US FDA&EU cGMP Standard

R13/237
2013-02-16

Medichom International Greece CS-1 TABLET FRIABILITY TESTER (US FDA&EU cGMP Standard)

Presented to:

Medichom International Greece

Presented by:

Leroy.Zou Rotech Pharmaceutical Engineering Co., ltd. www.rotechmachinery.eu

Design and Manufacturing Under FDA&cGMP Standard

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US FDA&EU cGMP Standard

Index

INTRODUCTION......................................................................................... 3 MACHINERY DESCRIPTION................................................................... 4 ROTECH LAB INSTRUMENT.................................................................. 4 MACHINERY DESCRIPTION................................................................... 4

MACHINE PICTURE ........................................................................................ 4 LAYOUT DRAWING ........................................................................................ 5 INTRODUCTION AND FEATURES..................................................................... 7 INTRODUCTION ......................................................................................... 7 FEATURES ................................................................................................. 7 TECHNICAL PARAMETER ............................................................................... 13 CONFIGURATION LIST13 DOCUMENTATION.15

PRICES .......................................................................................................... 17 ROTECH HPJ CAPSULE POLISHER AND SORTER MACHINE ..................... 17 DOCUMENTATION & TESTS .......................................................................... 18 SALES CONDITIONS ................................................................................. 19

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US FDA&EU cGMP Standard

Introduction
Following up your enquiry by e-mail message dated 2013-02-09, for which we thank you very much, we are pleased to submit you our preliminary quote # R13/237 for the lab instruments of the customer in Russia.

The proposed line includes: ROTECH LAB INSTRUMENT

Our Offer will also include: . Documentation package.

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Proposal

US FDA&EU cGMP Standard

Machinery Description
Tablet Friability Tester Model CS-1
CS series of instruments are used for detecting friability/abrasion of tablet. Features Two drums run synchronously. Auto stop at timing point. The drum is made of high quality hyaline acryl. The speed and revolution of the drum can be preset at any time, either preset or real data is displayed on the LED. A MPU is used to control all operations; high accuracy is achieved in testing rotary speed and circle number. Automation: auto-test, auto-diagnose, auto-alarm

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US FDA&EU cGMP Standard

Tablet Friability Tester Cylinder number Cylinder radius Cylinder depth Tablet fall height Rotation count Rotation count accuracy Rotation speed Rotation speed accuracy Power Dimension

CS-1 2 286mm 39mm 156mm (10~900) r 1r (20~90) rpm 1rpm 220V/50HZ/60W 110V/60HZ/60W (370*300*340) mm3 or

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Prices

US FDA&EU cGMP Standard

Prices
Price Validity: 60 (sixty) days. Currency: USD

Number Description 1

Model

Tablet Friability Tester CS-1 Freight Cost

Unit price (USD) 750.00 150.00 Total900.00

Quantity 1

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US FDA&EU cGMP Standard

Sales Conditions
DELIVERY

10 days from the receipt of order, samples and definition of technical details.

PAYMENT

100%

down with the order

CONTRACT AND TEST

Customer is required to supply the following information in times as indicated in the contract: - machine lay-out drawing approval - supply of materials for in-house machine trials - supply of materials for FAT at ROTECH with the customer - dates of FAT agreed at least three weeks in advance.

WARRANTY

ROTECH guarantees its machines for a period of one year against material or manufacture defects "as long as used and kept in normal state". Every implied guarantee is also valid for a period of one year from the delivery date from ROTECH site. The guarantee expires if the machine has been damaged for unsuitable use or for other causes not due to materials or manufacture defects. During the above period, every intervention which requires the disassembly of the machine and its essential parts, when it is not authorised by ROTECH, makes immediately expire the guarantee of the machine and its parts.

Note: - Samples should be received at our site, free of any shipping charges.

SCHEDULED WORKING TIME Morning Afternoon 8:00 - 12:00 13:00 - 17:30 * One relax hour must always be foreseen *