Your signature indicates that the requirements pertaining to your area of expertise were included.

Approved by:

Engineering / Operations Representative

Ken Weerts Manager B103 Parenteral

Eng/Ops


Your signature indicates that the requirements with product quality impact accurately reflect current process knowledge.

Quality Representative

Anne Renton Assoc Quality Consultant


Your signature indicates that individuals with the appropriate expertise reviewed and approved this document..

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1.0 TABLE OF CONTENTS

Table of Contents

2.0

2.0 Introduction................................................................................................................................. 5

2.1 Purpose.................................................................................................................................. 52.2 Scope..................................................................................................................................... 5

2.3 System Description................................................................................................................5

2.4 Assumptions.......................................................................................................................... 5

2.5 Proposal Submittals ..............................................................................................................5

3.0 Technical Specifications Matrix ..................................................................................................6

3.1 General Design .....................................................................................................................6

3.1.1 6

Outer Bag Removal Station......................................................................................................11

3.2 Mechanical.......................................................................................................................... 22

3.3 Materials of Construction....................................................................................................26

3.4 Safety...................................................................................................................................29

3.5 Electrical ............................................................................................................................32

3.6 Enclosures

34

3.7 Auxiliary Controls...............................................................................................................35

3.8 Automation, Instrumentation and Controls ........................................................................35

4.0 DocumentaTion and Data ..........................................................................................................41

4.1 Documentation ................................................................................................................... 41

4.2 Data 42

5.0 Commissioning And Qualification ............................................................................................42

5.1 Commissioning....................................................................................................................42

5.2 Factory Acceptance Test (FAT)..........................................................................................43

5.3 Shipping and Installation.....................................................................................................44

5.4 Site Acceptance Test (SAT)...............................................................................................45

5.5 Installation Qualification (IQ) and Operational Qualification (OQ)...................................53

6.0 General Options..........................................................................................................................53

7.0 Appendices........................................................................................................................... 54

7.1 Appendix A - Syringe and Plunger Reference Document................................................. 54

7.2 Appendix B - Product Defect Criticality............................................................................56

7.3 Appendix C Detailed Description of FAT Testing.......................................................... 57

7.4 Appendix D Vendor Documentation Requirements................................................... 58

7.5 Appendix E Right Information (Component) Data Requirements.............................58

7.6 Appendix F Submission Transmittal Form............................................................... 58

7.7 Appendix G Good Documentation Practices

59

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2.0 INTRODUCTION

2.1 Purpose

This document identifies and describes the Technical Specifications for the design and

operation of a Syringe Filling Line to be installed at the Eli Lilly and Company Lilly

Technology Center Building103 site! The "endor shall pro#ide a design cost and scheduleproposal for a Syringe Filling Line in accordance $ith this specification! The "endor shall becompletely responsible and liable for all e%uipment supplied $hether manufactured or

subcontracted to a third party supplier!

2.2 Scope

This document is limited to the Syringe Filling Line to be installed at the Eli Lilly and

Company Lilly Technology Center Building103 site!

2.3 System Description

The Syringe Filling Line to be located in the B103 Commercialization Launch Facility is a

direct impact system that receives 0.5ml or 1mL Long glass syringes or 3mL polymer

cartridges in a pre-sterilized nested tub format. The line debags, delids, and aseptically fills thesyringes (fill volumes between 0.20 mL and 3 mL) using either rotary piston pumps or

peristaltic pumps, inserts a plunger, and sends the filled and plungered syringes to an outfeed

conveyer. The filler will perform checkweighing at a variable, user-defined frequency. On the

outfeed conveyor, the tubs are detained until released by the filler when passing checkweigh

results are obtained. The tubs are coded with an ink jet printer, manually closed with a plastic

snap-on lid, and staged for palletization.

The Syringe Filler will be designed to operate up to a maximum rate of 600 units per minute

using up to 10 filling needles. This filling line will be used to produce clinical trial material

and approved pharmaceutical products that meet USFDA, EU and JP cGMPs.

2.4 Assumptions

&ey pro'ect assumptions are gi#en belo$(

)ll components designed to run on the filler or used for F)T testing are as listed in

Section *!1 )ppendi+ ) , Syringe and -lunger .eference /ocument and meetspecifications!

The product fluid to be tested during F)T $ill be $ater or buffer! )cti#e

-harmaceutical ngredient )-2 $ill not be used for F)T testing! Eli Lilly Buyer2

$ill pro#ide aterial Safety /ata Sheets S/S2 for all ingredients and anappro+imate composition for the buffer4placebo!

2.5 Propos! Su"mitt!s

)ny E+ceptions to the technical re%uirements in the specifications must be noted

$ithin the Submittal! Failure to note e+ceptions $ill be regarded as confirmation thatthe "endor5s Submittal complies $ith the specification!

"endor may be contacted for technical %uestions or clarifications during the re#ie$

period! "endor shall pro#ide contact information for such %uestions and

clarifications!

6ith -urchase 7rdera$ard Submittals $ill either be 8)ppro#ed as 9oted: using the

clarifications and .Fs as support for any modifications to the submittals or8)ppro#ed:!

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3.0 T#C$NICA% SP#CI&ICATIONS 'ATRI(

3.1 )ener! Desi*n

ID# Description ER Reference

3.1.1This Specification, together with attachments to it, and with

referenced Owners SECTIONS, codes and standards, covers the

scope of work and the minimum requirements for the design,

fabrication, inspection, testing and delivery of a fully integrated

syringe filling line for use in a sterile parenteral pharmaceutical

cGMP environment. This Specification covers the following:

Tag

Number

Description/Size

Outer bag removal station

Inner bag stretching and tub

accumulation conveyors

Debagger

Delidder

Filler including in-process

checkweigh

RABS enclosure for

debagger, delidder and filler

3.1.2 The post,fill process e%uipment is currently co#ered in the ;;;Specification 9o! ;;;!

3.1.3 7missions in this Specification or in thedesign of Supplier dra$ings shall in no $ay

relie#e the Supplier from its responsibilityfor furnishing e%uipment $ithin the ob#ious

intent of this Specification!

3.1.4 7ther $or< performed may include the

follo$ing(

E%uipment recei#ing and unloading

1. E%uipment installation and connections to process and utilityser#ices

=tility lines conduits and $iring routed to the e%uipment tie,in

points

Support foundation for e%uipment

Connection to 7$ner5s net$or0 S=BTT)LS

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3! SECT79 01@10 C7SS799A .E=.EE9TS F7.

C79T.)CT7.S

>! SECT79 11D> 7T7.S T.7=A ?D0 -

D! SECT79 1@@D ELECT.C)L .E=.EE9TS F7.

-)C&)AE/ E=-E9T

! SECT79 1D@1 C79T.7L -)9ELS

*! SECT79 11DD )C )/G=ST)BLE /."ES

! SECT79 1@1 9ST.=E9T ). S=--LH

@!SECT79 1@10 9ST.=E9T)T79 F7. -)C&)AE/E=-E9T

10!SECT79 1D?00 HAE9C --9A

11!SECT79 1D?00 *00 --9A SCE/=LE

1?!SECT79 1D?00 !1 --9A SCE/=LE

3.1.7 .eferences( )bbre#iations and )cronyms

)SC )merican nstitute of Steel Construction

)9S )merican 9ational Standard nstitute

)SE )merican Society of echanical Engineers

)ST )ST nternational

)6S )merican 6elding Society

CF. Code of Federal .egulations

CA- Current Aood anufacturing -ractices of the Food and

/rug )dministration =nited States /epartment of ealth anduman Ser#ices Title ?1 =!S! Code of Federal .egulations

CF.2 -arts 11 ?10 ?11 and 00

A)- Aood )utomated anufacturing -ractices published by

the nternational Society for -harmaceutical Engineering

EST nstitute of En#ironmental Sciences and Technology

S) nstrumentation Systems and )utomation Society

S7 nternational Standards 7rganization

S-E nternational Society for -harmaceutical Engineering

9E) 9ational Electrical anufacturer5s )ssociation

9EC 9ational Electrical Code

9F-) 9ational Fire -rotection )ssociation

9ST 9ational nstitute of Standards and Technology

7S) 7ccupational Safety and ealth )dministration

=L =nder$riter5s Laboratories

=S- =nited States -harmacopoeia

3.1.8 The following industry, association, and government codes and

standards shall be followed, as applicable to the design, fabrication,

assembly, and testing of all equipment furnished under this

Specification:

)9S B11!T.3,?000 Ireferenced belo$J

)9S B>!1 8Surface Te+ture Surface .oughness 6a#iness and

Lay2:

)9S B1DD!1 8-ac

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)9S KD3D!1 8Safety Colors:

)9S KD3D!? 8En#ironmental and Facility Safety Signs:

)9S KD3D!3 8Criteria for Safety Symbols:

)9S KD3D!> 8-roduct Safety Signs and Labels:

)9S KD3D!D 8Safety Tags and Barricade Tapes for Temporaryazards2:

)SSE K?>>!1 8Control of azardous Energy Loc

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E%uipment .is< )ssessment operator safety ris< analysis2 incompliance $ith )9S B11!T.3,?000 for =S and -uerto .ico

installations2 or E9 10D0 for European installations2!

3.1.11 Supplier shall either perform or pro#ide a

%uantitati#e ergonomic analysis usingindustry accepted calculation tools e!g!

97S Lifting e%uation2 to determine theneed for material handling e%uipment

during lifting pushing or pulling of machinecomponents!

The Syringe Filling system shall bedesigned such that an operator $ill not be

re%uired to lift more than 30! lbs 1>

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1! 7uter bag remo#al station

?! nner bag stretching con#eyor tub accumulation con#eyor

and debagger

3! /elidder

>! Filler including in,process chec

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to #endor5s main control panel! "endor is responsible for allpo$er and instrumentation #oltage interconnections and

distribution from this main feed! The interconnection $iring

shall be labeled both cables and indi#idual $ires and used

during the e%uipment #endor5s chec

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pass airflo$ to minimize the li to

E91?? @@!@@DN collection efficiency2 $ith Flanders Blu,Gel Seal

system and prefilters must be of type Class A> to E9**@! The

system shall include #alidation connections for the supply and

measurement of ra$ gas concentration of E-) filter integrity testaerosol e!g! -)7 polyalphaolefin22! /ifferential pressure acrossthe filters $ill be monitored but not controlled!

3.1.29 ) po$ered outfeed roller con#eyor shall be included to transport thetubs to$ards an inner bag stretching con#eyor housed in the Arade C

debag room the outfeed con#eyor shall not e+tend into the debagroom! )n operator in the debag room $ill call for a tub by

depressing a button or foots$itch thereby acti#ating the outfeed

con#eyor!

3.1.30 ) mousehole plus deadplate shall be employed to separate the outerbag remo#al station con#eyor from the inner bag stretching

con#eyor! Facility differential pressure from the debag room to theouter bag remo#al room $ill ensure continuous out$ard airflo$

through the mousehole! ) gate $ill be considered for isolation of thedebag room from the outer bag remo#al room!

3.1.31 ) $aste receptacle on $heels shall be pro#ided for accumulation ofouter bags $ith a minimum bag capacity e%ui#alent to 10 minutes

of run time at 00 syringes per minute! The bin shall be easilyreachable from the left,hand side of the enclosure through an

opening for loading $ithout the operator ha#ing to remo#e glo#edhands from under the unidirectional airflo$! .emo#al of the bin for

emptying shall be from outside the enclosure!

3.1.32 eans of remo#ing re'ected tubs prior to transport into the debag

room shall be pro#ided at the left side of the bag remo#al station!This may be in the form of a short roller con#eyor!

3.1.33 Con#eyors associated $ith the 7uter Bag remo#al station shall ha#e

an integral e,stop button protected mushroom button style!ounting locations to be sho$n on submittal dra$ings!

Inner * Stretc,in* Con/eyor Tu" Accumu!tion Con/eyor n De"**er


3.1.34 The inner bag stretching con#eyor shall be of pharmaceutical grade

and shall allo$ an operator to easily access a tub belo$unidirectional airflo$ and e+tend the tab of the inner bag to permit

subse%uent capture and slitting of the bag on the debagger machine!

3.1.35 The tub accumulation con#eyor shall pro#ide ade%uate accumulationof tubs upstream of the debagger under unidirectional airflo$

protection and shall be of hinged style to permit access to the rear ofthe line for tan< transport and line maintenance!

3.1.36 The debagger shall be of pharmaceutical grade and shall consistentlyautomatically remo#e inner bags from tubs $ithout damaging the

tubs or lids!

3.1.37 Tubs and lids shall not be contaminated during remo#al of the inner

bag! achine components contacting the bag shall a#oid contacting

the tub or lid to the greatest e+tent possible!

3.1.38 Lid integrity shall not be compromised!

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fre%uency pro#ided that the end of the bag has been properlyoriented and smoothed by the operator on the con#eyor upstream of

the debagger!

3.1.40 Failure to transfer the bag to the $aste bin shall not e+ceed 1N!

3.1.41 Limits for damage to tub nest and syringe can be found in the

/ebagger datasheet!

3.1.42 The slitting hours per day se#en days per $ee

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and prefilters must be of type Class A> to E9**@! ) CA,manifoldshall not be used on the do$nstream side of the E-) filters!

3.1.55 The system shall include #alidation connections for the supply andmeasurement of ra$ gas concentration of E-) filter integrity test

aerosol e!g! -)7 polyalphaolefin22!

3.1.56 The status of each indi#idual .)BS door shall be monitored andalarmed audible and #isual2! n order to open a door the operatormust first release the door at the !

3.1.57 The enclosure shall be pro#ided $ith automatic differential pressurecontrol achie#ed #ia #ariable fre%uency fan speed control! n the

e#ent of a lea0 bags

e%ui#alent to 11 minutes of run time at 00 syringes per minute2!

.emo#al of the bin for emptying shall be from belo$ the enclosure$ithout ha#ing to open the enclosure guarding! ) spare bin shall be

pro#ided to ensure uninterrupted processing!

3.1.61 ncomplete remo#al of the inner bag or incomplete disposal into the

main $aste bin shall be automatically detected and cause a machinestoppage and audible alarm!

3.1.62 Alo#es to be pro#ided by the customer2 $ill be used to clearincompletely opened bags disposal 'ams and other faults! Alo#e

mounting ports shall be pro#ided by the #endor $ith the enclosureand shall be designed to accommodate in,place integrity,testing of

the glo#es! o$e#er integrity testing may be performed off,line!aterials of construction and dimensions shall be e%ui#alent to those

used for the glo#eports on the .)BS surrounding the delidder andfiller!

3.1.63 Light barriers shall be pro#ided to cause immediate machinestoppage upon e+tension of glo#es to ensure safety! .estart of

machine operation must be done at the !

3.1.64 Tubs re%uiring remo#al from the line $ill be accessed by openingone of the .)BS doors and remo#al by a glo#ed operator! )s noted

abo#e in order to open a door the door must first be unloc

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De!ier


3.1.67The delidder shall be of pharmaceutical grade and shall accurately

remo#e lids and liners from tubs $ithout damaging the tubs ordamaging or contaminating the syringes and nests residing therein!

Satisfactory performance is defined by the follo$ing criteria(

3.1.68 ncomplete lid remo#al shall not e+ceed 1N fre%uency!

3.1.69 Failure to transfer the lid to the $aste bin shall not e+ceed 1N!

3.1.70 ncomplete liner remo#al shall not e+ceed 0!DN!

3.1.71 Failure to transfer the liner to the $aste bin shall not e+ceed 1N!

3.1.72 Limits for damage to tub nest and syringe can be found in the

/elidder data sheet!

3.1.73 The delidder shall not e+perience more than three percent do$ntimeannually during operation ?> hours per day se#en days per $ee

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$ill be re'ected at the e+it of the filler!

3.1.86 Alo#es pro#ided by the customer2 $ill be used to clear 'ams but are

not currently planned as bac

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3.1.98 The Syringe Filler system shall be able to complete the Rdose,inRphase $ith minimal product loss achie#e acceptance limits $ithin 3

cycles and target fill $eight 1 S/ in no more than 10 line cyclesafter line purging2!

"endor to %uote dose,in and do$n,dose 100N $eigh dosing mo#e

needles o#er scale2 for peristaltic dosing system only option!2!

3.1.99 The absolute accuracy for the chec

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syringes produced4 theoretical number produced at ma+imum speed!ean time bet$een failure mean time bet$een line stoppages due

to machine fault2 shall be no less than 1D minutes for each syringe

size!

3.1.108

) .)BS enclosure $ith dedicated laminar flo$ shall maintainArade ) internal conditions $ith the machine sitting in an e+ternal

Arade ) en#ironment! ) positi#e differential pressure shall be

maintained bet$een the filler and delidder at a minimum of D -a atall times! See Section 3!1!1;;for additional performance

re%uirements for the .)BS enclosure!

3.1.109Each -rocess 7perating -arameter shall ha#e user programmablealarm limits that are recipe dri#en! )larms shall be captured

electronically!

3.1.110 Engineering parameters shall be configurable $ithin recipes!

3.1.111 The control system furnished shall pro#ide a means for physical and

logical security!

3.1.112 The computer system furnished shall be ?1CF. -art 11 compliant!

3.1.113 Product fluids will be supplied to the filler from a small, 316L

stainless steel surge tank (by Vendor) fed by either a pressurized

formulation tank or a disposable bulk-fluid bag (both by Buyer).

3.1.114 Le#el control shall be pro#ided on the surge tan

the formulation tan< or disposable bag #ia a pinch #al#e!

3.1.115 The surge tan< $ill function $ith t$o li%uid product filters on thetan< inlet and t$o gas filters on the tan< compressed air supply!

Filters pro#ided by Buyer!

3.1.116 ) slight tan< headspace pressure is desirable for sterilitymaintenance purposes! For rotary piston filling this headpressure

can be maintained by the control system during filling operations!For peristaltic filling this headpressure $ill be used prior to filling

operations or during prolonged machine stoppages but must be#ented to atmospheric pressure for filling!(correc#"

3.1.117 The surge tan< shall be capable of recei#ing drug product at a flo$rate of at least 1! liters per minute!

3.1.118 The surge tan< shall be designed for cleanability out,of,place to a

standard of #isually clean!

3.1.119 The surge tank outlet will feed a filling manifold that will be able to

be directed to either the rotary pumps or the peristaltic pump dosingsystem, whichever is installed.

3.1.120 The manifold shall include product temperature measurement

means but not temperature control!

3.1.121 The product filters shall be sterilizable off,line in an autocla#e

preassembled to the pumps4tubing and needles and later asepticallyinstalled! The filters pro#ided by the 7$ner shall be of 7pticap >:

;L type!

3.1.122 The product filters shall be located belo$ the height of the sterile

holding tan< bottom outlet and abo#e the base of the surge tan

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be connected to the machine table and be mechanically complete$ithin a t$o hour time period!

3.1.124 Filling and plunger handling components shall be capable of beinginstalled using aseptic techni%ues using locating pins and minimal

tools and zero aseptic connections! Final assembly and ad'ustment

steps shall be feasible through glo#eport rather than #ia open .)BSdoors!

3.1.125 The filler shall include automatic $eight ad'ustment based on

feedbac< from an -C chec

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3.1.136 The Syringe Filler system5s plungering operation shall operate atline speed despite t$inned or clumped plungers! This can be

achie#ed by a mechanism $hich sorts and discards clumps or

t$ins!

3.1.137 mproperly filled or plungered syringes shall be automatically

detected and re'ected as an entire tub at a re'ect station on the filler!mproperly plungered syringes include those missing a plunger andthose $ith plungers in a high position! )ll syringes must be

plungered before re'ection! The Syringe Filler $ill maintain acorrect count of plunger faults o#er the course of a batch filling

operation! issing and improperly positioned plunger re'ects shallnot e+ceed ?N of total units filled! Tubs continuing on to the

outfeed con#eyor $ill be automatically counted!

3.1.138 Tubs containing out,of,spec fill $eight syringes shall be trac

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enclosure to Arade )! The .)BS enclosure for the debagger shallcontrol the internal en#ironment to Arade B!

3.1.145 Satisfactory performance is defined by the follo$ing criteria(The.)BS enclosure shall not e+perience more than 0!DN percent

do$ntime annually during operation ?> hours per day se#en daysper $ee: or 0!?:

6A2! )#erage air #elocity $ithin the .)BS continuouslymonitored shall be @0 feet per minute!

3.1.152 E-) filters must be of type Class 1> to E91?? @@!@@DNcollection efficiency2 $ith Flanders Blu,Gel Seal system and

prefilters must be of type Class A> to E9**@! ) CA,manifold $illnot be used on the do$nstream side of the E-) filters!

3.1.153 /ifferential pressure across the E-) filters and air #elocity shall be

monitored and alarmed!

3.1.154 The system shall include #alidation connections for the supply andmeasurement of ra$ gas concentration of E-) filter integrity test

aerosol e!g! -)7 polyalphaolefin22

3.1.155)ir temperature $ithin the enclosure shall be continuouslymonitored but not controlled!

3.1.156 Lighting $ithin the enclosure shall be to JD00 Lu+!

3.1.157 Alo#eports shall be o#al in shape $ith opening size of ma'ordiameter 3> mm and minor diameter ?3 mm! eight of the ports

off the floor and horizontal locations $ill be determined by Lilly atthe #endor5s location during fabrication using temporary clear

plastic $all panels! -orts $ill be positioned to pro#ide glo#eaccessibility for all critical machine manipulations to be confirmed

at F)T! The glo#eport used for opening the .T- plunger transferdoor $ill be raised higher off of the floor in order to reach the .T-

port and $ill be accessed #ia a portable platform of height ?1: off

the floor!

3.1.158 Alo#eports shall be designed to mate $ith -iercan or 9orth Safety-roducts ypalon ambide+trous isolator glo#es and slee#es pro#ided

b h 7 Al f 0 > hi < 330 l h i D

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10!

3.1.159 Light barriers shall be pro#ided to cause immediate filling machine

or delidder stoppage upon e+tension of glo#es to ensure safety!achine restart must be done at the !

3.1.160 =nit shall include necessary hard$are for continuous non#iable

particulate monitoring! Supplier to include iso

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3.2.4

E%uipment shall be of sanitary design and shall include pro#isions

for ease of maintenance and cleaning of all components! )llcon#eyance mechanisms and tray tables shall be of sanitary design

raised clean2 and shall be constructed to permit easy cleaning and

inspection!

3.2.5

Syringe tubs and syringes shall be transported and handled

throughout the line in a seamless and controlled manner throughoutthe entire operating range $ithout causing more than(

a) 0!1N critical and ma'or syringe defects

b) 0!DN minor syringe defects

.eference Section *!? for description and classification of defects!

3.2.8

Each component of the Syringe Filling Line shall be pre,piped and

pre,$ired such that the Buyer only needs to connect utilities to form

a completely functional and integrated system! )ll utility

connections are to be clearly identified by the "endor to insure easeof installation at the Buyer5s facility!

3.2.9

-roduct path connections shall be Buyer appro#ed sanitary fittings=!S! tri,clamp style2! This applies to all product path or

compressed gas2 fittings not only surge tan< connections e+cludingthe rotary piston pump inlet and outlet connection!

3.2.:

Surge tan< fed from Buyer,pro#ided product tan

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3.2.12

The .)BS enclosures $ill direct uniform air flo$ =)F2 do$n$ard

to belo$ the syringe height before e+hausting into the surroundingroom! Enclosure panels and doors $ill pro#ide the ma+imum

possible #ie$ of con#eying debagging delidding filling and

plungering operations!

3.2.13

E#ery location $ithin the .)BS,enclosed Syringe Filling line

re%uiring access during normal operations shall be reachable from aglo#eport!

3.2.14

Alo#eports shall be o#al in shape! Alo#eports shall be designed tomate $ith -iercan or 9orth Safety -roducts glo#es! )mbide+trous

isolator glo#es and slee#es! Alo#es of 0!> mm thic

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3.2.23

)ll #ertical shafts on the filling line shall be sealed by bello$s or an

e%ui#alent engineering solution such as dual lip seals2 to pre#entcontamination by the #ertical motion of the shafts bet$een the

mechanical dri#e system4mechanisms belo$ the machine plate and

the syringe filling area abo#e the machine plate! 6iper use should

be minimized $here possible! )ll machine penetrations must ha#edual sealing or bello$s to

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3.2.33

)ll subcomponents that are labeled $ith a tag number identifier on

"endor -Z/s shall ha#e a permanent physical tag $ith the sametag number placed on the component on the machine! Tags for

components that are present in the aseptic area $ill be 31 stainless

steel!

3.2.34

Syringe Filler shall include necessary hard$are for three 32

continuous non#iable particulate monitoring stations! Supplier toinclude iso

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surface imperfections such as mandrel mar!1!

3.3.3 The fabrication and assembly of thise%uipment shall be performed in an area

used e+clusi#ely for fabrication of stainlesssteel materials! Tools used in the assembly

of this unit shall be e+clusi#ely forfabrication of stainless steel e%uipment! The

Supplier shall demonstrate that this and

other practices $ithin the fabrication areaensure that no particles of carbon steel can

be deposited on the stainless steel material

during fabrication! /uring fabrication

de#iations in satisfying these practices arecause for re'ection of parts!

3.3.4 Supplier shall furnish nameplates that are

permanently attached to the e%uipment!The nameplates shall be easily accessible

stainless steel plate $ith embossed letters atleast 0!?D0 inches mm2 high and

containing the follo$ing information(

-urchase 7rder 9umber

/ate of manufacture

odel number

Serial number

7$ner5s E%uipment 9umber

7$ner5s 9ame

3.3.5 aterials shall be ne$ free from defects and completely suitable for

cA- pharmaceutical use!

3.3.6 9on,metallic contact surfaces such as gas

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Components $ith surfaces that cannot be directly sanitized must becompletely sealed in cladding or an enclosure that can be sanitized!

3.3.9 aterials of construction shall not contain asbestos chloride leadcadmium mercury or chromate!

3.3.10 )ll metal li%uid,product,contact parts and plunger contact parts $ill

be electropolished E-2 and passi#ated! nterior surfaces of rotarypiston pumps are allo$ed to be chrome plated! &no$n e+ceptions tothe E- re%uirement are the filling needles due to their thin $alls2!

-roduct contact surface finish shall be ?D .a ma+ 0!3 Um ma+2!

3.3.11 =nless other$ise specified materials of construction shall be the

"endor[s standard! aterials for tubing shall be as indicated belo$(

Ser/ice 'teri!< Intern! Sur+ce &inis,

-roduct tubing 31L SS .a 0!3 m ma+ $4 E-

-roduct tubing

alternate2

Teflon or

-t,cured Si

standard

nstrument )ir SS or -"C standard

-rocess )ir or #acuum 31L SS .a 0!3 m ma+ 9o E-

Q ill test reports are re%uired for metallic product contact parts!aterial certificates are re%uired for nonmetallic product contact

parts! E+ceptions to this must be appro#ed by the Buyer!

3.3.12 )ll non,metallic product contact tubing shall be Teflon or Buyer

appro#ed silicone!

3.3.13 -roduct contact surge,tan< pinch #al#e tubing shall be European

-harmacopoeia and =S- compliant! "endor to pro#ide certification

for this! Tubing shall ha#e suitable durability for 100000 pinchcycles! "endor shall pro#ide testing data supporting this! "endor topro#ide Buyer $ith list of all tubing types a#ailable meeting these

criteria and pro#ide tubing manufacturer5s data!

3.3.14 )ll product, or plunger,contact nonmetallic materials other than

tubing e!g! gas

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fabrication! "endor shall certify that no animal source or ferrous,based surface polishing compounds e!g! 'e$eler5s rouge2

lubricants or materials $ere used! =se of unappro#ed polishing

compounds is cause for re'ection of e%uipment!

3.3.20

9o ferrous brass copper or plated materials piston pumps

e+cepted2 shall be used $here they $ould be e+posed and sub'ect todaily cleaning or sanitization!

3.3.21 )ll fiber optic or electric cable should be armored smooth surfaces

only2 and protected from sanitizing agent contact!

3.3.22 aterials used for the .)BS shall be ne$ free from defects and

completely suitable for cA- pharmaceutical use!

3.3.23 etallic surfaces on the interior of the enclosure shall be 31 or

31L or both2 stainless steel! Supplier to notify 7$ner ofe+ceptions!

3.3.24 6indo$s and see,through doors shall be hardened safety glass!

-ositioning of glo#eports shall be determined during pre,F)Tthrough the use of disposable panels prior to the installation of

$indo$s and doors! Alass load,bearing hard$are shall be used!

3.3.25 For the re%uired materials of construction and surface finishes for#arious parts of the enclosure refer to the .)BS e%uipment data

sheet! Supplier shall pro#ide material certificates!

3.3.26 Ser#ice utilities shall be accessible from the mechanical area if

appropriate2!

3.4 S+ety


3.4.1 )ll machine safeguarding shall be based on the e+ecuted E%uipment.is< )ssessment generated by the Supplier in order to meet E9re%uirements! )ll machine safeguarding shall be consistent $ith

)9S B11!1@!

3.4.2 )ll mo#ing parts shall be enclosed $ith 7S) and CF. 1@10!??

and 1@10!?1@ appro#ed safety guards! n compliance $ith CEE@43@? CEE @143 CEE @34 E9 ?@? E9 >1> guarding shall

minimize the use of special tools for remo#al and reinstallation!

3.4.3 Feed scre$s $orm gears star $heels and con#eyor head and tail

sproc

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3.4.7 nterloc< safety s$itches shall fail in the fail,safe position and shallbe classified as safety s$itches!

3.4.8 f an interloc

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ergonomically designed to accommodate the $or:!

3.4.1: )ll controls and gauges used in the normal course of daily operation

and4or routine basis must be ergonomically designed and positioned!Controls must be positioned to allo$ operation $ith the upper limb'oints in neutral position! and operated de#ices such as toggles

s$itches

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e%uipment load calculations along $ithanchor point details!

3.4.25 -roper signs should be included on e%uipment $arning personnel ofdanger from mo#ing parts #oltage heat etc!

3.4.26 )ll e%uipment $ith pneumatic or hydraulic utility sources shall besupplied through a fi+ed and pad,loc0 " 4 3

ph 4 0 z2 for each ma'or piece of e%uipment e!g! one fordebagger one for filler4delidder combination2! The "endor shall

pro#ide all electrical components necessary for the operation of themachines including but not limited to( motor starters transformers

and all po$er distribution and control $iring!

3.5.2

)ll electrical components must be labeled

$ith =L or other nationally recognizedtesting laboratory! The machine and

electrical cabinet do not re%uire a separate=L inspection! Electrical e%uipment and

components that are not =L labeled orother e%ui#alent listings2 must ha#e

documentation that asserts that thee%uipment is safe for its intended use on the

basis of test data! Copies of test data shallbe sent to the 7$ner! E+ceptions must be

appro#ed by Lilly!

3.5.3The electrical area classification of the Buyer5s e%uipment location

shall be 9on,azardous per 9EC!

3.5.4

6iring(

a! 6iring standards shall be per 9EC 4 =L 4 9F-) *@!

b! E+posed $iring abo#e the machine plate shall be enclosed in

silicone tubing or e%ui#alent for protection and to facilitatecleaning!

c! 6iring e+posed outside of the .)BS shall be enclosed inarmored sheathing for protection!

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3.5.5

Labeling and nameplates(

a! )ll electrical cables and $ires shall be uni%uely identified in

English per 9EC 4 =L!

b! -ro#ide permanent nameplates for each instrument

component terminal bloc"!

E+ceptions must be appro#ed by Lilly!

d! Transformers shall be mounted in control panels $here size

and heat dissipation re%uirements permit!

e! S$itching po$er supplies shall not be used! E+ceptions must

be appro#ed by Lilly!

3.5.7

/isconnects and Fuses(

a! The Supplier shall pro#ide disconnects for each electrical point

of contact!

The main po$er disconnect shall be either a fused disconnect

or circuit brea

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3.5.9

The Vendor shall provide control voltage UPS backup for the PLC,

HMI and control voltage components! The =-S $ill be sized to

pro#ide po$er for 10 minutes and $ill pro#ide an orderly systemshutdo$n!

3.5.10

The systems shall be electrically grounded and isolated to ensure

personnel and equipment safety and signal integrity.

a! ) copper bus e%uipped $ith compression lugs shall be pro#idedfor 7$ner5s ground conductor connection!

1. The "endorshall supply one set of terminals for

Isolated Instrument Ground and an additional set of

terminals for Electrical Equipment Ground. Each

grounding source shall be dropped to one location

within the Suppliers package.

2. The Vendor shall separate Instrument Ground from

Electrical Equipment Ground in order to minimize

electrical interference within the system. Isolated

instrument ground terminals shall be electrically

isolated from skid, panel, and electrical equipment

ground.

b. Ground conductors shall be sized per NEC Article 250, green or

green w/yellow stripe and appropriately insulated.

c. All enclosures and raceways shall be properly bonded together

and connected to the metal skid frame. Equipment grounding

conductors shall be installed within the raceways. Utilizing

raceways as grounding conductors is unacceptable.

d. Transformers supplied for 120VAC circuits shall have a

common grounding point for transformer secondary by

grounding one leg of each circuit. Other than overload circuits

no contact shall be wired between coils and the grounded leg.The ungrounded leg of the transformer secondary shall be

properly fused

3.8 #nc!osures


3.8.1

Enclosures to be located in process areas shall be 9E) >; 4 -Dstainless steel at a minimum! Enclosures to be located in mechanical

areas shall be 9E) 3 4 -D> at a minimum! Enclosure doors shallbe gas

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3.9 Au=i!iry Contro!s


3.7.1

The "endor shall select controls pushbuttons selector s$itches

indicating lights etc!2 suitable for the en#ironment in $hich they

$ill be located!

3.7.2

The follo$ing color scheme shall be used $here applicable(

a! .E/ shall be used for Stop Emergency Stop or 7ffoperations only!

b! A.EE9 shall be used for Start or 7n operations!

c! -ushbuttons that cause mo#ement $hen pressed and stopmo#ement $hen they are released e!g! 'ogging2 shall be

BL)C&!

d. Reset pushbuttons shall be BLUE, BLACK, WHITE, or

GRAY except when they also act as a Stop or Off button, in

which case they shall be RED.

3.7.3-ushbuttons shall be constructed or mounted to minimize inad#ertentoperation!

3.7.4ndicating lights shall be push,to,test type suitable for operation on

?>" /C! Lamps and caps shall be replaceable from the front!

3.: Automtion Instrumenttion n Contro!s


3.8.1 The Supplier shall furnish a fully functional control systemincluding but not limited to designing documenting procuring

configuring installing and testing all components soft$are and$iring as re%uired for complete operation of the Supplier,pro#ided

e%uipment!

3.8.2 The Supplier shall be responsible for pro#iding components

re%uired for the complete fabrication of the pac

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-rocess Control System controller code shall be created using.oc

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upon failure instrument readings fail to an alarm state and de#ices$ill re#ert to their safest state!

3.8.16 All instruments shall have a sufficient accuracy and range for the

designated process. Instruments will utilize a 4-20 mA convention or

use bus technology. Exceptions must be approved by Lilly. Smartinstruments shall be used if possible.

3.8.17 The nstrumentation Tagging strategy shall be one of the follo$ingto be identified as separate line item costs2!

a! The "endor5s standard tagging methodology!

b! The "endor5s standard tagging methodology $ith the

re%uirement that tagging must be consistent for all soft$areand documentation! ndi#idual components shall only ha#e

one tag identifier $hich is used throughout the soft$areelectrical dra$ings -Z/ dra$ings 7 manual etc!

The Buyer5s tagging methodology $ith the re%uirement thattagging must be consistent for all soft$are and documentation!

Buyer $ill not specify tagging for e#ery component but $illemphasize -Z/ tags!

3.8.18 The Supplier shall pro#ide a completely $ired and tested electrical

control cabinet! E%uipment or piping connections $hich re%uireser#ice shall not be located behind the cabinet! The cabinet shall be

at a minimum 9E) > or -D> and shall pro#ide functionality to

physically apply a loc< to pre#ent access!

3.8.19 )ny electrical supply and4or air isolation #al#es2 shall be fitted

$ith isolation loc>!1,?003!

3.8.20 )ll logic including scaling to engineering units shall be performed

in the -LC not the !

3.8.21 The "endor shall furnish a control system using the follo$ing =nitsof easure(

-rocess "ariable )cceptable =nits

Temperature degrees C C

-ressure differential -a

-ressure abo#e atmospheric bar

-ressure belo$ atmospheric mbar

Le#el percent range N

6eight g"olume Liters

/ensity g4cc

Speed re#olutions .-

Speed air #elocity m4s

Speed machine S-

3.8.22 The system shall include the follo$ing e+ternal interfaces(

a! The system shall be configured to recei#e a hard$ired signalfrom the Buyer5s "iable onitoring System! This signal $ill

create an alarm and function as an interloc< to notify theSyringe Filler $hen the "iable onitoring System is out of

ser#ice!b! The system shall be configured to recei#e a hard$ired signal

from the Buyer5s 9on,"iable -articulate onitoring System!

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notify the Syringe Filler $hen the 9"- System is out ofser#ice!

3.8.23 The control system on the debagger shall include the follo$ingcontrols $ith alarming for each(

(to be completed)

a! inimum tub accumulation detection at the infeed!

b! Tub counting at the infeed and outfeed \100N accuracy #iaphysical sensor O not shift register]!

c! ncomplete bag remo#al

d! Tub con#eying 'am

e! igh le#el in empty bag $aste container

3.8.24 The control system on the delidder shall include the follo$ingcontrols $ith alarming for each(

(to be completed)

a! inimum tub accumulation detection at theinfeed!

b! Tub counting at the infeed and outfeed \100Naccuracy #ia physical sensor O not shift register]!

c! ncomplete lid remo#al

d! Tub con#eying 'am

e! igh le#el in lid $aste container

3.8.25 The control system on the filling machine shall be capable of

controlling $here applicable2 the surge tan< le#el plungering#acuum le#el fill $eight and other parameters $ithin defined

limits!

3.8.26 The control system on the filling machine shall include the follo$ingcontrols $ith alarming for each(

a! inimum tub accumulation detection at the infeed!

b! Tub counting at the infeed and outfeed \100N accuracy #ia

physical sensor O not shift register]!

c! Tub detection and counting at the re'ect station \100N

accuracy]! The system shall #erify that all re'ected tubscorrectly enter the re'ect station!

d! .aised syringe detection!

e! .aised filling needle detection!

f! Syringe $eight outside of predetermined product based limits!

g! inimum plunger accumulation detection in the sorting bo$l!h! inimum plunger accumulation detection in the feed lanes2!

i! issing plunger detection on all syringes processed!

'! .aised plunger detection on all syringes processed!

handling shafts!

l! Lo$ #acuum le#el for star$heels or plungering!

3.8.27 The system shall re%uire the follo$ing safety controls(

a! Emergency Stop buttons large red mushroom,type2 on each

machine $hich stop the machine immediately and de,energizeall de#ices #ia a hard$ired safety rated relay! )t a minimum

restarting after an emergency stop shall re%uire manual releaseof the Emergency Stop button ac

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b! )n Emergency Stop shall release all pneumatic pressure to themachine! achine mechanisms that $ill retain potential

energy in the e#ent of an air pressure loss must be designed to

be in a safe condition $hen the air is released! "enting of air

should be done e+terior to the classified filler room or be

#ented into the room through a sterilizing filter! "acuummaintaining products should ne#er be released!

c! -rocess Stop button $hich performs a soft stop of themachine in a manner that does not 'eopardize product in the

machine!

d! nterloc

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3.8.33 The control system shall re'ect syringes based on monitored processconditions! )ll re'ection reasons are to be identified by the "endor

and appro#ed by Lilly but must include the follo$ing(

a! Filling $eight outside acceptance limits!

b! issing plunger!

c! .aised plunger!3.8.34 The system shall alarm and stop the syringe filling process if the

follo$ing conditions occur(

a! ) consecuti#e number of syringes from the same plungeringstation ha#e missing plungers during continuous filling! The

number of consecuti#e syringes that triggers this alarm shall bean ad'ustable parameter!

b! ) consecuti#e number of syringes from all plungering stationsha#e missing plungers during continuous filling! The number of

consecuti#e syringes that triggers this alarm shall be anad'ustable parameter!

3.8.35 The system shall alarm and stop the syringe filling process if thefollo$ing conditions occur(

a! ) consecuti#e number of syringes from the same plungeringstation ha#e raised plungers during continuous filling! The

number of consecuti#e syringes that triggers this alarm shall bean ad'ustable parameter!

b! ) consecuti#e number of syringes from all plungering stationsha#e raised plungers during continuous filling! The number of

consecuti#e syringes that triggers this alarm shall be anad'ustable parameter!

3.8.36 The system shall pro#ide a 8line clearance: mode $hich can bemanually initiated #ia a button on the ! This mode $ill inhibit

tubs from entering the infeed and transport all syringes4tubscurrently in the machine to the appropriate location clearing the line!

3.8.37 The system shall display at least ;;sets of fill $eight data on the format to be agreed upon2! The information displayed for

each syringe shall include the follo$ing(

a! Aross $eight

b! Tare $eight

c! 9et $eight

For $eight #alues displayed on the the display shall usebac

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filling! The number of consecuti#e measurements thattriggers this alarm shall be an ad'ustable parameter!

3.8.40 The Syringe Filler System must ha#e the capability to re'ect a

configurable number of tubs after it has been inacti#e for a

configurable time period by product!

3.8.41 The Syringe Filler control system shall function in an en#ironmentof D@, F and 10,0N .!

3.8.42 The Syringe Filler System shall alarm and stop the line if an

e+pected re'ect is not present!

4.0 DOCU'#NTATION AND DATA

4.1 Documenttion


4.1.1 The "endor shall supply at a minimum the documents listed inthe "endor /ocumentation .e%uirements table in the English

language! )ppendi+ /2

4.1.2 /ocuments are supplied in hard copy and electronic format!

a! /raft #ersions of documents for Lilly re#ie$ shall be pro#ided

in electronic format $hene#er possible!

b! The turno#er pac

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4.1.6 )ll documentation submission materials shall be directed to theLilly designated primary contact for the pro'ect!

4.1.7 E%uipment as,builts2 detailed control panel and

instrument4control circuit

dra$ings instrument location plans process andinstrumentation diagrams

shall be pro#ided $ithin four $ee

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5.1.12 The 7$ner may $ai#e shop inspection or e%uipment inspection!nspection by 7$ner or $ai#er of inspection shall not relie#e the

Supplier of their responsibility to meet the re%uirements of thisSpecification!

5.2 &ctory Acceptnce Test &AT


5.2.1 The Syringe Filler shall be sub'ected to an F)T Factory )cceptance

Test2 $hich $ill be carried out at the "endor5s premises!

5.2.2 The "endor shall perform preliminary F)T testing prior to the F)T!

The Buyer representati#es shall be allo$ed to be present during pre,F)T testing!

5.2.3 The F)T protocol is to be generated by the "endor for Buyer5sre#ie$ edit and appro#al! The Buyer reser#es the right to utilize its

o$n F)T protocol! "endor $ith Buyer participation2 shall beresponsible for e+ecuting the F)T! Buyer and "endor $ill agree in

ad#ance $hat tests $ill be performed and4or $itnessed by the Buyer!5.2.4 F)T protocols shall contain(

a! co#er page that identifies the e%uipment or subsystem tag

name

b! appro#er5s signature page

c! signature log that documents signature printed name initials

and company identification

d! test pages $ith test steps initialed and dated by e+ecutor

e! test e%uipment calibration log

f! F)T acceptance letter summarizing test results and any openpunch list items

g! a re#ision number and document date

5.2.5 The F)T shall consist of the follo$ing(

a! /ocumentation "erification

b! /ata "erification

c. Mechanical / Installation Verification

d. P&ID and Pneumatic Drawing Verification

e! =tility "erification

f. Power Verification

g! 6iring "erification

h. Programmable Device Configuration Verification

i. Instrumentation Calibration Verification

j. Test Instrumentation Verification

k. Source Code Verification

l. Maintenance Verification

m. Operational / Functional Testing

n. Performance Testing

o. Component Verification

See Appendix C for detailed descriptions.

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5.2.6 F)T Timing .e%uirements(

a! The "endor shall inform the Buyer not less than t$el#e 1?2

$ee2 $ee

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for easy reassembly at the site!

5.3.4 )ccessories and parts shipped separately shall be bo+ed and properlyidentified $ith durable $aterproof shipping tags attached $ith

stainless steel $ire or plastic tie strips and mar

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5.4.1 The Syringe Filler shall be sub'ected to an S)T Site )cceptanceTest2 $hich $ill be carried out at the Buyer5s premises $ith

representation from the Buyer and "endor!

5.4.2 The S)T protocol is to be generated by the "endor for Buyer5s

re#ie$ edit and appro#al! The Buyer reser#es the right to utilize its

o$n S)T protocol! "endor $ith Buyer participation2 shall beresponsible for e+ecuting the S)T! Buyer and "endor $ill agree inad#ance $hat tests $ill be performed and4or $itnessed by the Buyer!

5.4.3 Supplier shall submit the S)T protocol to the 7$ner or 7$ner5srepresentati#e at least $ee

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5.5 Inst!!tion >u!i+iction I> n Opertion! >u!i+iction O>


5.5.1 and 7 $ill be performed by the Buyer $ith the option topurchase from the "endor ser#ices for protocol de#elopment and

e+ecution!

f and 7 ser#ices and protocols are purchased the protocolsshall be generated by the "endor for Buyer5s re#ie$ edit andappro#al!

5.5.2 The "endor shall be a#ailable to support the Buyer during theseacti#ities!

8.0 )#N#RA% OPTIONS

The "endor shall pro#ide separate costs for each of the follo$ing ser#ices in the proposal(


8.1.1 .ight nformation Component2 /ata!

6.1.2 7perator4aintenance Training for Lilly Technicians at Supplierand "endor sites2!

6.1.3 )ll necessary spare parts to allo$ commissioning and one year5soperation of the machine!

6.1.4 7n,Site start up and acceptance test S)T2 e+ecution /aily .ate2!

6.1.5 -rotocol /e#elopment!

6.1.6 7 -rotocol /e#elopment!6.1.7 Cost per day for continued de#elopment and optimization $or

b103 syringe filler 072709

Documents