Type III DMF-Silicon Tubes (Himsan Polymer)

Himsan Polymer Private limited (An ISO 9001:2008 Certified Company)
TYPE III
DRUG MASTER FILE
“PLATINUM CURED SILICON

TUBES & BRAIDED HOSES”
Himsan Polymer Private Limited
Volume I of I
1
TYPE III DMF FOR “PLATINUM CURED SILICON TUBES & BRAIDED HOSES”
JUNE – 2015 (Version 1.0)
Himsan Polymer Private limited

B/1, Vishal Indl Estate,
Near HP Gas Godown,
Goddev- Fatak Road,
Bhayander (E), Dist: - Thane,
Mumbai – 401105 (INDIA)
Tel no: - +91-22-28171509
Email: - info@himsanpolymer.com
Web site: -www.himsanpolymer.com
2
TYPE III DMF OF “PLATINUM CURED SILICON TUBES & BRAIDED
HOSES.”
COMPREHENSIVE TABLE OF CONTENTS
SECTION
CONTENTS PAGE NO.
NO.
Introduction 4
1.0 Product Description 4
2.0 Process Description 5
3.0 Statement of Confidentiality 6
Section A Administrative Information 7
Persons Authorized to Incorporate the D.M.F. 15
Section B
by Reference
Section C Descriptive Information 17
A Description of the Package Component 18
B Materials of Construction 19
Section D Manufacturing Process Description 21
Section E Specifications 28
1.0 Specifications for Material of Construction 29
2.0 In process tests 35
3.0 Specifications for Finished Products 37
Section F Test Methods 39
Specifications and standard test procedures for 40
A.
raw materials
Specifications and standard test procedure for in- 44
B.
process sample
Specifications and Standard Test Procedures For 51
C.
Finished Product
Section G Quality System 54
1.0 Quality System Manual 55
3
INTRODUCTION
1.0 PRODUCT DESCRIPTION
Himsan Polymer Pvt. Ltd. is known as the “Sealing Expert in Silicone” and
manufacture a variety of products. The company’s Prime Products are Platinum
Cured Silicone transparent Tubes, Platinum Cured Silicone Transparent Braided
hoses, Platinum Cured Silicone Transparent FBD Gaskets. Besides the above,
company also manufacture a host of products such as :-
 Silicone colour tubings

 Silicone sheets
 Silicone TC gaskets
 Silicone bellows
 Silicone round and square cords
 Silicone extruded gaskets of different sizes.
 Silicone sleeves for the corona treater application
 Silicone Diaphragms, seals
 Silicone strips, sponge gaskets, silicone tips, septas
 Rubber Expansion bellows
 Autoclave door gaskets
 Medical Sterilizer Gaskets
 Lypholization Door gaskets
The company is spending average 15% turn over for the Research & Development
equipments and new products.
4
2.0 PROCESS DESCRIPTION
The company is engaged in the manufacture of Platinum Cured Silicon tubes. All the
type of component materials used in the manufacture of Platinum Cured Silicon tubes
as detailed elsewhere in the document, are food grade certified.
The Manufacturing process of Silicon tubes mainly includes the following steps.
1. Dedusting: -
 Dedusting of Platinum Cured Silicon rubber box

 Dedusting of Platinum Cured Silicon Rubber Curing Agent
 Dedusting of Polyester Yarn
2. Passing thru Pass box.
3. QC Inspection
4. Weighing
5. Mixing
 Mixing Compound Inspection
6. Extrusion
 Extrusion Inspection.
7. Post Curing operation
8. Final Inspection
9. Packing
5
3.0 STATEMENT OF CONFIDENTIALITY
Information presented in this DMF is confidential and should be treated as

confidential to the extent possible in accordance with 21 CFR 314.430 and 21 CFR
20.61.
Information from this file should not be provided to any unauthorized persons without
the written consent of Himsan Polymer Pvt. Ltd.
6
SECTION A
ADMINISTRATIVE INFORMATION
7
ADMINISTRATIVE INFORMATION
01. Name and address of Himsan Polymer Pvt.Ltd.

the DMF holder R-1, sai krupa niwas,
Opp. Kamlakar bhandari house,
Charkop Village, Kandivali (west),
Mumbai-400067.
Email : - info@himsanpolymer.com
Web site : -www.himsanpolymer.com
02. Address of Corporate Himsan Polymer Pvt.Ltd.

Headquarters R-1, sai krupa niwas,
Opp. Kamlakar bhandari house,
Charkop Village, Kandivali (west),
Mumbai-400067.
Web site : -www.himsanpolymer.com
03. Address of Himsan Polymer Pvt.Ltd.
Manufacturing Facility B/1, Vishal Indl. Estate,
Goddev Fatak Road, Panchal,
Near HP gas Godown,
Bhayander (E),Dist. Thane,
Mumbai – 401105. Maharashtra. India.
Tel no : - +91-22-28171509
Mob No. : - +91-7715871508, 09 , 10
04. Name, Address and Title Mr. Sreesanth Saruvil (Director)
of the contact Person for E-Mail – Sreesanth@himsanpolymer.com
FDA Correspondence
Name, Address and Title Mr. Himanshu Kumar (Director)

of the Alternate contact E-Mail – himanshu@himsanpolymer.com
Person for FDA
Correspondence
05. Name and address of
Agent
8
BRIEF INFORMATION ABOUT THE COMPANY
FACILITIES-GENERAL DESCRIPTION
Himsan Polymer Private Limited
Since 2014 Himsan Polymer Pvt Ltd. has been manufacturing high temperature and
high performance Silicon Transparent Tubings for the Food, Pharma, Biotech
Industries, commercial, industrial markets & many other various applications.
 Having an individual testing laboratory of approx. 400 sq.ft. area with well
equipped lab equipments for testing of different physical properties of Silicon
rubbers the list of testing equipments are as below.
 Aging test oven

 Specific Gravity apparatus
 Shore A Hardness testing gauges with stand.
 Tensile testing Machine
 Thickness gauge with stand
 Pneumatic testing apparatus.
Himsan Polymer Pvt Ltd is located just 1.5Kms from Bhayander rly stn &
5Kms off highway NH-8. We are in in Thane district and approx 45mins Drive from
the capital city of Mumbai.
 Having an individual testing laboratory of approx. 150 sq.ft. area with well
equipped lab equipments for testing of different physical properties of Silicon
rubbers the list of testing equipments are as below.
1) Specific Gravity apparatus

2) Shore A Hardness testing gauges with stand.
3) Thickness gauge with stand.
4) Pneumatic testing apparatus.
9
10
ORGANISATIONAL CHART
ORGANISATION CHART
Himsan Polymer Pvt. Ltd.
11
Key Staff Members: Brief Resume
12
SECTION B
PERSONS AUTHORIZED TO INCORPORATE

THE DMF BY REFERENCE
13
PERSONS AUTHORIZED TO INCORPORATE THE DMF

BY REFERENCE
Authorized Description and location of Referencing Drug

Person information referenced Product and
Application number
Nil Nil Nil
14
SECTION C
DESCRIPTIVE INFORMATION
15
DESCRIPTIVE INFORMATION
A. DESCRIPTION OF PACKAGE COMPONENT
PRODUCT NAME : Platinum Cured Transparent Silicon Tubing’s
PRODUCT DESIGNATION: Platinum Cured Transparent Silicon Tubing’s, which

are used extensively for most precious and intricate applications for Food, Pharma,
Medical and Heavy Engineering, Thermal Power Stations and also to major PSUs in
India.
Product Description: Different types and grades of silicon tubes in a variety of sizes,
colors, shapes, designs and finishing are manufactured. The product range includes:
 Silicone colour tubings

 Silicone sheets
 Silicone TC gaskets
 Silicone bellows
 Silicone round and square cords
 Silicone extruded gaskets of different sizes.
 Silicone sleeves for the corona treater application
 Silicone Diaphragms, seals
 Silicone strips, sponge gaskets, silicone tips, septas
 Rubber Expansion bellows
 Autoclave door gaskets
 Medical Sterilizer Gaskets
 Lypholization Door gaskets
The comprehensive range of Silicon Tubes are manufactured using optimum quality
Raw material.
16
B. MATERIALS OF CONSTRUCTION
All Raw Materials are in compliance with Federal Regulation 21 CFR.
Materials used in the manufacturing of Platinum Cured Silicon tubes & Braided
Hoses mainly are the following:
No Name of Raw Material Code No Shelf Life

1 Elastosil R Plus 4305/50 001 1 Year
4 Silicon Rubber TSE 2570/6U 004 1 Year
5 Silicon Rubber TSE 2570/7U 005 1 Year
6 Platinum Cured Silicon RubberSH 1061/U 006 1 Year
9 Elastosil Aux Batch PT-1 009 1 Year
10 Curing Agent SH0003A 010 6 Months
11 Curing Agent SH0002B 011 6 Months
12 Curing Agent SH0004A 012 6 Months
13 TC25A (Platinum Catalyst) 013 1 Year
14 TC25B (Platinum Catalyst) 014 1 Year
15 Polyster Yarn 1000/1x2nw 015 1 Year
16 Polyster Yarn 1000/1x3nw 016 1 Year
17
The details of the primary suppliers for Raw Material are as per follows:
The Raw Materials are obtained from the following company(s)
Sr. Material Name Manufacturer Name & Address DMF

No. Reference
No.
1. Sili. Platinum Elastosil R Plus M/s. Wacker Metroark NIL
4305/50-60-70 Chemical Pvt. Ltd.,
Elastosil Aux Batch PT-1 1st & 2nd Floor, CTS No. 521,
Village Pahadi, Sonawala Cross
Road, Off. I.B. Patel Road.
Goregaon – Mumbai – 63
2. SILICONE RUBBER Bhavik Enterprise NIL
KCC 1061U Administrative Office : -
KCC 2660U Suite No : - 327 ,
KCC 1072U Bhaveshwar Archade,LBS Marg,
Curing Agent SH0003A OPP.Shreyas Cinema,
Curing Agent SH0002B Ghatkopar - West,
Curing Agent SH0004A Mumbai - 400086.
Sili.Platinum Rubber 1072-U per kg
Platinum Cure Silicone Rubber SH
1061 U/60
3. Sili.Platinum Cure Rubber M/s. Momentive NIL
TSE 2570 6U / 7U kohinoor hotel, J B nagar,
TC25A(Platinum Catalyst) mumbai- 400059.
TC25B(Platinum Catalyst)
4. Polyester Yarn 1000/1 x 2 nw Pragati Enterprises NIL
Polyester Yarn 1000/1 x 3 nw D/105, Shivdham, Near Movie
Time, 62 Link Road, Malad (W)
18
SECTION D
MANUFACTURER PROCESS DESCRIPTION
19
MANUFACTURER PROCESS DESCRIPTION
Dedusting: -
 Dedusting of Silicon rubber box
 Remove the Silicon rubber Bale from the cartoon box along with the
polythene cover
 Dedust the silicon rubber thoroughly using a vaccum cleaner.
 Dedusting of Silicon Rubber Curing Agent
 Remove the curing agent container from the cartoon or Plastic cover.
 Dedust it with Vaccum cleaner throughout the outer body.
 Dedusting of Polyester Yarn
 Remove the polyester yarn Cartridge from the cartoon box along with the
polyethylene bag.
 Dedust the product with Vaccum Cleaner.
Passing thru Pass box
 Open the outer gate and keep the raw material inside the Pass Box.
 Close the outer gate and Keep the material for 3 – 4 seconds inside the pass
box under UV Light.
 Open the inside gate and remove the raw material from inside the pass box and
keep the RM in under testing area for Qc approval.
QC Inspection
 Now QC will inspect the raw material as per the QAP.

 If the raw material is approved as per the QMS send the material to the storage
area, if not send the material to the Quarantine area.
Weighing
 Cross check the weighing scale readings by putting different master weights.
 Serially weigh the ingredients according to the formulation card as per
displayed in SOP stand.
 Weigh the batch ingredients according to the Production Plan.
Mixing
20
 The Material received from the RM stores is thoroughly checked.
 Then the machine is thoroughly checked for
a) Lubrication
b) Nip gap ( gap between both the rolls ) to be adjusted as per the need ( upto
3mm max)
c) Temperature of both the rolls (should be cool enough i.e. below 45 deg) as
the higher temperature may cause the precuring and scorching of
compound.
 Then the machine is started & first loaded with silicon rubber & preheated.
 When the silicon rubber is sufficiently plasticized (preheated) the band of
material will slowly transfer from the slow roll to the fast roll
 When this process occurs the Silicon rubber is ready for the addition of curing
agent.
 If the rubber looks Grainy tightening the nip (gap between two rolls) should
improve the Mixing. Crumbs of compound which falls into the mill pan for
any length of time they may not mill smoothly leaving lumps which will give
poor appearance to the finished product.
 Finally the catalyst is added but before adding the catalyst care should be
taken to make sure the compound temperature is cool enough, particularly in
the case of low temperature catalyst.
 Then the rubber should be cut with the help of scraper (Knife) in the form of
sheets.
 The sheeted rubber compound is laid out flat on release paper or waffled
surface polyethylene until cool.
 It is then rolled up with an inter leaf.
 The outside of the wrapper is clearly identified with the compound number the
weight of the batch and the date of compounding.
 The compound is now ready for Extrusion.
Mixing Compound Inspection:
 A small section say a size of 2” x 2” is cut from a sheeted mixing compound &
tested for the below given detailed process as per the testing procedure given
in the test method.
21
Sr.
N
Characteristics Sampling Specification Test Method
o
.
As Per
1. Hardness Button Formulation Hardness Tester
Card
As Per
Tensile Testing
2. Tensile Strength Test Slab Formulation
Machine.
Card
As Per
Tensile Testing
3. Elongation Test Slab Formulation
Machine.
Card
Compression set
Once in Three
As per Apparatus,
Month for
4. Compression Set Formulation Hot Air Oven
each
Card & Hardness
Compound
Tester.
T.S. testing
Once in Three
As per Machine,
Month for
5. Heat Ageing Test Formulation Hardness
each
Card Tester & Hot
Compound
Air Oven.
Extrusion
 After the mixing material approval the compound is forwarded directly to the
Extrusion machine
 The material is then cut to even sizes strips for feeding to the Extrusion
machine.
 The overall temperature of the machine & the water running into the machine
is checked (not more than 45deg’s) .
 The temperature of the water is ensured for overall even temperature by means
of a TCU( temperature control unit ) which is responsible for the flow of water
with even temperatures in all the zones of the extruder m/c including barrels ,
rotary & die head.
 The machine is ensured for the complete clean from inside so that there is no
mixing of two compounds.
 Then the breaker plate with a set of wire mesh front 80 & back 60 is put in the
front of the Extruder supported with a die holder for fitting of the die & pin of
the recquired size.
 Now the silicon rubber strips are feeded to the Extruder thru the hooper
containing feed roller for feeding the rubber strips at even rate.
 The rubber now flows from the hopper to the die & outside the die with a even
controlled temperature & flow rate without changing any of its properties &
uniform recquired dimensions.
22
 The dimensions & the wall thickness is controlled by a screw adjustment
located on the 4 sides equally distributed on the top of the die head.
 When the material comes out of the die the adjustment is done and a sample of
the tube is cut & cured in online infrared curing oven to check the dimensions
of the tube after curing.
 After ensuring all the parameters the material is now extruded to a desired size
& simultaneously passed thru an online curing oven which in turn is placed on
a conveying conveyer whose speed is synchronized with the speed of the
Extruder as if there is any variation in the conveying speed that is directly
reflected on the dimensions of our end product.
 Parallely then the material is wound on an open perforated SS 316L Oven trey.
 In this complete process it is completely ensured that there is least human
touch to avoid contamination.
 After the extrusion process is done the material is kept to cool for some time.
23
Extrusion Inspection
 The following parameters are checked during the Extrusion process.
Sr Characteristics Sample Specification Test Method

Dimension
Inner Diameter Verify with Veanier.
st As per product realization
1. Outer Diameter 1 Piece Verify with ID Gauge for
plan
Width / Height Tube.
Wall Thickness
Verify the piece visual and
There Shall not be Cuts, shall not be Cuts,
2. Visual 100 % marks, Finishing Cracks, marks, Finishing
pore Holes, air bubbles. Cracks, Holes, air
bubbles.
Post Curing operation
 All the Treys and sides of the oven are cleaned properly & ensured that there
is no contamination.
 Then the post curing oven temperature and time is set as per the desired
( i.e.200 degs for 4hrs)
And start the Oven.
 Place the Extruded products inside the oven along with the SS Treys after the
required temperature is acquired.
 Care should be taken when Loading that there should be no direct contact of
the material to the heater covers
 The material is Loaded inside the oven upto its capacity level.
 Never open the oven door or load/unload during Post curing cycle.
 After the post curing cycle is over the material is unloaded and moved to the
Waiting for final Inspection area.
Final Inspection
 After receiving the intimation for final inspection the samples are collected
from the lot waiting for inspection in waiting for final inspection area.
 Sampling inspection is done as per the following table.
24
SR Characteristics Sample Specification Test Method
0 To 1000
Dimension
3 Piece. Verify with Venire
Inner Diameter As per Product
1. 1001 to 5000 and Verify with ID Gauge
Outer Diameter realization plan
above 5 for Tube.
Width / Height
Piece
0-50mtr,-3 Steps As per Product
2. Length Verify with Scale.
51-200-5 Steps. realization plan
Verify the Piece visual
There Shall not be Cuts,
and shall not be
marks, Finishing
3. Visual 100 % Cuts, marks,
Cracks, pore Holes,
Finishing Cracks,
air bubbles.
Holes, air bubbles.
As per Product
4. Pressure Test One Piece Per Lot Air Pressure Machine.
realization plan
 The inspection details are recorded in the pre-dispatch inspection record.

 The results specifications are compared with the required parameters if found
ok and complies fully to our requirement the lot is approved by putting the
release status on it & send for final packing.
 If in any case the material does not meet the required parameters the material
is rejected and send to non-conformity area and then follow the QA Procedure.
Packing: -
 Now the QC passed material is In warded to the packing area.

 The Qty of material processes is measured & cut to the required length.
 The measured material is cleaned thoroughly.
 Now the cleaned finished material is rolled properly & placed in a food grade
plastic bag.
 The opened ends of the plastic bags are sealed properly through an pedal
operated hot sealing machine.
 Now the packet is labeled properly according to the size, batch nos, Qty with
QC stamp.
25
26
FLOW CHART OF THE MANUFACTURING PROCESS
27
SECTION E
SPECIFICATIONS
28
1.0 SPECIFICATIONS FOR MATERIALS OF CONSTRUCTION
S. Raw Material Specification / T.C. Self

No. Name Grade Maker T.C. Details Life
(HC- One
01 Silicone Rubber Dow Corning --
30/8110) Year
SH 1040U/
One
02 Silicone Rubber HC 40 KCC --
Year
(KCC)
Hardness : 55-64
SH 1060U / Specific Gravity : 1.13 to
One
03 Silicone Rubber HC 60 KCC 1.17
Year
(KCC) T.S. : 80 kg/cm² (min)
Elongation : 250%
Food Grade One
04 Silicone Rubber Momentive --
HV3 522 Year
Hardness : 56-64
Food Grade Dencity : 1.14 to 1.18 One
05 Silicone Rubber Momentive
HV3 622 T.S. : 9N/mm²(min) Year
Elongation : 400%
Hardness : 66-74
Elongation : 400%
Hardness : 66-74
Elongation : 400%
T.S. : 8.5 Mpa
Food Grade One
08 Silicone Rubber Rhodia (min)
71791/60U Year
Elongation : 360%
One
09 Silicone Rubber K - 740 Dow Corning Visual
Year
29
Hardness : 66-74
Bhavik
SH 1070U Sp. Gravity : 1.17 to 1.22 One
10 Silicone Rubber Enterprises(Supplier)
HC 70/KCC T.S. : 75 kg/cm² (min) Year
KCC
Elongation : 150 %
Hardness : 66-74
Food Grade Sp. Gravity : 1.16 to 1.20 One
11 Silicone Rubber Rhodia Silicone
71791/60U T.S. : 8.5 mpa (min) Year
Elongation : 330% (min)
One
12 Silicone Rubber GE – 960 Momentive --
Year
One
13 Silicone Rubber GE – 980 Dow Corning --
Year
30
Food Grade
14 Silicone Rubber Wacker -- One Yea
60 E
Food Grade
15 Silicone Rubber Wacker -- One Yea
70 E
K – 740/
16 Silicone Rubber Dow Corning -- One yea
N - 140
Dow Corning/ Hardness : 50 - 55
17 Silicone Rubber MM – 1151 U B.P. T.S. : 70 kgf/cm² (min) One Yea
Chemical(Suppliar) Elongation : 300% (min)
Silicone Rubber
18 8110/60 (HC HC–60 -8110 Dow Corning -- One Yea
60)
Food Grade
19 Silicone Rubber Dow Corning -- One Yea
GE - 980
Density : 1.07 to 1.11
Hardness : 36 to 44
20 Silicone Rubber HV3 - 422 Momentive One Yea
T.S. Strength : 6 N / mm²
Elongation : 550%
PDS – 50 Degussa/Nobel/Pera
21 PDS - 50 Visual One Yea
(Accelerator) gan.
Appearance: White Crystal
Dicup 98 Dupont/Degussa/A
22 Dicup - 98 Assay : 99 to 100 One Yea
(Accelerator) KZONOBEL
Melting Point: 38.5 to 40.5
23 Silicone Oil 350 CSTK D.P. Silicone -- One Yea
Hardness : 37 – 44
Bhavik
T.S. Strength : 60 kg/cm²
24 Silicone Rubber 0040U Enterprises(Supplier One Yea
Elongation : 300%
)
Sp. Gravity : 1.1 to 1.15
25 Silicone Rubber 462 Momentive -- One Yea
26 Silicone Rubber 472 Momentive -- One Yea
27 Silicone Rubber 5060U KCC -- One Yea
Sp. Gravity : 1.11
Hardness : 36
28 Silicone Rubber SH 1030U KCC One Yea
Tensil Strenth N/mm:
32(31).Elongation : 760
31
2.0 IN PROCESS TESTS
Processing conditions at various stations can have significant influence on the final
quality and behavior of the Finished Products (Silicon Tubes). Through experience
and Product Data Sheets of different input materials, the Company has endeavored to
standardize optimum processing conditions at each station.
The standard processing conditions are seen as broad guidelines and fine tuning of the
individual parameter is the responsibility of the operator so as to ensure that the end
product from one particular station meets the desired quality levels for which the
operator needs to comply with respective SOP.
Process records are maintained in pre-designed formats at all stations listed below:
1. RAW MATERIAL INWARD INSPECTION. RUBBER, CHEMICALS, OILS

ETC.
1.1: Test-certificate:
Elastocil R Plus 4305/50 , Elastocil R Plus 4305/60 , Elastocil R Plus 4305/70 ,

Silicon Rubber TSE 2570/6U , Silicon Rubber TSE 2570/7U , Platinum Cured Silicon
Rubber SH 1061/U , Platinum Cured Silicon Rubber SH 2660/U , Platinum Cured
Silicon Rubber SH 1072/U , Elastosil Aux Batch PT-1 , Curing Agent SH0003A ,
Curing Agent SH0002B , Curing Agent SH0004A , TC25A ( Platinum Catalyst ) ,
TC25B ( Platinum Catalyst ) , Polyster yarn 1000,1/2 Denier , Polyster yarn 1000,1/3
Denier.
Sr. Characteristics Sampling Specification Test Method

1. Visual 100% There shall be no damages, Verify visually
fungal, etc.
02. MIXING(Compound) Inspection.
32
Sr.
N
o
.
As Per
1. Hardness Button Formulation Hardness Tester
Card
As Per
2. Tensile Strength Test Slab Formulation Tensile Testing Machine.
Card
As Per
3. Elongation Test Slab Formulation Tensile Testing Machine.
Card
Once in Three Compression set
Month for As per Formulation Apparatus, Hot Air
4. Compression Set
each Card Oven & Hardness
Compound Tester.
Once in Three
T.S. testing Machine,
Month for As per Formulation
5. Heat Ageing Test Hardness Tester &
each Card
Hot Air Oven.
Compound
3. IN PROCESS INSPECTION
3.1 EXTRUSION / CURING

Dimension
Inner Diameter Verify with Vernier.
As per product realization
1. Outer Diameter 1st Piece Verify with ID Gauge for
plan
Width / Height Tube.
Wall Thickness
Verify the piece visual and
There Shall not be Cuts, shall not be Cuts,
2. Visual 100 % marks, Finishing Cracks, marks, Finishing
pore Holes, air bubbles. Cracks, Holes, air
bubbles.
FINAL INSPECTION
3.2 (Extruding)
33
0 To 1000
Dimension
1. 1001 to 5000 and Verify with ID Gauge for
above Tube.
Width / Height
5 Piece
0-50mtr,-3 Steps As per Product
2. Length Verify with Scale.
51-200-5 Steps. realization plan
There Shall not be
Cuts, marks,
and shall not be
Finishing
Cracks, pore
Finishing Cracks,
Holes, air
Holes, air bubbles.
bubbles.
As per Product
4. Pressure Test One Piece Per Lot Air Pressure Machine.
realization plan
3. SPECIFICATIONS FOR FINISHED PRODUCTS
We Manufacture Silicon transparent tubings in the following sizes.
1.1 Platinum Cure Silicone Transparent Tube.
ID OD Thick ness Length

No min max min max min max min max
0.5 147 152 100

1 1 mm 0.25 mm 6 mm 10 mtr
mm mm mm mtr
1.2 Platinum Cure Silicone Transparent Braided Hose
34
ID OD Thick ness Length

No
min max min max min max min max
8.25
1 3 mm 60 mm 70 mm 2.6 mm 5 mm 500 mm 50 mtr
mm
PACKING DETAILS:
35
SECTION F
TEST METHODS
36
Following test methods are followed for incoming Raw Materials, In-Process Samples
and Finished Products.
A. SPECIFICATIONS AND STANDARD TEST PROCEDURES FOR RAW

MATERIALS
1. RAW MATERIAL INWARD INSPECTION.
1.1 RUBBER
Platinum Cure Silicone Rubber (Elastosil 4305/60), Platinum Cure Silicone (Elastosil
4305/70), Platinum Cure Silicone Rubber (Elastosil 4305/50), Platinum Cure Silicone
Rubber (SH 1072 U), Platinum Cure Silicone Rubber (SH 1061U), Platinum Cure
Silicone Rubber (SH 2660 U), Platinum Cure Silicone Rubber (TSE 2570/5 U),
Platinum Cure Silicone Rubber (TSE 2570/6 U),Platinum Cure Silicone Rubber (TSE
2570/7 U).
1.2 CHEMICALS
Platinum Cure Curing Agent ( PT – 01), Platinum Cure Curing Agent (TC 25B),
Platinum Cure Curing Agent (TC 25A), Platinum Cure Curing Agent (SH0003A),
Platinum Cure Curing Agent (SH 0002B), Platinum Curing Agent (SH 0004A).
Sr.
Characteristic Sampling Specification Test Method
No
All the Test
Hardness, Tensile
Certificate
Strength, Elongation,
1. Test Certificate 100% Shall review as
Specific Gravity,
per list of Raw
Tear Strength
Material
As per List of Raw
2. Grade & Make 100% Material Verify Visually
(D:QA:02)
There shall be no
3. Visual 100% Verify Visually
Damages, fungal, etc
2. MIXING (Compound) Inspection.
Sr.
No
As per Formulation
1 Hardness Button Q : TM : 01
Card
As per Formulation
2 Tensile Strength Test Slab Q : TM : 02
Card
Elongation at As per Formulation
3 Test Slab Q : TM : 02
Break Card
37
As per Formulation
4 Tear Strength Test Slab Q : TM : 06
Card
Once in
three month As per Formulation
5 Compression Set Q : TM : 03
for each Card
Compound
As per Formulation
6 Specific Gravity Every Batch Q : TM : 05
Card
Once in
Hot Air Ageing three month As per Formulation
7 Q : TM : 04
Test for each Card
Compound
3. PRODUCT SPECIFICATION
No Characteristics Sample Specification Test Method

There shall not be cuts, Verify the pieces
finishing cracks, pore visual & shall not
1 Visual 100%
holes, air bubbles, dot be cuts, cracks,
Marks, etc air bubbles.
2 ID 100% As per Item Master ID Gauge
3 OD 100% As per Item Master Vernier Caliper
4 Thickness 100% As per Item Master Vernier Caliper
3.1 Platinum Cure Silicone Transparent Tube.

There shall not be
Verify the pieces
cuts, finishing
visual & shall not
1 Visual 100% cracks, pore holes,
be cuts, cracks,
air bubbles, dot
air bubbles.
Marks, etc
One mtr per
5 Pressure Test As Per Item Master Hydro Test Pump
lot
Two Piece per
6 Adhesion Test Q : TM : 08
Lot
7 Breaking Strength Two Piece per Q : TM : 07
38
roll
3.3 Post Curing .

1 Visual 100%
2 Hard ness 100% As per Item Master ID Gauge
There shall not be cuts,
finishing cracks, pore
3 Visibility 100% Vernier Caliper
holes, air bubbles, dot
Marks, etc
4. FINAL INSPECTION.
4.1 Platinum Cure Silicone Transparent Tube

0 To 1000
Dimension
1. 1001 to 5000 Verify with ID Gauge for
and above Tube.
Width / Height
5 Piece
0-50mtr,-3
As per Product
2. Length Steps Verify with Scale.
realization plan
51-200-5 Steps.
There Shall not be
Cuts, marks,
and shall not be
Finishing
Cracks, pore
Finishing Cracks,
Holes, air
Holes, air bubbles.
bubbles.
One Piece Per As per Product
4. Pressure Test Hydro Test Pump
Lot realization plan
39

There shall not be
Verify the pieces
cuts, finishing
visual & shall not
be cuts, cracks,
air bubbles, dot
air bubbles.
Marks, etc
4 Pressure Test One mtr per lot As Per Item Master Hydro Test Pump
Two Piece per
Lot
Breaking Two Piece per
6 Q : TM : 07
Strength roll
40
SUB :- TO DETERMINE TENSILE STRENGTH & ELONGATION AT BREAK OF

VULCANIZED RUBBER.
Equipment/Instruments/Apparatus/In-puts Reqd.:-
1. Dumb-bell Cutter.
2. Universal Tensile Testing Machine.
3. Moulding Press & Die for Slab.
4. Measuring scale.
Activity:-
1. Cure the slab in die as per specified time and temperature.
2. Make three dumb-bell piece having dimension as mentioned below with Die-
C-cutter.
Width at the centre = 3 mm.

Thickness = 2±0.2 mm.
Calculation:-
A) T.S.= : (Load/Thickness X Width) kg/cm²
B) Elongation at Break = (Final Length – Initial Length) X 100%
Result:
A) T.S. = (…………………..) Kg/cm²

B. SPECIFICATIONS AND STANDARD TEST PROCEDURE FOR IN-
PROCESS SAMPLE
Elongation at Break = (…………………………) %.

Doc. No: Q: TM: 02 / 01.02.2012
41
SUB:- TO DETERMINE THE INDENTATION HARDNESS OF ELASTOMERIC

MATERIALS
Equipments/Instruments/Apparatus/In-put Reqd.:-
1. Die for Button.

2. Compression Press.
3. Shore-A-Durometer.
ACTIVITY:-
1. Condition the test specimen 23±2°C for 1 hrs.

2. The test specimen of at least 6mm thickness & 30 mm diameter with flat surface
is made by compression moulding.
3. Place the test specimen on a non-conducting hard flat horizontal surface.
4. Hold the shore-A durometer in a vertical position with the point of indenter at
least 12 mm from any edge.
5. Take the maximum scale reading within the least possible time after applying
the pressure foot to the specimen without any shock.
6. Check the hardness at three different points and calculate the mean reading.
Result:- (……………)°Shore A.
Doc. No: Q: TM: 01 / 01.02.2012
42
SUB: TO DETERMINE HEAT AGEING PROPERTY OF VULCANIZED

RUBBER
Equipment / Instruments / Apparatus / In-puts Req.:
1. Dumbbell cutter.
2. Universal tensile testing machine.
3. Molding press & Die for slab.
4. Hardness tester.
5. Oven with ±2oC accuracy.
6. Weighing of 0.01 gm (min) accuracy
Preparation :
a) Clean all the Equipment / Apparatus properly

b) Arrangement of test equipment / apparatus & take required quantity of chemicals
C)Set that instruments to required parameters & use calibrated Instruments /
Equipment
Activity:
1. Cure the slab in die as per specified time and temperature. Cure the button and
measure the hardness after half an hour at three different points & record the
average value of these.
2. Make six dumb-bell pieces having dimension as mentioned below
Width at the centre 4 mm

Thickness = 2 ± 0.2 mm.
Length = more than 1 inch
3. Measure the thickness of all the six dumbbells at three points and record the
minimum value.
4. Place three test specimens in UTM for tensile testing & % elongation & record the
average of the three.
5. Place other three dumbbells in the oven properly hanged quite away from each
other & condition for specified time and temperature.
6. After completion of ageing take the sample out. Relax the sample for minimum
16 hours & check the tensile strength and elongation at break.
7. Record the average.
Calculation:
a) Change in hardness = (final hardness - initial hardness) °
shore -A
b) Change in tensile strength = [ (final TS - initial TS) / initial TS ]
x 100%
43
c) Change in ultimate elongation = [ (final EB - initial EB) / initial
EB] x 100%
Result:
a) Change in hardness = (...............) oShore A
b) Change in tensile strength = (...............) %
c) Change in ultimate elongation = (...............)%
Responsibility : Q.C. In charge.
Doc. No: Q: TM: 04 / 01.02.2012
SUB: TO DETERMINE THE COMPRESSION SET OF VULCANIZED RUBBER
1. Compression press.
2. Plates & bolts arrangement with spacer.
3. Oven with ± 2oC accuracy.
4. Measuring scale.
Preparation :

Set that instruments to required parameters & use calibrated Instruments / Equipment
Activity:
1. Mould the button of dimension

Thickness = 12.5±0.5 mm
Diameter = 29.0±0.5 mm
2. Condition the test buttons for minimum 20 hrs.
3. Place the spacers and button in between the plates and bolt – up the plates up-to
the spacer height.
4. After setting the plates keep it in the oven as per test condition.
5. Take out the plates from oven & debolt the set for relaxation.
6. Measure the button height soon after half an hour and calculate the compression
set as following.
Calculation:
H1 = initial height of the button.
H2 = spacer height.
H3 = compressed rubber height.
44
% Compression set = [ (H1- H3) / (H1- H2) ] x 100
Result:-
Compression Set = (...............) %.
Responsibility : Q.C. In charge.
Doc. No: Q: TM: 03 / 01.02.2012
SUB : TO DETERMINE THE SPECIFIC GRAVITY OF RUBBER
REF Std. No : ASTM D 297-93
Equipment/Instruments/Apparatus/ In-puts Req. :
1. Beaker.
2. Distilled water.
3. Weighing balance (Chemical).
4. Copper wire.
Preparation :

c) Set that instruments to required parameters & use calibrated Instruments /
Equipment
Activity :
1. Weigh the sample specimen first in air (A).

2. Suspend the sample in water (with sinker if necessary) with the help of a copper
wire (B).
3. Weigh the blank copper wire (with sinker if necessary) in water (C).
Calculation :
Specific gravity = 0.9971 x A / [ A-(B-C) ]
Result: (……………….)
Responsibility : (QA)
45
Doc. No: Q: TM: 05 / 01.02.2012
SUB: TO DETERMINE THE BREAKING STRENGTH AND ELONGATION OF

FABRIC / CORD BY
UNIVERSAL TENSILE TESTING MACHINE.
REF Std. No: ASTM – D - 751-79

2. Scissors.
Preparation:

c) Set that instruments to required parameters & use calibrated Instruments /
Equipment
Activity:
1. Keep the sample at room temperature / and 65±2% relative humidity for 1 hour.
2. Cut three samples each with 150 mm length and 25 mm width in case of fabric
and 150 mm length in case of cord.
3. Feed the speed of the UTM at 300mm / min, unless specified otherwise.
4. Place the specimen symmetrically in between the jaw grips with the longer
dimension parallel to the direction of application of force. Attention should be
given that the specimen doesn’t slip or break within the grips.
5. Record the breaking load and elongation.
6. Report the average of the results of the three individual tests.
Calculation:-
T.S. a) x
b) y ( load in Kg/cross sec.area in cm² )
c) z
E.B = Final Length – Initial Length x 100 %

Initial Length
46
Result:- T.S. = x + y + z /3 kg/cm²
EB = A+B+C/3
Responsibility : DH (QA)
Doc. No: Q: TM: 07 / 01.02.2012
SUB: TO DETERMINE THE ADHESION STRENGTH OF HOSE
REF Std. No: ASTM D 380-81
Equipment/Instruments/Apparatus/ In-puts Req.:
1. A sharp cutting tool.

2. Temperature control bath.
Preparation :

Set that instruments to required parameters & use calibrated Instruments / Equipment
Activity:
1. Cut adhesion test specimens transversely from the sample in the ring of 25mm
width.
2. Condition the test specimen at 23±2oC for 2 hrs.
3. Place the test specimen symmetrically in the jaws attached to the fixed grip with
separating edge towards the jaws in the UTM.
4. Apply the tension load until the rubber either separates from the adhesive surface
or ruptures.
5. Record the total at the time of failure.
Result:-
Adhesion = ------------------Kg/inch
47
Responsibility : DH(QA)
Doc. No: Q: TM: 08 / 01.02.2012
48
C. SPECIFICATIONS AND STANDARD TEST PROCEDURES FOR

FINISHED PRODUCT
PRODUCT SPECIFICATION

1 Visual 100%
Platinum Cure Silicone Transparent Tube.
Platinum Cure Silicone Transparent Braided Hose

There shall not be
Verify the pieces
cuts, finishing
visual & shall not
be cuts, cracks,
air bubbles, dot
air bubbles.
Marks, etc
One mtr per
5 Pressure Test As Per Item Master Hydro Test Pump
lot
Two Piece per
Lot
Two Piece per
7 Breaking Strength Q : TM : 07
roll
49
Post Curing

1 Visual 100%
2 Hard ness 100% As per Item Master ID Gauge
There shall not be cuts,
finishing cracks, pore
3 Visibility 100% Vernier Caliper
holes, air bubbles, dot
Marks, etc
Platinum Cure Silicone Transparent Tube

0 To 1000
Dimension
1. 1001 to 5000 Verify with ID Gauge for
and above Tube.
Width / Height
5 Piece
0-50mtr,-3
As per Product
2. Length Steps Verify with Scale.
realization plan
51-200-5 Steps.
There Shall not be
Cuts, marks,
and shall not be
Finishing
Cracks, pore
Finishing Cracks,
Holes, air
Holes, air bubbles.
bubbles.
One Piece Per As per Product
4. Pressure Test Hydro Test Pump
Lot realization plan
50
Platinum Cure Silicone Transparent Braided Hose

There shall not be
Verify the pieces
cuts, finishing
visual & shall not
be cuts, cracks,
air bubbles, dot
air bubbles.
Marks, etc
4 Pressure Test One mtr per lot As Per Item Master Hydro Test Pump
Two Piece per
Lot
Breaking Two Piece per
6 Q : TM : 07
Strength roll
51
SECTION G
QUALITY SYSTEM
52
QUALITY SYSTEM MANUAL
Refer to the enclosed ANNEXURE-II
53

Type III DMF-Silicon Tubes (Himsan Polymer)

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Type III DMF-Silicon Tubes (Himsan Polymer)

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Himsan Polymer Private limited (An ISO 9001:2008 Certified Company)

“PLATINUM CURED SILICON

Himsan Polymer Private Limited

Himsan Polymer Private limited

COMPREHENSIVE TABLE OF CONTENTS

1.0 PRODUCT DESCRIPTION

 Silicone colour tubings

2.0 PROCESS DESCRIPTION

 Dedusting of Platinum Cured Silicon rubber box

2. Passing thru Pass box.

 Mixing Compound Inspection

7. Post Curing operation

3.0 STATEMENT OF CONFIDENTIALITY

Information presented in this DMF is confidential and should be treated as

01. Name and address of Himsan Polymer Pvt.Ltd.

02. Address of Corporate Himsan Polymer Pvt.Ltd.

Name, Address and Title Mr. Himanshu Kumar (Director)

Himsan Polymer Private Limited

 Aging test oven

1) Specific Gravity apparatus

PERSONS AUTHORIZED TO INCORPORATE

PERSONS AUTHORIZED TO INCORPORATE THE DMF

Authorized Description and location of Referencing Drug

Nil Nil Nil

PRODUCT NAME : Platinum Cured Transparent Silicon Tubing’s

PRODUCT DESIGNATION: Platinum Cured Transparent Silicon Tubing’s, which

 Silicone colour tubings

All Raw Materials are in compliance with Federal Regulation 21 CFR.

No Name of Raw Material Code No Shelf Life

Sr. Material Name Manufacturer Name & Address DMF

MANUFACTURER PROCESS DESCRIPTION

 Dedusting of Silicon rubber box

 Dedusting of Silicon Rubber Curing Agent

 Dedusting of Polyester Yarn

Passing thru Pass box

 Now QC will inspect the raw material as per the QAP.

Mixing Compound Inspection:

 The following parameters are checked during the Extrusion process.

Sr Characteristics Sample Specification Test Method

Post Curing operation

 The inspection details are recorded in the pre-dispatch inspection record.

 Now the QC passed material is In warded to the packing area.

S. Raw Material Specification / T.C. Self

1. RAW MATERIAL INWARD INSPECTION. RUBBER, CHEMICALS, OILS

Elastocil R Plus 4305/50 , Elastocil R Plus 4305/60 , Elastocil R Plus 4305/70 ,

Sr. Characteristics Sampling Specification Test Method

02. MIXING(Compound) Inspection.

SR Characteristics Sample Specification Test Method

3. SPECIFICATIONS FOR FINISHED PRODUCTS

We Manufacture Silicon transparent tubings in the following sizes.

1.1 Platinum Cure Silicone Transparent Tube.

ID OD Thick ness Length

0.5 147 152 100

1.2 Platinum Cure Silicone Transparent Braided Hose

ID OD Thick ness Length

A. SPECIFICATIONS AND STANDARD TEST PROCEDURES FOR RAW

1. RAW MATERIAL INWARD INSPECTION.

2. MIXING (Compound) Inspection.

No Characteristics Sample Specification Test Method

3.2 Platinum Cure Silicone Transparent Braided Hose

No Characteristics Sample Specification Test Method

3.3 Post Curing .

No Characteristics Sample Specification Test Method