Foreword
This document is drafted in accordance with GB/T 1.1-2020&Guidelines for Standardization Part 1: Structure and Drafting Rules of Standardization Documents.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume the responsibility of identifying patents. This document is proposed by China Pharmaceutical Equipment Industry Association.
This document is under the jurisdiction of the National Technical Committee for Standardization of Pharmaceutical Equipment (SAC/TC 356).
1 Scope
This document specifies the model, requirements, environmental test methods, inspection rules, marks, operation instructions, packaging, transportation and storage of the melting point tester.
This document is applicable to the tester for measuring the melting point of solid drugs (hereinafter referred to as "melting point tester").
2 Normative References
The contents in the following documents, through normative references, constitute indispensable provisions of this document. Where, for dated references, only the version corresponding to that date applies to this document; For undated references, the latest version (including all amendments) is applicable to this document.
GB/T 191 Packaging Pictorial Marks for Storage and Transportation
GB/T 9969 General Rules for Operating Instructions of Industrial Products
GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling and Gun Inspection
GB/T 13384 General Technical Conditions for Packaging of Mechanical and Electrical Products
GB/T 14710-2009 Environmental Requirements and Test Methods for Medical Appliances
GB/T 36035-2018 Requirements for Electrical Safety of Pharmaceutical Machinery
JB/T 20188-2017 Pharmaceutical Machinery Product Model Preparation Method
Verification Regulation of JJG 701-2008 Melting Point Tester
3 Terms and definitions
There are no terms and definitions to be defined in this document.
4 Model
The melting point instrument model is prepared as follows according to JB/T20188-2017:
5 Requirements
5.1 Appearance
The external surface of the melting point meter shall be smooth and flat by visual inspection, and there shall be no particles falling off. The coating on the surface allowed to be coated shall be dense and shall not fall off.
5.2 Performance
Run the melting point meter to check the linear heating rate, which should at least include 0.5 ℃/min, 1. o C/min, 1.5 C/min, 3.0 ℃/min,
5.3 Finished product quality
5.3.1 The indication error of melting point meter shall meet the requirements of Table 1 when measured according to the method specified in 6.3.2.1 of JJG 701-2008,
5.3.2 Determine according to the method specified in 6.3.3 of JJG701-2008, and the repeatability of the melting point meter shall meet the requirements of Table 1.
5.3.3 Determine according to the method specified in 6.3.4 of JJG701-2008, and the linear temperature rise rate error of the melting point meter shall meet the requirements of Table 1.
Table 1 Performance Index
performance index
project
5.4 Electrical safety
5.4.1 The continuity of the protective bonding circuit of the electrical system shall comply with Chapter 7 of GB/T 36035-2018. 5.4.2 The insulation resistance of the electrical system shall comply with the provisions of 6.1 in GB/T 36035-2018.
5.4.3 The voltage withstand test of the electrical system shall comply with the provisions of 6.2 in GB/T 36035-2018.
5.5 Environment
The test shall be carried out according to the test methods given in Chapter 6. The adaptive environment of the melting point instrument shall comply with the provisions of climatic environment group I and mechanical environment group II in GB/T 14710-2009.
6 Environmental test methods
The melting point meter shall be placed in the test site for 24h, and then measured according to the provisions of GB/T 14710-2009. The test items and time shall comply with Table 2.
7 Inspection Rules
7.1 Inspection classification
The inspection of melting point instrument includes delivery inspection and type inspection.
7.2 Delivery inspection
7.2.1 The melting point instrument shall be inspected one by one by the quality inspection department of the manufacturer according to the provisions in Table 3, and it is allowed to leave the factory after passing the inspection and attaching the product certificate.
Table 3 Delivery Inspection Items
Inspection items
Corresponding chapter and article number required
Chapter number corresponding to the test method
appearance
five point one
Finished product quality
five point three
Electrical safety
7.2.2 During the inspection of the melting point instrument, if any nonconformity is found, it is allowed to return it for repair. If it is still unqualified after repair, the product will be judged as unqualified.
7.3 Type inspection
7.3.1 Type inspection conditions
In case of any of the following circumstances, type inspection shall be conducted;
a) New product finalization or production appraisal
b) The structure, material and process of the product have been greatly improved, which may affect the performance
c) When production resumes after one year of production suspension
D. The results of factory inspection are significantly different from those of the previous type inspection
e) When the national quality supervision institution requires type inspection;
f) When quality is required.
7.3.2 Type inspection items
7.3.3 - Sampling rules
10% of the prototype of type inspection shall be taken from the products passing the factory inspection according to the method of GB/T 10111 as the prototype (at least 3 samples shall be taken), and 1 sample shall be tested.
7.3.4 Judgment rules
In type inspection, if all items are qualified, the product is judged as qualified. If one of the continuity, insulation resistance and withstand voltage of the protective connecting circuit of the electrical system is unqualified, the product is judged as unqualified in the type inspection. If other items are unqualified, it is allowed to double the number of retested unqualified items in the sampled prototype. If still unqualified, the product is judged as unqualified in the type inspection.
8 Marks, instructions, packaging, transportation and storage
8.1 Marking
8.1.1 Ex factory products shall have the following marks on their obvious parts:
a) Product model and name
b) Main technical parameters;
c) Factory number and date;
D Name and trademark of the manufacturer
e) Executive standard No.
8.1.2 The packaging, storage and transportation pictorial marks shall comply with the provisions of GB/T 191, with such marks as "upward", "rain proof", "no rolling", etc,
8.2 Operating instructions
The product manual shall comply with GB/T 9969.
8.3 Packaging
The product packaging shall comply with the provisions of GB/T 13384. The following documents are attached to the packing box: a) product instructions;
b) Product certificate; c) Packing list;
D Other documents (such as supporting instrument documents).
8.4 Transportation
The products shall be transported in accordance with the relevant national regulations on railway, highway and waterway freight transportation.
8.5 Storage
The packaged products shall be stored in a dry, ventilated room without corrosive gas.
Foreword
1 Scope
2 Normative References
3 Terms and definitions
4 Model
5 Requirements
6 Environmental test methods
7 Inspection Rules
8 Marks, instructions, packaging, transportation and storage
