equipment selection guides and vendors july 2013

7/27/2019 Equipment Selection Guides and Vendors July 2013

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GMP and Plant Safety14 weeks/ meetingsSWISS GERMAN UNIVERSITY

14-Jul-13 Paulus Gunawan 1

Some Hints and Tips in Selecting

Equipment / Machine

Including Vendor Selection


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Concerns

In making this study/ recommendation,evaluate a number of potential concerns,

feedback against the following criteria : Special treatment for raw materials CapacityQuality (Machine Workmanship)

Maintenance and support requirement Historical data of present machines


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Concerns

Initial investment (company resources) Set up time, changing size parts and cleaning

consumption time

Easy and friendly to operate Comply to cGMP standard other standards Support of agent including past experience GMP knowledge and Up-date Regulations Company/ agent reputation and support


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Concerns Future machine features to meet our coming

demand and various products

Life time and Life Cycle Resale / Salvage Value and Market Value Compatibility to our existing and future

manufacturing machine

Operators/ Users skills to operate themachines (adaptable) Human Resources


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Concerns

Information from other users/ benchmarkfrom users who have been using the

machine/ equipmentAccuracy cost due to weight variation (more

raw material / exceeding weight standard,and fills into capsule) - Yields

Excess raw material cost due to waste (lostmaterials that cannot be utilized)


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Concerns

Validation Documents (Qualifications) Completeness of Documents Yearly Operating Cost including

consumable parts Calculation for 5 years ahead Guarantee and after sales service Trade in with old machine Equipment Inspection (Pre factory visit,

FAT, SAT and Commissioning)


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Waste packaging/ raw materials Operating and energy cost Availability of spare part Training provided by manufacturers Update information from the manufacturers

regarding same type of machine/ similar one

Periodical Inspection (quarterly/annual)either by agent or principals to check the

machine/ equipment performance


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Other concerns Continuity of equipment model and type Availability critical part to be supplied within

certain period

Accessible to get the latest equipmentinformation, latest and update of informationfrom OEM on the subject of purchasedequipment. Including OEM decision prior todiscontinue / terminate the purchasedequipment or experimental machine

Long term support / on-line support even thelocal agent changed/ no longer exist


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Other Concern

Service agreement and willingness to keepmaintaining and monitoring equipment that have

been sold to customers Regular and periodical customer visit by

principals whilst giving advices to improper

equipment operation, inappropriate preventive

maintenance and unacceptable replacement parts(not genuine/ not recommended)


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Other

Available to have material equivalence(composition, treatment etc), which could

give effect to equipment performance.OEE

Other aspects related to financial, physicaland appearance, performance, supportingdocuments etc.


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Benchmark Third Party Opinion

Collect all information prior to purchaseequipment, these can be obtained through

network (personal and business/organizational mailing list). Informal data

sometimes are very helpful which can be

traced from shop floor operators/rightsource instead of supervisor/manager

Agent should provides these data


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Supporting Data

List of users that have utilized the machines,at least 2 years + the very old purchased and

the latest one

List of projects (on-going projects) List of potential /prospective / promising

customersnearly miss project including unsatisfiedcustomers

vContact Persons/ Factory, email address,

phone numbers and address (local and overseas)



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Benchmark Third Party Opinion

Visit and watch the equipment operation,including performance, preventive

maintenance records if factorys visit isallowed

Discuss and have comprehensive talk to theend users regarding the overallperformance, management reasons and

decision in selecting the equipment


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Most important factors

Know best own capability and abilityrelated to company sources (financial/

money initial investment, management /knowledge coming marketing/ sales /

economic perspectives including politic/

labor, human resource/ trained operators/team , facility / premises and supporting

critical utilities)


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Other important factors ----

Regulation and Regulators : equipmentmust be in line (not obsolete) with the guide

line based on cGMP EHS (environment health and safety)

factors have to be considered

Green Machinery Concept


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Possibility to expand to combine tointegrate with existing machine and comingequipment in the future

Engineering Economy : Discount, Flexiblepayment, equipment life time, spare-partsand after sales service, salvage/ resale value

Machine purchased at the exhibition is

commonly cheaper than normal one, with

some reasons : first batch, prototype model

or do not have to pay extra transportation

cost, handling charges etc/ extra cost


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Business Agreement

Step / Sequential ProcessPreliminaryLast Decision

How to satisfy all parties (win-win-winsolution) long term /life cycle approach

including risk-based approach (technical,service etc) reputation reliable entity



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THE UTMOST

Data and Information from 3rd PartyTrust Business EthicsHistorical / Background of OEM

Principals / Agent Their Long Term

Business Relation including knowledge of

cGMP and other standards.



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3 C : Critical

quality, traceability, good documentedevidences, manufactured under proper GMP

conditions, in compliance with regulatoryagencies, good quality agreements, good

product stability and shelf life.



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Business Terms

Different perception of the Term :Turn-Key ProjectDelivery Systems (ex. Factory, FOB, CIF, at

users warehouse or at dedicated production

room)

Nation Ethic / Behaviour



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Suggestion

Comment Other Concern



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GOODS PATHWAY

From Seller to Buyer

From Manufacturer to User


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Manufacturer


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Shipment and Sale Terms

EXW ~ ex-works : goods at manufacturing site FCA ~ free carrier FAS ~ free alongside ship FOB ~ free on board CFR ~ cost and freight CIF ~ cost, insurance and freight DDP ~ delivery duty paid / landed cost / factory

site (at buyer warehouse)


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14-Jul-13 Your Name 26

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Terms in freight and carry (words) Transportation :Forwarder / Courier /Post / Travel :

Land (truck, trailer, other vehicles)Sea/ Ocean (ship, ferry, boat)Air (airplane : passenger, cargo)Hand- carry / Person