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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices

Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices
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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 1

Full Performance Solutions for Pharmaceutical Packaging and Medical Devices Labthink Instruments Company launched its PRAMA MED-01 Medical Packaging Tester. Equipped with 17 independent test modes and more than 100 grips, MED-01 Medical Packaging Tester can carry out test for over 1000 materials. Below are the detailed testing methods that MED-01 Medical Packaging Tester used to test some typical pharmaceutical packaging and medical devices: rubber closures, flexible packaging bags, syringes and ampoule. 1. Medical Rubber Closure prepare the specimen. Take 10 pcs of tested closures and parameter-preset closures respectively and place them onto half-filled infusion bottles. Seal the bottles with aluminum caps and keep them inside the hi-pressure steam sterilizer under temperature of 121℃± 2℃. After a period of 20min, reduce to room temperature and carry them out. Next, prepare puncture test apparatus as in accordance with diagram 1, then place the bottle at the designated position where the closure center set to be punctured, and set the puncture speed at 200± 50mm/min. Start to have specimens tested alternatively and record the force imposed having the bottle pierced. Test stops by the last prepared specimen.

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 2

Diagram 1 Puncture test for medical rubber closure Note: 淬硬-quench hardened As stipulated, the maximal force to pierce the bottle should be less than 80N and averaged at 75N, and no closures should be pressed into the bottles. Procedures as demonstrated in diagram 2.

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 3

Diagram 1 Puncture test for medical rubber closure 2. Medical flexible plastic packaging bag Widely used in pharmaceutical industry, medical flexible plastic packaging bags (referred to as bag or bags) have various applications such as blood bag and infusion bag depending on the fields. In order to ensure sound and standard application performance, scientific industry standard has been elaborated on the bags of various forms. Take blood bag as an example, specific contents on its structure and size, material, appearance, physical property, chemical property as well as biological property...

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 4

Diagram 3 structure of disposable plastic blood bag 1-保护件-protective part, 2-包括堵塞装置可以没有的转移管-transfer line with/without blockage, 3-输血插口-blood transfusion interface, 4-孔眼-hole, 5-采血管-blood collection tube, 6-标签区-label position, 7-保护箱-protective case, 8-采血针-blood taking needle Test procedures: fill the blood bag with distilled water of PH value at5.5-5.6 to nominal capacity, then put it into a centrifugal cup. Impose 5000g centrifugal force for 30min at 4℃ and 12℃ respectively, followed by placing the bag between two flat panels and sticking the blue litmus paper. Gradually increase the...

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 5

low in cost, its defects are also noticeable: inconvenience, poor acid/alkali resistance, environment pollutants. Early 1990s emerged a new pharmaceutical packaging, which functioned both as storage and injector, as well were made up of materials with sound compatibility and stability. Compared with traditional “bottle-syringe” model, the new design, convenient in usage and low potential environment pollution risk, maximally reduced cost from producing to using. That was refilled syringes, massively applied and manufactured. However, on the opposite side, in case the refilled syringes...

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 6

Diagram 5 sketch of needle base-needle-cap 1-针座-needle base, 2-连接部-connection, 3-针管-needle, 4-护套-cap Connection force refers to the test of fastness between needle and base. The highlight of the test is through the determination of reasonable fastness coefficient to reduce hazard to life caused by separation of needle and base during injection. The test keeps the needle onto the driving mechanism connected with measuring instrument, and is carried out by pulling at speed of (100 ±5)mm/min with pulling force no less than 22N (pulling force between 22-69N while needle diameter 0.3-1.2mm)....

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 7

Diagram 6 fastness test of needle and base Piston sliding resistance refers to the opening force at the very start of and sustaining force during the piston movement, and aims to the evaluation of piston movement resistance. Mostly, syringes are operated by delicate females, force excessive would on one hand cause injection impossible and on the other risk the life of patient as potion may be injected into body instantly as piston rod pushed heavily. In the test, refilled syringe as shown in the following diagram is clamped and its rod both pulled and pushed by driving mechanism. The real...

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 8

Diagram 7 piston sliding resistance test Table 1 sliding resistance Nominal capacityml Opening forceFmax Sustaining forceFmax 4. Ampoule Ampoule, slim in neck and thick in body, is a type of tiny sealed glass bottle containing potion and oral liquid, etc, and normally used by break its neck with hands or assisted by grinding wheel and saw unit. According to statistics, glass related injury tops the injuries caused by medical appliances

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 9

with a percentage of 54.4%, which partly because instructions are not fully followed and partly because the poor quality of Ampoules that either with poor fracture resistance or neck too hard to break. Therefore, fracture resistance is a vital test item to Ampoule. Diagram 8 fracture resistance test of Ampoule Firstly mount relative test accessories as shown in diagram 8. Place one piece specimen on to the supportive panel, keep Ampoule neck perpendicular to the center of upper test instrument. Set test rate, parameters and click start button to start the test automatically. Test data,...

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Full PErformance Solutions for Pharmaceutical Packaging and Medical Devices - 10

medical packaging performance tester, suitable to basic tests like tensile strength, tear, hot seal and peel resistance, and can be extended to tests of puncture test to artificial skin, permeability of syringe body, tear strength of oral liquid cap, rubber closure pullout resistance, opening resistance of combined caps, is the most powerful and advanced test instrument with most comprehensive functions in pharmaceuticals packaging industry.

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