On April 2, 2026, the recommended national standard titled Cleanliness of Primary Packaging for Medical Devices – Part 1: Test Method for Particulate Contamination was officially released for public comment by the National Medical Products Administration (NMPA). The standard plan number is pending, with a project cycle of 18 months, and the public comment period ends on May 2, 2026.
This standard is led by the Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection and aims to establish a scientific test method for evaluating particulate contamination in primary packaging for medical devices. The significance of this standard includes:
1. Standard Background and Significance
1. Regulatory Alignment
Clause 5.1.7 e) of GB/T 19633.1-2024 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems explicitly states that materials must demonstrate acceptable levels of cleanliness, particulate contamination, and linting. The introduction of this national standard provides technical support for this regulatory requirement.
2. Improved Quality and Safety
As an integral part of medical devices, the cleanliness of primary packaging directly affects product quality and patient safety. In particular, implantable or interventional vascular devices (e.g., cardiac stents, catheters) require manufacturing in ISO Class 5 (Class 10,000) environments, while devices contacting blood or bone tissue (e.g., orthopedic implants) require ISO Class 6 (Class 100,000) environments. The particulate contamination level of packaging materials directly reflects the production environment and process control, making it a key indicator of packaging quality.
3. Filling a Standardization Gap
Previously, the industry primarily relied on YY/T 1556-2017 Test Method for Particulate Contamination of Medical Infusion, Transfusion, and Injection Instruments and the group standard T/CAMDI 009.1-2020 Cleanliness of Primary Packaging for Aseptic Medical Devices – Part 1: Test Method for Particulate Contamination – Air Elution Method. This national standard integrates existing methods and establishes a more authoritative and universally applicable technical specification.
2. Scope of Application
This standard applies to the detection of particulate contamination in primary packaging materials for medical devices, specifically covering:
Packaging material types: paper, plastic film, polyolefin nonwovens, and other sheet materials
Packaging finished product types: paper bags, paper-plastic bags, glass containers, plastic containers, etc.
It should be noted that this standard applies to various types of primary packaging for medical devices (non-standalone registered/notified products), where the contents include most medical devices.
3. Three Core Test Methods
The standard establishes three testing methods for particulate contamination, depending on the form and application scenario of the primary packaging:
(1) Air Elution Method
Principle: Clean air (filtered through an air filter) blows particles off the surface of the test material, while a sampler collects the particles under negative pressure into a sensor for measurement.
Applicable scenarios: Suitable for evaluating surface particulate contamination of packaging materials in a dry state, especially for liquid-sensitive materials.
Relevant standards: T/CAMDI 009.1-2020 Cleanliness of Aseptic Medical Device Primary Packaging – Part 1: Particulate Contamination Test Method – Air Elution Method.
(2) Liquid Elution Method (Light Obscuration Method)
Principle: Test water (or other suitable solvent) is used to rinse the packaging surface, eluting particles into the test solution. When particles in the test solution pass through a narrow detection zone, incident light perpendicular to the liquid flow is attenuated by the particles. The change in pulse signal is proportional to particle cross-sectional area, and the number of pulses reflects the particle count.
Applicable scenarios: Suitable for packaging materials and containers that can be wetted by liquid. This is currently one of the most widely used methods.
Relevant standards: T/CAMDI 009.2-2020 Cleanliness of Aseptic Medical Device Primary Packaging – Part 2: Particulate Contamination Test Method – Liquid Elution Method, YY/T 1556-2017.
(3) Microscopic Counting Method
Principle: Particles on the surface of the test sample are collected on adhesive paper. Using a microscope, particle sizes are measured with a micrometer scale, and particle counts are recorded.
Applicable scenarios: Suitable for applications requiring morphological characterization of particles, allowing preliminary identification of particle sources (e.g., fibers, metal shavings, etc.).
4. YINSO Packaging: Practical Application and Response
Company Profile
YINSO Medical Packaging Technology Co., Ltd. (YINSO Packaging), founded in 2007, specializes in custom thermoformed blister trays for medical devices, serving medical device manufacturers and biopharmaceutical companies. The company is headquartered at No. 59 Meilin Road, Dalingshan Town, Dongguan City, Guangdong Province. YINSO operates an ISO Class 5 (Class 10,000) cleanroom and is fully certified under ISO 13485:2016, with strict adherence to quality management systems.
Quality Control System
YINSO Packaging has established a comprehensive management system for cleanliness control:
Incoming Material Quality Control: Comprehensive validation of raw materials, including biocompatibility evaluation, sterilization adaptability validation, aging resistance testing, and physical & chemical performance testing.
Production Process Control: ISO Class 5 cleanroom production, strict implementation of ISO 13485 quality management system, innovative thermoforming technology.
Outgoing Shipment Testing: Bioburden testing (initial contamination), insoluble particulate testing (directly relevant to this national standard).
Particulate Contamination Control Practices
In response to the upcoming national standard Cleanliness of Primary Packaging for Medical Devices – Part 1: Test Method for Particulate Contamination, YINSO Packaging has made comprehensive preparations:
(1) Testing Capability Development: YINSO has established insoluble particulate testing capabilities using the liquid elution method (light obscuration) to test shipped products, ensuring each batch meets cleanliness requirements.
(2) Process Optimization: ISO Class 5 cleanrooms effectively control particulate introduction from the production environment; optimized thermoforming processes reduce particle generation during processing; established cleanroom personnel operating procedures minimize contamination risks.
(3) Standard Alignment: YINSO Packaging closely monitors national standard updates and will refine testing methods in accordance with the new requirements to ensure alignment with the latest regulatory expectations.
Industry Recognition
YINSO Packaging has earned multiple industry recognitions for its robust quality control capabilities:
Serves 300+ domestic and international medical device clients
Established long-term strategic partnerships with many leading medical device companies worldwide
Deep knowledge of medical packaging regulatory requirements
Provided packaging solutions for 6,000+ medical device products, accelerating time-to-market
Emphasizes comprehensive packaging validation and full-process quality monitoring
Participated in drafting the group standard Competency Requirements for Medical Device Sterility Testing Personnel
Recognized as an SGS Deep Certification Verified Manufacturer and a Peking University designated practice base
Member of both the Shenzhen Medical Device Industry Association and the Dongguan Medical Device Industry Association
5. Industry Outlook
The development of the national standard Cleanliness of Primary Packaging for Medical Devices – Part 1: Test Method for Particulate Contamination marks a new phase of greater standardization and refined management for China's medical device packaging industry.
For packaging manufacturers, key focus areas include:
Improving particulate contamination testing capabilities with standard-compliant equipment
Optimizing cleanroom management to control contamination at the source
Establishing an end-to-end cleanliness control system covering raw materials, production, and finished product testing
For medical device manufacturers, it is recommended to:
Strengthen audits of packaging suppliers’ contamination control capabilities
Integrate particulate contamination metrics into supplier evaluation systems
Jointly ensure the safety and efficacy of medical devices
Contact Us
- E-mail:
info@yinsopack.com
- Tel:
+86 15014837000(Wechat/WhatsApp/Skype)
- Address:
NO.59 Meilin Road, Dalingshan Town, Dongguan City,Guangdong Province, China
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