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Imapure™ - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber • Manufactured & Packaged in Clean room class of ISO ‐7, ISO 9001 QMS, ISO 14001 & OHSAS 18001 certified Facility. • Inspected by Laser online Inspection Device to maintain Critical dimensional Consistency • Laser Etched For Traceability. Excellent Flexibility along with flex crack resistance. • Excellent transparency with no odor and taste. • Extractable study available upon request • Excellent Biocompatibility due to inertness to tissues and cells. • Sterilizable by using different techniques like Autoclaving, Ethylene Oxide, Gamma Radiation. • Available with FDA compliant color coding for ease of identification. • Custom dimension and length size available • Custom hardness available Critical sterile transfer and filling in pharmaceutical industries Chemical and Analytical analysis Fermentation in biotech industries Vaccine transfer Biopharmaceutical & microbiological applications Sanitary application Load cell and media processing Drug delivery and sampling APPLICATION Silicone tubing can be sterilized by using Steam, Dry Air, Gamma Radiation & Ethylene Oxide. Steam Sterilization validation report is available upon request. STERILIZATION VALIDATION CHARACTERISTICS Imapure™ is Planum Cured Silicone Tubing designed for peristalc pump and fluid transfer in Pharmaceucal and Biotech applicaons. is translucent silicone tubing known for its Imapure™ ultra smooth bore to prevent any parcle entrapment. It is especially designed to comply with requirements of crical Food and Pharmaceucal standards of regulatory markets.

Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber •

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Page 1: Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber •

Imapure™ - Platinum Cured Silicone Transparent Tube

• Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber

• Manufactured & Packaged in Clean room class of ISO ‐7, ISO 9001 QMS, ISO 14001 & OHSAS 18001 certified Facility.

• Inspected by Laser online Inspection Device to maintain Critical dimensional Consistency

• Laser Etched For Traceability.

• Excellent Flexibility along with flex crack resistance.

• Excellent transparency with no odor and taste.

• Extractable study available upon request

• Excellent Biocompatibility due to inertness to tissues and cells.

• Sterilizable by using different techniques like Autoclaving, Ethylene Oxide, Gamma Radiation.

• Available with FDA compliant color coding for ease of identification.

• Custom dimension and length size available

• Custom hardness available

• Critical sterile transfer and filling in pharmaceutical

industries

• Chemical and Analytical analysis

• Fermentation in biotech industries

• Vaccine transfer

• Biopharmaceutical & microbiological applications

• Sanitary application

• Load cell and media processing

• Drug delivery and sampling

APPLICATION

• Silicone tubing can be sterilized by using Steam,

Dry Air, Gamma Radiation & Ethylene Oxide.

• Steam Sterilization validation report is available

upon request.

STERILIZATION VALIDATION

CHARACTERISTICS

Imapure™ is Pla�num Cured Silicone Tubing designed forperistal�c pump and fluid transfer in Pharmaceu�cal and Biotechapplica�ons. is translucent silicone tubing known for itsImapure™

ultra smooth bore to prevent any par�cle entrapment. It isespecially designed to comply with requirements of cri�cal Foodand Pharmaceu�cal standards of regulatory markets.

Page 2: Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber •

PROPERTY

Hardness

Color

Tensile Strength

Elogation at Break

Tear Strength die B

Specific Gravity

Max. Operating Temprature

STANDARD

ASTM D 2240

ASTM D 412

ASTM D 412

ASTM D 624

ASTM D 792

UNIT

Shore A°

Kg/Cm²

%

kN/m

gm/cc

RESULT

60

Translucend

95

300

30

1.15

220°C

STANDARDS

FDA 21 CFR 177.2600

EP 3.1.9

German BfR VI

France: Arrete du 25

USP Class VI

ISO 10993

ROHS Certification

Phthalates / Bis Phenol / Plasticizer

TSE/BSE Free Confirmation

Shelf Life

USFDA DMF Registration

Extractable Study

Validation Pack

RESULT

Complies to rubber articles intended for repeated use in contact with food.

Complies to “Silicone Elastomer for closures & tubing.”

Complies to German Food Grade Standard.

Complies to France Food Grade Standard.

Complies to USP Class VI (Acute Systemic Toxicity, Intracutaneous Toxicity, Implantation Test)

Complies with ISO 10993 ‐ Part 1 Biological Evaluation of medical device.

Restricted Content of EU listed Hazardous Substances.

Free of Any Phthalate / Bis Phenol derivatives & Plasticizers.

Available

3 years from the Date of Manufacturing.

Registered with USFDA DMF #26201.

Extractable study available upon requested.

Available upon request.

Imapure™ - Platinum Cured Silicone Transparent Tube

TECHNICAL DATA SHEET

CERTIFICATIONS & COMPLIANCES

STORAGE CONDITION & USAGE

IMPORTANT NOTE

• Additional Testing performed on tubing is available upon request are pump life, MSDS, Chemical compatibility chart,

shelf life, burst pressure, vacuum rating.

• Store the tubing in Room Temperatures (27°C) & Dry Place. Keep it away from sunlight .

• Ready for sterilization. Needs to sterilize before usage. Gamma sterilized tubes are available upon request.

• All Data available as technical guide are derived in standard lab conditions as per reference standards.

• User is responsible for selection of silicone tubing as per desired suitability in intended area of applications. We recommend

conducting laboratory testing in case of any critical regulatory requirement to determine tubing's effective performance for

usage in particular application.

• Pack size available from min 25 mt pack.

Page 3: Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC Controlled latest Extrusion Technology & World Class Platinum Grade Silicone Rubber •

Imapure™ - Platinum Cured Silicone Transparent Tube

STANDARD AVAILABLE SIZES

CATALOGUE #

901‐203‐60

901‐113B‐60

901‐114‐60

901‐115‐60

901‐204‐60

901‐117‐60

901‐118‐60

901‐205‐60

901‐119‐60

901‐120‐60

901‐121‐60

901‐206‐60

901‐207‐60

901‐122‐60

901‐123‐60

901‐125‐60

901‐126‐60

901‐127‐60

901‐128‐60

901‐129‐60

901‐130‐60

901‐131‐60

901‐132‐60

901‐133‐60

901‐171‐60

901‐208‐60

901‐209‐60

901‐140B‐60

901‐139‐60

901‐140‐60

901‐141‐60

901‐143‐60

901‐145‐60

901‐146‐60

901‐177B‐60

901‐191‐60

901‐172‐60

901‐193‐60

901‐149‐60

901‐150‐60

901‐210‐60

901‐151‐60

901‐152‐60

901‐153‐60

901‐194‐60

901‐173‐60

901‐195‐60

901‐196‐60

ID (IN MM)

1.60

1.60

2.00

2.00

3.17

3.00

3.00

3.00

4.00

4.00

4.00

4.00

4.00

4.76

4.76

5.00

5.00

5.00

5.00

6.00

6.00

6.00

6.00

6.00

6.35

6.35

6.35

7.90

8.00

8.00

8.00

8.00

9.00

9.00

9.50

9.50

9.50

9.50

10.00

10.00

10.00

12.00

12.00

12.00

12.70

12.70

12.70

12.70

OD (IN MM)

3.17

4.76

4.00

5.00

6.35

6.00

7.00

8.00

6.00

7.00

8.00

9.00

10.00

7.90

9.50

8.00

9.00

10.00

11.00

8.00

9.00

10.00

11.00

12.00

9.50

11.11

12.70

12.70

11.00

12.00

14.00

16.00

15.00

16.00

12.70

14.28

15.87

19.05

14.00

16.00

18.00

16.00

18.00

20.00

17.46

19.05

22.22

25.40

ID (IN INCH)

1/16

1/16

5/64

5/64

1/8

1/8

1/8

1/8

5/32

5/32

5/32

5/32

5/32

3/16

3/16

13/64

13/64

13/64

13/64

15/64

15/64

15/64

15/64

15/64

1/4

1/4

1/4

5/16

5/16

5/16

5/16

5/16

23/64

23/64

3/8

3/8

3/8

3/8

25/64

25/64

25/64

15/32

15/32

15/32

1/2

1/2

1/2

1/2

OD (IN INCH)

1/8

13/64

5/32

13/64

1/4

1/4

9/32

5/16

1/4

9/32

5/16

23/64

25/64

5/16

3/8

5/16

23/64

25/64

7/16

5/16

23/64

25/64

7/16

15/32

3/8

7/16

1/2

1/2

7/16

15/32

35/64

5/8

19/32

5/8

1/2

9/32

5/8

3/4

35/64

5/8

45/64

5/8

45/64

25/32

11/16

3/4

7/8

1

WT (IN INCH)

1/32

1/16

3./64

1/16

1/16

1/16

5/64

2/32

3/64

1/16

5/64

3/32

1/8

1/16

3/32

1/16

5/64

3/32

1/8

3/64

1/16

5/64

3/32

1/8

1/16

3/32

1/8

3/32

1/16

5/64

1/8

5/32

1/8

9/64

1/16

3/32

1/8

3/16

5/64

1/8

5/32

5/64

1/8

5/32

3/32

1/8

3/16

1/4