Complete Fluid Transfer & Single-Use Solutions for Pharma & Biopharma Manufacturing

From high-purity silicone tubing to complete single-use assemblies, AMI Polymer delivers sterile, compliant, and customizable solutions for your most critical processes.

Our Products

Our High-Purity Product Family Designed for Safety, Sterility, and Compliance

SINGLE USE 2D AND 3D BAG

A 2D bag is commonly used in smaller assemblies (50 L and under) and is usually not placed inside a supporting tank or container. Instead, it is often laid flat in rockers or hung using insert holes at the top. Support rods can also be used to help the bag maintain its shape while being hung or carried.

MIXER BAG

It is designed to address the needs of the single-use disposable and bio-pharmaceutical industries. It offers a wide range of internal dimensions to meet process requirements. The manufacturing process is carried out in a clean room of ISO Class 7, where the process is carefully controlled from the raw material to the finished product

PUPSIT ASSEMBLY

The PUPSIT assembly (Pre-Use Post-Sterilization Integrity Testing) is vital in biopharmaceutical manufacturing. It verifies sterile filter integrity after sterilization but before product use, ensuring no damage occurred. This mandatory test, especially in sterile drug production, prevents contaminants from passing through critical processes.

SINGLE USE ASSEMBLY

Ami Polymer Pvt. Ltd. provides a wide range of gamma-irradiated single-use assemblies for critical applications in biopharmaceutical industries. Offerings range from simple tubing with connectors to complex manifolds. All assemblies are manufactured in Class 7 cleanrooms, with critical components assembled in Class 5 cleanrooms.

ImaLINK™

Ami Polymer Pvt. Ltd. ImaLINK™ manifold is designed to minimize the need for fittings, connections, or assembly of all leak points and entrapment areas have been eliminated. Single use ImaLINK™ manifolds are manufactured by moulding straight sections of tubing or with connectors such as T’s, Y’s, X's, and Tri-Clamps.

POWDER BAG

The powder bag is a specialized packaging solution for bioprocess applications, designed to safely handle and store powdered materials in the biopharmaceutical industry. Built to prevent static electricity buildup, it ensures safe handling of fine powders such as active pharmaceutical ingredients (APIs) and excipients.

QUICK-CONNECTOR

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.

SAMPLING MANIFOLD

The sampling manifold is a critical component in the biopharmaceutical industry, designed to facilitate the aseptic collection of samples from various process streams. It typically consists of multiple ports, allowing for simultaneous sampling from different locations within a system, such as bioreactors or storage tanks.

ImaFrostTM

Ultra-low temperature resistant silicone tubing is ideal for applications involving the storage and transportation of bulk drugs at low temperatures. This specialized tubing is designed to maintain its integrity and flexibility even in extremely cold conditions, ensuring that it can safely handle and protect sensitive pharmaceutical materials.

Reinforced Hoses

Reinforced hoses are used for safe and reliable fluid transfer in pharmaceutical and biopharmaceutical processes. Designed to withstand pressure, vacuum, and repeated flexing, they provide a secure and leak free flow path. Manufactured under GMP-compliant conditions in a controlled cleanroom environment, these hoses ensure consistent performance and process safety. Validation support and documentation are available to meet regulatory and quality requirements.

Pharma Grade Tubing

Pharma-grade tubing enables safe and consistent fluid transfer in pharmaceutical and biopharmaceutical processes. Silicone tubing provides excellent flexibility and temperature resistance, while TPE tubing offers low extractables and is ideal for single-use applications. Both options ensure chemical compatibility, durability, and reliable performance across critical process steps. Suitable for upstream, downstream, and final fill operations.

Filters

Pharma-grade filters ensure contaminant-free operations across critical biopharmaceutical processes. Capsule, cartridge, syringe, and vent filters can be used for media preparation, buffer sterilization, formulation, and final fill steps. They provide reliable microbial and particulate retention, maintaining product integrity and process efficiency throughout the manufacturing workflow.

About Us

At AMI Polymer, we specialize in high-quality polymer products, including platinum cured silicone transparent tubing. With a commitment to innovation and excellence, we provide reliable solutions for various industrial needs. Our products meet stringent standards to ensure superior performance and durability. Trust AMI Polymer for your polymer product requirements.

  • Quality and Innovation

    At AMI Polymer, we are committed to delivering high-quality polymer products that meet the evolving needs of various industries. Our focus on innovation ensures that we provide cutting-edge solutions that enhance performance and reliability.

  • Comprehensive Solutions

    We offer a wide range of products, including platinum cured silicone tubing, welding solutions, single-use bags, hoses, gaskets, and more. Our diverse product lineup is designed to meet the stringent standards and demands of our customers.

Years Of Experience

Employees

Products

Industries

Frequently Asked Questions

Pharma & Biopharma Solutions

What products does AMI Polymer offer for pharma and biopharma applications?

We provide a complete sterile fluid transfer portfolio including platinum-cured silicone tubing, peristaltic pump tubing and sets, single-use assemblies, manifolds, braided hoses, ultra-low temperature tubing (ImaFrost™), and fully customized solutions for upstream, downstream, and fill-finish processes.

Are AMI Polymer products compliant with global regulatory standards?

Yes. Our products meet or exceed USP Class VI, ISO 10993, FDA 21 CFR 177.2600 requirements and are BSE/TSE free. We also comply with REACH and RoHS regulations. Every batch is traceable and supplied with a Certificate of Compliance.

Do you manufacture in a cleanroom environment?

All pharma and biopharma products are manufactured in ISO Class 7 cleanrooms to maintain sterility and minimize particulate contamination.

How do AMI Polymer solutions perform during sterilization?

Our platinum-cured silicone products are compatible with multiple sterilization methods including autoclave and CIP/SIP processes. Gamma irradiation sterilization is available upon request.

What industries do you serve besides pharma and biopharma?

In addition to pharma and biopharma, we serve food & beverage, medical devices, chemical processing, and other high-purity industries. However, our pharma solutions are specially developed for GMP environments.

Testimonials

Clients

Michael Andersen

Production Manager

Ami Polymer’s single-use assemblies have been an excellent addition to our biologics production line. The sterility assurance and robust documentation met all of our EU compliance requirements with ease.

Sarah Mitchell

Director of Process Development

We rely on Ami Polymer for our high-purity SUS components, and their consistency is remarkable. Deliveries are always on time, and the assemblies integrate seamlessly into our single-use platforms.

Dr. Lukas Hoffmann

Head of Engineering

Switching to Ami Polymer’s tubing and SUS assemblies significantly improved our turnaround times. The quality is comparable to global leaders, but with far more flexibility in customization.

Emily Carter

Operations Lead

The technical support from Ami Polymer has been outstanding. Their team worked closely with us to design bespoke single-use solutions for our clinical production runs. Reliable, responsive, and professional.