Legendary Service. Superior Results.cdn.thomasnet.com/ccp/00366350/28083.pdf · Legendary Service....
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Transcript of Legendary Service. Superior Results.cdn.thomasnet.com/ccp/00366350/28083.pdf · Legendary Service....
Legendary Service. Superior Results. www.AphenaPharma.com
www.AphenaPharma.com
Mission Statement
Aphena Pharma Solutions, Inc., specializes in
providing quality, compliant pharmaceutical
packaging and manufacturing services by
exceeding customer expectations through
strong teamwork, empowered employees
and continuous improvement.
Our Shared Values
Quality Without Compromise
Customer-Driven Excellence
Innovative Solutions
Success Through Our People
Integrity In Everything We Do
Legendary Service. Superior Results.
About Aphena
www.AphenaPharma.com
Aphena Pharma Solutions, Inc., is a high-performance organization providing turnkey
contract packaging, repackaging and manufacturingsolutions for the pharmaceutical, OTC, nutraceutical,animal health, health and beauty, consumer health andmedical device markets. Aphena is a leader indesigning and implementing processes that are robustand capable of meeting and exceeding predeterminedspecifications through the use of leading-edgeequipment and technology.
Aphena provides clients with a full range of solutions toaddress their pharmaceutical packaging andmanufacturing requirements. With our continuedinvestment in technology, advanced packaging systemsand rigorous cost control, we can deliver solutions thatare highly cost effective as well as comprehensive.Through every step in the development of a product —including concept, manufacturing, packaging anddistribution — we provide clients with services andsolutions to help ensure a successful product launch.
History
Aphena was formed by a family of well-established, seasoned companies (PrePakSystems, TestPak, Celeste and IntegratedPharmaceutical Packaging). Some of theseestablished companies have been in this
industry for more than 25 years. The strategicalliance is now called Aphena PharmaSolutions. The products Aphena is activelyhandling are solid dose, liquids, gels, creams,ointments, foams, suspensions and lotions.
Quality
Aphena's facilities are FDA registered andDEA and State Board of Pharmacy licensed.The FDA's current Good ManufacturingPractice (cGMP) governs standard
operating procedures. The organizationmeets and exceeds FDA standards for 21 CFR, Parts 210 and 211.
Facilities
Aphena includes four FDA-inspected solid-dose packaging sites and one FDA-inspectedliquid manufacturing and packaging site,which handles liquids, lotions, creams, gels,ointments, suspensions and foams. Withapproximately 500,000 square feet,Aphena’s facilities offer state-of-the-art
security that includes 24-hour, full-facilitysurveillance; point-of-entry limitations; andalarm systems. All controlled substancesare secured, handled and stored inaccordance with DEA regulations. Aphenaoffers over 70 environmental controlledpackaging suites for customer projects.
Legendary Service. Superior Results.
Aphena Pharma Solutions, Inc., is a high-performance organization providing
turnkey contract packaging, repackaging and manufacturing solutions for the
pharmaceutical, OTC, nutraceutical, animal health, health and beauty,
consumer health and medical device markets. Formed by a family of well-
established companies (PrePak Systems, TestPak, Celeste and Integrated
Pharmaceutical Packaging), Aphena currently handles solid dose, liquids,
gels, creams, ointments, foams, suspensions and lotions. Being a market
leader, Aphena currently maintains some of the highest production capacity
levels in our industry, offering over 250 million bottles, over 400 million
pouches, over 300 million blisters, over 10 million tubes and mixing over 1.5
million gallons of product. Aphena defines success through customer-
focused performance and customer satisfaction. Aphena's personnel,
equipment and facilities operate under cGMP, are registered with the FDA
and hold State Board of Pharmacy licenses. Over 75 percent of the U.S.
population can be reached within a day's drive, which means reduced freight
costs and supply-chain simplification for our clients.
Legendary Service. Superior Results.
Capabilities
Aphena is equipped for pharmaceutical packaging projects of every sizeand complexity. Being a market leader, Aphena currently maintains some ofthe highest production capacity levels in our industry, offering over 250million bottles, over 400 million pouches, over 300 million blisters, over 10million tubes and mixing over 1.5 million gallons of product. Aphena definessuccess through customer-focused performance and customer satisfaction.
Service
Our team of seasoned experts collaborates with clients and addresses everyaspect of their product. We partner with clients to develop the solutions theyneed to succeed in a highly competitive marketplace, and we're committedto delivering an end result that is on schedule and cost effective.
Communication
Aphena customers enjoy reduced cycle time, cost and resources associated withinventory handling while maintaining control of information. Aphena managesreceiving, storage and shipping of customer inventory, including accurate, timelyand seamless information flow. Aphena's Inventory and Production ControlDepartment tracks inventory through all stages of processing. From receipt toshipping, inventory reports reflecting the location of the customer's product areavailable for review. Daily access to inventory information for larger customers isavailable via direct contact or electronic communication.
Distribution
Because our plants are situated across the eastern U.S., we are logistically and geographically positioned with access to the nation's major transportationlanes and carriers. Over 75 percent of the U.S. population can be reachedwithin a day's drive, which means reduced freight costs and supply-chainsimplification for our clients.
www.AphenaPharma.com
Solid Dose Division
Aphena's Solid Dose Division provides a full range of solid,semisolid and powder packaging solutions backed by
dedicated customer service, robust quality and continuousimprovement programs, project management, and in-housevalidation programs.
In addition, Aphena Pharma Solutions provides a full range ofproduct development resources, including package design,materials, clinical supplies, stability packaging and tradesamples. We offer competitive pricing, turnkey proposals andmultiyear supply agreements.
www.AphenaPharma.com
Bottling
Aphena offers bottling solutions forsolid-dose products: tablets, capsules,caplets, soft gels, and gel caps. Our turnkeyservices include purchasing all of the components,including a broad selection of bottle sizes andresins, cotton or rayon fillers and desiccants,outserts/inserts, CRC or dispenser caps withinduction seals, and digital or screen-printed labelswith serialization, if required.
Blister Carding, Cartoning and Compliance Packaging
Aphena offers an array of blister packaging inthermoform and cold-form blisters. Our control of theblistering process delivers faster and more cost-effectiveturnaround of product runs. The automated blisterequipment allows for short- or long-run production whilereducing up-front tooling costs for projects.
Pouching
Aphena operates both high-speed and low-volume pouching machines for OTC products, physician sampledistribution and hospital unit-dose programs. Ourpouching lines can accommodate a wide range ofsizes and materials, as well as in-line printing.
Clinical Supplies
Aphena provides independent, third-partyservices in packaging and randomization forclinical studies. We have implemented rigorousprocedures to assure total drug accountability and comply with current Good Manufacturing Practices (cGMP) and GoodClinical Practices (GCP) regulations, standards and guidelines.
Legendary Service. Superior Results.
www.AphenaPharma.com
Unit-of-Use/Unit Dosing
Aphena's solid-dose products are sealed instandard- or custom-packaging designs,including fully-labeled pouches, bottles, orblisters. Each primary packaged component
then can be placed into another custom,secondary carton configuration based on the customer’s needs.
Kitting
Aphena fills custom-designed, turnkey requeststhat meet customer demand for many kit-requiredapplications. Custom labeling ensures that kitsprovide market-appropriate usage information,whether distribution is to consumers, hospitals,
physicians and nursing homes, or for short-runclinical trials. Prepackaged, disposable unitsand flexible operations processes provide fullyintegrated solutions for pharmaceuticalapplications.
Secondary Packaging
Aphena's secondary-packaging option targetsclinical trials, physician sample distribution, orcustom retail display requirements with yourvendors and marketing teams. If required,Aphena will assist with labeling and carton
design or point-of-sale displays to providemarket-appropriate usage information, whetherdistribution is to consumers, hospitals, physicians,short-run clinical trials, or wholesale groups.
Aphena’s solid-dose facilities are DEA licensedto handle class III-V controlled substances. One Aphena facility is licensed to package and
distribute class II products. All controlledsubstances are secured, handled and stored in accordance with DEA regulations.
Controlled-Substance Packaging Handling CII-CV Products
Aphena Pharma Solutions, Inc., is a high-performance organization providing
turnkey contract packaging, repackaging and manufacturing solutions for the
pharmaceutical, OTC, nutraceutical, animal health, health and beauty,
consumer health and medical device markets. Formed by a family of well-
established companies (PrePak Systems, TestPak, Celeste and Integrated
Pharmaceutical Packaging), Aphena currently handles solid dose, liquids,
gels, creams, ointments, foams, suspensions and lotions. Being a market
leader, Aphena currently maintains some of the highest production capacity
levels in our industry, offering over 250 million bottles, over 400 million
pouches, over 300 million blisters, over 10 million tubes and mixing over 1.5
million gallons of product. Aphena defines success through customer-
focused performance and customer satisfaction. Aphena's personnel,
equipment and facilities operate under cGMP, are registered with the FDA
and hold State Board of Pharmacy licenses. Over 75 percent of the U.S.
population can be reached within a day's drive, which means reduced freight
costs and supply-chain simplification for our clients.
Legendary Service. Superior Results.
Liquid & Topicals Division
www.AphenaPharma.com
Our packaging division has various containeroptions, from bottles to custom form-fill-and-sealpacket designs. Aphena stands ready to handle any complex project need.
◗ Pouches• Towelettes, swabs
◗ Bottles• Pumps, sprays, foams and multiple sizes• Monobloc and in-line filling/bottling• Crèmes, lotions, gels• Flammables and solvents• Wide range of fill volumes, starting at 0.4mL
◗ Packets• Single-use, flexible packets• Impregnated swabs• Impregnated wipes• Creams, lotions, gels• Directional spout packets• Unit-of-use dosage• Flammables and solvents• Microdose, starting at 0.1mL
◗ Tubes• Metal and plastic tube filling
capabilities• Crèmes, lotions, gels, pastes• Flammables
◗ Totes◗ Secondary packaging
• Clamshells• Blisters• Kitting• Point-of-purchase displays• Floor displays• Clip strips
◗ KittingAphena can manage all aspects of yourcontract manufacturing and then pack outthese units into custom-labeled Tyvek/polypacks. Once packed out, we can then manageall aspects of the sterilization process. Offeringa true turnkey solution to your outsourcing andprocedural kit manufacturing needs, Aphena isyour total one-stop shop for all of youroutsourcing needs.
◗ Other custom designs
Aphena's Liquid & Topicals Division specializes inchemical mixing, blending and packaging of various
types of liquids, creams, gels, suspensions, foams andlotions in the pharmaceutical and consumer caremarkets. We offer turnkey solutions for pharmaceuticalproducts (OTC and Rx) and medical devices includingpackaging design and prototyping, product scale-up,materials sourcing, stability studies, compatibility studies,regulatory filing assistance, primary and secondarypackaging selection and design, value engineering andsterilization management. In addition, our on-sitelaboratories are capable of handling analytical testing,compatibility testing, accelerated and real-time stabilitytesting and microbiological testing.
Legendary Service. Superior Results.
Packaging
Aphena Pharma Solutions, Inc., is a high-performance organization providing
turnkey contract packaging, repackaging and manufacturing solutions for the
pharmaceutical, OTC, nutraceutical, animal health, health and beauty,
consumer health and medical device markets. Formed by a family of well-
established companies (PrePak Systems, TestPak, Celeste and Integrated
Pharmaceutical Packaging), Aphena currently handles solid dose, liquids,
gels, creams, ointments, foams, suspensions and lotions. Being a market
leader, Aphena currently maintains some of the highest production capacity
levels in our industry, offering over 250 million bottles, over 400 million
pouches, over 300 million blisters, over 10 million tubes and mixing over 1.5
million gallons of product. Aphena defines success through customer-
focused performance and customer satisfaction. Aphena's personnel,
equipment and facilities operate under cGMP, are registered with the FDA
and hold State Board of Pharmacy licenses. Over 75 percent of the U.S.
population can be reached within a day's drive, which means reduced freight
costs and supply-chain simplification for our clients.
Legendary Service. Superior Results.
Manufacturing
Aphena has the ability to blend a wide range of viscosities. Our liquid-dose manufacturingoperation covers 60,000 square feet andcontains six environmental isolation suites to
meet your products’ requirements. Aphena'scomputerized blending systems take theguesswork out of blending while assuring a high degree of repeatability.
◗ Liquids◗ Creams◗ Gels◗ Lotions◗ Ointments◗ Suspensions◗ Foams◗ Aqueous and solvent-based products◗ Flammable and nonflammable◗ Various viscosities◗ Hot and cold blending capabilities
◗ Environmental controlled storage of components and finished goods
◗ Validated purified-water system◗ Full-service laboratory
• Microbiological testing• Analytical testing
- Qualitative and quantitative testing- Method development and
validation• Compatibility testing• Accelerated and real-time stability testing
◗ In-house tooling design and fabrication
Packaging Development
Aphena's turnkey solutions range from product development to product launches and commercialization. Here are some of
the many ways Aphena serves our clients' liquid-dose development needs:
◗ Custom packaging design• Analytical method and testing
development• Stability testing
◗ Tech transfer◗ Sourcing (domestic and global)
◗ Graphics support◗ Equipment and production validations◗ Manufacturing◗ Stability packaging◗ Sterilization management◗ Trade samples
www.AphenaPharma.com
Health & Beauty Division
www.AphenaPharma.com
About Aphena Health & Beauty
Aphena Health & Beauty, a sister company to AphenaPharma Solutions, Inc., was founded by a group of industryprofessionals with exceptional know-how in plant andequipment design, industry marketing, manufacturing,packaging materials and cGMP packaging processes. With more than 75 years of combined experience, ourmanagement team and packaging experts offer creativepackaging solutions, complete turnkey services, industrymarketing insight and much more.
Our Facility
Aphena Health & Beauty maintains state-of-the-art facilities in Easton, MD, and Whippany, NJ,including a total of 220,000 square feet ofmanufacturing, packaging and warehousespace. We offer dedicated packaging suites
with individual air handling systems; electronic product verification systems; and modular,washable construction. In addition, we have aclimate-controlled, bulk and finished goodsinventory storage area.
A Focus on Quality
Aphena Health & Beauty is focused on productintegrity and safety at every phase of theproduction cycle. Throughout the entire process,regular quality checks are conducted to ensurepackage integrity. As an industry leader, AphenaHealth & Beauty remains at the forefront ofsafety and quality, offering:
◗ A staff committed to the highest processing standards
◗ Individual production rooms with separately controlled environments
◗ Full cGMP compliance◗ Fully trained, professional, quality-
assurance and engineering staff
Legendary Service. Superior Results.
Aphena Pharma Solutions, Inc., is a high-performance organization providing
turnkey contract packaging, repackaging and manufacturing solutions for the
pharmaceutical, OTC, nutraceutical, animal health, health and beauty,
consumer health and medical device markets. Formed by a family of well-
established companies (PrePak Systems, TestPak, Celeste and Integrated
Pharmaceutical Packaging), Aphena currently handles solid dose, liquids,
gels, creams, ointments, foams, suspensions and lotions. Being a market
leader, Aphena currently maintains some of the highest production capacity
levels in our industry, offering over 250 million bottles, over 400 million
pouches, over 300 million blisters, over 10 million tubes and mixing over 1.5
million gallons of product. Aphena defines success through customer-
focused performance and customer satisfaction. Aphena's personnel,
equipment and facilities operate under cGMP, are registered with the FDA
and hold State Board of Pharmacy licenses. Over 75 percent of the U.S.
population can be reached within a day's drive, which means reduced freight
costs and supply-chain simplification for our clients.
Legendary Service. Superior Results.
Aphena Health & Beauty has the ability to blenda wide range of viscosities, from aqueous basedto crèmes, lotions, liquids and gels. Hot-blending and cold-blending capabilities areavailable to fit your specific needs. Aphena'scomputerized blending systems take theguesswork out of blending while assuring a highdegree of repeatability. This assures that onlythe highest quality products leave our facility.
In addition, we offer:
◗ Controlled-environment isolation suites to suit your products and needs
◗ Validated, purified-water system◗ Environmental controlled storage of
components and finished goods as needed◗ Analytical and microbiology laboratories◗ Test-method development and validation◗ Packet design and prototyping◗ In-house tooling design/build
Manufacturing Capabilities and Services
Aphena Health & Beauty combines innovativeideas, expertise in packaging and equipmentdesign to provide quality, cost-effective products.
◗ Blister packs◗ Bottle and jar filling◗ Tube filling◗ Packette and pouch filling◗ Sampling stix◗ Custom design
Packaging Capabilities and Services
www.AphenaPharma.com
www.AphenaPharma.com
Aphena Pharma Solutions, Inc., is a high-performance organization providing
turnkey contract packaging, repackaging and manufacturing solutions for the
pharmaceutical, OTC, nutraceutical, animal health, health and beauty,
consumer health and medical device markets. Formed by a family of well-
established companies (PrePak Systems, TestPak, Celeste and Integrated
Pharmaceutical Packaging), Aphena currently handles solid dose, liquids,
gels, creams, ointments, foams, suspensions and lotions. Being a market
leader, Aphena currently maintains some of the highest production capacity
levels in our industry, offering over 250 million bottles, over 400 million
pouches, over 300 million blisters, over 10 million tubes and mixing over 1.5
million gallons of product. Aphena defines success through customer-
focused performance and customer satisfaction. Aphena's personnel,
equipment and facilities operate under cGMP, are registered with the FDA
and hold State Board of Pharmacy licenses. Over 75 percent of the U.S.
population can be reached within a day's drive, which means reduced freight
costs and supply-chain simplification for our clients.
Legendary Service. Superior Results.
Locations
Solid Dose Division
◗ Corporate Office1920 Fisk RoadCookeville, TN 38506931.372.2041
◗ 301A Robey StreetFranklin, KY 42134270.586.7979
◗ 40 Aberdeen Drive Glasgow, KY 42141270.629.4044
◗ 125 Algonquin ParkwayWhippany, NJ 07981973.887.4440
Liquid & Topicals Division
◗ 7978 Industrial Park RoadP.O. Box 3382Easton, MD 21601410.822.6200
www.AphenaPharma.com
Legendary Service. Superior Results.
Legendary Service. Superior Results. www.AphenaPharma.com
www.AphenaPharma.com
Mission Statement
Aphena Pharma Solutions, Inc., specializes in
providing quality, compliant pharmaceutical
packaging and manufacturing services by
exceeding customer expectations through
strong teamwork, empowered employees
and continuous improvement.
Our Shared Values
Quality Without Compromise
Customer-Driven Excellence
Innovative Solutions
Success Through Our People
Integrity In Everything We Do
Legendary Service. Superior Results.
