New materials and new solutions are introduced and applied in the field of pharmaceutical packaging and medical apparatus, yet, the limitations of existing testers are becoming acute. Thus, how to eliminate deviations caused by changes of standards, materials and external forms, is greatly concerned by manufacturers and testing institutions. Based on the situation, Labthink has proposed a set of solutions, which can not only extend the instrument applications, but also have advantages in testing range, purchasing costs, instrument maintenance, operation safety, structural optimization and extended applications, etc.


Pharmaceutical packaging, medical apparatus, syringe, syringe needle, ampoule

Pharmaceutical packaging and medical apparatus are directly related to human health and life safety of the patients. Therefore a high standard for their safety is set forth with strict and complete testing requirements. However, owing to the variety of pharmaceutical packaging and the complexity of external forms of medical apparatus, multiple test items are required to test and several testing instruments are required for a complete set of tests of one specimen. Moreover, because of the unique external forms of the specimen, it is not compatible for all the instruments. Besides, the change of standards, replacement of materials and variation of external forms have brought about new subjects to the manufacturers and testing institutions.

1. Limitations of Specialized Testing Instruments
At present, new materials, new packaging forms and new external designs have found their applications in the fields of pharmaceutical packaging and medical apparatus. Such new developments are beneficial to offset the existing defects in traditional packaging forms, which make specialized testers devalued with the changing product design. At the same time, reconstruction of those testers based on new standards is costly.
Take rubber closure as an example, which is one of the important parts of the glass IV bottle. It’s strictly required in standards for the parameters of rubber closures. However, with the popularization of plastic IV bottle and bags, rubber closures and glass IV bottles are gradually disappearing. Correspondingly, the specialized testing instruments for rubber closures are less likely to be used, or even abandoned.

2. Labthink Testing Solutions
Based on the development of pharmaceutical packaging and medical apparatus, Labthink introduces i-Meditek 1300 Medical Packaging Tester, an instrument for testing pharmaceutical packaging and medical apparatus. The instrument applies to the mechanical property testing of syringe, hypodermic needle, ampoule, rubber closure and flexible medical pouches, such as PVC blood pouches and platelet bag as well as single or double chamber IV bags, etc. The testing subjects can be further increased. Though varied in external forms and different in materials, they share generality in structure for mechanical testing. Therefore, the development of an instrument with multiple testing components is feasible for the new testing demands.

Medical Packaging Tester

Labthink i-Meditek 1300 Medical Packaging Tester can test piercing force of rubber closures and syringe needles, breaking force of ampoule, external-pressurized sealability of flexible plastic containers, combination force of syringe barrel and needle hub, unmating force of needle shield, sliding performance of plug stopper and dovetail property, etc.

3. The Distinguished Features of i-MEDTEK 1300 Medical Packaging Tester
Limitations of the previous specialized testers have been successfully overcome by Labthink i-MEDTEK 1300 Medical Packaging Tester which can test 8 test items and has the following outstanding features.

3.1 Broad Range of Testing Subjects
It’s common to see instruments of similar principles but irregular testing ranges and precisions, which has direct links to the varied progress of different standards. However, the selection of the tester based on just one standard would probably lead to future discrepancy between the purchased instruments and the latest revision of the standards. Thus, many standards of pharmaceutical packaging and medical apparatus have been comprehensively taken into consideration in designing the instrument, and the highest precisions, the broadest testing ranges are selected as the basis for development. Meanwhile, multiple testing ranges are available so as to satisfy testing demands of varied standards with better practicability. Therefore, i-Meditek 1300 Medical Packaging Tester applies to testing pharmaceutical packaging and medical apparatus, including syringe, syringe needle, flexible medical pouches, ampoule and rubber closure, etc.

3.2 Low Testing Costs
Sensor is the core of testers for mechanics, and one of the most expensive components in the testers. When developing this tester, Labthink didn’t just compile the mechanical testing items together, but selected on certain terms so as to strengthen the practicability of each sensor, to eliminate useless configuration and to reduce instrumental costs. Moreover, though multiple testing items are configured, addition or deletion of configuration is available. Thus, quantity of the instruments can be reduced, which can facilitate instrumental management and save spaces in the labs. Meanwhile, owing to the regular calibration requirements for mechanical testers, i-MEDTEK 1300 Medical Packaging Tester can significantly reduce expenditure on calibration for its 8-in-one functional design.

3.3 Powerful Software
i-MEDTEK 1300 Medical Packaging Tester is equipped with powerful software for its operation. The software can display real time data, testing results and curves as well as multiple data comparison and analysis. At the same time, languages and units are easy to select, and the pre-installed help documents can be referred to at any times. Combining the powerful environmental and energy monitoring functions of the instrument, the software can provide operators with energy consumption records and its curve analysis, utility rate of the instrument and statistics on testing frequencies, etc.

3.4 Innovative Design for Operational Safety
Some samples are tested with contents or substitutes. Tests like breaking strength test of ampoules and pressure resistance test of IV bags or blood pouches would accomplish with the destruction of the samples. It’s not rare to see reagent contents or sample fragments splashed onto the operators’ clothes or left in the testers, which lead to difficulties in clearing the instruments and endanger the operators. Thus, engineers from Labthink developed testing chamber with protective functions, which can prevent most of the potential dangers, and rid the instrument of clearing reagents or substitute left inside. By this means, there is no need to clean the instrument, and effectively diminish instrumental destruction caused by improper protection.

3.5 Excellent Testing Expandability
The packaging materials and packaging forms are under gradual changes for pharmaceutical packaging and medical apparatus. Such changes would inevitably bring forth replacement of the out-dated instruments. Thus, the focus for most testing institutions is how to satisfy present testing needs while guarantee testing expandability. When developing i-MEDTEK 1300 Medical Packaging Tester, Labthink have fully taken into consideration the functional expandability, so as to facilitate adding testing samples, increasing testing items and improving testing parameters. In this way, the operators can, based on their practical needs, fulfill testing demands by adding or changing testing fixtures or parts.
Labthink have developed more than 40 sets of professional fixtures for i-MEDTEK 1300 Medical Packaging Tester that can greatly expand the testing fields, including pharmaceutical packaging, medical apparatus, film, food packaging and special packaging forms, etc. Besides, new testing demands can be satisfied by customized testing fixtures.

4. Conclusion
Labthink i-MEDTEK 1300 Medical Packaging Tester is a specialized instrument to solve the problems of manifold testing items for pharmaceutical packaging and medical apparatus and the corresponding high costs. The instrument can accomplish several testing items that can greatly relieve financial burdens and reduce maintenance costs of testing institutions so that instrumental utility ratio can be improved. The practical, scientific and considerate design of the instrument is also advantageous in future expandability of testing items and compatibility of more subjects to be tested, so as to expand testing scopes to the utmost and eliminate influences brought by changes of standards, materials or external forms.

Would you like to participate in our free study?

Yes     No