1. High-Standard Clean Environment
NEST has established a high-standard clean manufacturing system covering life science consumables and medical device pharmaceutical packaging fields. The current cleanroom facilities include:
Class 100,000 cleanroom: 10,600 m²
Class 10,000 cleanroom: 3,600 m²
Injection pen controlled workshop: 2,300 m²
Prefillable syringe forming controlled workshop: 850 m²
From raw material intake to finished product release, the entire process is strictly controlled under validated conditions.
2. End-to-End Quality System
NEST has established a comprehensive quality management system covering R&D, procurement, production, inspection, sterilization, and delivery. The Quality Center is supported by 71 professional quality management personnel.
Key Testing Equipment:
Malvern Spraytec (UK) spray particle size analyzer
Proveris SprayVIEW (USA) spray pattern analysis system
ZwickRoell (Germany) universal testing machine
Dedicated pharmaceutical packaging testing equipment
3. Global Certifications
International Quality Systems:
ISO 9001, ISO 13485, ISO 14001, ISO 45001, ISO 14644
Global Market Approvals:
EU MDR certification, CE marking
MDSAP certification
FDA DMF filing, FDA 510(k) registration
IVDR-related registrations and approvals
Class II medical device registration certificates and manufacturing licenses
Pharmaceutical packaging material registration and filing approvals
4. Data Validation System
Cell Culture Product Validation:
Cell adhesion, cell proliferation, sterility, endotoxin, and cytotoxicity testing
Liquid Handling Product Validation:
Pipetting accuracy, sealing performance, leakage testing, and centrifugation performance
Pharmaceutical Packaging Validation:
Biocompatibility, drug compatibility, extractables & leachables, stability, and packaging integrity testing
NEST also continuously conducts third-party testing and benchmarking against leading global competitors to ensure that product advantages are supported by robust and reliable data.
