质量详情-无锡耐思生命科技股份有限公司

Validation program for pen injector assembly

Dose accuracy validation test

With reference to the Pharmaceutical Standard of the People's Republic of China "Medical Needle Injection System - Requirements and Test Methods - Part 1: Needle Injection System" (YY/T1768.1-2021), the dosage accuracy test of the disposable injection pen (Model No. NEST-1A) is shown in the following Table 1, and the results of the test meet the requirements of the regulations.

Test item	Test summary	Probability component P	Dose combinations per pen R	Total measurements per V measurement Number of measurements n	Bilateral target K-value	Test basic principle (Refer to YY/T1768.1-2021 standard)
Cool, standard and warm atmospheres	5℃±3°℃、23℃C±5℃ and 40°±2℃ test dose accuracy (DA)	0.975	1	60	2.670	These tests are expected to measure the performance of the pen injector over a range of temperature and humidity variations representative of indoor or outdoor controlled or uncontrolled "in-use" environments. Outdoor conditions include seasonal (winter to summer) variations and indoor conditions include year-round variations in "room temperature".
Free Fall	Test dose accuracy (DA) after a one-meter fall in three directions	0.95	1	21	2.731	The purpose of the free fall test is to verify the performance of the product after landing on impact in the unused condition without the outer packaging (or carrying case). A nominal height of 1m is used (this is the most likely height at which the pen injector will be placed on a table).
Dry Heat/Freezing	70℃±2℃ and -40℃±3℃,test dose accuracy(DA)	0.975	1	60	2.670	The test is expected to measure the performance of pen injectors after exposure to extremely hot and cold storage and transportation conditions, as well as extreme behaviors with potential users (e.g., placing a pen injector on the dashboard of a car in hot weather or accidentally storing it in a freezer).
Vibration	Test DA after vibration	0.975	1	20	2.760	The vibration test is expected to simulate ambulatory patient storage, such as when the patient carries the pen injector for use during the day (e.g., on public transportation or while running).
Last dose DA	Test DA for the last dose	0.975	Only the last Unit	60	2.670	The final dose is considered to be as important as any other dose and therefore it is appropriate to meet the same accuracy requirements.
Thermal humid	Test DA after 40℃, 93%RH for 96 hours	0.975	1	20	2.670	This test is intended to measure the performance of a pen exposed to the same temperature as the dry heat test temperature but at a much higher humidity.

Resistance, needle fit and leakage check validation program

With reference to the medical industry standard of the People's Republic of China, "Medical Needle Injection System-Requirements and Test Methods-Part 1: Needle Injection System" (YY/T1768.1-2021), "Medical Needle Injection System-Requirements and Test Methods-Part 2: Needle" (YY/T1768.2-2021), and with regard to the number of samples of the test of injection resistance set internally by the factory, the number of samples for the test of injection resistance and needle adaptability and leakage check of the pen injector is detailed in the following table 1: Injection resistance and needle adaptability and leakage check test. The number of samples for the injection resistance test is set by the factory, and the injection resistance of the pen syringe and the needle adaptability and leakage inspection test are shown in Table 1 below:

Dose Accuracy Test Item	Test Environment	Samples for Resistance	Samples for Needle Fitting	Samples for Leakage Check
Standard Atmosphere	23°C±5°C	10	20	10
Cold Atmosphere	5°C±3°C	10	20	10
Warm Atmosphere	40°C±2°C	10	20	10
Dry Heat	70℃±2℃	10	20	10
Freezing	-40°C±3℃	10	20	10
Vibration	After vibration	10	20	10
Thermal Humid	40℃, 93%RH for 96 hours	10	20	10

Stability Verification

Select 603 pen injectors and place them in an aging chamber (60±2 ℃) for accelerated aging. Leave them in the aging chamber for 28 days (1-year expiration), 85 days (3-year expiration), and 141 days (5-year expiration) respectively. Under each aging condition, take 201 samples, use purified water as the test medium, and perform tests with a BD 31G/5mm needle. The test items include appearance, dosage indication on the cartridge chamber, dosage indication on the injection, stability of the dosage adjustment knob, dosage accuracy in cold/standard/warm atmospheric environments, injection resistance in cold/standard/warm/dry heat/frigid/thermal humid atmospheric environments, free-fall test, dry heat freezing experiment, thermal humid experiment, and leakage test, totaling nine tests. The test results should comply with the standards. (For the complete version of this chapter's test report, please contact us for more information.)
Periodic Monitoring

According to the standard YY/T 1768.1-2021 (ISO 11608-1:2014, NEQ), periodic monitoring is required every year, excluding stability testing. It involves repeating the verification of product performance for all other test items.
Batch release test
- Appearance Inspection
  
  According to the performance specifications of the pen injector, under environmental lighting conditions of (215±20) lx and a viewing distance of 40cm to 70cm, a visual inspection is performed on the appearance of the product. The product should be free from defects that affect its appearance, such as burrs, patterns, shrinkage, flow marks, scratches, etc. There should be no cracks on the inside, and the printed markings should be clear. The appearance inspection should comply with the standards.
- Cartridge Chamber Dosage Indication Inspection
  
  According to the performance specifications of the pen injector, under environmental lighting conditions of (215±20) lx and a viewing distance of 40cm to 70cm, a visual inspection is conducted on the cartridge chamber. The cartridge chamber should have dosage (IU) indications for the cartridge bottles. The cartridge chamber should be transparent, allowing visual estimation of the volume of medication delivered and the remaining volume of medication. The inspection should comply with the standards.
- Injection Dose Labeling Inspection
  
  According to the performance specifications of the pen injector, under environmental lighting conditions of (215±20) lx and a viewing distance of 40cm to 70cm, a visual inspection is performed on the product. The inspection focuses on the injection dosage indication. Through the window, clear observation of the calibration lines corresponding to the set dosage and their corresponding values should be possible. The calibration lines should be evenly distributed, and the numeric values on the injection dosage scale should range from 0 to 60. The inspection should comply with the standards.
- Injection Dosage Knob Stability Test
  
  According to the performance specifications of the pen injector, a test is conducted on the stability of the injection dosage knob. Each rotation of one integer scale should produce an audible "click" sound. After setting the injection dosage, it should be allowed to be reset if needed. The test should comply with the standards.