Aseptic Packaging Companies

Last updated: January 2026

This directory lists 72 aseptic packaging companies across the United States, from integrated solutions providers offering complete aseptic carton and bottle filling services to specialized manufacturers focusing on advanced flexible aseptic pouches and componentry.

Buyers engage these specialized firms to solve critical challenges: extending product shelf life without refrigeration, reducing cold chain logistics costs, protecting sensitive ingredients, and ensuring microbial safety for ambient distribution. This often involves optimizing barrier properties against oxygen, moisture, and light, or meticulously managing headspace control for sensitive beverages, all while adhering to stringent food safety and pharmaceutical grade standards for sterile product delivery.

The supplier landscape encompasses several types. Some are vertically integrated, offering everything from packaging material conversion to aseptic filling for diverse product matrices like dairy, plant-based alternatives, or low-acid foods. Others specialize in a particular format, such as pre-formed aseptic bottles or high-speed roll-fed aseptic carton systems. There are also contract manufacturers focusing purely on aseptic packaging components, providing lids, closures, or specialized fitments for customer-supplied primary packaging, each bringing distinct expertise in maintaining a robust sterile barrier system.

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Company Directory

72 companies nationwide

AbbVie Contract Manufacturing

abbviecontractmfg.com
North Chicago, IL

Based in North Chicago, IL, AbbVie Contract Manufacturing provides aseptic fill-finish manufacturing services for parenteral drug products. They offer comprehensive solutions for both prefilled syringes and vials, encompassing development and manufacturing capabilities for pharmaceutical clients.

abbviecontractmfg@abbvie.com+18002401043

ADMA Biologics, Inc.

admabiologics.com
Boca Raton, FL

ADMA Biologics, Inc. provides in-house aseptic fill-finish and final packaging services for clinical-stage and commercial biologics. The company offers comprehensive contract manufacturing solutions, leveraging its vertically integrated process to meet diverse aseptic filling requirements for specialty biologics.

info@admabio.com+12014785552

Afton Scientific

aftonscientific.com
Charlottesville, VA

Based in Charlottesville, VA, Afton Scientific provides comprehensive aseptic manufacturing and fill-finish services for pharmaceutical products. They specialize in sterile filling and aseptic processing for biologics and small molecules, ensuring product integrity and regulatory compliance. The company offers expert contract manufacturing solutions and advanced laboratory testing services.

information@aftonscientific.com+14349793737

ApiJect

apiject.com
Stamford, CT

ApiJect develops prefilled single-dose injection devices utilizing Blow-Fill-Seal (BFS) aseptic packaging technology. The company aims to transform drug delivery, offering customized, affordable, and accessible injectors. Their solutions provide sustainable, resilient, and scalable manufacturing, making injections easier for various medical applications.

solutions@apiject.com+12039986176

Aran Group

aranp-group.com
Greer, SC

Aran Group manufactures innovative Bag-in-Box (BIB) systems and aseptic packaging for liquid foods, from 1 to 1500 liters. With global production and a US facility in Greer, SC, the company focuses on sustainable, eco-friendly mono-material options. They provide technologically advanced, high-quality aseptic packaging solutions.

dayan@aranp-group.com+14442955992

Asept Pak, Inc.

aseptpak.com
Malone, NY

Based in Malone, NY, Asept Pak, Inc. provides sterile manufacturing and aseptic packaging for the healthcare community. They specialize in Blow-Fill-Seal (BFS) technology, offering low-cost solutions for medical devices, ophthalmic drops, and inhalation solutions. This technology ensures minimal contamination risk for diverse aseptic applications.

ghanley@aseptpak.com+15186512026

Nitto Avecia Pharma Services

aveciapharma.com
Irvine, CA

Based in Irvine, CA, Nitto Avecia Pharma Services offers expert cGMP aseptic fill and finish services for pharmaceutical vials, from 2 mL to 100 mL. They specialize in formulation development, lyophilization cycle development, and parenteral manufacturing solutions.

custserv@aveciapharma.com+19499514425

Avrio Biopharmaceuticals, LLC

avriobiopharma.com
Irvine, CA

Based in Irvine, CA, Avrio Biopharmaceuticals, LLC provides aseptic manufacturing and filling for clinical trial and commercial batches. Specializing in aseptic fill and finish for 1mL-100mL vials, they offer flexible solutions, lyophilization, packaging, and labeling support from their cGMP facility.

custserv@avriobiopharma.com+18666956658

California Aseptic Beverages

caasepticbev.com
—

California Aseptic Beverages provides aseptic packaging services, operating Tetra Pak high-speed iLines from its facilities in North America. Established in 2009, the company specializes in beverage packaging for commercial B2B clients.

sales@caasepticbev.com+19093565100

Centerpiece Life

centerpiece.life
Solana Beach, CA

Based in Solana Beach, CA, Centerpiece Life provides contract manufacturing and sterile packaging for the medical device supply chain. Services include cleanroom kitting, bar and tray sealing, custom form-fill-sealing, and foil flow wrapping for medical devices. They also offer in-house ETO sterilization and sterilization compatibility services.

info@centerpiece.life+18583456146

Cleanroom Film & Bag (CFB)

cleanroomfilm.com
Placentia, CA

Cleanroom Film & Bag (CFB) manufactures sterile and cleanroom packaging solutions, including bags and films, for diverse industries. Based in Placentia, CA, they serve medical, electronic, aerospace, semiconductor, and food sectors with custom products. CFB operates ISO 9001:2015 certified cleanrooms, ensuring high purity with a 100% no-regrind guarantee, utilizing virgin resins for all packaging.

sales@cleanbags.com+17147448361

Cretex Medical

cretexmedical.com
Elk River, MN

Based in Elk River, MN, Cretex Medical is a contract manufacturer providing manufacturing and engineering services for the medical device industry. They offer comprehensive solutions, including robust quality systems, ISO 13485 certification, and FDA registration. Their services include validated cleaning, sterile packaging, and complete kitting of medical devices.

infocrjobs@cretex.com+17634412121

Dordan Manufacturing

dordan.com
Woodstock, IL

Based in Woodstock, IL, Dordan Manufacturing specializes in custom thermoformed medical device packaging. They engineer trays for sterility, performance, and ease of use, leveraging advanced cleanroom thermoforming. Dordan provides tooling and thermoforming services for aseptic medical packaging applications, with expertise since 1962.

sales@dordan.com+18153340087

Eagle Medical Inc.

eaglemed.com
Paso Robles, CA

Based in Paso Robles, CA, Eagle Medical Inc. provides contract packaging and sterilization services for medical products. The company is certified to ISO 13485:2016 requirements, offering quality assembly and sterilization solutions. They partner with customers to find efficient sterilization methodologies to speed market penetration.

info@eaglemedmail.com+18052387401

GBI Biologics

gbibio.com
Plantation, FL

GBI Biologics is a full-service biopharmaceutical CDMO based in Plantation, FL, offering cGMP-compliant aseptic fill and finish services for biologics and advanced therapeutics. They provide manufacturing strategy development, project management, regulatory support, quality control, and biomanufacturing planning, aiming to reduce client manufacturing risks effectively.

info@gbibio.com+19543215300

Gehl Food & Beverage

gehlfoodandbeverage.com
Germantown, WI

Based in Germantown, WI, Gehl Food & Beverage specializes in aseptic processing and packaging for food and beverage products. They create high-quality, shelf-stable items with 12-18 month shelf life, requiring no refrigeration. Offerings include Tetra Pak, cans, flexible pouches, and bag-in-box for private label and contract manufacturing clients.

help@gehlfoods.com+18005212873

Greenwood Aseptics

greenwoodassociates.com
Niles, IL

Based in Niles, IL, Greenwood Aseptics offers state-of-the-art aseptic filling services for various food and beverage ingredients. They process juices, purees, custom blends, and other liquid products using their advanced aseptic packaging system.

gaisales@greenwoodassociates.com+18475795500

Guardian Medical

guardianmedicalusa.com
Swanton, OH

Based in Swanton, OH, Guardian Medical designs, develops, and manufactures novel terminally sterile packaging systems for medical implants. They offer integrated seal and rigid packaging, including CapSure™, providing custom solutions for complex medical devices with a focus on protection, regulatory compliance, and sustainability.

info@guardianmedicalusa.com+14198254040

ICPG

icpg.co
Putnam, CT

ICPG, based in Putnam, CT, provides advanced aseptic packaging materials and custom solutions. Specializing in rigid thermoformed and FFS applications for the food industry, they leverage visionX Technology for precise quality monitoring. The company offers a diverse portfolio of sustainable rigid barrier materials.

icpg@impactgroup.co+18609631976

Impak Corporation

impakcorporation.com
Sebastian, FL

Impak Corporation manufactures FDA-approved food grade flexible spout pouches designed for liquid contents. They offer a variety of materials and fitment options, catering to commercial and industrial B2B customers requiring specialized packaging solutions for sensitive liquid products.

flprocessing@impakcorporation.com+17727838000

JOINN Biologics

joinnbio.com
Richmond, CA

Based in Richmond, CA, JOINN Biologics is a multi-site CDMO providing comprehensive development and manufacturing services for complex biologics. The company offers cGMP manufacturing, process development, and fill and finish support, including aseptic liquid filling and capping in Grade A environments for drug products.

info@joinnbio.com+15102950222

KPAK

kpak.com
Grand Prairie, TX

Based in Grand Prairie, TX, KPAK develops specialized packaging solutions for food and beverage companies. The company focuses on extending product shelf life and maintaining quality through advanced packaging technologies designed to meet specific customer demands.

kpak@kpak.com+18003215725

Meissner Filtration Products, Inc.

meissner.com
Camarillo, CA

Based in Camarillo, CA, Meissner Filtration Products provides advanced filtration solutions, TepoFlex® biocontainers, and single-use assemblies. The company specializes in critical filtration applications and offers solutions for fast, secure aseptic transfer and freeze & thaw security, serving the life sciences industry with a focus on automation and sustainability.

service@meissner.com+18053889911

Nivagen Pharmaceuticals, Inc.

nivagen.com
Sacramento, CA

Nivagen Pharmaceuticals, Inc. is a specialty pharma CDMO based in Sacramento, CA, specializing in developing and manufacturing generic and specialty drugs. Their c-GMP sterile injectables facility produces various dosage forms, including aseptic and terminally sterilized IV bags, vials, PFS, cartridges, and ophthalmics for institutional clients.

business@nivagen.com+18779770687

Oakwood Labs

oakwoodlabs.com
Oakwood Village, OH

Based in Oakwood Village, OH, Oakwood Labs operates an FDA-approved aseptic GMP manufacturing facility. With 28 years of experience, they provide full R&D through GMP capabilities for over 100 long-acting injectable projects, utilizing a patent-protected process. They offer comprehensive aseptic services.

bd@oakwoodlabs.com+14407033615

PCI Pharma Services

pci.com
—

PCI Pharma Services is a CDMO providing integrated end-to-end drug development, manufacturing, and packaging solutions. Specializing in sterile fill-finish and lyophilization, the company offers advanced packaging capabilities for conventional and specialty injectable drug products, focusing on speed to market.

talkfuture@pci.com+12156133600

Packaging Compliance Labs

pkgcompliance.com
Grand Rapids, MI

Based in Grand Rapids, MI, Packaging Compliance Labs (PCL) provides comprehensive sterile packaging solutions for medical devices. They specialize in ISO 11607-compliant package testing, expert packaging engineering, and contract sterile packaging, including device assembly, cleaning, and labeling. PCL helps medical device manufacturers ensure compliant market entry.

info@pkgcompliance.com+16162274540

Plastic Technologies Inc.

plastictechnologies.com
Holland, OH

Based in Holland, OH, Plastic Technologies Inc. specializes in hot-fill and aseptic plastic packaging innovation, product design, and development. They provide testing, simulation, and production lab services for diverse industries such as food, beverage, personal care, and pharmaceutical sectors.

info@pti-usa.com+14198675400

ProAmpac

proampac.com
Anaheim, CA

ProAmpac manufactures flexible packaging solutions for diverse industries, with a focus on medical devices. They develop packaging designed for aseptic handling, meeting stringent requirements for sterile environments. The company also offers sustainable ProActive Recyclable films and fiber-based products.

info@proampac.com+15136711777

Pro-Tech Design & Manufacturing, Inc.

protechdesign.com
Santa Fe Springs, CA

Based in Santa Fe Springs, CA, Pro-Tech Design & Manufacturing, Inc. provides FDA-registered and ISO 13485 certified medical device contract packaging and assembly. They offer end-to-end solutions, including sterilization services, crucial for maintaining device sterility. With over 40 years of experience, they serve diverse medical clients.

info@protechdesign.com+15622071680

Renaissance Lakewood, LLC

renpharm.com
Lakewood, NJ

Based in Lakewood, NJ, Renaissance Lakewood, LLC provides aseptic fill-finish services for sterile vials and nasal sprays. They operate multiple lines for unit-dose, bi-dose, and multi-dose preserved nasal sprays, supporting clinical through commercial volumes. Their GMP manufacturing capabilities span from development to high-throughput commercial scales.

info@renpharm.com+17323679000

Resilience

resilience.com
San Francisco, CA

Resilience is a biomanufacturing CDMO focused on providing end-to-end solutions for the safe and scalable manufacturing of complex medicines and therapeutics. The company delivers high-quality production services for its partners, ensuring reliability for patients. Their comprehensive capabilities support the entire manufacturing lifecycle, including processes requiring aseptic conditions.

resiliencehr@resileince.com+18887372460

RiteDose

ritedose.com
Columbia, SC

Based in Columbia, SC, RiteDose is a Contract Development and Manufacturing Organization (CDMO) and generics manufacturer. The company specializes in sterile Blow-Fill-Seal (BFS) technology, providing aseptic processing and unit-dose delivery for pharmaceutical products, including critical medications.

info@ritedose.com+18038063300

Singota Solutions

singota.com
Bloomington, IN

Based in Bloomington, IN, Singota Solutions is a CDMO specializing in aseptic injectable manufacturing and filling. They provide small-batch, early-phase solutions for pharmaceutical, biotechnology, and animal health industries. Using advanced gloveless robotic SA25 aseptic filling technology, Singota offers services from drug development through supply chain management.

employment@singota.com+18129611700

SunOpta

sunopta.com
Eden Prairie, MN

Based in Eden Prairie, MN, SunOpta offers customized supply chain solutions, specializing in aseptic blending and packaging for plant-based beverages, broths, and nutritional drinks. They utilize a nationwide network of aseptic plants to serve top brands, retailers, and foodservice providers across North America with oat, almond, and soy-based products.

info@sunopta.com+19528202518

TPS Rental Systems

tpsrentalsystems.com
Randolph, NJ

Based in Randolph, NJ, TPS Rental Systems provides reusable IBC containers for aseptic storage and transportation of bulk liquid products. They offer efficient, environmentally friendly rental solutions designed to optimize space utilization and reduce costs for businesses requiring aseptic liquid handling, promoting a circular supply chain.

ramon_conte@tpsrentalsystems-us.com+19739369000

UltraPhil

ultraphil.com
Rochester, NY

Based in Rochester, NY, UltraPhil specializes in small-scale, bottle-based aseptic R&D and pilot production. The company provides best-in-class aseptic processing and filling technologies. They support clients in developing and validating sterile packaging solutions, offering essential capabilities for innovation in the aseptic sector.

info@ultraphil.com+15859102925

VGXI

vgxii.com
The Woodlands, TX

Based in The Woodlands, TX, VGXI provides convenient, in-house GMP aseptic fill/finish services. The company is committed to offering compliant packaging solutions, specializing in the sterile filling and finishing of various pharmaceutical and biological products within their US-based facilities.

info@vgxii.com+18669018494

Winning Foods

winning-foods.com
Richardson, TX

Winning Foods is an aseptic beverage manufacturer based in Richardson, TX, specializing in protein beverages. The company leverages an agile approach and available capacity with a high-powered team to provide manufacturing solutions. They offer comprehensive aseptic manufacturing services for beverage brands.

info@winning-foods.com+12142102081

Woodstock Sterile Solutions

woodstocksterilesolutions.com
Woodstock, IL

Based in Woodstock, IL, Woodstock Sterile Solutions provides sterile development and manufacturing solutions using advanced aseptic technology. The company employs blow-fill-seal (BFS) technology to form, fill, and seal product containers. They specialize in complex liquid projects, primarily serving ophthalmic and respiratory applications.

info@woodstocksterilesolutions.com+18153389500

Elopak

elopak.com
Novi, MI

Elopak is a global supplier of sustainable carton packaging solutions for liquid food. The company specializes in aseptic packaging technology, offering a range of innovative carton formats like the Pure-Pak® Sense Aseptic, designed for extended shelf life and improved functionality.

elopak@elopak.com

Graphic Packaging International

graphicpkg.com
Atlanta, GA

Based in Atlanta, GA, Graphic Packaging International provides comprehensive aseptic packaging solutions for liquid food products. They specialize in high-quality, safe, and efficient aseptic cartons, offering extended shelf life and product protection for items like milk, juices, and other beverages.

accommodations@graphicpkg.com

Molded Devices, Inc.

moldeddevices.com
Tempe, AZ

Based in Tempe, AZ, Molded Devices, Inc. specializes in single and double sterile barrier packaging for medical devices. They offer cleanroom manufacturing, medical device assembly, and diverse molding techniques like injection, dip, and blow. Serving healthcare, industrial, and aerospace sectors with over 50 years of experience.

info@moldeddevices.com

Suntado

suntado.com
Burley, ID

Suntado, based in Burley, ID, is a co-packer offering aseptic (UHT) and extended shelf life (ESL) beverage manufacturing. Their state-of-the-art facility processes organic and conventional dairy-based, along with plant-based, beverages. They are vertically integrated with direct dairy farm connections.

info@suntado.com

Aesculap USA

aesculapusa.com
—

Aesculap USA specializes in providing rigid sterile containers for the medical industry. The company serves leading orthopedic, spine, and specialty instrument manufacturers, offering packaging solutions engineered to maintain device sterility and support validated processes.

+18002581946

AFP advanced food products llc.

afpllc.com
—

Based in New Holland, PA, AFP advanced food products llc. specializes in advanced food product manufacturing and co-packing. The company provides versatile packaging and filling solutions through its Flex Line, offering operational and environmental benefits over traditional glass. They focus on modern, efficient packaging for diverse food products.

+17173558500

Argonaut Manufacturing Services

argonautms.com
Carlsbad, CA

Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish for vials, syringes, and cartridges. They also offer lyophilization, drug-device combination product manufacturing, and comprehensive analytical and quality control support.

+18888348892

Black Forest Containers

blackforestmktg.com
Greenville, SC

Based in Greenville, SC, Black Forest Containers specializes in providing stainless steel containers for sterile production and storage. They offer aseptic totes, bag-in-box solutions, laboratory bottles, and specialty drums. The company provides sales, leasing, and rental options, adhering to UN/DOT and ASME compliance.

+18642822301

Byrne Dairy

byrne1933.com
Cortlandville, NY

Byrne Dairy is a US co-manufacturer specializing in aseptic and ESL dairy packaging. They produce UHT beverages in refrigerated and shelf-stable formats, offering gable top and Tetra Pak cartons. Their aseptic line processes conventional and organic dairy milk, cream, and non-dairy beverages, providing extended shelf-life products for customers.

+18008991535

California Juice Packers

californiajuicepackers.com
Anaheim, CA

California Juice Packers is a family-owned contract manufacturing and private label firm specializing in aseptic packaging for beverages. Based in Anaheim, CA, they provide shelf-stable bottling and packing services, utilizing advanced aseptic technology to preserve product quality, flavor, and nutrients without refrigeration. They support a wide range of beverage clients.

+19099480797

CDF Corporation

cdf1.com
—

CDF Corporation is a Plymouth, MA-based manufacturer of flexible packaging systems, specializing in deep draw vacuum-forming, blow molding, and heat sealing. They produce high-quality bag-in-box and IBC liners for the food and beverage, chemical, and cosmetic industries, often compatible with aseptic or extended shelf-life applications.

+18004431920

DPT Laboratories, LTD.

dptlabs.com
York City, NY

DPT Laboratories, LTD. is a pharmaceutical CDMO. Their 175,000-square-foot facility offers aseptic processing suites and advanced filling equipment for manufacturing. Services include drug pre-formulation, clinical trial supplies, and cGMP commercial scale manufacturing, with expertise in fill-finish solutions for liquids and semi-solids.

+12104768100

Extra Packaging

extrapackaging.com
Boca Raton, FL

Based in Boca Raton, FL, Extra Packaging provides comprehensive cleanroom packaging. With over 50 years of experience, the company custom fabricates a range of packaging sizes and thicknesses, offering manufacturing solutions for diverse applications and client needs.

+18008727548

Grand River Aseptic Manufacturing

grandriverasepticmfg.com
Grand Rapids, MI

Based in Grand Rapids, MI, Grand River Aseptic Manufacturing (GRAM) is a contract development and manufacturing organization (CDMO). The company specializes in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges, supporting pharmaceutical and biotechnology partners through clinical trials and commercialization.

+16166782400

Lyons Magnus, LLC.

lyonsmagnus.com
Westlake, OH

Lyons Magnus, LLC is a food and beverage manufacturer providing foodservice and co-manufacturing solutions. The company offers capabilities for high-acid aseptic beverage syrups and sauces, delivering custom product development and innovative packaging. Based in Westlake, OH, Lyons Magnus partners with businesses to create and produce high-quality food and beverage products.

+18003447130

MSI Express, INC

msiexpress.com
Portage, IN

MSI Express, INC is a contract manufacturing and packaging company offering comprehensive solutions for liquid blending and packaging, including aseptic services for juices and shelf-stable liquids. They also provide dry food, vitamin, supplement, and pet food packaging. Facilities hold Organic, Kosher, SQF, FDA, and GMP certifications.

+12197624855

Nelson Packaging Company

nelsonpackagingco.com
Lima, OH

Nelson Packaging Company, based in Lima, OH, offers contract chemical blending, filling, and packaging services. They emphasize sanitary design mixers in clean room environments and perform microbial content testing in bio safety cabinets, ensuring sterile and high-quality packaging across various container sizes.

+14192293471

NLX Beverage Solutions

nlxbeveragesolutions.com
Englewood, CO

NLX Beverage Solutions, based in Englewood, CO, is an aseptic co-packing and contract manufacturer for shelf-stable beverages. They specialize in aseptic processing and packaging, utilizing state-of-the-art filling lines. Services include aseptic filling for juices, plant-based milks, teas, and functional beverages in Tetra Pak cartons and PET bottles.

+18155993085

Oliver Healthcare Packaging

oliverhcp.com
Grand Rapids, MI

Based in Grand Rapids, MI, Oliver Healthcare Packaging manufactures flexible sterile barrier packaging for the healthcare industry. They develop and design solutions for medical devices, diagnostics, pharmaceuticals, and biopharmaceuticals, ensuring product sterility and safety until the point of use for a global clientele.

+18334654837

Plastiform Inc.

plastiform-dallas.com
Dallas, TX

Plastiform Inc. creates custom plastic thermoformed packaging, including PETG medical trays and lids designed for sterile use in operating rooms. They offer insert trays, clamshells, and cushion packaging for medical, retail, industrial, and food sectors, providing product design and mold building.

+18664730978

Plastikon

plastikon.com
Hayward, CA

Based in Hayward, CA, Plastikon specializes in aseptic liquid fill contract manufacturing, utilizing Blow/Fill/Seal (BFS) technology. They offer full-service plastic injection molding and B/F/S aseptic filling capabilities for the healthcare and pharmaceutical industries, including prototyping and clean room environments.

+18885389374

Rapak

rapak.com
Woodridge, IL

Based in Woodridge, IL, Rapak specializes in flexible packaging and Bag-in-Box solutions for liquids. They offer standard, large format, and aseptic bags, alongside Bag-in-Box filling equipment for fresh, stable, and aseptic liquids. Rapak serves diverse end markets including dairy, soda, smoothie, and wine.

+13178720172

St. Paul Beverage Solutions

spbevso.com
St. Paul, MN

Based in St. Paul, MN, St. Paul Beverage Solutions is a fluid beverage processor offering comprehensive contract manufacturing services. The company specializes in HTST, ESL, and aseptic processing capabilities, providing a variety of packaging solutions for beverages.

+16518556455

SPS Corporation

sps70.com
Edison, NJ

SPS Corporation, based in Edison, NJ, offers comprehensive packaging engineering, design, and supply chain optimization. Their dedicated SPS Aseptic Team provides cost-effective packaging solutions, including various films, tapes, labels, bags, and pouches. They support industries such as contract packaging and pharmaceutical & healthcare.

+18009449689

Steuben Foods Inc

steubenfoods.com
Elma, NY

Based in Elma, NY, Steuben Foods Inc. is a food and beverage manufacturer specializing in low-acid aseptic packaging. The company processes dairy and plant-based products using state-of-the-art facilities and innovative HydroReleased Ingredients technology, offering a complete manufacturing solution including R&D.

+17166554000

UFP MedTech

ufpmedtech.com
—

UFP MedTech provides comprehensive manufacturing solutions for single-use and single-patient medical devices, specializing in sterile packaging. They offer full-service design, development, and production, compatible with autoclave, gamma, and EtO sterilization methods for enhanced sterility.

+18003723172

Alcami

alcami.com
Durham, NC

Based in Durham, NC, Alcami is a US-based contract development and manufacturing organization (CDMO). The company specializes in comprehensive sterile fill-finish manufacturing services for pharmaceuticals and biologics, including prefilled syringes. Alcami provides fully integrated lab services, drug product manufacturing, and cGMP pharma storage.

No contact on file

Amcor

amcor.com
—

Amcor develops and manufactures responsible packaging solutions, including advanced aseptic packaging tailored for dairy and beverage industries. With significant US manufacturing operations, Amcor’s aseptic solutions ensure product safety, quality, and extended shelf life across various food, beverage, pharmaceutical, and medical applications.

No contact on file

AscentX Medical, Inc.

ascentxmedical.com
San Diego, CA

Based in San Diego, CA, AscentX Medical, Inc. specializes in aseptic fill and finish processes. The company utilizes ISO Class 5 sterile suites and ISO Class 8 clean rooms for syringe and vial filling. They leverage these capabilities for injectable regenerative therapy, focusing on advanced soft tissue engineering with autologous microspheres.

No contact on file

Boehringer Ingelheim BioXcellence

boehringer-ingelheim.com
—

Boehringer Ingelheim BioXcellence delivers specialized aseptic filling services, drawing on over 25 years of industry experience. The company provides tailored filling solutions to meet the unique needs of its diverse partners, focusing on high-quality and reliable packaging processes for sensitive products.

No contact on file

Patheon

patheon.com
—

Patheon, a pharmaceutical contract development and manufacturing organization (CDMO), provides flexible sterile fill-finish services. Its global facilities accommodate various molecules and parenteral dosage formats, supporting pharmaceutical product development and manufacturing.

No contact on file

Viant

viantmedical.com
—

Viant provides comprehensive finished device services for the MedTech industry. Offerings include sterile barrier packaging, sterilization management, labeling, printing, and global distribution support. They specialize in solutions for interventional and inhalation medical devices, supporting complex design and manufacturing challenges.

No contact on file

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How to Choose a Company

  • Validate their Aseptic Process Authority: Insist on detailed documentation of their thermal process validation, including spore log reduction studies (e.g., 5-log for low-acid foods) performed by an accredited Process Authority, specific to your product matrix and target microorganisms.
  • Assess Sterile Barrier System Integrity: Evaluate their methods for post-packaging integrity testing, such as dye penetration tests, vacuum decay, or seal strength analysis, crucial for ensuring your product's long-term microbial stability in ambient conditions.
  • Scrutinize Regulatory Compliance: Verify adherence to critical regulations like FDA 21 CFR Part 113 for thermally processed low-acid foods packaged in hermetically sealed containers, and demand evidence of current cGMP and HACCP certifications for their aseptic lines.
  • Confirm Particulate Handling Capabilities: For products containing particulates (e.g., fruit pieces, vegetable bits), ensure the supplier's aseptic processing and filling equipment can handle your specific particle size and density without causing damage or compromising the sterile environment, a common challenge in this niche.
  • Examine Packaging Material Expertise: Understand their experience with various barrier materials (e.g., EVOH, aluminum foil laminates, silica-coated films) and sealing technologies required for your product's shelf life, oxygen sensitivity, and sustainability goals.
  • Red Flag: Vague Validation Data: Be wary of suppliers who provide only generic "aseptic" claims without specific thermal process schedules, critical factor limits (e.g., minimum temperature, holding time), and detailed validation reports relevant to your exact product and packaging format.
  • Evaluate CIP/SIP Protocols and Automation: Deep dive into their Clean-in-Place (CIP) and Sterilize-in-Place (SIP) procedures for their filling lines, ensuring they utilize advanced automation and robust protocols to prevent recontamination, which is paramount for aseptic integrity.

Frequently Asked Questions

What specific regulatory certifications are non-negotiable for an aseptic packaging supplier for low-acid foods?

For low-acid aseptic foods, strict adherence to FDA 21 CFR Part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) and 21 CFR Part 108 (Emergency Permit Control) is absolutely critical. Suppliers must also demonstrate current cGMP (Current Good Manufacturing Practices) compliance, often complemented by HACCP or FSSC 22000 certifications, validating their commitment to food safety and sterile operations.

How do I ensure the supplier’s aseptic process is truly validated for my unique product (e.g., viscous, particulate-laden)?

Request their thermal process validation reports, specifically looking for documentation from an accredited Process Authority that addresses your product's exact pH, water activity, viscosity, and particulate content. The validation should demonstrate a minimum 5-log reduction of Clostridium botulinum for low-acid products, ensuring sterility under worst-case scenarios.

What critical post-packaging integrity tests should an aseptic supplier perform to guarantee product safety?

Essential post-packaging tests include seal integrity checks (e.g., burst strength, dye penetration), visual inspections for defects, and container compression tests. For flexible pouches, vacuum decay or leak detection systems are crucial to detect microscopic holes, while carton or bottle integrity is often verified through stress tests and visual analysis of the sterile barrier system.

What's the difference in sterile barrier requirements between an aseptic carton and a blow-fill-seal (BFS) container?

Aseptic cartons typically rely on multi-layer laminates (often including aluminum foil or EVOH) to provide the sterile barrier and oxygen protection, which are then aseptically filled and sealed. BFS containers, however, form, fill, and seal the package in a single, sterile operation from molten resin, minimizing external contamination risk. The sterile barrier for BFS is inherent in the container's robust plastic structure itself, offering different mechanical and barrier properties compared to a multi-material carton.

How can I assess a potential supplier's capability to handle my product's Extended Shelf Life (ESL) requirements without compromising quality?

Beyond their core aseptic process, scrutinize their material science expertise. Inquire about their experience with high-barrier films (e.g., those containing EVOH or metallization) or multi-layer structures, and ask for data from real-time or accelerated shelf-life studies performed on similar products. Also, ensure they have precise headspace control capabilities, especially for oxygen-sensitive or vitamin-rich products.

What are the key considerations for aseptic packaging if I'm looking for more sustainable options?

When seeking sustainable aseptic packaging, investigate suppliers offering solutions like bio-based or renewable content cartons, lightweighted designs, or materials with higher recyclability (e.g., monomaterial pouches). Discuss their specific initiatives for reducing material usage, their capabilities with closed-loop recycling programs, and their certifications for sustainable forestry (for carton-based solutions) or recycled content.

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