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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
Company Overview: Ami Polymer Pvt. Ltd. (APPL) is a leader in polymer products for fluid transfers, sealing, and contamination control, serving sectors such as pharma, biopharma, medical, laboratory, food, beverage, and engineering. Established in 1998, APPL utilizes advanced manufacturing technologies and ISO-certified cleanroom facilities.
Certifications and Compliance: APPL's facilities are certified with multiple ISO standards, including ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016, and ISO 15378:2017. The company complies with international standards and regulations like FDA, USP, and EU directives, ensuring products are free from hazardous substances and animal-derived ingredients.
Product Offerings: APPL offers a variety of polymer films for life sciences applications, such as:
  • Imaflexell™ B01: A five-layer film with ULDPE contact layer and EVOH gas barrier, suitable for biopharma applications requiring low oxygen transmission and high mechanical strength.
  • Imaflexell™ L01: A three-layer film with ULDPE contact layer, providing high strength and flexibility for biopharma processing.
  • Imaflexell™ A01: A three-layer film with antistatic properties, ideal for sterile packaging and electrostatic protection in pharmaceutical applications.
  • Imaflexell™ A02: Similar to A01 but with antistatic properties on both sides, used for flexible enclosures and isolators.
  • Imaflexell™ C01: A five-layer film with EVA contact layer, designed for cryogenic conditions, offering flexibility and barrier properties for freezing applications.
Technical Specifications: Each product includes specific technical data such as tensile strength, elongation, haze, transmittance, density, and permeability rates, tested according to ASTM standards.
Applications: The films are utilized in liquid storage, mixing systems, sterile packaging, and cryogenic storage, ensuring product integrity and safety.
Testing and Biocompatibility: Products undergo extensive testing for biological reactivity, endotoxins, extractables, physicochemical properties, hemocompatibility, and skin sensitization, complying with USP and ISO standards.
Compliance and Testing: APPL ensures compliance with standards such as USP <88> for bacterial endotoxins, LAL Test USP<85>, BPOG Guidelines for extractable studies, USP <661.1> for physicochemical tests, ISO 10993-4 for hemocompatibility, ISO 10993-10 and ISO 10993-23 for skin sensitization and irritation, ROHS Directive (EU) 2015/863, REACH (EC) No 1907/2006, and TSE/BSE Declaration.
Corporate and Manufacturing Presence: APPL has a corporate office in Mumbai, India, and a USA office in Woburn, Massachusetts, with manufacturing units in Silvassa, India, and a global supply network.
Contact Information: Detailed contact information is provided for branches across India, including cities like Bengaluru, Chennai, Delhi, Goa, Ahmedabad, Hyderabad, Indore, Mumbai, Haridwar, Sikkim, Vizag, Pune, and Silvassa.
Company Philosophy: APPL emphasizes ethical business practices, rapid 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™ 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™ 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™ 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™ 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.