Test methods for sterile medical device package — Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape
1 Scope
This part describes a means of evaluating ink or coating adhesion to flexible packaging materials This part is intended for use on flexible packaging materials whose surfaces are not damaged by the application and removal of tape.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 2918 Plastics — Standard atmospheres for conditioning and testing (GB/T 2918-1998, ISO 291:1997, IDT)
3 Significance and use
3.1 Poor adhesion of ink or coating to the base substrate can impact the readability of printed materials, affect the functionality of coated materials, or create a source of contamination. This part provides a means for evaluating the adhesion of ink or coating to a flexible packaging material.
3.2 For purposes of resolving inter-laboratory disagreements, test methods developed from this part may be improved by defining and controlling the pressure and method of tape application, (for example, using weighted roller), and the speed and angle of tape removal.
3.3 This practice does not address acceptability criteria. These need to be jointly determined by the user and producer of the product.
4 Apparatus
Special test tape is commonly used for this procedure, typically 19 to 25 mm wide. Whichever tape is chosen should be agreed upon by customer and supplier.
Manufacturers storage and shelf-life recommendations should be followed or acceptability determined through real-time aging and laboratory tests.
5 Sampling
The number of samples tested should be adequate to be predictive of performance. Caution should be taken when eliminating samples with defects as this can bias results.
6 Conditioning
6.1 According to the requirements of GB/T 2918, the test samples shall be conditioned for at least 24h at (23±2)°C with the relative humidity of (50±5)% before test.
6.2 Before testing catalyzed or cured inks or coatings, or both, ensure that the samples have been exposed to the appropriate conditions for sufficient time to allow complete cure.
7 Procedure
7.1 Lay sample to be tested on a flat surface. Sample should lay flat and smooth without wrinkles, creases, or folds.
7.2 Cut a piece of tape long enough to cover the printed or coated area of test sample. For large areas it may be easier to work with several shorter pieces of tape. Handling application and removal of tape is simpler when length of tape does not exceed 30 cm.
7.3 Apply tape to sample using a smooth even motion without wrinkling tape or sample. Run thumb or forefinger along tape to make sure it is fully adhered, without any bubbles in surface.
7.4 Hold sample flat to surface with one hand, use other hand to peel back tape at an angle of approximately 120° to 150°. Lift tape, pulling back with an even, moderate motion. Typically, 300 to 450 mm per second.
Note 1: Varying the amount of time after tape is applied may affect the results.
Foreword i
1 Scope
2 Normative references
3 Significance and use
4 Apparatus
5 Sampling
6 Conditioning
7 Procedure
