For medical devices, optical components and high-end precision electronics, even tiny dust particles can trigger product failure, regulatory non-compliance or cosmetic defects. That’s why JBRplas built a purpose-built, independent ISO 8 (Class 100,000) clean room injection molding facility in Shenzhen, fully certified to ISO 13485 for medical manufacturing.
Strict Clean Room Standard & Full Environment Control
Our workshop applies HEPA filtration and positive pressure to block external contaminants, with stable temperature & humidity strictly controlled per ISO 14644-1 standards. Every shift records particle counts, temperature and humidity for full lot traceability.
We enforce complete personnel gowning protocols, dedicated cleanroom-only machines and isolated material handling systems to eliminate cross-contamination from regular production areas.
Full-Set Dedicated Clean Room Equipment
The clean room runs exclusive servo injection presses (60T–250T), automated robot part removal, sealed raw material storage and in-house packaging stations. All tools, molds and storage areas are temperature & humidity regulated separately from standard workshops.
Two Core Application Fields
1. Medical Device Molding (ISO 13485 Certified)
We produce diagnostic cartridges, surgical handles, respiratory parts, centrifuge tubes and hearing aid shells. Every batch comes with a full traceability document package: lot traveler, material certificates, FAI reports and dimensional inspection records, supporting FDA 510(k) and CE marking submissions.
2. Precision Electronics & Optical Components
Our ESD-controlled clean room is ideal for lenses, sensor housings, fine-pitch connectors and semiconductor test sockets. Anti-static flooring, ionizing air blowers and ESD-safe packaging prevent static damage to delicate micro-components.
Certified Medical-Grade Materials Available
We stock full compliance medical resins including PP, ABS, PC, PEEK, TPE with USP Class VI & ISO 10993 certifications, fully traceable from raw resin to finished goods.
End-to-End Quality Assurance
From pre-production first article inspection to post-molding CMM dimensional verification, 100% visual inspection and retained environmental monitoring logs, we lock in zero particle contamination risk for your high-spec parts.
If your plastic parts touch human tissue, require dust-free optical surfaces or demand strict medical regulatory compliance, our ISO 8 clean room molding service is your reliable manufacturing solution.
