Tekniflex^® PGA and Tekniflex^® PGOA offer Improved
Moisture and Oxygen Barrier Blister films for
Medical Products

Tekni-Films, a division of Tekni-Plex, Inc, has developed a new range of rigid films for the Medical packaging industry offering high moisture and oxygen barrier properties. Tekniflex^® PGA and PGOA films are based on multi-layer lamination constructions based on PETG, EVOH and PCTFE. These specialty film laminations have applications where ultra high barrier qualities and clarity are needed in a blister packaging application for medical devices or drug product / device combinations.

For this specific application, Tekni-Films selected Eastar^® 6763 copolyester (PETG) from Eastman Specialty Plastics, because it offers excellent thermoforming properties for often complex medical trays, is sterilizable by irradiation (Gamma or e-beam) and the final package offers good physical protection due to its stiffness and resilience. Eastar copolyester can be used in combination with a wide variety of lidding structures offering an easy method of seal integrity inspection by visualization of the seal through the blue tint of the sheet.

Many Medical Device companies are facing the challenges of the tightened FDA regulations of Drug-Device combination products, which now require stability testing at high temperature and humidity conditions of up to 40°C / 75% RH.  Tekni-Plex specializes in adding thin layers of barrier film to basic thermoformable structures such as PVC and PETG. This offers high barrier properties against moisture and oxygen that freely permeate through the polymer. The company has 30 years of experience in high barrier pharmaceutical blister packaging, where the same high temperature and humidity testing requirements apply surrounding drug product stability.

With a multitude of barrier polymers in its portfolio, Tekni-Plex wanted to opt for the best possible result at the start of this particular development program.  Within the same capability of PETG regarding thermoformability and transparency, 2 flexible thin gauge barrier films have been selected :

• PCTFE, offers a high moisture barrier.
• EVOH, offers a high oxygen barrier.

Various combinations of PETG / PCTFE and PETG / EVOH / PCTFE have been made available, whereby the PCTFE is always on the outside of the structure and PETG on the inside. This offers 2 advantages:

• current lidding foils sealable and pealable to PETG can be used and
• the EVOH is kept dry by the PCTFE, which further enhances its oxygen barrier.

The oxygen barrier of EVOH is dependent on the humidity inside the polymer. PETG is available in standard 10mil, 15mil, 20mil, 25mil and 30 mil gauges, and other thicknesses are available upon request. The PETG thickness is not important in total barrier function of PGA and PGOA laminates. A barrier property comparison table can be found below:

PCTFE (polychloro-trifluoroethylene) is a fluoropolymer known under the tradenames Aclar™ and Vaposhield™. It is a high density amorphous polymer offering high clarity and excellent thermoformability. PCTFE offers the best available water barrier films available, that are clear and thermoformable. PVC / PCTFE laminates have been the blister packages of choice for many leading pharmaceutical products in the past 30 years.

Sample data sheets for PVC-based 4 mil high barrier films may be reviewed at www.tekni-films.com in the Medical Films- section of Product Data Sheets

Tekni-Films also offers a series of pealable or weld-sealable lidding foils to PETG blisters. It is recommended to utilize aluminum based backing foil or lidding foil structures as the preferred means of closing the blister. Only by using a foil lid, the moisture and oxygen barrier properties will be maintained. The aluminum foil can be laminated to paper for printing purposed or to polyester for increased strength.

Tekni-Films also offers a series of pealable or weld-sealable lidding foils to PETG blisters.

Tekni-Films is a leading supplier of blister films for the pharmaceutical, medical, OTC and nutritional markets. In addition to Mono PVC, the company's product line includes PVdC, Tekniflex COC films, Tekniflex PCTFE (usually referred to as either Aclar or VapoShield, plus a wide range of other film products for specialized applications, e.g. Barex^® and PETG films and laminates.

Tekni-Films is a Tekni-Plex company, and has locations in Somerville, New Jersey; Erembodegem, Belgium; Cambridge, Ontario; Buenos Aires, Argentina; and Singapore. Headquartered in Somerville, New Jersey, Tekni-Plex is a global, diversified manufacturer of packaging, products, and materials for the healthcare, consumer, and food packaging industries. The company has built a leadership position in its core markets and focuses on vertically integrated production of highly specialized products.

For more information on the capabilities of Tekni-Films, visit www.tekni-films.com  or call the company at (908) 722-4800.

Aclar is a registered trademark of Honeywell.
Eastar is a registered trade mark of Eastman Chemical Company
VapoShield is a trademark of Tekni-Plex.
Tekniflex is a trademark of Tekni-Plex.

About Eastman Chemical:

Eastman Chemical Company (NYSE: EMN) manufactures and markets chemicals, fibers and plastics worldwide. It provides key differentiated coatings, adhesives and specialty plastics products; is the world’s largest producer of PET polymers for packaging; and is a major supplier of cellulose acetate fibers. Eastman is leveraging its heritage of innovation and strength in polyester, acetyl and organic chemistry technologies to drive growth and meet increasing demand in four select markets: building and construction, packaging, healthcare, and electronics. Founded in 1920 and headquartered in Kingsport, Tenn., Eastman is a FORTUNE 500 company with 2004 sales of $6.6 billion and approximately 12,000 employees.

For more information about Eastman and its products, visit www.eastman.com.

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