Ami Polymer “Sealing Expert in Silicone” NSF-51 CERTIFIED SILICONE RESIN SLE-(P-T) 30 TO SLE-(P-T)-80 MANUFACTURING EXCELLENCE IN• SINGLE-USE BAGS & ASSEMBLIES • PHARMA TUBING • REINFORCED HOSES • INFLATABLE SEALS

Since 1998, APPL has been engaged in the business of polymer products, which ultimately provide solutions to fluid transfers, sealing and contamination controls for the pharma, biopharma, medical, laboratory, food, beverage and engineering sectors worldwide. APPL has ISO class 7 and 8 cleanroom facilities certified with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013 and ISO 13485:2016. We also have a BPOG extractables program for our products for regulatory markets worldwide. APPL has world-class manufacturing technology with end-to-end process capabilities to fulfill the needs...

Fastest Delivery, Ultimate Quality and also very Competitive Rates. Expanding manufacturing capacity by adding a new world-class manufacturing facility with a total area of 2,50,000 sq ft (including 60,000 sq ft of clean room) located in Kala, Dadra Nagar Haveli Daman and Diu, India 25+ registered brands with a global sales footprint in 50+ countries A dedicated strength of 600+ employees, which includes qualified polymer technologists, biotechnologists, engineers, and management professionals Excellence in the manufacturing process through world-class extrusion, molding and tooling facilities...

APPL CLEAN ROOM CLASS 10000 CERTIFIED FACILITYOur Strength A DMF #26201,32560,32558, 32556, 32559, 32561 & 32549 (Drug Master File) for manufacturing of Tubes and Hoses accredited by USFDA a Clean Room of Class 10000 Certified Facility * NSF-51 Certification on Platinum Cured Silicone Resin (84% Standards of USFDA are derived from NSF) A BPOG standardized extractables test reports on single-use products •* TOXIKON Lab (USA) based E8<L study, USP class87, ISO 10993 biocompatibility studies on products A TUV Nord Certified IMS (Integrated Management System) facility High Performance Capability...

Platinum Cured Silicone Tubing for Critical Pharmaceutical Applications Imapure® Platinum Cured Silicone Tubing is designed for critical fluid transfer applications in pharmaceutical industry. Tubing has excellent Peristaltic Pumps life which ensures risk free fluid flow operations. It has an ultra-smooth bore that prevents particle entrapment. It is completely designed to meet all regulatory market requirements covering detailed extractable study program according to PQRI and BPOG Guidelines. Manufactured by using PLC controlled latest extrusion technology and world class platinum grade silicone...

TUBING APPLICATIONS i- STORAGE GUIDELINES -l Store in cool and dry place A Keepawayfromsunlight x Shelf life Syearsfrom mfg. date A Available in sterilizable packaging Antistatic silicone tubing is specially developed to remove static electric charge while transfer of flammable flu id. Antistatic tubing is successfully tested for food grade FDA 21 CFR 1 77.2600Test. Specially developed Static Dissipative Formulation (107 to 109n-cm)

Imapure®-EPL Platinum Cured Silicone Tubing with Extended Pump Life for Continuous Peristaltic Pump OperationsCHARACTERISTICS Imapure® EPL is specially formulated tubing for continuous peristaltic pump operations. ^ Tubing is having excellent peristaltic pump life and flex crack resistance over longer period of continuous operations. x Manufactured in clean room facility of Class 10000. COMPLIANCE & CERTIFICATIONS a USP <87> in Vitro USP <88>ln Vivo x Phtholate Free x ISO 10993-1 1 Pyrogen Test x FDA 21 CFR 177.2600 -*■ Extractable Study (BPOG guideline) Nitrosamine Free Declaration -*• ISO 10993-4...

Standard Sizes for Imapure* EPL - STORAGE GUIDELINES- Store in cool and dry place A Keep awayfrom sunlight x Shelf life Syearsfrom mfg. date A Available in sterilizable packaging

Ultra-low Temperature Resistant Silicone Tubing CHARACTERISTICS Suitable for applications related to low-temperature bulk drug storage and transportation. -*■ Maintains flexibility and dimensional stability at extremely low temperatures (-112 °C). Manufactured and packaged in an ISO 9001 certified clean room of class 10000. Tubing can be customized for single-use manifolds or bag assemblies. CompliantwithTSE/BSE-free and Nitrosamine impurity free requirements. -*• Loser coding is available for lot traceability. Manufactured and inspected through online auto inspection technology. -*■ Sterilizable...

A/I Platinum Cured Silicone Tubing for Transfer of High Purity Fluids Imaflow® is platinum grade silicone tubing designed for fluid transfer applications in food and pharmaceutical industries. It is compatible for peristaltic pump application and covering all basic compliances of food and pharma grade requirements. x Manufactured by using high quality platinum grade silicone rubber. -*■ Manufactured and packaged in Clean room of class 10000 facility audited byTUVNord. x Better fluid transfer characteristics compare to peroxide silicone tubing. x Available with FDA approved silicone based color...

Platinum Cured Silicone Tubing Comparison Chart SPECIFICATIONS

Dairy Silicone TubingSilicone Tubing for Dairy Application Silicone Tubing which ensures milk processing or transfer of milk with safe, hygienic and high performance. Platinum Cured Silicone Tubing is designed for the application in Automatic milking system / rotary milking parlour/robotic milking / Peristaltic Pumps. Our transparent silicone tubing is known for its ultra-smooth bore to prevent any particle entrapment, reduces the chances of butterfat occurrence. It eliminate the probability of Microbial growth within the milk transfer line and ensures smooth transfer of milk. Superior flexibility...

Peroxide Cured Silicone Tube Imapex® Peroxide Grade Silicone Tubing is designed for general, non-critical and engineering applications. It is translucent silicone tubing having good flexibility and resiliency. It is suitable for peristaltic pump applications for non-critical fluid transfer. It meets with food grade requirements as per FDA 21 CFR 177.2600 Manufactured by using highqualityperoxidegradesiliconerubber. Manufactured and packaged in dust free environment of facility audited byTUV Nord. Good physical properties like compression set and tensile strength. Good flex fatigue resistance...