Quality-无锡耐思生命科技股份有限公司

Quality Management System

NEST evaluates, controls and manages the quality of its products according to relevant national or international standards. NEST also ensures quality compliance and registration certification to ensure the safety, reliability, and effectiveness of its products, as well as to meet national and international legal requirements.
These measures aim to reduce product quality issues and risks and improve production efficiency and management level. If you need to obtain NEST's quality compliance and registration certificates, please refer to the appendix or download them from the official website www.cell-NEST.com.

www.cell-nest.com

FDA Registration

Since 2011, NEST has registered and sold its products with the US FDA. Our products comply with relevant US laws, regulations, and technical standards, and possess safety and effectiveness.

FDA Registration
YY/T 1768.1-2021; YY/T 1768.2-2021

NEST pen injectors are developed and tested based on the “Needle-based injection systems for medical use - Requirements and test methods” YY/T 1768.1-2021 (ISO 11608-1:2014, NEQ) and YY/T 1768.2-2021 (ISO 11608-2:2012, NEQ) of the People's Republic of China pharmaceutical industry. We strictly adhere to these standards to ensure that our products meet the requirements and demonstrate reliability and effectiveness.

YY/T 1768.1-2021; YY/T 1768.2-2021
ISO9001、ISO13485

ISO9001 is a certification for quality management systems applicable to organizations of various types and sizes. Its purpose is to help organizations achieve customer satisfaction and continuously improve their business processes. ISO13485 is a certification for medical device quality management systems, applicable to manufacturers, suppliers, and distributors, ensuring that their products comply with relevant regulations and legal requirements for medical devices.
NEST's ISO9001 and ISO13485 certifications are authorized by TÜV Rheinland, an authoritative EU notified body. TÜV Rheinland Group is authorized to conduct assessments for industrial and consumer products to ensure that NEST's products comply with most EU directives and regulations.

ISO9001、ISO13485
Medical Device Manufacturing License

NEST obtained medical device manufacturing license in 2021. We have a wide range of medical products including customizable pen injectors, pen injector assemblies, and disposable nasal spray devices. High-precision pen injectors are difficult medical devices that require high-precision processing equipment and technology and strict quality control. Therefore, obtaining a license to manufacture high-precision pen injectors requires a high level of technical strength and quality assurance. We apply the same technical strength and quality control requirements to our laboratory consumables.

Medical Device Manufacturing License

Process Design Assurance

With the development of the times, people's demands on the quality of drug delivery systems, pharmaceutical packaging and combination products are constantly increasing. NEST's quality management starts at the source. At the mold development and production stages, we use a variety of equipment to ensure the quality of our products, so that "high quality" can be maintained throughout the product and production process. The Quality Assurance Department is involved in all aspects of the production process and works closely with other related departments.

Quality Center Assurance

As the guardian of quality, the Quality Center comprehensively guarantees the quality of products, which cannot be separated from the close cooperation between the two core areas of Quality Laboratory and Quality Engineering. These two areas of work, like twins, work together to protect the excellent quality of products.
Our quality management team consists of 76 people, including a director, managers, laboratory personnel, quality assurance (QA) personnel, quality control (QC) personnel and quality engineers (QE) and other elites.
They not only have profound professional knowledge, but also have been trained in a series of systematic quality tools, such as APQP, FMEA, PPAP, SPC, MSA, 8D, 5W, QC7, etc. Team members are able to skillfully use these tools for continuous improvement and follow the PDCA cycle to ensure the continuous improvement of product quality.
In the quality lab, each working group is responsible for conducting rigorous physical and chemical analyses of raw materials, as well as detailed damage analyses of manufactured components, assembly units or medical products. At the same time, functional tests are carried out on all types of products during the product development phase, and the measuring equipment, measurement records and measurement methods required for this purpose are certified and validated. We develop functional tests not only for individual components, but also for assembly units. For each functional test, we carefully design specific test specifications and set them in accordance with the customer's acceptance criteria. Functionality testing is a key part of product design validation and is performed by a specialized functionality test team. The test results are evaluated and approved by the project quality manager, who is under the supervision of the quality engineering department.

Raw Material Safety Guarantee

For the certification and validation of pen injectors, we take into account all relevant standards and regulations: GMP Guidelines (GxP), GAMP5 Guidelines, 21 CFR Chapter 820, 21 CFR Chapter 11, as well as the ISO 9001, ISO 13485 standards, the MDD 93/42/EEC regulation, the AMG/MPG/AMWHV regulation.

Incoming control of specific materials, physical and chemical analysis

NEST has implemented strict controls on supplier access and approval of raw materials/packaging materials. We perform detailed material, physical and chemical analyses of plastic pellets and, where necessary, analyze the causes of damaged parts. Our well-equipped laboratory has the capability to perform physico-chemical analysis of viscosity, residual moisture and density. In addition, we are equipped with an infrared spectrometer and thin-section microscope to provide strong technical support for our experiments. Our analytical services are complemented by in-depth expertise in developing and implementing analytical methods that meet the individual needs of our customers.
The company ensures that all raw materials/packaging materials meet product technical requirements through layered control in the following steps:

Supplier questionnaires

Supplier on-site audits

Raw material/packaging material report review

Raw material/packaging material performance validation

Raw material/packaging material batch inspection

These measures ensure the stability of the supply chain and the quality of our products. This section will also provide declarations regarding NEST's control over raw materials and packaging materials:

Declaration of Raw Material Compliance: (ROHS, REACH)

The raw material particles used in NEST pen injectors are supplied by manufacturers with relevant reports complying with ROHS and REACH, including but not limited to ABS, PC, PP, etc.
ROHS: NEST strictly complies with the European Union directive "Restriction of Hazardous Substances in Electrical and Electronic Equipment" (2011/65/EU) (ROHS), which aims to control the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers in products.
REACH: NEST strictly complies with the European Union regulation "Registration, Evaluation, Authorization, and Restriction of Chemicals" (2006/1907) (REACH), which controls the substances of very high concern (SVHC) in raw materials.

Laboratory for the analysis of materials dedicated to drug delivery devices and pharmaceutical packaging

Samples for development, clinical trial studies and stability studies

Validation Program for Pen Injectors and Pen Injector Assemblies

Product Performance Test	Batch Release Test
Injection button trigger force testing	Appearance inspection
Final dose accuracy testing	Cartridge chamber labeling inspection
Free-fall dose accuracy testing	Injection dose labeling inspection
Cool/Standard/Warm ambient environment dose accuracy testing	Injection dose knob stability testing
Dry heat/Frozen atmospheric environment dose accuracy testing
Vibration test dose accuracy testing
Cool/Standard/Warm ambient environment injection resistance, leakage check, and needle compatibility testing
Dry heat/Frozen atmospheric environment injection resistance, leakage check, and needle compatibility testing
Vibration test injection resistance, leakage check, and needle compatibility testing
Injection button trigger force testing
Final dose accuracy testing
Stability verification testing
Life cycle testing (Reusable pen injector only)
Cycled environment testing (Reusable pen injector only)

The tests are performed in accordance with the national standard YY/T 1768.1-2021 (ISO 11608-1:2014, NEQ) and YY/T 1768.2-2021 (ISO 11608-2:2014, NEQ). For other test reports apart from the ones provided in this chapter, please contact us to obtain them.

Validation program for pen injector assembly

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.
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Resistance and 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 injector and the needle adaptability and leakage inspection test are shown in Table 1 below:
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