Adhesive Tape
» Adhesive Tape consists of fabric and/or film evenly coated on one side with a pressure-sensitive, adhesive mixture. Its length is not less than 98.0 percent of that declared on the label, and its average width is not less than 95.0 percent of the declared width. If Adhesive Tape has been rendered sterile, it is protected from contamination by appropriate packaging.
Packaging and storage— Preserve in well-closed containers, and prevent exposure to excessive heat and to sunlight. Tape that has been rendered sterile is so packaged that the sterility of the contents of the package is maintained until the package is opened for use.
Labeling— The package label of Tape that has been rendered sterile indicates that the contents may not be sterile if the package bears evidence of damage or previously has been opened. The package label indicates the length and width of the Tape, and the name of the manufacturer, packer, or distributor.
Dimensions— Measure its length: it is not less than 98.0% of the labeled length. Measure its width at 5 locations evenly spaced along the center line of the Tape: the average of 5 measurements is not less than 95% of the labeled width of the Tape.
Tensile strength— Determine the tensile strength of Tape, after previously unrolling and conditioning it for not less than 4 hours in a standard atmosphere of 65 ± 2% relative humidity, at 21 ± 1.1 (70 ± 2F), with a pendulum-type testing machine, as described under Tensile Strength 881. The Tape made from fabric has a tensile strength, determined warpwise, of not less than 20.41 kg (45 pounds) per 2.54 cm of width. The Tape made from film has a tensile strength of not less than 3 kg per 2.54 cm of width.
Adhesive strength— Determine the adhesive strength of Tape that is made from fabric by cutting a strip of the Tape 2.54 cm wide and approximately 15 cm long, and applying 12.90 sq cm, 2.54 cm by 5.08 cm, of one end of the strip to a clean plastic or glass surface by means of a rubber roller under a pressure of 850 g, passing the roller twice over the Tape at a rate of 30 cm per minute. Adjust the temperature of the plastic or glass surface and the Tape to 37, and conduct the test immediately thereafter as directed under Tensile Strength 881, using a pendulum-type testing machine, the pull being exerted parallel with the warp and the plastic or glass surface: the average of not less than 10 tests is not less than 18 kg.
Sterility 71 Tape that has been rendered sterile meets the requirements.
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Topic/Question Contact Expert Committee
Monograph Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(GTMDB05) General Toxicology and Medical Device Biocompatibility
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3654