On March 28, 2017, the State Food and Drug Administration issued the “Pharmaceutical Infusion, Blood Transfusion, and Special Materials for Thermoplastic Polyurethanes for Injectors” pharmaceutical industry standard, and will formally implement it on April 1, 2018.
The original text is as follows:
Tablet drug delivery mechanism
Foreword
This standard was drafted in accordance with the provisions given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The publishers of this document do not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This standard was drafted by: Lubrizol Management (Shanghai) Co., Ltd., Covestro Polymers (China) Co., Ltd., Shandong Medical Device Product Quality Inspection Center.
The main drafters of this standard: Bai Bing, Bo Xiaowen, Yan Ge, Li Hao.
Lubrizol Polymer Tablet Delivery Mechanism
introduction
Medical thermoplastic polyurethane has good extensibility and flex resistance, high strength, wear resistance, and good biocompatibility. At the same time, the polyurethane material has good physical and mechanical properties and processing performance, which makes it widely used in the medical field, such as Indwelling needle cannula and extension tube, infusion drip chamber, dropper, tubing, etc.
Based on the synthesis process of polyurethane pellets, residual diisocyanate monomers may be present in the pellets. This type of monomer may also be produced during its processing. It has been reported that residual monomers and their hydrolysis products have certain toxicity.
Text content
1 Scope
This standard specifies the technical requirements and test methods, signs, packaging and storage of medical infusion, blood transfusion, thermoplastic polyurethane special materials (TPU) (hereinafter referred to as polyurethane special materials) for syringes.
This standard applies only to polyurethanes with a single component. It does not apply to blended polyurethane special materials (such as polyurethane/polyvinyl chloride, polyurethane/polyoxymethylene, etc.) and other components (such as developer, colorant, glass fiber, etc.) ) polyurethane special material.
Lubrizol Polymer Tablet Delivery Mechanism
2. Normative references
The following documents are indispensable for the application of this document. For dated references, only dated editions apply to this document. For undated references, the latest edition (including all amendments) applies to This document.
GB/T528-2009 Determination of tensile stress and strain properties of vulcanized or thermoplastic rubbers
GB/T529-2008 Determination of tear strength of vulcanized or thermoplastic rubbers (trousers, rectangular and crescent shaped specimens)
GB/T1040.1-2006 Determination of tensile properties of plastics - Part 1: General
GB/T2411-2008 Plastics and hard rubbers Determination of indentation hardness (Shore hardness) using a durometer
GB/T2918-1998 Plastic Specimen Conditioning and Test Standard Environment
GB/T3398.2-2008 Plastics hardness test Part 2: Rockwell hardness
GB/T6682-2008 Analysis Laboratory Water Specifications and Test Methods
GB/T9352-2008 Plastic Thermoplastic Material Specimen Compression Molding
GB/T14233.1-2008 medical infusion, blood transfusion, injection equipment - Part 1: Chemical analysis
GB/T16886.1 Biological evaluation of medical devices Part 1: Evaluation and testing
GB/T17037.1-1997 Preparation of thermoplastic injection moulded specimens for thermoplastic materials Part 1: General principles and preparation of multipurpose specimens and strips
Pharmacopoeia of the People's Republic of China (2015 version 4)
3. Requirements
3.1 Identification
According to the Chinese People's Republic of China Pharmacopoeia 2015 edition No. 0402 Infrared spectrophotometry, the infrared spectrum of medical polyurethane special materials should be consistent with the manufacturer's map.
3.2 Appearance
According to 4.3 test, medical polyurethane special material is uniform particles, no foreign impurities.
3.3 Physical properties
The physical properties of medical polyurethane special materials should comply with the provisions of Table 1.
3.4 Chemical properties
The chemical properties of medical polyurethane special materials should meet the requirements of Table 2.
3.5 Biocompatibility
When GB/T 16886.1 evaluates biological materials for medical polyurethanes, the evaluation results should show that there are no unacceptable biological hazards.
Note: The biological test method specified in GB/T14233.2 should be considered as a supplement to the method specified in GB/T16886. The biological evaluation should be based on the specific conditions of the material and the sterilization process it undergoes.
4. Test methods
4.1 Preparation of Samples
The physical properties of the test using compression molded test pieces, its preparation according to the provisions of GB/T9352-2008. Biological evaluation can also be used injection test pieces, the preparation according to the provisions of GB/T17037.1-1997.
Note: In order for the test results to represent the performance of the final device, the test piece can be subjected to the expected sterilization process of the medical device after preparation.
Lubrizol Polymer Tablet Delivery Mechanism
4.2 Standard Condition for Condition Adjustment and Test of Samples
The state of the sample is adjusted in accordance with the provisions of GB/T 2918-1998. The conditions for state adjustment are Level 2 standard environment (23/50). The adjustment time is at least 40h but not more than 96h.
4.3 Appearance
Under natural light or fluorescent light, observe with normal or corrected vision.
4.4 Physical Performance
4.4.1 Hardness
For special materials with a nominal hardness of less than 85D, test pieces shall be tested in accordance with GB/T 2411-2008. The hardness tester shall use Shore A and the applied load shall be 1.00kg±0.01kg. When the value of Type A hardness tester is greater than 90, D-type hardness tester, applied load 5.00kg ± 0.01kg. For the special material with a nominal hardness greater than 100D, the test piece shall be tested according to GB/T3398.2-2008. The test point shall not be less than 5.
4.4.2 Tensile strain at break
Prepare the test piece according to 4.1. The test piece is adjusted according to the provisions of 4.2.
Take the adjusted test piece, according to GB/T528-2009 type 1 sample preparation sample, according to GB/T1040.1-2006 test, test speed 200mm/min.
4.4.3 Tensile strength
Prepare the test piece according to 4.1. The test piece is adjusted according to the provisions of 4.2.
Take the adjusted test piece, according to GB/T528-2009 type 1 sample cut sample, according to GB/T1040.1-2006 test, test speed 200mm/min.
4.4.4100% strain tensile stress
Prepare the test piece according to 4.1. The test piece shall be adjusted according to the provisions of 4.2.
Take the adjusted test piece, according to GB/T528-2009 type 1 sample cut sample, according to GB/T1040.1-2006 test, test speed 200mm/min.
4.4.5 Tear strength
Prepare the test piece according to 4.1. The test piece shall be adjusted according to the provisions of 4.2.
Take the adjusted test piece, according to GB/T529-2008 right-angled uncut test specimens, according to GB/T529-2008 test, test speed 500mm/min.
4.5 Dissolution Chemical Properties
4.5.1 Preparation of test solution
Weigh granules and rinse them with secondary test water according to GB/T 6682-2008. Add water at a ratio of mass (g) to water (mL) of 1:5, 37°C±1°C, leaching 72h, the sample was separated from the liquid and cooled to room temperature. The same batch of water was taken in the same manner as the blank contrast solution.
4.5.2 Reducing substances
The test solution and control solution prepared in 4.5.1 were obtained and tested according to 5.2.2 of GB/T14233.1-2008.
4.5.3 pH
The test solution and control solution prepared in 4.5.1 were obtained and tested according to 5.4.1 of GB/T14233.1-2008.
4.5.4 Evaporation residue
The test solution and control solution prepared according to 4.5.1 were tested according to 5.5 in GB/T14233.1-2008.
4.5.5 Metal ions
The test solution prepared according to 4.5.1 was tested according to 5.6.1 of GB/T14233.1-2008 and/or atomic absorption spectrophotometry (AAS) or equivalent method.
4.5.6 UV absorbance
The test solution prepared according to 4.5.1 was tested in the wavelength range of 220nm-350nm in accordance with 5.7 of GB/T14233.1-2008.
5 mark
The mark on the packaging bag of medical polyurethane special material should include the following contents:
a) product name;
b) the manufacturer's name or trademark;
c) model;
d) lot number;
e) Net weight.
6 packaging, storage
6.1 Packaging
Polyurethanes for medical use should be packed in double layers at least. The packaging should be guaranteed to be free from contamination during product transportation and storage.
6.2 Storage
Medical polyurethane special materials should be stored in a ventilated, dry, clean and maintained warehouse with good fire protection facilities. Store away from heat sources and prevent direct sunlight.