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2019 PDA Annual Meeting

• ANOVAFILL - Booth 418

  2020 Avon Ct., Charlottesville, VA 22902
  Tel: +1 (434) 979-3737 l Fax: +1 (434) 979-3738
  Website: www.anovafill.com

  AnovaFill provides cGMP contract sterile filling services
  of parenterals. Specializing in small batch clinical and
  commercial runs with capabilities to batch, sterilize, fill, label, serialize, and package. AnovaFill is a part of Afton Scientific. Afton is the world premiere provider of pre-packaged empty sterile vials, stoppers, and seals (Ready-to-Fill®).

• APTAR PHARMA - PASSPORT SPONSOR - Booth 600

  250 North Rt. 303, Congers, NY 10920
  Tel: +1 (845) 639-3700
  Website: www.aptar.com

  Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare, and biotech customers worldwide, enabling safe, convenient, and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components, and services that help them succeed. We have broad therapeutic expertise in nasal, pulmonary, injectables, eye care, and dermal delivery routes among others.

• BAUSCH + STROEBEL MACHINE COMPANY, INC. - Booth 601

  21 Commerce Dr., PO Box 206, North Branford, CT 06471
  Tel: +1 (203) 484-9933 | Fax: +1 (203) 484-9939
  Website: www.bausch-stroebel.com

  Bausch+Stroebel designs and manufactures filling and packaging machines for the pharmaceutical industry. Our equipment cleans/washes, sterilizes/depyrogenates, fills, closes/caps, checks/assembles, conveys and labels containers at any capacity range – from 1500 to 60000 containers per hour. Bausch+Stroebel machines are designed to comply with the latest FDA and GMP requirements.

• BD MEDICAL – PHARMACEUTICAL SYSTEMS - Booth 407

  1 Becton Dr., Franklin Lakes, NJ 07417
  Tel: +1 (201) 847-6850 l Fax: +1 (201) 847-4854
  Website: www.bd.com

  BD Medical – Pharmaceutical Systems provides high-quality, customized, clinically proven drug delivery systems to help pharmaceutical and biotechnology customers’ injectable drugs reach their full potential. BD offers a range of products, including glass and plastic prefillable syringes, and a variety of systems for the self-administration of injectables. With a broad range of innovative systems and services, BD provides pharmaceutical companies with support and resources to help them achieve their goals.

• Biomérieux Industry - Booth 511

  595 Anglum Rd., Hazelwood, MO, 63042
  Tel: +1 (314) 731-8500 l Fax: +1 (314) 731-8678
  Website: www.biomerieux.com

  We’re making endotoxin testing faster, easier, and ecologically friendly: With our ENDONEXT® assays and ENDOXPERTS® services, we accelerate innovation together with our Hyglos team. At this year’s PDA Annual Meeting, we are glad to introduce ENDOZYME® II GO – a new rFC assay providing great results with much less handling.

• Bioscience International, Inc. - Booth 611

  11333 Woodglen Dr., Rockville, MD 20852
  Tel: +1 (301) 231-7400 | Fax: +1 (301) 231-7277
  Website: www.biosci-intl.com

  The newest generation of SAS microbial air monitors, for ensuring full compliance with cGMP and international monitoring requirements, will be displayed.

• Biovigilant (a division of Azbil North America, Inc.) - Booth 505

  2005 West Ruthrauff, Suite 151, Tucson, AZ 85705
  Tel: +1 (520) 292-2342 | Fax: +1 (520) 292-2365
  Website: www.biovigilant.com

  Azbil BioVigilant Instantaneous Microbial Detection instruments provide continuous, real-time results for environmental monitoring of air and water. IMD® instruments detect particle size, count, and biological status…simultaneously. No staining, no reagents, no growth required. Visit with us to learn more about protecting your bottom line from the disastrous effects of microbial contamination.

• Boston Analytical - Booth 610

  14 Manor Pkwy., Salem, NH 03079
  Tel: +1 (603) 893-3758
  Website: www.bostonanalytical.com

  Boston Analytical, the Life Sciences Division of Alpha Analytical, is a cGMP compliant, FDA/DEA registered, ISO/ IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to pharmaceutical and medical device companies worldwide, including analytical testing/method development, microbiological testing/EM services, stability testing/ICHcompliant storage, and extractables and leachables studies.

• Commissioning Agents, Inc. - Booth 602

  652 N. Girls School Rd., Suite 240, Indianapolis, IN 46214
  Tel: +1 (317) 271-6082 | Fax: +1 (317) 271-6097
  Website: www.commissioningagents.com

  CAI Consulting is a proven resource that will help you attain your goals throughout the lifecycle of your products. We identify and implement cost improvement strategies, quality measures, and compliance programs to achieve sustainable, reliable production. We help biopharmaceutical and other regulated industries bring and keep products on the market. Our insights help you reach your objectives.

• Datwyler Pharma Packaging USA - Booth 510

  9012 Pennsauken Hwy., Pennsauken, NJ 08110
  Tel: +1 (856) 663-2202 l Fax: +1 (856) 663-2636
  Website: www.datwyler.com

  Datwyler is a key player in the healthcare world. Our state-of-the-art solutions for drug packaging and medical devices are built on more than 100 years of experience. We provide a unique range of products and services, including the most advanced elastomer formulations, coatings, aluminum seals, and processing technologies.

• Ecolab Life Sciences - Booth 519

  1 Ecolab Pl., St. Paul, MN 55102
  Tel: +1 (651) 250-2347
  Website: www.ecolab.com

  Ecolab Life Sciences is a trusted partner in pharmaceutical manufacturing. We provide innovative contamination control, disinfection, and cleaning solutions for critical manufacturing areas to ensure product quality and safety, while improving operational efficiency.

• Ellab, Inc. - Booth 522

  303 E. 17th Ave., Suite 10, Denver, CO 80203
  Tel: +1 (303) 425-3370 l Fax: +1 (303) 425-3384
  Website: www.ellab.com

  Ellab manufactures a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, and CO2 sensor options. Ellab also offers validation services provided by experienced engineers for all of your temperature mapping needs. These environments often include -80C freezers, incubators, stability chambers, autoclaves, and ovens. Ellab has the products and experience to meet all your validation requirements.

• Emergent Biosolutions, Inc. - Booth 411

  1111 S. Paca St., Baltimore, MD 21230
  Tel: +1 (800) 441-4225 | Fax: +1 (410) 843-4414
  Website: www.ebsi.com/CMO

  Emergent BioSolutions provides contract manufacturing services for both bulk drug substances and finished drug products. Emergent’s fill/finish service offering includes vials and syringes, for both liquid and lyophilized products (including lyo cycle development). Emergent’s manufacturing facilities currently produce 20 commercial products and have supported more than 200 clinical drug products.

• Exova SL Pharma - Booth 700

  1300 First State Blvd., Suite C, Wilmington, DE 19804
  Tel: +1 (302) 636-0202 l Fax: +1 (302) 636-0204
  Website: www.slpharmalabs.com

  Since 1997, SL Pharma Labs, Inc. has provided high-value drug product development, analytical, microbiological, and early phase clinical manufacturing services for generic and innovator parenteral, liquid, and topical products. SL Pharma Labs mission is to support clients in meeting product development, analysis, regulatory approval, commercialization timelines, and budgetary requirements.

• Garvey Corporation - Booth 315

  208 S. Route 73, Blue Anchor, NJ 08037
  Tel: +1 (609) 561-2450 | Fax: +1 (609) 561-2328
  Website: www.garvey.com

  Garvey is an innovative manufacturer of vial and bottle handling equipment. We specialize in accumulation, single filing, vial drying, and tray loading packaged pharmaceutical goods.

• Gerflor USA - Booth 307

  595 Supreme Dr., Bensenville, IL 60106
  Tel: +1 (847) 394-3944 l Fax: +1 (847) 394-3753
  Website: www.gerflorusa.com

  Specifications have been built on Gerflor for more than 80 years. As the original manufacturer of homogeneous sheet flooring (Mipolam, 1937), Gerflor continues to provide specialized resilient flooring solutions for many industries including healthcare, life science, and hi-tech manufacturing.

• IMA Life North America, Inc. - Booth 323

  2175 Military Rd., Tonawanda, NY 14150
  Tel: +1 (716) 695-6354 | Fax: +81 586 81 3678
  Website: www.imalife.com

  IMA Life North America Inc. is a global supplier of automated processing equipment for vials, ampoules, and syringes. Equipment range includes rotary and linear washers, depyrogenation tunnels, liquid and powder fillers, freeze dryers, loading/unloading systems, cappers, and labelers. We provide solutions for laboratory, pilot, and commercial processing needs.

• Lyophilization Technology, Inc. - Booth 419
  p>30 Indian Dr., Ivyland, PA 18974
  Tel: +1 (215) 396-8373 | Fax: +1 (215) 396-8375
  Website: www.lyotechnology.com

  Lyophilization Technology, Inc. is a contract development and manufacturing organization. The company conducts applied research, provides comprehensive scientific services and technical support ranging from developing new freezedried products and processes, streamlining operations to improving compliance, and manufacturing clinical supplies for freeze-dried pharmaceuticals, biologics, diagnostics, biopharmaceuticals, and fine chemicals.

• Nikka Densok USA, Inc. - Booth 310

  700 Corporate Circle, Suite H, Golden, CO 80401
  Tel: +1 (303) 202-6190
  Website: www.nikkadensok.com

  Nikka Densok USA provides high-speed online nondestructive pinhole inspection systems to detect pinholes, cracks, and defective seals in liquid-filled pharmaceutical packaging and containers using HVLD technology. Applications include pre-filled syringes, vials, ampoules, BFS containers, IV bags, and other flexible and rigid packaging made of glass, plastic, and poly laminates. Off-line units are available for laboratory testing and R&D purposes.

• Nipro Pharmapackaging - Booth 514

  1200 N. 10th St., Millville, NJ 08332
  Tel: +1 (856) 825-1400
  Website: www.nipro-pharmapackaging.com

  Nipro Pharmapackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or enhancement of packaging solutions of existing drugs. With a worldwide manufacturing footprint of 16 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform.

• NNE - PASSPORT SPONSOR - Booth 515

  1101 Slater Rd., Suite 120, Durham, NC, 27703
  Tel: +1 (510) 410-4854
  Website: www.nne.com

  NNE is an international company specialized in pharma engineering. Through focused pharma engineering, we enable our customers to deliver on demand.

• Novatek International - Booth 404

  2537 Rue Guenette, Saint-Laurent (Montreal), Quebec,
  H4R 2E9 Canada
  Tel: +1 (514) 668-2835 | Fax: +1 (514) 336-6537
  Website: www.ntint.com

  Novatek International is a leading supplier of regulatory compliant software for the pharmaceutical and biotech industries. Some of our products include software solutions for environmental monitoring, stability testing, cleaning validation, and quality systems. Novatek has 20 years of experience in the industry globally and provides best-in-class service.

• OMPI – A Stevanato Group Brand - Booth 301

  Via Molinella 17, Piombo Dese, PD, 35017 Italy
  Tel: +39 049 9318111
  Website: www.ompipharma.com

  OMPI, part of the Pharmaceutical Systems division of Stevanato Group, boasts a unique expertise in providing superior pharmaceutical containers from glass tubing. With operations in Italy, Slovakia, Mexico, China, and Brazil, OMPI offers a wide range of glass primary packaging, from vials and ampoules, to syringes and cartridges for auto/pen-injectors.

• Optima Machinery Corporation - Booth 304

  1330 Contract Dr., Green Bay, WI 54304
  Tel: +1 (920) 983-3133
  Website: www.optima-packaging-group.com

  Optima pharma designs and manufactures machinery in accordance with cGMP requirements for cleaning, sterilizing, filling, and closing, and assembly of syringes, vials, infusion bottles, and cartridges for liquid, viscous, and powder products, including freeze drying and clean-room technology.

• PTI Inspection Systems - Booth 311

  145 Main St., Tuckahoe, NY 10707
  Tel: +1 (914) 337-2005 l Fax: +1 (914) 337-8519
  Website: www.ptiusa.com

  PTI is a global leader package testing equipment.  We specialize in non-destructive package testing equipment for high risk packaging applications. PTI's inspection technologies are deterministic test methods that produce reliable and robust quantitative test result data.  We specialize in testing solutions for all parenteral and biologic products including vials, pre-filled syringes, cartridges, auto-injectors, blow-fill-seal and other packaging formats. 

• Rapid Micro Biosystems, Inc. - Booth 322

  1001 Pawtucket Blvd. West, Suite 280, Lowell, MA 01854
  Phone: +1 (978) 349-3200 | Fax: +1 (978) 349-2065
  Website: www.rapidmicrobio.com

  Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration technology-based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system automates and accelerates detection and enumeration in the areas of environmental monitoring and bioburden testing, eliminating manual steps and analysis.

• Rommelag USA, Inc. - Booth 306

  27905 Meadow Dr., Suite 9, Evergreen, CO 80439
  Tel: +1 (303) 674-8333 l Fax: +1 (303) 670-2666
  Website: www.rommelag.com

  Rommelag ENGINEERING is moving forward in the pharmaceutical industry in two primary ways: higher capacity and more efficient Blow/Fill/Seal (BFS) systems, leveraging our contract manufacturing resources to safely allow new products to utilize BFS technology designed to test and produce biological products: vaccines, antibodies, enzymes, and immunological substances.

• Sartorius Stedim North America, Inc. - Booth 300

  5 Orville Dr., Bohemia, NY 11716
  Tel: +1 (800) 368-7178 | Fax: +1 (631) 254-4253
  Website: www.sartorius-stedim.com

  Sartorius Stedim Biotech is a leading provider of cuttingedge equipment and services for the development, quality assurance, and production processes of the biopharmaceutical industry. Our integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management, and lab technologies support our global customer base to produce drugs safely, timely, and economically.

• SCHOTT North America, Inc. - Booth 701

  30 Lebanon Valley Pkwy., Lebanon, PA 17042
  Tel: +1 (717) 228-4200
  Website: www.us.schott.com/pharma

  SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental, and ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill and finish equipment.

• SIEVERS Instruments By SUEZ - Booth 420

  6060 Spine Rd., Boulder, CO 80301
  Tel: +1 (800) 255-6964
  Website: www.sieversinstruments.com

  Sievers® has deep expertise in ultrapure water quality monitoring and cleaning validation in the lifescience industries. Our unique total organic carbon (TOC) analysis technology, coupled with application expertise, validation support, and comprehensive service plans, allow you to meet regulatory requirements, improve process understanding, and optimize testing. Learn more about Sievers TOC Analyzers and our ISO Guide 34 and ISO/IEC 17025-certified reference materials at www.sieversinstruments.com.

• SIO2 Medical Products, Inc. - Booth 305

  350 Enterprise Dr., Auburn, AL 36832
  Tel: +1 (334) 321-5000
  Website: www.sio2med.com

  SiO2 Medical Products manufactures precision-molded primary containers molded from medical grade engineered polymer, such as Cyclic Olefin Polymer. SiO2’s products incorporate a silicon-based barrier coating system thatcombines the durability, pH stability, and dimensional consistency of plastic with the barrier properties and lowextractables of silica glass (i.e., quartz).

• SKAN US, Inc. - Booth 303

  7409 ACC Blvd., Suite 200, Raleigh, NC 27617
  Tel: +1 (919) 354-6380 l Fax: +1 (919) 354-6411
  Website: www.skan.ch

  SKAN is the world leader in aseptic/potent isolators and RABS (Restricted Access Barrier Systems) for biopharmaceutical production and sterility testing. Proven sterilization processes include integrated isolator H2O2 systems, SARA (20 minute rapid transfer airlocks), SKANFOG large area decontamination systems (also used for RABS), and E-Beam Tunnels as successfully validated technologies.

• SQA Services, Inc. - Booth 414

  550 Silver Spur Rd., Suite 300, Rolling Hills Estates, CA 90275
  Tel: +1 (310) 802-4454 | Fax: +1 (424) 581-0540
  Website: www.sqaservices.com

  SQA provides global supplier quality solutions to clients in quality-critical industries. Our fully managed programs for audits, engineering, source inspection, remediation, and corrective action management, combined with a global network of quality professionals in more than 50 countries, offers superior visibility and control for any supplier quality initiative.

• STERILINE S.R.L - Booth 520

  Via Tentorio, 30, 22100 Como, 22100 Italy
  Tel: +39 031 592064
  Website: www.steriline.it

  Steriline is an expanding European manufacturer founded in the Lake Como area in 1989, highly specialized in the production of complete lines for the aseptic processing of injectable products, supplying pharmaceutical companies worldwide.

• Steris Life Sciences - Booth 201

  5960 Heisley Rd., Mentor, OH 44060
  Tel: +1 (440) 354-2600 l Fax: +1 (440) 350-7081
  Website: www.sterislifesci.com

  For more than 100 years, STERIS Corporation has been known as a global leader, trusted partner, and solutions provider in the field of sterilization and contamination control. From formulated chemistries, to capital equipment to parts and services, STERIS Life Sciences is Science and Solutions for Life. For more information, visit www.sterislifesciences.com.

• Thermo Fisher Scientific - Booth 609

  12076 Santa Fe Trail Dr., Lenexa, KS 66215
  Tel: +1 (800) 255-6730 l Fax: +1 (800) 864-4739
  Website: www.thermofisher.com

  BIOPRODUCTION: Thermo Fisher Scientific supplies innovative solutions for the world's pharmaceutical and biopharmaceutical industries. With applications that span the drug development process – from drug discovery through large-scale commercial production - we provide a broad range of products and services, including single-use technologies, cell culture media, purification, and analytics. www.thermofisher.com/bioproduction.

• VELTEK Associates, Inc. - Booth 500

  15 Lee Blvd., Malvern, PA 19355
  Tel: +1 (610) 644-8335 | Fax: +1 (610) 644-8336
  Website: www.sterile.com

  VAI’s manufacturing and testing operations mirror current GMP/GLP standards. With more than 35 years of contamination control experience, our products and services include a comprehensive line of disinfectants, sporicides, residue removers, process cleaners, quality water, saturated and dry wipes, disposable garments, cleanroom paper, documentation materials, RFID tracking systems, printing systems, viable monitoring, particle counting, cleanroom cart systems, cleaning equipment, consulting, and laboratory services.

• Virtuosi - Booth 421

  850 Ralph McGill Blvd., NE, Unit 22, Atlanta, GA 30306
  Tel: +1 (216) 538-6001
  Website: www.virtuosivr.com

  Virtuosi® is THE revolutionary educational platform destined to change how life science employees learn. Based on the sound adult learning theory of Bloom’s Taxonomy, employees engage in thinking, learning, and most importantly understanding. The Virtuosi® platform focuses on analysis and evaluation – not just rote memorization.

• WAKO Chemicals USA, Inc. - Booth 306

  1600 Bellwood Rd., Richmond, VA 23237
  Tel: +1 (800) 992-9256 | Fax: +1 (804) 271-7677
  Website: www.wakopyrostar.com

  Long recognized as a world-renowned supplier of highpurity chemicals, Wako has dedicated more than 30 years of research and development to providing innovative endotoxin-specific reagents and consumables for “every user and for every method.” Visit us at www.wakopyrostar.com to learn how Wako can best support your quality testing needs.

• WEST Pharmaceutical Services, Inc. - Booth 400

  530 Herman O. West Dr., Exton, PA 19341
  Tel: +1 (610) 594-2800 l Fax: +1 (610) 594-2900
  Website: www.westpharma.com

  West works side by side with healthcare partners from concept to patient, designing and manufacturing packaging, diagnostic, and delivery systems that promote efficiency, reliability, and safety. West leads the way with cutting-edge technologies and quality systems, a thorough understanding of regulatory compliance, and an unmatched knowledge of pharmaceutical product testing, development, and packaging.

• WILCO Precision Testers USA, LLC - Booth 601

  21 Commerce Drive, North Branford, CT 06471
  Website: www.wilco.com

  Wilco AG manufactures in-line, at-line and laboratory machines with non-destructive testing methods. Wilco’s CCIT and Visual Inspection technologies are used to inspect vials, ampoules, cartridges, prefilled syringes, auto-Injectors, medical devices, BFS products, IV bags, blisters, pouches, trays and any pharmaceutical product that requires a quality declaration.