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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage

Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage

Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage

Product catalog summary
Overview
Ami Polymer Pvt. Ltd. (APPL) is a company that specializes in polymer products designed for fluid transfers, sealing, and contamination control. These products are used across various sectors such as pharmaceuticals, biopharmaceuticals, medical, laboratory, food, beverage, and engineering. The company operates ISO class 7 and 8 cleanroom facilities and holds multiple ISO certifications.
Certifications and Compliance
APPL's products comply with several standards, including USP Class <87>, FDA 21 CFR 177.1520, and are free from Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE). They also adhere to ROHS and REACH directives.
Product Offerings
  • Imaflexell™ B01: A five-layer film with a ULDPE contact layer and EVOH gas barrier, designed for biopharma applications, offering low oxygen transmission, flexibility, and puncture resistance.
  • Imaflexell™ L01: A three-layer film with a ULDPE contact layer, ideal for storage and handling in biopharma processing, providing high strength and flexibility.
  • Imaflexell™ A01: A three-layer film with antistatic properties, suitable for sterile packaging and sensitive drug formulations.
  • Imaflexell™ A02: Similar to A01 but with antistatic properties on both sides, ideal for electrostatic control in cleanrooms.
  • Imaflexell™ C01: A five-layer film with an EVA contact layer, designed for low-temperature applications, providing moisture and oxygen barrier properties.
Technical Specifications
Each product features specific technical data such as tensile strength, elongation at break, haze, transmittance, density, and permeability rates, tested according to ASTM standards.
Applications
The films are used in various applications including bioprocessing, storage, pharmaceutical packaging, and cryogenic conditions, ensuring product integrity and safety.
Compliance and Testing
The products comply with several standards and testing requirements, including USP <88> for bacterial endotoxins, extractable studies as per BPOG guidelines, physicochemical tests as per USP <661.1>, hemocompatibility tests according to ISO 10993-4, skin sensitization tests as per ISO 10993-10, and skin irritation tests following ISO 10993-23.
Regulatory Compliance
The products are ROHS compliant, REACH compliant, TSE/BSE free, and free from phthalate and Bisphenol A (BPA).
Corporate and Manufacturing Presence
The company has a corporate office in Mumbai, India, and a USA office in Woburn, Massachusetts. Manufacturing units are located in Silvassa, India, with a presence in multiple countries and various branches across India.
Company Philosophy
Ami Polymer Pvt. Ltd. emphasizes ethical business practices, quick development, fast delivery, high quality, and competitive pricing.
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Catalog excerpts

Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-1

FILMS | TUBING | HOSES | SINGLE USE ASSEMBLIES & BAGS | GASKETS & BELLOWS | INFLATABLE SEALS POLYMER FILMS FOR LIFE-SCIENCES INDUSTRY www.amipolymer.com

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-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, ISO 13485:2016 and ISO 15378:2017. 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...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-3

Imaflexell™ B01Aseptic Processing Film with ULDPE as contact layer & EVOH as barrier layer The ImaflexelH B01 features a five-layer structure with an inner contact layer of Ultra Low-Density Polyethylene (ULDPE) resists a wide range of chemicals, while enhancing mechanical strength and an outer layer of Low-Density Polyethylene (LDPE) that provides durability by resisting abrasions, punctures and tearing to prevent leaks. The core layer made of EVOH is barrier against oxygen, which helps in preserving the integrity and shelf life of sensitive products. | FILM COMPOSITION I 50 •• *LDPE - Outer...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-4

Imaflexell™ L01Aseptic Processing Film with ULDPE as contact layer for liners. The ImaflexelH L01 features a three-layer design with an inner contact layer of Ultra Low-Density Polyethylene (ULDPE), enhancing mechanical strength, flexibility and toughness. The outer layer is made of Low-Density Polyethylene (LDPE), providing resistance to abrasions, punctures and tears, effectively preventing leaks. The core layer, made of Linear Low-Density Polyethylene (LLDPE) for flexibility with enhanced toughness, improving puncture resistance. | FILM COMPOSITION I 50 •• *LDPE - Outer Layer | 60 •• *LLDPE...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-5

Imaflexell™ A01Aseptic Processing Film with Antistatic LLDPE as product contact layer. The ImaflexelH A01 features a three-layer design. The inner layer is made of low-density polyethylene combined with an antistatic agent, providing a permanent antistatic property. The core layer is composed of Metallocene linear low-density polyethylene, offering excellent tensile strength, transparency and durability. The outer layer is made of linear low-density polyethylene, providing excellent flexibility and resistance to punctures and tears. | FILM COMPOSITION I 50 •• *LLDPE - Outer Layer | 50 •• *mLDPE...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-6

Imaflexell™ A02Aseptic Processing Film with both side (inner/outer) Antistatic LLDPE layers. The ImaflexelH A02 features a three-layer structure with antistatic properties on both sides. The inner layer is made of linear low-density polyethylene combined with an antistatic agent, ensuring product cleanliness and providing a permanent antistatic effect. The core layer is composed of Metallocene linear low-density polyethylene, offering excellent tensile strength, transparency, and durability. The outer layer also consists of linear low-density polyethylene mixed with a long-lasting antistatic...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-7

Imaflexell™ C01 Freezing Application Film with EVA as Contact Layer The ImaflexelH C01 features a five-layer structure, with an inner contact layer made from Ethylene-Vinyl Acetate (EVA), providing mechanical strength and high flexibility in low-temperature environments. The outer layer is constructed from Low-Density Polyethylene (LDPE), providing transparency and flexibility. EVA ensures the film maintains its integrity in cryogenic conditions by resisting abrasions, punctures, stretching, and tearing, while staying flexible and not becoming brittle in low temperatures. The film enhance the...

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Imaflexell™ Multi-Layer Aseptic Processing Films for Biopharma Storage-8

Manufacturing Facility Our Branches in India BADDI (H.P.) CORPORATE OFFICE O ce No. 6 & 7, Upper Basement, Western Edge II, Behind Metro Stores, W.E. Highway, Borivali, Mumbai, Maharashtra - 400066 Cell: +91 9081 488 825/ +91 9223 290 943 800 West Cummings Park, Suite 3325 | Woburn, Massachusetts 01801 Cell: +1 (978) 482-5400/+1 (267) 810-3834 | Email: [email protected] Plot No. 66-D/E, Govt. Industrial Estate, Near Beekaylon Factory, Masat, Silvassa, UT of Dadra & Nagar Haveli and Daman & Diu, India 396230 Survey No. 106/2/1, 106/2/2, 113/3/P1, Opp. Guarniflon India Pvt. Ltd, Karajgam Road,...

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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.