Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC...
Transcript of Imapure™...Imapure - Platinum Cured Silicone Transparent Tube • Manufactured By using PLC...
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.
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.
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