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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS
1 /44Pages

Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS

Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS
1 /44Pages

Catalog excerpts

Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-1

Ami Polymer“Sealing Expert in Silicone”SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS TUV NORD CERTIFIED:- ISO 9001:2015 (QMS), ISO 14001:2015 (EMS), ISO 45001:2018 (HEALTH AND SAFETY), ISO 27001:2013 (ISMS), ISO 13485:2016 (MEDICAL DEVICES) CERTIFIED MANUFACTURING FACILITY OF CLEAN ROOM CLASS 10000 SINGLE USE SYSTEMSolution to Biopharma Industries www.amipolymer.com

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-2

About Us 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...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-4

Our Strengths •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. •25+ registered brands with Global global sales footprint in 50+ countries •A dedicated strength of 600+ employees, which includes qualified polymer technologists, biotechnologists, engineers, and management professionals •Excellence in manufacturing process through world-class extrusion, molding, and tooling facilities •Quick development of customized single-use manifolds...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-5

Single-Use System The biopharmaceutical industry is rapidly moving towards the use of single-use disposable systems for the development and manufacturing of a wide range of therapeutic proteins, mAbs, and vaccines. APPL offers a wide range of gamma-irradiated single-use assemblies for various critical applications in biopharmaceuticals. Our products range from simple tubing with connectors to a complex manifold with several joints and connections. All the assemblies are manufactured and packed in an ISO Class 7 certified cleanroom. Most of the key components used in our single-use assemblies...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-6

ImaLOK™A Solution for Bioprocessing Applications APPL's ImaLOK™ sanitary clamp is designed to address the needs of single-use disposable/biopharma industries. ImaLOK™ sanitary clamps are manufactured using a glass-reinforced FDA 21 CFR 1771500 grade, USP Class VI Nylon 66 is designed to be used as a component for single-use transfer lines and a widerange of bioprocess systems. | CHARACTERISTICS • These are offered in a wide range of internal dimensions to meet the process requirements. • The manufacturing process is carried out in a ISO Class 7 cleanroom. • Biopharmaceutical grade • Limited-slip...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-7

Single-Use Components Cleanroom molded PP connectors are intended to meet the requirements of single-use fluid path components developed for the biotech and pharmaceutical industries. Cleanroom molded connectors are manufactured within a facility operating an ISO 9001 quality management system. • Mode of Sterilization: Autoclavable up to 135°C for a maximum of 30 minutes and gamma irradiated up to 50 kGy. • Storage condition: Stored in the original packaging wherever possible in a cool, dry environment away from direct sunlight without exposure to stress or harsh chemicals. Normal warehouse conditions...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-8

| Cleanroom Molded PP End Plug | Cleanroom Molded PP Straight Connector

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-9

| Cleanroom Molded PP Y-Connector | Cleanroom Molded PP Reducer Threaded Pinch Clamp www.amipolymer.com [email protected]

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-10

Aseptic BushSealing solutions for Bio-process Applications Our aseptic bush is engineered to meet the standards of single-use bioprocessing applications. Crafted from biocompatible materials, this product ensures reliability and simplicity for the pharma and biopharma sectors. Its crimping design guarantees a secure, leakproof seal, eliminating the need for complex tools and reducing contamination risks during installation. With seamless compatibility across a wide spectrum of single-use bioprocessing components and a range of sizes available, our product excels in adaptability and ease of integration....

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-11

The pharmaceutical and bio-pharmaceutical production industries are at the forefront of transforming fluid systems functioning with Quick Connectors. It provides an assurance of reliable connections, a critical factor in the fluid systems integral to manufacturing pharmaceutical and bio-pharmaceutical products. • Designed to minimize the potential for cross-contamination, thereby safe guarding the integrity and purity of your valuable products. • Fluid transfer • Bioreactor tubing • Conveyance and retrieval lines • Laboratory tubing interfaces • Sequential Linkage • USFDA CFR title, Part 211.72...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-12

Filling NeedleA solutions for Bio-process Applications Single-use filling needles are essential components in the biopharmaceutical industry, designed to facilitate the aseptic filling of drug products into vials, syringes, or containers. These needles are specifically engineered for the accurate filling of both mobile and viscous drug products without drip formation. They offer ready-to-use filling solutions as part of complete, gamma-sterilized, single-use filling assemblies. Single-use filling needles are designed to prevent dip formation, enable accurate volume filling, and offer various...

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Single-Use Bioprocessing Systems: SINGLE-USE BAGS | SINGLE-USE ASSEMBLIES | SINGLE-USE COMPONENTS-13

Sampling Needle Sampling needle is design for use in biopharma applications, particularly in sampling system bag, offering excellent flexibility, and compatibility with various solutions. | FEATURES & BENEFITS • Closed and easy to use • Reduces risk of contamination • Presterilized, eliminating the need for cleaning and/or sterilization between samples. • Available in 1mm and 2mm needle hole • USP < 85> Bacterial Endotoxins -LAL test • USP < 788> Sub visible particulate matter Part Description | INSERTING PROCEDURE Step 1: Open the front TC portion of sampling port adapter by anti-clockwise rotating...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.