PSAs: Good Medicine for the Medical Industry

Pressure-sensitive adhesive systems are used in a range of healthcare products, and the market for these specialized PSAs is expected to grow significantly over the next several years. Factors that will contribute to this growth include longer life expectancy (resulting in a larger number of elderly in the population) and new medical technologies that are being developed, some of which will require the use of PSAs.

Pressure-sensitive adhesive systems are used in a variety of applications for many different body and skin types. Pediatric to geriatric users benefit from a range of low, moderate and aggressive adhesives for sensitive skin types. The selection of adhesives provides performance features like short-term wear uses and long-term applications.

There are two primary areas in which PSAs are used in the healthcare industry. One is for medical device applications, such as monitoring, pacing, defibrillation and wound care. Electrodes and devices are adhered to the body with PSAs featuring foam, film and fabric face stocks, such as those found in electrosurgical grounding pads, nerve stimulation devices, ostomy mounts, and diagnostic devices. These PSAs can be formulated for short- to long-term adhesion to these devices.

The other medical use for PSAs is transdermal drug delivery systems. These systems transmit active ingredients at controlled rates through the skin, resulting in no pain and fewer adverse side effects. The growth rate for transdermal drug delivery systems is expected to increase 12% annually through 2007. Conventional transdermal treatments include smoking withdrawal, angina, menopause, analgesic, blood pressure, birth control and motion sickness, while new applications continue to be developed for OTC drugs, cosmetics and alternative medicines.

A Sticking Point

A PSA system’s ability to conform to body movement is key to its functionality. The body is a complex application site for PSA systems, requiring the right adhesive system for skin type, age, activity level and environment. MACtac produces unsupported transfer tapes and single- and double-coated PSAs. Our expertise in advanced production allows us to offer aqueous, hot-melt and solventborne coatings, as well as intricate pattern coating. Driven by a proprietary web handling and inspection system, we’re able to carefully manipulate and monitor the most delicate substrate materials and coating deposition.

Another important consideration is choosing the appropriate face stock for the desired amount of breathability to prevent skin irritation from excess moisture. MACtac’s face stocks include white polyethylene foam, white and flesh-colored polyester nonwovens, nylon nonwovens, frosty-clear PVC film, and polyester film for varying applications and treatment sites. These PSAs are available on bleached polyethylene-coated kraft, bleached super-calendered kraft and polyolefin film release liners for easy use.

We manufacture both reservoir and matrix systems, offering transdermal therapeutic systems that are used worldwide in various pharmaceutical, cosmeceutical, and nutreceutical applications

PSAs Must Pass a Physical

Pressure-sensitive adhesives that are used in medical applications must meet stringent ISO and FDA cGMP (current Good Manufacturing Practice) guidelines. Finalized in 1978, cGMPs are intended to help ensure the safety and efficacy of all drugs and medical devices.

What exactly does it mean to be in accordance with cGMPs? A summary reveals a detailed process along the entire quality control chain.

• Sample raw materials according to statistical sampling plan

• Test according to established methods for conformance to set specifications

• Approve for use in the manufacturing process

• Manufacturing according to process parameters and batch formulas

• Monitor and test in-process materials for conformance to specifications

• Evaluate finished product for conformance to customer specifications prior to shipment

• All in accordance with standard operating procedures and documented as performed

The Diagnosis

In today’s dynamic medical market, products of tomorrow are expected to be developed and produced with the resources and budgets of today. The product challenges are many – from meeting stringent quality standards and patient satisfaction to keeping an eye on the calendar and bottom line. By evolving with the medical industry to supply innovative components for drug delivery systems and device constructions, we’re establishing PSAs as a vital part of the manufacturing process.