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Tapemark
1685 Marthaler Ln.
West St. Paul, MN 55118
Tel: 800/535-1998
Fax: 651/450-8403
Web: http://www.tapemark.com
E-mail: tmsales@tapemark.com
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MEDICAL DEVICE CONTRACT MANUFACTURING
Tapemark is privately-held contract manufacturer working with medical device manufacturers worldwide. We specialize in custom converting of medical devices and components utilizing materials such as films, nonwovens, foils, foams, gels, and hydrocolloids. Our capabilities include integrated specialty coating, narrow-web printing, folding, precision die cutting and laminating, and packaging. All development and production is done in a regulated, cGMP environment at our campus located in West St. Paul, Minnesota, where we maintain multiple clean rooms with pressure, particulate and temperature/humidity monitoring controls, and adjacent white rooms for packaging. Tapemark also offers onsite microbial and chemistry laboratories.
An Uncompromising Commitment to Quality
Tapemark's facilities are FDA Drug, Device, Food, and Cosmetics inspected and operate under cGMP/QSR guidelines. Our quality system is certified to ISO 9001:2000 and 13485:2003 standards. In addition, Tapemark has received a Certificate of Compliance to TGA/Australian Good Manufacturing Practices, and was audited by the MPA - Medical Products Agency of Sweden (a member of
the European Union), which verified compliance with EU-GMP.
A Strong History of Service to the Medical Device Industry
At Tapemark, we understand the intense challenges of medical OEMs, such as time-critical market introductions and FDA requirements. We should - we've been providing services to the medical industry since the late '70s. We can help you manage all phases of your product development including initial design, material sourcing, prototypes, clinical evaluation and validation runs, and full commercial production.
As a contract manufacturer, all the work Tapemark does is confidential. This list contains examples of medical devices we have collaborated on with our customers.
| Topical patches | Drug/device combination products |
| Active transdermal pataches | Non-invasive sensors and disposables |
| Passive transdermal patches | Catheter and cannula holders |
| Wound dressings | Probe shields and covers |
| Suture strips | Aromatherapy patches |
| Operating room assistance devices | Closures and attachment devices |
| Oral care devices | Printed labels, pouching and packaging |
Diagnostics
Tapemark is an experienced contract manufacturer of custom components for in-vitro, non-invasive and molecular diagnostics and biosensor applications. We are known for our ability to provide "next generation" concepts and solutions for the most technically challenging applications. Our customers include manufacturers and suppliers in both clinical and home test kit segments of the diagnostics market.
| Blood glucose diagnostics | Assay and reagent covers |
| Pregnancy/ovulation tests | Lateral flow assays |
| Substance abuse tests | Printing specialty inks/sensors |
| Microfluidic adhesive systems | Hydrophilic and hydrophobic components |
| Test kit components | Custom diagnostic components |
Drug/Device Combination Products
Our expertise in both medical devices and pharmaceutical products provides a strong foundation to meet today's growing interest in drug/device combination products. We are skilled in the addition of active ingredients to dressings and patches including antimicrobials, analgesics and other drug compounds. With our strong quality systems, we can produce products for you no matter whether classified as drug or device. With Tapemark's collaboration, you'll get your combo product to market in a timely, compliant, and sustainable manner.
Innovative Dosage Formats Matched to Single-Use Convenience
At Tapemark, the innovative marriage of coating and converting technologies has opened new doors for our customers to market products that deliver active ingredients in convenient, single use formats. An "active" such as a drug, vitamin, antiseptic or flavor, is combined with an appropriate single-use pad, oral or topical soluble film, transdermal or topical patch, specialty adhesive, or hydrogel.
The results include product innovations in oral care, skin care, cosmetics, consumer goods, medical devices, and drug delivery - whether over-the-counter (OTC), prescription (Rx), or a combination drug/device product.
As our newest dosage form, Snap! delivers a single dose of a cream, gel, paste, or lotion. This easy-to-use, disposable package requires only one hand to open, offering convenience that's ideal for busy health care providers or anyone who needs "an extra hand." Snap! is available in sizes to meet fill volumes from .5 ml to approximately 5 ml. Because of the unique design of Snap!, virtually the complete contents are dispensed with little waste.
50+ Years of Experience
For over 50 years, Tapemark has met the toughest challenges with creativity and an entrepreneurial spirit dedicated to creating solutions for the most complex projects. Throughout our history, we have been on the leading edge of changes in the converting industry, both in process development and in utilizing new materials. Tapemark's mastery of web handling and continual investment in new technology, coupled with our strong engineering backbone and well-defined project management approach, have earned us the respect of industry-leading and innovative entrepreneurial companies again and again.
Your complete resource for product development and outsourced manufacturing . . . from design through final packaging.
Categories this company is listed under in the North American Suppliers Directory:
- Adhesives and Adhesive Products: Adhesive Products: Liners (82 companies)
- Adhesives and Adhesive Products: Adhesive Products: Pressure-sensitive components (152 companies)
- Adhesives and Adhesive Products: Adhesive Products: Tapes and films (161 companies)
- Adhesives and Adhesive Products: Adhesive Products: Transdermal components (75 companies)
- Adhesives and Adhesive Products: Adhesives: Conductive (99 companies)
- Adhesives and Adhesive Products: Adhesives: Heat activated (89 companies)
- Adhesives and Adhesive Products: Adhesives: Hot melt (76 companies)
- Adhesives and Adhesive Products: Adhesives: Hydrocolloid/Hydrogel (44 companies)
- Adhesives and Adhesive Products: Adhesives: Polyester (65 companies)
- Adhesives and Adhesive Products: Adhesives: Silicone (106 companies)
- Adhesives and Adhesive Products: Adhesives: Urethane (83 companies)
- Adhesives and Adhesive Products: Adhesives: UV or light-cure (85 companies)
- Contract Manufacturing and Packaging Services: Company Features: Electromedical Contract Manufacturer (464 companies)
- Contract Manufacturing and Packaging Services: Company Features: FDA Registered (575 companies)
- Contract Manufacturing and Packaging Services: Company Features: ISO 13485 Certified (47 companies)
- Contract Manufacturing and Packaging Services: Company Features: ISO 9000 Certified (1170 companies)
- Contract Manufacturing and Packaging Services: Contract Services: Assembly (1491 companies)
- Contract Manufacturing and Packaging Services: Contract Services: Converting/Die-cutting (317 companies)
- Contract Manufacturing and Packaging Services: Contract Services: Extrusion (279 companies)
- Contract Manufacturing and Packaging Services: Contract Services: Prototyping (1403 companies)
- Contract Manufacturing and Packaging Services: Contract Services: R&D and design (1289 companies)
- Contract Manufacturing and Packaging Services: Packaging Services: Bagging/Pouching (422 companies)
- Contract Manufacturing and Packaging Services: Packaging Services: Cartoning (255 companies)
