Medicinal low-density polyethylene film and bag are widely used in the pharmaceutical industry. This paper mainly introduces the corresponding detection method by using the medicinal film produced by the rotting method and the blown film method (and the bag made by heat sealing). With test equipment. According to the standard of YBB00072005 "medicinal low-density polyethylene film and bag" published by the State Food and Drug Administration, the medicinal low-density polyethylene film and bag testing items mainly include: barrier properties (water vapor transmission and oxygen permeation) ), tensile strength, heat sealing strength and other indicators. In order to facilitate the medicinal low-density polyethylene film, bag manufacturers and pharmaceutical companies to better understand the specific requirements of YBB00072005, Jinan Languang Electromechanical Technology Co., Ltd. combined with "Languang Laboratory" and testing instruments are as follows:
I. Detection of barrier properties of medicinal low-density polyethylene film and bag
1. Test purpose: Barrier performance is an important performance index for examining medicinal low-density polyethylene film and bag. It plays a key role in the control of rancidity, anti-tarnishing, anti-hardening and oil-water separation.
2. Test method: The water vapor permeation amount is determined according to the method of YBB00092003* method-cup method (gravimetric test), the test temperature (38±0.6°C), the test relative humidity (90±2)%, the water vapor transmission amount shall not be greater than 15g/m2.24h. Oxygen permeation amount is tested according to the YBB00082003 standard method (pressure difference method for measuring oxygen permeation). The test temperature is 38±2°C (the oxygen permeation amount shall not exceed 4000cm3/m2.24h.0.1Mpa.
3, test equipment: water vapor transmission test using Labthink blue light W3 / 030 water vapor transmission rate tester, oxygen transmission test using VAC series differential pressure gas permeation instrument can be tested.
Second, medicinal low-density polyethylene film, bag mechanical properties (tensile strength, elongation at break) test
1. Test purpose: Low-density polyethylene solid pharmaceutical film and bag need to bear the weight of the content in use, and also subject to some external force, so the mechanical properties should be measured and the mechanical properties should be qualified by testing.
2. Test method: The tensile strength method refers to the tensile property measurement method (YBB00112003). The index is determined according to the experimental verification results. The average longitudinal and transverse tensile strength is not less than 10Mpa. The method of elongation at break refers to the tensile property measurement method (YBB00112003). The index is determined according to the experimental verification results. The film with a thickness of less than 0.05 mm requires an average elongation of not less than 130%; a film larger than 0.05 mm requires vertical and horizontal The average elongation at break shall not be less than 200%.
3. Test equipment: It can be inspected by Labthink Languang XLW series intelligent electronic tensile testing machine. Samples are prepared according to the standard regulations, and then clamped on the upper and lower fixtures of the intelligent electronic tensile testing machine to set the test speed (recommended) Start the test and test the test results by selecting the speed of 500mm/min.
Third, medicinal low-density polyethylene film, bag heat-sealing strength test
1. Test purpose: detection of heat seal strength of heat seal parts after film is made into bags
2. Test method: Test according to YBB00122003 standard. Cut 4 pieces of 100mm*100mm diaphragm, stack any two diaphragms, put them on the heat sealer for hot pressing sealing, heat sealing temperature 130-150°C, pressure 0.22Mpa, heat sealing time 1 second, heat sealing required The strength is not less than 7.0N/15mm.
3. Test equipment: The HST-H3 type heat seal tester of Labthink can be used to prepare the heat seal sample, and then the XLW series intelligent electronic tensile test machine can be used to test the heat seal strength.
The above information is specially arranged by Jinan Languang Electromechanical Technology Co., Ltd., in order to help the quality control of medicinal composite ointment tube manufacturing and use enterprises. At the same time, our company also has a professional laboratory to carry out the testing of all the above projects, hoping to Industry colleagues exchanged more questions. For details, please call: Jinan Languang.
We will provide many kinds of Medical Disposables, for example:
Transfusion Disposable Products
Cardiology Disposable Products
Infusion Disposable Products
Surgical Medical Gloves
Plastic Scissors
Plastic Mouth Piece for Endoscopes
Urology Disposables Products
Anaesthesia Disposable Products
General Surgery
Gynaecology and Paediatric Disposable Products
Non Woven Disposable Products
Surgical Blades & Scalpels
Blood Collection Tubes
Plastic Vaginal Speculum
Waste Management
Plastic Sponge Holder
Plastic Tweezers
Gastro Entrology Disposable Products
Surgical Dressings
Laryngeal Mask
Tube with Swab
ECG Electrodes
Maternity Pads
Blood Bag Systems
General Disposables
-
Medical Disposables
General Medical Disposables,Medical Mask,Medical Gauze,Medical Syringe
NOUVASANT PHARMhealth LTD. , https://www.nouvasant.com