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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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Click below for the latest Tapemark Press Release

Tapemark to be Recognized as MNSHARP Worksite Tapemark Founder, Wife to Receive Honorary Degrees from Hamline University Tapemark Expands its Snap Product Family

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.

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