PRIMARY PROPOSAL

for
MANUFACTURING PLANT OF
DISPOSABLE SYRINGES with NEEDLES
(PROPOSAL No : JP 18 – 02122)

12 FEBRUARY 2017

PREPARED BY

JEONG WON MEDICS CO., LTD.

MOBILE : 82-10-2671-2159
TEL : 82-32-670-7691
FAX: 82-32-670-7699
e-mail : jwmedicsceo@naver.com, jeongwonmedic@daum.net
Web Site : http://www.jwmedics.co.kr

Presented to ;

Mr. ROHIT SHAHA

INDIA

E-Mail : shaha.rohit@gmail.com
 CONTENTS

PART I. COMMERCIAL PROPOSAL

1. GENERAL
2. SUPPLIER'S SCOPE OF SUPPLY AND WORK
3. BUYER'S SCOPE OF SUPPLY AND WORK
4. PRICE SCHEDULE
5. TERMS AND CONDITIONS
6. SUPERVISION SERVICES
7. TRAINING OF BUYER'S PERSONNELS
8. ENGINEERING WORKS
9. GUARANTEE
10. FORCE MAJEURE
11. CONFIDENTIALITY
12. OTHER TERMS AND CONDITIONS
13. ARBITRATION

PART II. TECHNICAL PROPOSAL

1. GENERAL
2. PRODUCT PROFILE
3. BASIC DESIGN
4. PROCESS & MACHINE CAPACITY
5. GENERAL REQUIREMENT
6. COST ESTIMATE FOR EQUIPMENT & SERVICES
7. LABOR REQUIREMENT
8. PRODUCTION FLOW CHART
9. IMPLEMENTATION SCHEDULE
10. SPECIFICATION OF MACHINERY
11. PLANT LAY-OUT(SAMPLE)
PART I. COMMERCIAL PROPOSAL
1. GENERAL

This proposal has been prepared by Jeong Won Medics Co., Ltd.,-Korea for set up the Disposable
Syringe manufacturing factory under the terms and conditions described hereunder. The proposal
covers the design, engineering, supply of manufacturing machineries, molds, spare parts, raw
materials as well as other related items required and provide the technical know-how, installation
supervision, and conduct on-the-job training for the successful manufacturing.

The specification and model of equipment/machines in this proposal is subject to change and
modify without notice for improvement of efficiency & performance.

2. SUPPLIER'S SCOPE OF SUPPLY AND WORK

2.1 Design and engineering of the plant

Supplier shall provide Client the basic design as well as engineering of the plant, and
this service shall be inclusive of the relative drawings and documentation which are deemed
necessary for the efficient operation of the plant.

2.2 Supply of machinery & equipment.

Supplier shall produce and supply the machinery & equipment as per the description
specified herein. Shop test & inspection, packing of machinery & equipment shall be
performed by supplier.

2.3 Supervision of installation, commissioning and test run

Supplier shall provide services related supervision of installation, commissioning and start-up
operation of the plant. For these services, supplier shall send plant site technical persons
along with drawings and manuals etc.

2.4 Technical know-how transfer

Upon request of Buyer, supplier shall transfer technical know-how to buyer through
supervision services of installation, commissioning & test-run and training services of buyer's
technical personals. In this case, Buyer shall pay know-how transfer fee to Supplier and
amount of know-how transfer fee shall be determined by two parties.
Also, Supplier shall provide drawings, technical data, manuals and other related References of
machines necessary for producing of Disposable Syringe with Needle.

2.5 Supply of raw materials

Supplier shall supply raw materials related to manufacturing of the products at the
reasonable price upon request of the buyer.

3. BUYER'S SCOPE OF SUPPLY AND WORK

Buyer at their responsibility and own account shall take up the followings.

3.1 Site preparation and grounding work.

3.2 All civil and construction works including building and other auxiliary utilities in relation to
the plant and its premises.

3.3 Ocean freight, insurance, inland transportation, haulage and storing of the machinery
and equipment.
3.4 All taxes, custom duties and levies imposed by the authorities of buyer's country.

3.5 Foundation, installation, erection and test-run of the plant.

3.6 Clean room system for Production hall, Pollution controlling and environmental facility.

3.7 Ventilation and ducting system, air conditioning, lighting, fire fighting utilities.

3.8 Electric power, water and gas supply required for the plant operation.

3.9 Raw materials for commissioning and start-up.

3.10 All the piping and wiring from substation to the panel of machine.

3.11 Design of Products to be produced.

3.12 All other machinery & equipment, materials, devices, accessory, parts and auxiliary
facilities which are not stipulated in this proposal.

4. PRICE SCHEDULE

4.1 Machinery and Equipment

DESCRIPTION NUMBERS AMOUNT

1. INJECTION MOULDING LINE 1 LOT 1,176,500.-

2. ASSEMBLY, PACKING & STERILE 1 LOT 1,135,100.-

TOTAL (F.O.B. KOREA) (U.S.Dollars) 2,311,600.-

4.2 Others

- Installation Charge : U$42,000.-

- Commissioning & Training : U$50,000.-

- Kow-How Fee : As Negotiation

4.3 Total Amount of the Project

4.1 + 4.2 = U$2,403,600.00

5. TERMS AND CONDITIONS

5.1 Payment Terms

Payment shall be made in U.S.Dollars. 40(Forty) percent by T/T in advance as down payment
within 15 days after the date of contract, and the balance 60(Sixty) percent shall be paid
upon receipt of notification of the supplier for readiness of shipment for the products
OR
40(Forty) percent by T/T in advance as down payment within 15 days after the date of contract
and the balance 60(Sixty) percent by irrevocable, transferable & confirmed L/C at sight.
5.2 Delivery

Shipment at Korean port shall be made within 6(six) months from the date of
receiving down payment by T/T.
Any delay attributable to the buyer's default may cause equitable adjustment of delivery
and/or contract amount, accordingly. Partial shipment and Trans-shipment shall be allowed.

5.3 Packing

Packing and marking shall be made in accordance with the supplier's seaworthy
standard.

5.4 Test and Inspection

Machineries and equipment shall be tested and inspected at the supplier's manufacturing
premises in accordance with supplier's quality control program.
Such test and inspection shall be final. Buyer may appoint any authorized inspector at their
cost to test and inspect the machine and equipment.

5.5 Validity

This proposal shall be valid until the end of March 2018.

6. SUPERVISION SERVICES

6.1 Supplier shall provide supervisory services by means of dispatching their technical
personals for installation and start-up operation for the period of 10 man-days including
Holydays from the date of their departure in Supplier's country.

6.2 Staffs of supplier's technical team is ;

Item No. of Supervisors Period

Injection Molding Line 3 below 15 days
Assembly & Packing 4 below 15 days
Sterilizer 1 below 15 days

6.3 For the supervision services, buyer shall pay U.S.$350.- as a supervision fee on the
basis of one man-day.

6.4 In the event that the supervision period shall exceed above prescribed period, the
additional supervision charge shall be borne by the Buyer per man-day to the supplier.

6.5 In connection with the supervision, Buyer shall provide the following facilities and
services for the Supplier's technical supervising team free of charge;

1. Round trip air fare between Korea and Buyer's country.

2. Hotel accommodation with meals.

3. Transportation to and from the plant site.

4. Communication facilities such as telephone and facsimile.

5. Taxes and arrangement of permits and certificates which may be required by the
authorities of Government of Buyer's country during their stay.

6. Medical cares and treatment.

 7. Raw materials, tools, utilities and labor required for erection and installation and
test-run of the machines and equipment.

8. Any other expenses to be incurred for their supervision services.

7. TRAINING OF BUYER'S PERSONNELS

7.1 Upon request of Buyer, Supplier shall give training to Buyer's technical engineers at the
Supplier's site in Korea. Number of trainee and period of training in Korea proposed by
Supplier are as follows;

Items No.of person Period

Injection Molding 1 20 days
Assembly & Sterile 1 20 days

Total 2 40 days

7.2 All expenses for trainees such as round air fares, lodging, medical care, health
insurance, local transportation, meals and telecommunication costs shall be Buyer's account.
If any of the Buyer's trainee is considered not suitable for further training, or not acceptable
due to his misbehaviors, Supplier shall have the right to ask Buyer for his repatriation.

8. ENGINEERING WORKS

Supplier shall provide Buyer the engineering services required for setting up the plant.
These services include the followings;

 Design of the Machines

 Details of Production Process
 Technical Specifications of Machinery & equipment
 Operational & Maintenance manuals of Machinery & equipment
 Positioning of machinery & equipment
 Plant layout
 Production standards & test methods
 Introduction of Raw material consumptions

9. GUARANTEE

Provided that all the Buyer's obligations expressed in this proposal have been
performed in a timely manner, and the operation of the Plant proves to have been
performed in accordance with the technical instructions provided by the Supplier.

9.1 Supplier shall guarantee that all machinery & equipment supplied shall be free from defects of
design, material, fabrication and workmanship for the period of 12(twelve) months from the
date of shipment.

9.2 This guarantee shall not cover any deficiency caused by normal wear and tear, erosion or
corrosion, or as a result of improper operation and handling, maintenance, or by negligence of
the Buyer acting contrary to the Supplier's technical instruction.
10. FORCE MAJEURE

Supplier shall not be liable for any delay or for any consequence of delay in the
production, delivery or commissioning of any of the machinery & equipment if such
delay shall be due to the fire, strike, lock-out, dispute with workman, flood, accident
or to any other cause beyond the Supplier's control.

11. CONFIDENTIALITY

Both parties shall treat in strict confidence of all drawings, technical data and information to
be supplied by the other party in connection with the contract, and shall not publish or use to
publish the content of the other party without prior written approval of the other party.

12. OTHER TERMS AND CONDITIONS

Any other terms and conditions which are not specifically expressed herein shall be
discussed and mutually agreed in the course of negotiation.

13. ARBITRATION

In the event that may dispute arises out of the execution of the contract, both parties
shall make their best efforts to settle such dispute amicably by mutual consultation. If
the parties fail in amicable settlement, such dispute shall be arbitrated in accordance
with the rules of conciliation and arbitration of the Korea Arbitration Court.
PART II. TECHNICAL PROPOSAL
1. GENERAL

1.1 Scope of the Project

The normal out-put capacity of the designed plant is, in round figures 9,000,000 pcs of
Disposable Syringes per one Month working on 1~3 shift(s) per day. The target production in
this Proposal is total 9,000,000pcs but, productivity can be easily increased once the staff has
acquire sufficient experience and by partly increasing of some equipment.

The Proposal includes Needle Assembly line but, Needle Cannula making line is exempted.

It is to be understood here that costs for land, plant buildings and public utilities are not
included. The client also should consider the additional expenses for custom duties,
transportation costs etc.

1.2 Purpose of this Project Report

This is a preliminary study, to be furtherly completed and amended in connection with the
actual conditions and requirements, and with the extension of the possible contract.

2. PRODUCT PROFILE

2.1 Description

The Syringe to be produced is 3 piece type (with gasket) consisting of barrel, plunger
and gasket, and Needle consisting of Cannula, Hub and Protection Cap.

This proposal has been designed to be used Elastomer gasket which is harmless latex free
material. Production line of Elastomer gasket can be excluded or modified in this proposal if
Buyer prefer to use other materials.

The plant includes the Injection molding process, Syringe assembling, and Packing, with
relevant ancillaries, and the Ethylene Oxide Gas Sterilizing department.

The production is performed in accordance with International Standard with automatic and or
Semi-automatic machinery and Products shall meet to Korean Standard KSP3004-1986, KS
P3001-1985 and I.S.O. 7886-1:1993 (Disposable Syringes) and 7864-1:1993 (Disposable
Needles).

.
2.2 Figures of Products

A) 3 Part Disposable Syringe

B) DISPOSABLE NEEDLE
2.3 Specification

2.3.1 Scope
This specifies requirements for an over the 3 components type Disposable Syringes and
Needles. Syringe & Needles are specified for single use, and are supplied in the form of
Syringe with Needle, which is being attached Needle to Syringe, or Syringe without Needle.

2.3.2 General

1) Components
In case of Syringe with or without Needle, all product assemblies shall include a Barrel,
Plunger, Gasket and Needle. Also, Needle itself consists of Stainless steel Cannula (cut and
ground for point sharpness), Hub and Cap. All components should be free of defects and
made of non-toxicity and non-pyrogenic materials.

2) Sterility
All products shall be provided with individual packages that maintain sterility of
the internal part.

3) Biological Hazards
All materials shall pass Biological tests.

2.3.3 Syringe Barrel

Barrel should be transparent and no burr and free defect on and inner surface.
Graduation marking and logo are printed on out-surface of barrel.

2.3.4 Plunger (Piston)

Syringe Plunger is made of polypropylene.

2.3.5 Gasket
When giving injection, movement of gasket in the syringe barrel shall be smooth. For
this, Silicone oil is used as a lubricant. Also, tightness of gasket within the inner surface of
syringe barrel should be proved as leak-proof when tested.

2.3.6 Conical fitting of nozzle

The conical tip of Syringe nozzle has a 6% conical taper.
When tested no leakage shall show at the joint of nozzle and Needle hub.

2.3.7 Needle Cannula

Point of Needle Cannula should be sharp enough and the cannula shall be no sign of
corrosion when tested.
Cannula is to be coated with silicone mixture to reduce drag and penetration force.

2.3.8 Hub
Hub shall have a conical socket and when tested with a plug gauge, it shall have 6% conical
taper.

2.3.9 Strength of joint between hub & cannula

Bond strength shall be tested in accordance with ISO 7864.

2.3.10 Needle Cap

Cap is to be an easily removable translucent cover over the needle that has a snap
fit to the hub.

2.3.11 Syringe Tip

There are 2 different types of Syringe tip. One is Luer Slip Tip that is normal
standard tip type and the other one is Luer Lock tip (Screw type). Customer may
choose either one of them according to the demand of the market.
2.3.12 Needle Hub Color
The Hub shall be uniformly colored in accordance with ISO specification/standard
or government standard of customer's country.

2.3.13 Needle Siliconizing

Needle Cannula shall be coated with silicon mixture to reduce drag and penetration forces.

2.3.14 Individual Packing/Syringe

Individual Thermoforming Blister Packaging with medical glade paper and soft plastic film.

3. BASIC DESIGN

3.1 Product Design

TYPE OF SYRINGE Curative 3 part Syringe

SIZE 2ml, 3ml, 5ml, 10ml

- Luer Slip or Luer Lock Tip,

TIP TYPE - Centric Tip or Eccentric Tip

INDIVIDUAL PACKING Peel Back Paper BLISTER PACKING

MIDDLE PACKING N/A

NEEDLE By Packed Needle

3.2 Capacity of the Plant

It is assumed that the following range of sizes will be produced per Month;

1) Disposable Syringe

TYPE SIZE NEEDLES QUANTITY

2ml & 3ml. 23G or 24G 4,000,000
3 Part type Syringe 5.0 ml. 22G 3,000,000
10.0 ml. 21G 2,000,000

SYRINGES 9,100,000
TOTAL NEEDLES
9,100,000
(ASSEMBLY ONLY)

NOTE : 2ml and 3ml shares the same Mold and Machines but, they are identified in the
Barrel Printing phase.
 2) NEEDLES (Assembly Only)

APPLICABLE
SIZE HUB COLOR QUANTITY Needle Cap REMARK
SYRINGE

24/23G x 1” 2ml/3ml BLUE 4,000,000 Middle Cap “

22G X 1-1/4” 5ml BLACK 3,000,000 Middle CAP “

21G x 1-1/2” 10ml GREEN 2,000,000 Long CAP “

TOTAL 9,000,000

3.3 Demand specific Mode of Syringe + Needle

There are three different types of Individual Packing for Syringe + Needle as follows;

a) Syringe without Needle

b) Syringe with by-packed Needle
c) Syringe with Needle – (or Syringe with mounted/ attached Needle)

This proposal is based on the individual packing of (b) SYRINGE BY PACKED NEEDLE TYPE.

3.4 Working Conditions

PROCESS WORKING SHIFT/DAY HOURS/DAY

INJECTION MOLDING 3 SHIFTS 24 Hrs.

ASSEMBLY & PACKING 1 SHIFT 8

STERILIZATON 2 CYCLES 16

* Shifts per day : 1~3 shifts.

* Working Hours per Shift : 8 Hours.
* Working days per Month (& year) : 24 days per month (288 days per Year)
* LOSS TIME
Loss time is resulting from;
 Pre-Heating of the machines
 Starting of the production
 Setting of the Machine
 Changing of Moulds or Accessory
 Machine or Electric Breakdown
 Cleaning of Machine, etc.
4. PROCESS DESCRIPTION & MACHINE CAPACITY

Disposable Syringe and Needle are manufactured according to the Korean Standard and ISO
Standard. Barrel, Plunger, Needle Hub and Cap are made of Polypropylene and Gasket is
made of Elastomer.
Needle Cannula is manufactured according to the Korean Standard and, or ISO Standard and
is made of AISI 304(SUS 304) type Stainless Steel.

4.1 Description of Production Process

The raw material used for the production of single use syringes are polypropylene for the barrel and
plunger and thermoplastic elastomer for gasket in form of granules. In the raw material store the
granules are filled from the bags in to the containers and from there they are conveyed to the
injection molding machine. During the filling into the containers, no dirt gets into the raw material.

4.1.1 Injection Molding

The plastics raw material is filled into the material hopper of the injection molding machines in
plasticized by the injection units of the machines. The plasticized material is injected under pressure
into the closed precision injection molds. Due to the cooling water system linked with the mold, the
plasticized material is cooled down again becoming the respective part, such as barrel, plunger, hub
and cap. At the end of the cooling down time the mold is open hydraulically and the shaped parts
are ejected. The individual injection molded parts are filled in to storage containers for
approximately 24 hours for further cooling down and shrinking to the definite measurement. First in
first out system is followed.

4.1.2. Barrel Printing

After storage the barrel are taken to the printing machines and plungers to the assembly machines.
The barrels are placed onto in feed conveyer which takes the barrels to printing drums and the ink
with the help of calibrated iron roller gets transferred from ink roller to the syringe

4.1.3.Syringe Assembly
The printed barrel as well as plunger and gasket are taken to the assembly machines and
automatically fed in to machines. In this machine the gasket is pushed into the plunger and
assembled plunger pushed into the barrel then after a required size of needle fixed on the nozzle of
syringe.

4.1.4 Needle Assembly

Hubs, Cannulas and Caps are assembled by Automatic Needle Assembly M/C. Siliconizing of
Cannula is performed in this process.
Assembled Needles are sent to Packing process for individual packing or to Syringe assembly
process.

4.1.5. Packing
After assembly the hypodermic syringes with needle are Blister packed using a plastic film suitable
for thermoforming and paper which is gas permeable but impermeable for germs. The film and
paper on rolls are hanging into the packing machine.
Syringes are fed and placed into the blister formed film of bottom web automatically by Auto-
Feeder. In the next step put the lidding Paper on the bottom film and Film and Paper are sealed by
heat.
After sealing the packages, the product leaves the clean room and is now protected all over against
contamination. The packages are then placed into inner boxes; the inner boxes are already printed;
only indications such as production date, lot no., expiry, etc. are stamped on. The inner boxes are set
into a dispatch carton which is also labeled with required data.
The dispatch boxes are closed and conveyed to sterilization area.

This Proposal does not include the Packing units for Box and master Cartons.
4.1.6. Sterilization
Syringes packed into the dispatch cartons are placed into the sterilization chamber. Sterilization is
done by ethylene oxide gas.
After the sterilization chamber has been filled with syringes, chamber door is closed and locked,
then steam is led into the chamber which supplies the required humidity. The chamber remains in
this state for approximately 1 hour so that the humidity (60% to 80%) and temperature (40ºC to
50ºC) can penetrate into packages.
At the end of this hour of humidification and required volume of gas is led into the chamber via the
evaporator. When the whole determined volume/quantity of gas is in the chamber the exposure
time starts. The pipes to the chamber are all closed and the chamber remains in this state for
approximately 6 hour. By the remains vacuum in chamber it is granted that door can not be opened.
In this course of the exposure time the vacuum pressure usually increases slightly.
At the end of the exposure time the chamber is evacuated again to approximately 0.05 bars with the
vacuum pump, thus removing the main portion of the ETO. The fresh air is led into the chamber
through a filter. Just before reaching the pressure balance the chamber evacuated to remove
remaining gas rests. This is done twice in the third step fresh air in led is until the pressure balance is
reached. Then the chamber is unloaded and sterilized products are taken to the quarantine store.
4.2. Production Capacity

4.2.1 Molding Injection

Barrel, Plunger and Gasket are made by molding injection.

Prepared raw materials (Polypropylene etc.) are fed into the various Injection Molding
machines. Molded parts are packed into suitable plastic container and pre-stored.

 Injection Capacity & Productivity/Mold

Q'TY
CAVITY CYCLE Q’TY PRODUC-
TYPE SIZE ITEM TIVITY / DAY
/ MOLD / Hr. / Hr.
(24 Hrs)
BARREL 44 165 7,260 169,012
2.0ml &
PLUNGER 44 210 9,240 215,107
3.0ml
GASKET 92 145 13,340 310,555
BARREL 44 165 7,260 169,012
3 Component
5.0 ml PLUNGER 40 210 8,400 195,552
Syringes
GASKET 92 145 13,340 97% 310,555
BARREL 28 160 4,480 104,294
10 ml Plunger 28 200 5,600 130,368
GASKET 56 145 8,120 189,033
NEEDLES HUBS 92 180 16,560 385,516
24/23G, 22G, 21G CAPS 92 180 16,560 385,516

 Number of Injection Molding M/C & Mold Required

Materials Q'ty per year / Q'ty per day Working days and Number of Molds
2/3ml Barrel: 4,000,000pcs/ 169,012 pcs ≒ 23.7 days --- 1 Mold
2/3ml Plunger: 4,000,000pcs/ 215,107 pcs ≒ 18.6 days --- 1 Mold
2/3ml Gasket: 4,000,000pcs/ 310,555 pcs ≒ 12.9 days --- 1 Mold
5 ml Barrel,: 3,000,000pcs/ 169,012 pcs ≒ 17.8 days --- 1 Mold
5 ml Plunger: 3,000,000pcs/ 195,552 pcs ≒ 15.3 days --- 1 Mold
5 ml Gasket: 3,000,000pcs/ 310,555 pcs ≒ 9.7 days --- 1 Mold
10ml Barrel: 2,000,000pcs/ 104,294 pcs ≒ 19.2 days --- 1 Mold
10ml Plunger: 2,000,000pcs/ 130,368 pcs ≒ 15.3 days --- 1 Mold
10ml Gasket: 2,000,000pcs/ 189,033 pcs ≒ 10.6 days --- 1 Mold
Needle Hubs: 24/23G 4,000,000 pcs/ 385,516pcs ≒ 10.4 days --- 1 Mold
22G 3,000,000 pcs/ 385,516pcs ≒ 7.8 days --- 1 Mold
21G 2,000,000 pcs/ 385,516pcs ≒ 5.2 days --- 1 Mold
Needle Cap,
Short; For 24/23G : 4,000,000pcs/ 385,516 pcs ≒ 10.4 days --- 1 Mold
Medium, for 22G : 3,000,000pcs/385,516 pcs ≒ 7.8 days --- 1 Mold
Long:; for 21G, 2,000,000pcs/ 385,516 pcs ≒ 5.2 days --- 1 Mold

 Total Working Days of Barrel & Plunger injection = 109.9 days

 Total Working Days of Hub & Cap injection = 46.8 days
 Total Working Days of GASKET injection = 33.2 days
 Total Number of Injection Molding M/C required : 9 M/Cs
- for Barrel & Plunger Injection ; 109.9 days ÷ 24 days = 4.58 = 5 M/Cs
- for Hub & Cap Injection ; 46.8 days ÷ 24 days = 1.95 = 2 M/Cs
- for GASKET Injection ; 33.2 days ÷ 24 days = 1.38 = 2 M/C
 Number of Molds required = 25 Molds
  Total Number of Injection Molding Machines & Molds

ITEM WORKING WORKING DAY No. OF M/Cs INJECTION No. of

(INJECTION WORK) DAYS/YEAR ÷ 24days(Month) REQUIRED M/C MOLDS

BARREL & PLUNGER 109.9 4.58 5 180~200 TON 6

HUB & CAP 46.8 1.95 2 130~160 TON 6

GASKET 33.2 1.38 2 130~160 TON 3

TOTAL 189.9 9 15

4.2.2. Printing on Barrel

Scale marking and logo are printed on the out surface of Syringe Barrel by Automatic Gravure
Printing Machine.

* Printing capacity per Printing M/C

CAPACITY WORKING PRODUTS Number of
SIZE
PER HOUR HOURS/SHIFT Per 1 SHIFT M/C. Rqd.
2/3 ml 21,000 PCS 8 Hrs/ DAY 168,000 PCS 1 set

5 ml 21,000 PCS 8 Hrs/ DAY 168,000 PCS 1 set

10 ml 16,000 PCS 8 Hrs/ DAY 128,000 PCS 1 set

 Total Number of Printing Machine : 3 M/C

4.2.3. Syringe Assembly

Each parts of Syringe i.e, printed Barrel, Plunger and Gaskets are fed to
Assembly machine and Each parts are assembled by Syringe assembly machine
automatically. Siliconizing of the barrel is also performed in this process.
Needles are not Assembled to Syringes but packed with Syringe by side in the Blister Packing
process.

* Assembly capacity of Syringe Assembly M/C

CAPACITY WORKING PRODUTS Number of
SIZE
PER HOUR HOURS/SHIFT Per 1 SHIFT M/C. Rqd.
2/3 ml 21,000 PCS 8 Hrs/ DAY 168,000 PCS 1 set

5 ml 21,000 PCS 8 Hrs/ DAY 168,000 PCS 1 set

10 ml 16,000 PCS 8 Hrs/ DAY 128,000 PCS 1 set

 Total Number of Printing Machine : 3 M/C

4.2.4. Needle Assembly

Needles are produced in many different sizes and must be handled with absolutely no damage to
the sharp point. Needle Cannulas and plastic parts (Hub & Cap) are fed & oriented, assembled,
glued and Siliconized, inspected with various systems on a Needle Assembly machine. Failed
assemblies are pneumatically ejected into a reject bin, while completed Needles are accumulated
and then output into trays as a final station of the procedure

 Needle Assembly Capacity

SIZE Production/ Hr Production / shift

All sizes 62,000~ 65,000 pcs 496,000~520,000 pcs

 Number of M/C required; 9,100,000pcs ÷ 500,000pcs = 18.2 days = 1 Machine

4.2.5. Individual Packing

Completely assembled Syringes are fed to Blister Packing machine for Individual Packing.
Syringes are supplied to the web/packing mold of Packing Machine by manual or by Auto
Feeding system. In this Proposal, Syringe is supplied to the Blister Packing Machine by
separate Auto-Feeding Machine for the high efficiency.

Syringes are fed to Hopper of Auto-Feeding Machine of Blister Packing machine and Auto-
Feeding Machine load syringes to the web of Packing Machine automatically.

Also, separate Needle Feeding Machines are required as Needles are packed by side the
Syringe and not being attached to Syringe.

After individual packing process, syringes are sent to master packing process for boxing and
cartoning.

No. of Cavity of PRODUCT Number of PRODUCTS/ Q’TY/Shift

SIZE
Packing Mold FEEDING Cycles/ Min. Hour ( 8 Hours)
2 & 3 ml 11 x 2 row Auto 14 18,480 PCS 147,840 PCS

5 ml 10 x 2 row Auto 14 16,800 PCS 134,400 PCS

10 ml 8 x 2 row Auto 14 13,440 PCS 107,520 PCS

* Number of Packing M/C required

2/3ml ; 4,000,000pcs ÷ 147,840 pcs= 27.1 days – 9 Hrs working /day
5 ml ; 3,000,000pcs ÷ 134,400 pcs= 22.3 days – 1 shift
10ml ; 2,000,000pcs ÷ 107,520 pcs= 18.6 days – 1 shift

 Total Number of Blister Packing M/C = 3 Machines

 Total Number of Syringe Auto Feeding Machine = 3 Machines
 Total Number of Needle Auto Feeding Machine = 3 Machines

NOTE : Production Capacity of Syringes is determined by productivity of Blister Packing

Machine
 4.2.6. Sterilization

Syringes are Sterilized in a Sterilization Chamber by means of Ethylene Oxide Gas

Parameters. Finally, the Syringes are subjected to bacteriological and biological tests.
To do this, a series of samples is taken according to the determined plan.
If all test results show that the syringes produced are sterile and good, they can be released
for sale. One cycle of Sterilization takes aprx. 7~8 hours and normally 2 cycles of Sterilization
is carried out per day.

 Sterilization capacity per each 10 cu.meter size sterile chamber

CAPACITY/ PRODUTS/DAY
SIZE CYCLES/ DAY
CYCLE ( 2 CYCLES)

2ml/3 ml 250,000PCS 2 500,000 PCS

5 ml 180,000PCS 2 360,000 PCS

10 ml 125,000PCS 2 250,000 PCS

 Number of Sterilization Chambers required

2/3ml : 4,000,000pcs ÷ 500,000pcs = 8 days
5 ml : 3,000,000pcs ÷ 360,000pcs = 8.3 days
10 ml : 2,000,000pcs ÷ 250,000pcs = 8 days

Total Working = 24.3 Days ÷ 24 days = 1.01 = 1 Machine

5. GENERAL REQUIREMENT

5.1 Space Requirement

For the Plant to produce 9,000,000pcs of Syringes per Month, production space required to
2
have a size of aprx. 950m . This space excludes office site, medicare space, warehouse, store
room, corridor, locker room and shower room etc.

Recommended size of each production rooms are as follows;

- Injection Molding Room : aprx. 300 sq.m

- Syringe & Needle Assembly Room : aprx. 400 sq.m
- Box, Carton Packing : aprx. 150 sq.m
- Sterilization Room : aprx. 100 sq.m

5.2 Manufacturing Area

It is recommended that Production room has to be kept as a clean and microbial or bioburden
limit area. Normally, the following level of cleanroom classification is required.

- Syringe & Needle Assembly Room : Clean Room, Class 100,000~10,000

- Injection molding Room : Clean Room, Class 100,000 or Clean condition
- Others : Ordinary but clean condition
5.3 Utility Requirement

Electricity : 3P 220/380V, aprx. 500Kw/Hr.

3
Compressed Air : aprx. 7.5M /Min. At 6Kgf/cm
Water Consupmtion : aprx. 0.5 Ton/Day or lower (excluding circulating water)

 MAX. UTILITY CONSUPMTION

KW/ Hr. TOTAL
ITEM AIR WATER
/ EACH M/C KW/Hr.
Injection Molding
32KW x 9 288 Kw 270 ltr/min Circulation
Machine

Hopper Loader 2.3Kw x 9 20.7 Kw

Chiller 48Kw x 1 48 Kw 900 ltr Circulation

Crusher 21Kw x 4 84 Kw

Spure Eject Robot 0.1 Kw x 2 0.2 Kw 0.2 ltr/min

Water Cooling
15Kw x 1 15 Kw 800 ltr Circulation
System, 60R/T
Others/ Injection
3Kw x 1 3 Kw
Room

Syringe Printing MC 3Kw x 3 9 Kw 450 ltr/min

Syringe Assembly MC 5Kw x 3 15 Kw 1,800 ltr/min

Needle Assembly MC 20 Kw x 1 20 Kw 1,300 ltr/min

Blister Packing MC 9.5Kw x 3 28.5 Kw 1,500 ltr/min

Air Compressor 37Kw x 2 74 Kw

120
EO Sterilizer 44 Kw x 1 44 Kw 2~3 ltr/ cycle
ltr/cycle
6. COST ESTIMATE FOR EQUIPMENT & SERVICES

6.1 Injection Molding Room

NO. DESCRIPTION Q'TY U/PRICE AMOUNT

1. MOLDS FOB BUSAN/ U.S.$

for 2/3 ml Barrel 44 Cavity 1 27,000 27,000
Plunger 44 " 1 23,000 23,000
Gasket 92 " 1 22,000 22,000
for 5 ml Barrel 44 Cavity 1 27,000 27,000
Plunger 40 " 1 23,000 23,000
Gasket 92 " 1 22,000 22,000
for 10 ml Barrel 28 Cavity 1 25,000 27,000
Plunger 28 " 1 23,000 23,000
Gasket 56 " 1 22,000 22,000
for Needle Hubs 92 “ 3 23,000 69,000
for Needle Caps 92 “ 3 23,000 69,000
2. Injection Molding Machines 5 64,000 320,000
HYBRID SERVO SYSTEM(Energy Saving Type)
Auto Control,
Clamping Force : 200 Ton
Auto-safety isolation, Microprocess Controller
Cylinder : 45~50Ø
3. Injection Molding Machines 4 58,000 232,000
HYBRID SERVO SYSTEM(Energy Saving Type)
Auto Control,
Clamping Force : 150 Ton
Auto-safety isolation, Microprocess Controller
4. Other equipment Sets for Injection
Molding Machine & Molds
(Appurtenances & Accessory sets)
Hopper Loader(2.5Kw) 9 1,700.- 15,300.-
Hopper, 25Kg 9 600.- 5,400.-
Raw Material Storage Tanks 9 1,600.- 14,400.-
Sprue Ejecting Robot 2 3,900.- 7,800.-
Crushers (5Kw) 4 8,800.- 35,200.-
Chiller, Auto, 45Kw 1 54,000.- 54,000.-
Cooling system structuring work 1 42,000.- 42,000.-
with Pipes and necessary parts
Water Cooling Tower and Pumps, 60R/T 1 48,000.- 48,000.-
Auto Tumbler Mixer 2 8,300.- 16,600.-
Coloring Machine 1 9,400.- 9,400.-
Movable Electric Hoist, 1 Ton 1 5,600.- 5,600.-
Carrying Cart 8 600.- 4,800.-
Other Appurtenances & Accessory sets 1 12,000.- 12,000.-
(Tool Set & Spare Parts of Molds for 1 year etc.)

Sub Total; U$1,176,500.-

6.2 Assembly & Packing Room

NO. DESCRIPTION Q'TY U/PRICE AMOUNT

FOB BUSAN/ U.S.$

1. Syringe Barrel Printing M/C
- Centrifugal Parts Feeder Type 3 27,000 81,000
- Elevation Conveyor
- Auto Control
- For 2/3ml, 5ml, 10ml
2. Syringe Assembly Machine
- Centrifugal Parts Feeder Type 3 47,000 141,000
- Elevation Conveyor
- Auto Control
- For 2/3ml, 5ml, 10ml
3. Blister Packing Machine
- Auto Control by PLC 3 67,000 201,000
- Cycle : max. 17 cycles/min.
- for 2/3ml, 5ml, 10ml
4. Ink-Jet printer for Blister Packing Machine
- Printing of Lot. No., Exp Date, Size 3 11,700 35,100
- Instead of existing Stamp Printing device
5. Forming/Sealing Die(Packing Mold) 3 6,800 20,400
for 2/3ml, 5ml, 10ml
6. Syringe Auto. Feeding Machine 3 34,000 102,000
for Blister Packing Machine
- Auto Control
- for 2/3ml, 5ml, 10ml
7. Needle Auto. Feeding Machine 3 27,000 81,000
for Blister Packing(for by-packed Needle)
- for 2/3ml, 5ml, 10ml
8. Line Conveyor for connecting of 3 1,800 5,400
Printing M/C and Assembly M/C
for 2/3ml, 5ml, 10ml
9. Auto Needle Assembly Machine 1 230,000 230,000
- Auto Control
- 2 steps Inspection System for Needle point
- Combined use for all sizes of Needles
3
10. Sterilization Chamber. 10 M 2 126,000 126,000
- Auto Control
- One Door type
11. Air Compressor, Screw type. 50HP 2 53,000 106,000
12. Gasket Siliconizing Mixer 1 6,200 6,200

Sub Total : U$1,135,100.-

6.3. Total Amount of Equipment & Machines

6.1 + 6.2 = FOB BUSAN, KOREA …………………………. U$2,311,600.-

6.4 Installation Charge

8 Persons x U$350/Day x 15 Days = Total : U$42,000.00

6.5 Commissioning, Supervising & Training Fee …………………………………… U$50,000.00

6.6. Total Cost of Project (FOB Korea) .......................................................... US$2,403,600.00

7. LABOR REQUIREMENT(MAX.)

ITEMS NUMBER SHIFT TOTAL

PRODUCTION MANAGER 1 1 1

SUPERVISOR / INJECTION MOLDING 1 2 2

INJECTION MOLDING OPERATOR 6 3 18

PRINTING OPERATOR 3 1 3

SYRINGE ASSEMBLY LINE 3 1 3

BLISTER PACKING 3 1 3

PACKING (BOX + CARTON) 7 1 7

NEEDLE ASSEMBLY 2 1 2

STERILIZATION 2 1 2

QUALITY CONTROL 2 1 2

MAINTENANCE 1 1 1

STORE AND WAREHOUSE 2 1 1

CLEANER 1 1 1

GUARD, OFFICER AS REQUIRED

ELECTRICIAN 1 1 1
8. PRODUCTION FLOW CHART
Incoming Components:-- Polypropylene(for Syringe Barrel & Plunger)
-- Elastomer(for Gasket)
-- Printing Ink
-- Silicone oil
-- Ethylene oxide gas
-- Packing materials etc.

RAW MATERIALS RECEIVING

ACCEPT ------ INSPECTION ------ REJECT ------ ?

STORAGE

POLYPROPYLENE & ELASTOMER. NEEDLE CANNULA

INJECTION MOLDING

GASKET BARREL PLUNGER HUB & CAP

BARREL PRINT NEEDLE

INSPECTION INSPECTION

SYRINGE ASSEMBLY

INSPECTION

PACKING

STERILIZATION

FINISHED PRODUCT ANALYSIS

RELEASE REJECT
9. IMPLEMENTATION SCHEDULE

Under the normal conditions as a whole maximum 10 months will be sufficient to complete
installation of machineries and equipment.

MONTH
1 2 3 4 5 6 7 8 9 10 11
PROCESS
CONTRACT
OPENING L/C &
DOWN PAYMENT
MANUFACTURE
OF M/C
TEST &
INSPECTION
PACKING &
LOADING
SHIPPING & *
SAILLING
CLEARANCE &
UNLOADING
INSTALLATION

TEST OPERATION
CONSTRUCTION
OF BLDG.
POWER SUPPLY &
UTILITY SYSTEM
TRAINING

PRODUCTION
11. SPECIFICATION OF MACHINARIES

No SPECIFICATION & DESCRIPTION IMAGE

INJECTIO MOLDING ROOM

INJECTION MOLD-Cold Runner Type
 Material

- Standard Frame : S55C

- Core & Cavity : NAK 80
 Injection System : Cold Runner Type
Ring in Plate. Sprue is being ejected with
internal core
1  Cavity
Barrel Plunger Gasket
1 ml 44 52 92
2/3 ml 44 44 92
5 ml 44 40 92
10 ml 28 28 56
20 ml 16 16 44
50 ml 8 8 24
INJECTION MOLDING MACHINE(Hydraulic Type)
 Clamp Force : 170~180 Ton
 Shot weight : abt.15 oz
 Screw diameter : 50 mm
 Injection pressure : 1600 Kg/cm2
 Injection rate : 197 cm3/sec
 Screw revolution : 0-270 rpm
 Ejector Force : 4 ton
 Ejector Stroke : 140 mm
 Electric Motor : aprx. 22Kw, 30 HP
 Heater Capacity : aprx.10 Kw
2
 Dimension : 5.4(L)m x 1.4 x 1.7(H)
 Cooling Water : 50L / min.
 Machine Weight : aprx. 6.9 Ton
 Technical Characteristic :
- Double Toggle Type
- Multiplex Microprocessor Control
- Visual Graphic HMI Screen Configuration
- Multiple Language Screen
- Statistical Process Control Function
- Automatic Mold Height Adjustment & Mold
Clamping Force Set-up.
APPURTENANCES & ACCESSORY SET OF
INJECTION MOLDING MACHINE & MOLDS
 Hopper Dryer
- Capacity : 50Kg
 Hopper Loader
- Capacity : 2HP
3  Crusher
- Capacity : 35~45Kg/ Hr.
- Revolution : 29 rpm
- Motor : 5HP CRUSHER CHILLER
 Chiller : Air Type
 Spur Take-Out Robbot etc.

 ASSEMBLY & PACKING ROOM
FULL-AUTO. SYRINGE BARREL
PRINTING MACHINE
 Printing type : Photo Gravure
 Type of Machine: Cotinuous Motion Rotary type
 Weight : aprx. 400Kg
 Electricity : AC220V, 3Kw/Hr
 Air Consumption : 6Kg/ cm2, 150L/min.
 Main Driving Motor: D.C Motor- 1 HP
 System Control : PLC Controller
4
 Barrel Feeder : Centrifugal Parts Feeder with
Elevation Conveyor & linear Feeder
 Printing type : Gravure.(Ink transfer with Silicone
Rubber roller)
 Ink Supply : Gear Pump
 Printing Roller size : 95Ø
 Silicone Roller size: 190Ø
 Frame Material : AL6061
 Dimension : 2260mm x 2020 x 1700(LxWxH)
FULL-AUTO. SYRINGE ASSEMBLY MACHINE
 Type of Machine : Continuous motion Rotary type
 Dimension : 4000mm x 2700 x 1800 (LxWxH)
 Weight : About 1500Kg
 Electricity : AC 220V, 5.0Kw/ Hr
 Air Consumption : 6Kg/cm2, 600L/min
 Main Driving Motor : D.C Motor 1HP
 Siliconizing : Nozzle Spray (Continuity)
 Frame Material : AL6061
 System Controller : P.L.C Controller
 Drum Material : M.C
 Safety Window Cover: Installed
5
 Production Capacity
1cc : 18,000 pcs ~ 22,000 pcs
3cc ; 20,000 pcs ~ 27,000 pcs
5cc ; 20,000 pcs ~ 27,000 pcs
10cc ; 14,000 pcs ~ 18,000 pcs
20cc ; 10,000 pcs ~ 16,000pcs
50cc ; 6,000pcs ~ 9,000pcs
 Number of Worker(s) : 1~2
 Material Feeding :
Centrifugal Parts Feeder with Elevation Conveyor
+Linear Feeder and Vibratory Bowl Parts Feeder +
linear feeder
BLISTER PACKING MACHINE
 Production Speed: 12~17 Cycles/Min.
 Machine Body Material : AL6061 & Stainless Steel
 Operation & Machine Control : P.L.C Control
 Digital Temperature Controller
 Driving Motor : Servo Driver 1 HP x 1/20
 Forming Methods : Vacuum,
6  Sealing : Up & Down Moving
 Vertical Cutting : by Loadless Cylinder Knife
 Stamp/Print : Movable Printer-Pressing Plate Type
 Horizontal Cutting : Roll Cutter(SKD11)
 Applicable Film : 380~440mm/W x 60~150µ,
PP+PE or PP + PVC or Nylon film etc.
 ApplicablePaper:350~400mm/W x 50~150gr/cm2
Coated with PE or Non-Coated paper.
  Dimension : 6250/L x 1100/W x 1800mm/H
 Weight : aprx. 2000Kg
 Electricity : AC 3P 220V/380V, 50/60Hz, 9.5KW
2
 Air Consumption : 6Kg/Cm , 500L/Min.
AUTO. FEEDER FOR BLISTER PACKING M/C
 Dimension : 6400 x 1200 x 2450 (L x W x H)
 Weight : About 1500Kg
 Electricity : AC 3P 220V/380V N.G 50/60Hz, 2.5KW
2
 Air Consumtion : 6Kg/cm , 200L/min
 Production Capacity : 13 ~ 17 Cycles/min
7  Feeding Type : Centrifugal Parts Feeder
with Elevation Conveyor
 Conveyor Meterial : P.V.C
 Drum Dia : Ф960
 Drum Meterial : M.C
 Syringe Fixing Type : Vacuum Type
 Main body Material : AL6061

E.O Gas STERILIZER(AUTO-CONTROL)

 Size of Chamber : 10 cubic meter, Single Door
 Dimension : 1950mm/W x 2250/H x 5300/L
 Chamber Size : 1450mm/W x 1500/H x 4600/L
 Weight : 9,800 Kg
 Door Opening : Astoria System, One Door Type
 Operational mode: Automatic system
 Electricity : 4P 220/380V, 50/60hz, 44Kw
 Vacuum Pump : 20Kw
8  Circulation Pump: 0.8Kw
 Humidity Generator: 5.0Kw
 Maximum Internal Pressure : 2 Kgf/cm2
 Internal Vacuum Pressure : 680~720 mmHg
 Gas leakage Monitoring system,
Full microprocessor control system
 Process Monitoring : Temperature, Humidity,
Pressure & Time Recording system
 Humidifier, Steam Boiler, Emergency Alarm System
 Negative & Positive Combine Pressure Sterilization

AIR COMPRESSOR-SCREW TYPE

(with Relevant Accessory & System)
3
 Air Delivery : 7 Bar, 3.62m /min
 Power : 30HP
 Electricity : AC 3P, 220/360/440, 50/60Hz, 22Kw
 Weight : 650KW
9
 Dimension : 1150mm x 890 x 1370
 Auxillaries
- Air Receiver Tank
- Air Dryers
- Air Filters
- After Cooler etc.
AUTO. NEEDLE ASSEMBLY MACHINE
 Dimension : 8900mm/L x 4000 x 2550
 Weight : About 3000Kg
 Electric Power : AC 3Px220/380V, 50/60Hz
 Electric Consumption: About 20Kw/H
10
 Air Pressure : 6Kg/Cm2
 Air Consumption : About 1300L/min
 Cannula Supply Type : Lift Type
 No. Of Worker :2
  Main Frame Material :
SS41 Cr Hard Coating & AL6061
 Parts Feeder :
Low noise vibrator feeder (Pre-feeding system)
 Corona Treatment for Hub : 25000V( Transformer)
 Needle Bonding : Wheel Type with Servo
Controller
 Epoxy Drying : Drying Tunnel, 100~130°C
 Inspection Range ( Double Inspection System) :
Reverse needle, Point of Needle, Blockage , Bent
Needle, No Cannula.
 Blockage Test : Non Glass Pipe Type
 Ejection Of Rejected Needle : Auto Ejection
 Silicon Coating :
Dipping Type + Silicon Heating Dry
 Auto Capacity Counter
 Hub Holding Jig : 50 pins/ Jig x 400Pcs.
 Production Capacity : 62,000 ~ 70,000Pcs/Hour
OPTIONAL DEVICES

CENTRIFUGAL PARTS FEEDER & ELEVATOR SYSTEM

1 (INSTALLED)
For PRINTING MACHINE & ASSEMBLY MACHINE

Line Conveyor for Connecting from Printing M/C to

2 (INSTALLED)
Assembly Machine

Line Conveyor for Connecting whole Assembly

3 Line : Connecting of Printing M/C – Assembly (INSTALLED)
Machine – Blister Packing M/C

Ink Jet Printing System for Blister Packing M/C

4 (INSTALLED)
(instead of existing Stamp Printing Device)

Subject to change of specification and/or model of the machines without prior notice for improvement
NOTE of the performance of whole plant project system.
11. PLANT LAY-OUT (SAMPLE)