Buyer Requirements Details

Pharmaceutical Mill For The Liquid Product Section

Posted Date: 13-Jul-2019

Product Description

pharmaglobiz Buyer From Russia Is Looking Suppliers Of pharmaceutical Mill For The Liquid Product Section


Minimum Order Quantity :
1
Approx Price :
., Moscow, RUSSIA

More Information

 

item

specificatioin

  1.  

purpose

the Mill Is Designed For Grinding Pharmaceutical Substances And Excipients. shreddedproductsaresenttothescreeningstage.

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object

pharmacuticalmill– 1 pc.

the Schematic Diagram And Options Are Necessarily Agreed With The Customer.

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performance

upto100 kgs/hour

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requirements For Materials From Which The Equipment Is Made

all Surfaces In Contact With The Product Should Be Made Of Stainless Steel En 1.4404 Or Equivalent (certificate 3.1., Confirming The Type Of Material) With A Surface Roughness Of Ra ≤ 0.8 μm.

all Surfaces That Are Not In Contact With The Product Should Be Made Of Stainless Steel En 1.4301 Or Equivalent (certificate 2.1., Confirming The Type Of Material) With A Surface Roughness Of Ra ≤ 1.6 μm.

seals In Contact With The Product Must Be Made Of Food Grade Materials (fda Declaration Of Conformity).

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features Of Design

the Raw Material Is Loaded Into The Mill Manually Through A Hopper With A Hermetic Valve Or A Metering Device That Prevents The Spread Of Dust.

a Ventilation System Should Be Provided For The Working Area Of ​​the Mill With An Exhaust Air Filtration Device.

the Crushed Product Is Collected In A Container Hermetically Connected To The Mill. The Design Of The Mill Should Ensure The Extraction Of At Least 99% Of The Product.

all Connections Must Be Tri-clamp.

all Welds Must Be Made In A Protective Environment (argon), Descale, Polished And Passivated.

at Least 10% Of Welds (including Endoscopic) For Orbital Welding And 100% Control For Manual Welding Should Be Selectively Tested.

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Требования к ведению монтажных работ

room Features:

  • purityclass - D;
  • temperature: 18 ° С - 25 ° С;
  • relative Humidity: 40% - 60%;
  • height: 2600 Mm;
  • width: 3800 Mm;
  • depth: 2100 Mm;
  • area: 7.8 M2.
  • smallestmounting Hole (door):
  • height: 2100 Mm;
  • width: 710 Mm.
  • maximum Floorload: 500 Kg / M2.
  • availableengineeringenvironments:
  • compressedairtool: 3-6 Bar;
  • clean Compressedair: 3-6 Bar;
  • inert Gas (nitrogen): 6 Bar;
  • purifiedwater: 3-5 Bar;
  • power Supply: 400 V, 3 Phases, 50 Hz
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control systemrequirements

the Grinding Process Must Be Controlled By A Programmable Logic Controller (plc) And A Touch Control Panel (hmi).

the Control System Should Include The Following Functions:

• Control And Regulation Of Input Parameters And Management Of User Commands;

• Providing Data On The System Status, Alarms;

• Archiving Data, Events, Malfunctions And Operator Actions;

• Equipment Management;

• Ensuring The Safety Of Personnel, Equipment And The Environment;

• Ensuring The Availability Of Data And Physical Process Values;

• Ensuring Reproducibility Of Established Operating Parameters;

• Backup Strategies In Case Of Breakdown Or Failure In Work.

all Installed Software Must Have Version Control.

backup Copies Should Be Provided To Restore The Software.

the Necessary Keys, Licenses Or Devices For Restoring Software Without External Support Should Be Provided.

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indication Of Accidents And Errors

a Visual And Audible Indication Of Alarms And Errors Should Be Provided, With Messages Displayed On The Hmi Panel Display.

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sound Alarm

it Should Be Possible To Turn Off The Sound Signal After Familiarizing The Operator With An Accident Or Error (acknowledgment).

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listing All Processed Alarms, Warnings And Messages

it Should Be Possible To Display A List Of All Processed Accidents, Warnings And Messages In English And Russian.

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savingalarms

alarm Messages Should Be Stored In The Non-volatile Memory Of The Control System, With The Possibility Of Subsequent Output In The Form Of A Report.

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gmp Requirements

the Equipment Must Have A Hygienic Design That Prevents Contamination, Allow For Effective Cleaning And Meet The Requirements Of Gmp Rules (rules Of Good Manufacturing Practice Approved By The Order Of The Ministry Of Industry And Trade Of The Russian Federation No. 916 Of June 14, 2013 (as Amended On December 18, 2015), Ispe, Even If It Is Not Explicitly Stated.

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requirements For Cleaning And Sanitation

equipment Cleaning Is Done Manually. The Equipment Should Be Made Of A Smooth, Easy-to-clean Material, Resistant To Water And Detergent, And Allowing Easy Cleaning. The Design Should Ensure The Disassembly Of All Components In Contact With The Product. There Should Be No Corners, Slots, Grooves That Are Hard To Reach For Cleaning, In Which A Product Or Detergent Solution Can Stagnate.

primary Cleaning And Passivation Of The Supplied Equipment Should Be Carried Out.

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characteristicsandadditionalrequirements

volume Of Feedstock Bunker: At Least 3 L.

the Granulometric Composition Of The Feedstock: Dmax ≤ 2 Mm.

the Granulometric Composition Of The Product After Grinding: D90 <100 μm.

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ensuring Electrical Safety, Risk Control, Represented By Sources Of Electrical Current

all Items Of Equipment Must Be Grounded.

all Electrical Components Must Be Insulated And Sealed To Prevent Any Risk Of Contact With Liquid.

a Minimum Ip55 Protection Class Should Be Provided.

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mechanicalinjuryriskcontrol

the Equipment Must Be Designed In Such A Way As To Avoid The Risk Of Causing Any Mechanical Damage To Personnel.

a System For Blocking The Launch Of Equipment In An Unencrypted Condition Should Be Provided.

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cutriskcontrol

the Performance Of The Metal Parts Of The Equipment And Components In The Line Must Be Of Such Quality As To Prevent The Risk Of Causing Cuts And Damage To Personnel Operating The Equipment In The Line.

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noisetolerance

the Maximum Permissible Noise Level During Operation Is Nothigher Than 70 Db.

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emergencystopbuttons

equipment Must Have At Least One Emergency Stop Button That Is Easily Accessible To The Operator; It Should Be Impossible To Accidentally Press This Button.

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documentation

the Following Documentation Must Be Supplied:

• Operation Manual - In English And Russian

• Manual And Maintenance Plan - In English And Russian

• General Equipment Layout

• Electrical Circuit With A List Of Components

• Pneumatic Circuit (if Available)

• Software User Guide

• Spare Parts List

• List Of Alarm Messages - In English And Russian

• Declaration And Certificates Of Conformity (technical And Sanitary Standards), Including Materials In Contact With The Product.

each Document Folder Should Have A List Of Contents.

all Documentation Must Have Unique Identification And Version Control.

documentation Must Be Supplied In 2 Paper Copies.

all Documentation Should Also Be Submitted In Electronic Format On A Cd Or Usb Flash Drive.

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technicalsupport

the Maintenance System Must Be Described By The Supplier In The Form Of A Work Plan, Which Should Be Carried Out With The Established Frequency Of Their Implementation.

the Supplier Must Guarantee The Availability Of Spare Parts For At Least 10 Years After The Date Of Delivery.

the Supplier Must Provide A List Of Spare Parts Required During Normal Operation For 2 Years.

the Supplier Must Provide Support For The Necessary Planned Maintenance Of Equipment Upon A Separate Request (indicating The Cost Of Work And Materials And The Frequency Of The Proposal) And Repair Of Equipment (indicating The Cost Of Work).

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validationandqualification

a Standard Qualification Service Package Should Be Offered As An Option. The Proposal Should Contain A Detailed Description Of The Content Of This Package.

cleaning Of Equipment In Contact With The Product Must Be Validated.

the Installed Software Must Be Validated.

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spare Parts

spare Parts Should Be Supplied To All Equipment For 2 Years Of Normal Operation. thepricemustbeindicatedintheoffer.

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inspections And Tests

tests Should Be Carried Out At The Place Of Manufacture (fat) With The Participation Of The Customer’s Representative. thepricemustbeindicatedintheoffer.

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shipping

the System Must Be Transported Under Cip To The Location Of The Customer. costmustbeincludedintheoffer.

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installation

the Installation Of The System On The Site Will Be Carried Out By The Customer With The Condition Of Supplier’s Supervision. The Cost Of Supervision Should Be Included In The Offer.

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acceptance And Qualification

the Vendor Must Run And Conduct Equipment Testing (sat) To Demonstrate Performance And Compliance. The Cost Of These Tests Must Be Indicated In The Offer.

acceptance Tests And Checks Must Be Confirmed By The Customer And Documented In The Appropriate Forms.

the Supplier Must Provide Equipment Qualification Protocols Dq / Iq / Oq (forms).

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training

training Of Customer’s Personnel In The Use Of Equipment Should Be Included In The Scope Of Supply With Daily Rates.

the Proposal Should Also Include Special Technical Staff Training.

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warranties

the Supplier Must Guarantee The Buyer That All The Products Supplied Are Free From Defects In Materials And Workmanship And That The Equipment Does Not Fail To Function For At Least 12 (twelve) Months After Commissioning Or 18 (eighteen) Months After Delivery, Depending On What Period Earlier.

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