Controlled environment
ISO 8 classification provides a defined cleanroom environment for suitable medical and hygienic applications.
Cleanroom INJECTION MOLDING
ISO 8 Cleanroom Injection Molding
Controlled injection molding for medical and hygienic applications, in two ISO 8 clean rooms operating within Rimoni’s ISO 13485 medical manufacturing system.
2 × ISO 8Clean rooms in Israel
ISO 13485Medical quality system
Modi’incleanroom inside the central manufacturing site
Kiryat Shmonacleanroom inside the northern manufacturing site
CONTROLLED FROM MOLDING ONWARD
A clean environment matters most when it stays connected to the manufacturing process.
Some components cannot be treated like ordinary molded parts. When cleanliness, medical quality requirements or sensitive product surfaces matter, the molding environment becomes part of the manufacturing specification.
Rimoni’s two ISO 8 clean rooms sit inside manufacturing sites that also support engineering, tooling, injection molding and assembly, keeping responsibility connected as the product moves into serial production.
Medical quality system
cleanroom molding operates as part of Rimoni’s ISO 13485 medical manufacturing system.
Two manufacturing locations
cleanroom capability is available in Modi’in and Kiryat Shmona.
Connected manufacturing
Engineering, tooling, molding and assembly can remain within one manufacturing organization.
cleanroom IN PRACTICE
Controlled manufacturing should be visible, not only described.
Use this space for authentic images of cleanroom molding, operators, machines, controlled handling or downstream cleanroom operations.
ISO 8 cleanroom CAPABILITY
cleanroom molding is a manufacturing requirement, not a decorative add-on.
The required environment should be defined around the product, its surfaces, its downstream use and the applicable quality requirements.
ISO 8Two clean rooms classified ISO 8, formerly known as Class 100,000.
Filtered environmentAir is filtered and exchanged continuously as part of the controlled cleanroom environment.
Controlled accessGowning and airlock entry are part of the operating discipline of the cleanroom.
Integrated manufacturingThe clean rooms sit inside plants that also support tooling, molding and assembly capabilities.
cleanroom PROFILE
The facts a project team needs to qualify the manufacturing environment.
These are the cleanroom details currently published by Rimoni. Product-specific validation and controls are defined according to project requirements.
- Classification
- ISO 8 Class 100,000
- Number of clean rooms
- 2
- Locations
- Modi’in and Kiryat Shmona
- Medical quality system
- ISO 13485
- Typical applications
- Medical-device housings, fluid-path components and hygienic parts where ISO 8 is appropriate
- Manufacturing continuity
- Engineering, tooling, molding and assembly within one manufacturing organization
CONNECTED CAPABILITIES
cleanroom molding works best when the surrounding manufacturing decisions stay connected.
The value is in keeping product engineering, tooling, molding and downstream operations aligned with the cleanroom requirement instead of treating the cleanroom as an isolated step.
Engineering & DFMProduct engineering and DFM that reduce tooling risk, optimize materials and prepare designs for reliable serial production.
Molds ManufacturingIn-house design and manufacturing of precision injection molds for complex, high-volume and long-term production programs.
Injection MoldingCleanroom molding sits inside Rimoni’s broader injection-molding platform, allowing process and tooling knowledge to stay within one manufacturing organization.
Assembly & AutomationWhere the project requires it, molding can continue into controlled assembly and downstream operations without breaking the manufacturing chain.
INDUSTRIES
Controlled molding starts with the product requirement, not with the room itself.
Medical and hygienic products are the clearest fit today. Other sensitive applications should be qualified according to their actual environmental and quality requirements.
KNOWLEDGE CENTER
Cleanroom decisions belong early in product and manufacturing planning.
Related articles can expand on medical manufacturing, injection molding, DFM, validation and the transition from development into controlled serial production.
QUALITY & CONTROLLED MANUFACTURING
The cleanroom is one part of the quality system around the product.
Rimoni’s medical manufacturing operates under ISO 13485, with cleanroom classification, process discipline and project-specific controls working together around the production requirement.
Quality & CertificationsISO 13485Medical quality management system
ISO 8Defined cleanroom classification
Process disciplineControlled entry and operating practices
Project requirementsControls and validation defined according to the product
cleanroom MANUFACTURING INSIDE RIMONI
The cleanroom is connected to the people who design the product, build the mold and run serial production.
Rimoni combines engineering, in-house tooling, injection molding, cleanroom production, assembly and automation. For regulated and sensitive programs, that continuity reduces unnecessary transfers and keeps manufacturing responsibility in one organization.
FAQ
Questions that often come before a cleanroom molding project starts.
What cleanroom classification does Rimoni operate?
Rimoni operates two ISO 8 clean rooms, formerly referred to as Class 100,000, in Modi’in and Kiryat Shmona.
Is cleanroom molding part of Rimoni’s ISO 13485 medical manufacturing system?
Yes. Rimoni’s medical manufacturing operates under an ISO 13485 quality system and includes injection molding in two ISO 8 clean rooms.
Can tooling, cleanroom molding and assembly stay within one manufacturing organization?
Yes. Engineering, tooling, injection molding and assembly capabilities are integrated within Rimoni, reducing handovers as a program moves into serial production.
Is ISO 8 automatically the right classification for every product?
No. The required manufacturing environment should be defined according to the product and project requirements. Rimoni’s current cleanroom molding capability is ISO 8.
LET’S TALK
Does your product require controlled cleanroom molding?
Send the drawings, material, volumes and cleanliness or medical requirements. We can review whether the current ISO 8 capability fits the project and how tooling, molding and downstream operations should connect.